Patent Application
20230248215
This disclosure relates generally to medical devices and aspects thereof. More particularly, at least some embodiments of this disclosure relate to intruding/protruding features, e.g., corrugated features, of medical devices that may be used in various applications, e.g., endoscopic procedures, etc.
Features of medical devices used during endoscopic procedures, e.g., tubes, shafts, articulation joints, etc., generally require a specific set of properties that allow the features to function as intended, and to efficiently navigate towards the target anatomy. As a result, the aforementioned medical device features may require composite structures formed of a plurality of layers of different materials, e.g., an inner coil/tube, a surrounding layer of braiding, an outer layer, etc., as a single material generally does not encompass all of the individual properties, e.g., hoop strength, flexibility, variable flexibility, torquability, and tensile/compression properties, the medical device features may need to possess. However, manufacturing composite structures may be both costly and complex.
The present disclosure includes, for example, a medical device comprising a shaft, wherein the shaft has a corrugated body, and wherein the corrugated body includes a plurality of hoops extending around a circumference of the shaft, a plurality of indentations, wherein the plurality of indentations extend around a portion of the circumference of the shaft and define a reduced-diameter portion of the shaft relative to a diameter of the plurality of hoops, and wherein each of the plurality of hoops is spaced apart from an adjacent hoop of the plurality of hoops by at least one of the plurality of indentations, and a plurality of nodes, wherein each node extends between and connects adjacent hoops of the plurality of hoops, and wherein each of the plurality of nodes is radially offset relative to adjacent nodes along a longitudinal axis of the shaft.
In at least one example, at least some of the plurality of indentations are offset from adjacent indentations by approximately 90°. Adjacent nodes of the plurality of nodes spiral from a first end of the shaft to a second end of the shaft such that adjacent nodes are offset from each other by approximately 5° to approximately 85°. In another example, adjacent nodes are offset from each other by approximately 5°. In another example, each node of the plurality of nodes is orthogonal to the adjacent hoops of the plurality of hoops that each node connects.
According to some aspects herein, each of the plurality of indentations span less than 50% of the circumference of the shaft, and wherein adjacent hoops of the plurality of hoops are separated by a pair of indentations and are connected to one another by a pair of nodes. In some aspects, each of the plurality of indentations are V-shaped radially inwards. In some aspects, each pair of indentations are offset from an adjacent pair of indentations by approximately 90°. In some aspects, the corrugated body further includes at least a first set of openings aligned along a first plane and a second set of openings aligned along a second plane, wherein the first set of openings and the second set of openings are each configured to receive a steering wire. In some aspects, the corrugated body is configured to articulate along two planes, in four different directions. In some aspects, the corrugated body is configured to articulate along two planes independently or simultaneously.
According to some aspects herein, the medical device further comprises a first end including a first connective portion and a second end including a second connective portion. In some aspects, the shaft is an articulation joint configured to be connected to an end effector. In some aspects, a pitch of each of the plurality of indentations is perpendicular relative to a longitudinal axis of the shaft. In some aspects, the corrugated body comprises a thermoplastic resin.
The present disclosure also includes a medical device comprising a corrugated shaft including a plurality of hoops extending around a circumference of the shaft, wherein each of the plurality of hoops is longitudinally offset from one another along a length of the shaft, a plurality of indentations, wherein adjacent hoops of the plurality of hoops are spaced apart from one another by a pair of indentations, wherein each of the plurality of indentations spans less than 180° around a circumference of the shaft, wherein a first indentation of a pair of indentations is separated from a second indentation of the pair of indentations by at least one node extending between and connecting adjacent hoops of the plurality of hoops, and wherein each pair of indentations is radially offset from an adjacent pair of indentations by approximately 90°. The corrugated body may further include a first set of openings aligned along a first plane and a second set of openings aligned along a second plane, wherein the first set of openings and the second set of openings are each configured to receive a steering wire. Each of the plurality of indentations may span greater than 160° but less than 180° around the circumference of the shaft. The corrugated shaft may further include a lumen and a wall surrounding the lumen, wherein a thickness of the wall is about 5 to about 30 thou.
The present disclosure also includes a medical device comprising a shaft, wherein the shaft includes a corrugated body including a plurality of hoops, a plurality of indentations, wherein each of the plurality of hoops is separated from adjacent hoops of the plurality of hoops along a length of the shaft by at least one of the plurality of indentations, and a plurality of nodes, wherein each node extends between and connects adjacent hoops of the plurality of hoops, wherein each of the indentations extends around a portion of the circumference of the shaft, wherein each of the plurality of nodes extends orthogonal to adjacent hoops of the plurality of hoops, and wherein each of the plurality of indentations is radially offset relative to adjacent indentations along the length of the shaft by approximately 90°, and adjacent nodes of the plurality of nodes spiral from a first end of the shaft to a second end of the shaft such that adjacent nodes of the plurality of nodes are radially offset from each other by approximately 5° to approximately 85° along the length of the shaft.
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate various exemplary embodiments and together with the description, serve to explain the principles of the disclosed embodiments.
Reference will now be made in detail to aspects of the disclosure, examples of which are illustrated in the accompanying drawings. Wherever possible, the same or similar reference numbers will be used through the drawings to refer to the same or like parts. The term “distal” refers to a portion farthest away from a user when introducing a device into a subject (e.g., a patient). By contrast, the term “proximal” refers to a portion closest to the user when placing the device into the subject.
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 ±10% in a stated value or characteristic.
As used herein, the term “corrugated” refers generally to a pattern of intruding and protruding features, regardless of the relative orientation of the intruding and protruding features. For example, corrugated features may or may not be parallel with one another.
Embodiments of the disclosure may solve one or more of the limitations in the art. The scope of the disclosure, however, is defined by the attached claims and not the ability to solve a specific problem. The disclosure, in certain embodiments, is drawn to medical devices including at least one corrugated feature. The medical device is not particularly limited and may be, as an example, any scope (e.g., bronchoscope, duodenoscope, endoscope, colonoscope, ureteroscope, etc.), tubing, catheter, tool, instrument, or the like, having at least one insertable, corrugated feature that extends distally from a first end towards a second end of the device.
The corrugated feature may be any suitable flexible aspect of a medical device, e.g., a shaft, insertion tube, umbilicus tube, articulation joint, etc. In some examples, the corrugated feature may include at least one lumen for receiving any number of additional devices, e.g., scopes, tools, instruments, cables, fluids, or the like. The corrugated feature may be of any suitable biocompatible material that may be corrugated, and also appropriate for the intended use/function of said feature. For example, the corrugated feature may be formed of any suitable thermoplastic material, such as nylons, polyesters, fluoropolymers, polyolefins, etc.
Dimensional characteristics of the corrugated feature may vary depending on the instrument with which they are intended for use. For example, the corrugated feature may have any suitable outer diameter that may be appropriate for the feature's intended purpose. Likewise, the corrugated feature may have any suitable inner diameter, i.e., the diameter defining the lumen of the feature, that may be appropriate for the intended usage of the lumen. The outer diameter of a corrugated feature intended for insertion into larger body lumens may be larger than the outer diameter of a corrugated feature intended for insertion into narrower body lumens. Likewise, the inner diameter may depend, at least in part, on the size of the outer lumen and/or the size of the tools that must be received within the corrugated feature in order to perform a procedure. For example, the outer diameter and inner diameter of a catheter may be smaller, relative to the diameters of an umbilicus tube.
The wall thickness of the corrugated feature, i.e., the difference between the outer diameter (the diameter of the catheter) and the inner diameter (the diameter of the lumen) in a given location on the catheter, may range from about 5 thou to about 30 thou (i.e., 1/1000 of an inch). Wall thickness, e.g., ‘t’ as shown in
The shape or contour of the corrugation, i.e., the alternating pattern of peaks and indentations, may define the various characteristics of the corrugated feature. For example, the patterning of the corrugation and the arrangement of indentations along an exterior surface of the corrugation may define the torquability of the corrugated feature. The patterning of the corrugation may include the wrapping/spiraling angle (relative to a plane perpendicular to a longitudinal axis of the feature) of a pitch that goes around the feature, down the line. Other features, such as the ratio between the width of the each of the peaks and the width of each of the indentations may also help define flexibility, as well as crushing resistance, i.e., the resistance to radial forces acting on the catheter. The corrugation height, i.e., the height of the top of the peaks from a plane extending between the bottoms of adjacent indentations, e.g., ‘h’ as shown in
In some examples, each of the indentations of the corrugation may be defined by two different angles, i.e., a front angle and a back angle relative to a plane bisecting across the low point of each of the indentations in a direction that is perpendicular to a longitudinal axis of the corrugated feature. The front angle may be the angle that is distal to the aforementioned plane, and the back angle may be the angle that is proximal to the aforementioned plane. It is noted that the front and back angles may also help define the degree of flexibility of the corrugated feature. Thus, flex may be increased for a given wall thickness by adjusting the front and back angles and the ratio between the width of the peaks and indentations, accordingly. Exemplary corrugation patterns are discussed further below when referring to
Corrugated features may be formed in any suitable manner. In some examples, any suitable thermoplastic, e.g., an extrusion blow molding grade thermoplastic resin, may undergo an extrusion process, thereby forming an extrudate. The extrudate may then be continuously molded into a desired corrugated shape, thereby forming a corrugated feature. The corrugated feature may be further post-processed, e.g., for the inclusion of holes, connective markings, wires, microstructures, outer protective layers, etc., to prepare the feature for its intended use. It is noted that different portions of the extrudate may be subjected to a different mold, thereby forming a plurality of different corrugations along a single extrudate. The number of different corrugations is not particularly limited. The resulting corrugated feature may thus include a number of different corrugation profiles, each of which encompass different characteristics that may be suitable for their respective functions.
In view of the above, a corrugated feature may encompass a plurality of various properties, without having to include multiple layers of various materials. Moreover, the extrusion and molding process for forming a corrugated feature may be less costly and/or simpler than manufacturing a composite structure for each individual medical device feature.
Exemplary corrugated profiles, as shown in the figures, are now further discussed.
Shaft 20, as shown in
Unlike shaft 10, shaft 20 may have a helical corrugation profile, i.e., a number of adjacent indentations, separated by some gap, spiraling down the longitudinal axis of shaft 20 at some angle, dictated by the aforementioned gap. Thus, hoops 21 may define a single helix spiraling down the line of shaft 20, so that hoops 21 are at a specific pitch, as indicated by line A shown in
Shaft 30, as shown in
Like shaft 20, shaft 30 also has a helical corrugation profile. However, hoops 31 define two sets of helices, i.e., a double helix, spiraling down the line of shaft 30. Hoops 31 are at a specific pitch, as indicated by line C shown in
Shaft 40, as shown in
Unlike indentations 14 of shaft 10, indentations 44 only extend around a partial circumference of shaft 40, thereby defining a plurality of nodes 45, i.e., the non-recessed portions interrupting indentations 44 that connect adjacent hoops 41. Nodes 45 may spiral around shaft 40 along a length of shaft 40. As shown, nodes 45 may be linear and orthogonal to hoops 41. However, it is noted that, in other examples, nodes 45 may be non-linear, and may be transverse (non-orthogonal) to hoops 41. While
Adjacent nodes 45 (nodes 45 in adjacent indentations 44) may be offset from each other by approximately 90°. Furthermore, adjacent nodes 45 may spiral at approximately 5° to approximately 85°, e.g., approximately 5°, relative to one another, as shown in shaft 40. Such an arrangement of nodes 45, spiraling along a length of shaft 40, may impart torsional rigidity, without imparting any significant reduction in kink. Furthermore, the above-discussed arrangement of indentations 44 and nodes 45 may improve hoop strength, tensile strength, and compressive strength, relative to corrugated shafts without nodes, due to the resulting flex of shaft 40.
It is further noted that indentations 44 may be elliptical-shaped indentations. Thus, the corrugation depth may change, while traversing around the part radially. This may be intended so that shaft 40 may separate from a mold, while imparting desired radial properties, e.g., flexibility, torquability, tensile, and compression characteristics. Moreover, such radial properties may vary along at different locations along the length of shaft 40.
However, unlike shaft 10, each corrugated segment of articulation joint 50 includes a pair of V-shaped indentations 54 between adjacent hoops 51. It is noted that the V-shaped indentations may vary, as the indentations may be a sharper V or a more rounded V/U shape. The shape of indentations 54 and the wall angles, e.g., the front angles and back angles as defined above, may depend on a manufacturing process of articulation joint 50. A V-shaped indentation may have more material to extend during flexing, but a U-shaped indentation may have less resistance to compress during flexing. Moreover, as shown, the front angle and back angle, as defined above, may be equal and may vary, for example, from about 0 to about 30° from perpendicular to the longitudinal axis of articulation joint 50. In some examples, the front and back angles may vary at each indentation 54, such as a distal indentation being near vertical on the distal face (i.e., a first edge 553), a proximal indentation being near vertical on the proximal face (i.e., a second edge 557), and intermediary indentations 54 having symmetric or asymmetric cross-sections.
Indentations 54 do not extend around an entire circumference (i.e., 360°) of articulation joint 50. Rather, as shown in
The benefits of a corrugated articulation joint, e.g., articulation joint 50, include but are not limited to, being manufactured in one piece, and potentially the same piece as an insertion tube, not requiring expensive injection molds, not relying on thin breakable section of molded plastic that flex during articulation, and not being subjected to over-articulation as a result of individual segments shifting and overlapping.
Articulation joint 50 further includes a plurality of openings—a first set of openings 531, a second set of openings 532, a third set of openings 533 (shown in
Articulation joint 50 also includes a first end 57, which includes a first connective portion 571 and a second connective portion 572, and a second end 59, including a third connective portion 591. Connective portions 571, 572, and 591 are not particularly limited, and may be any suitable feature configured to engage an adjacent medical device aspect or feature, e.g., a shaft, end-effector, etc. For example, more or fewer connective portions may be included at each end, and the connectors may take different forms, sizes, and/or shapes depending on the connection mechanism required to affix articulation join 50 to a cooperating feature or medical device aspect. Other exemplary joints may include additional or less connective portions, or may be without such connection portions altogether.
In an alternate embodiment, alternate indentations may be approximately 0° from one another resulting in an articulation joint that may only bend in a single plane. Such an alternate embodiment, i.e., articulation joint 50′, is illustrated in
Articulation joint 50′ is similar to articulation joint 50 in many respects, and like reference numerals refer to like parts. As noted above, articulation joint 50′ include a plurality of indentations 54′, where each pair of adjacent indentations 54′ are approximately 0° relative to one another. Thus, articulation joint 50′ may compress and extend along only along a single plane. In view of this, articulation joint 50′ may only include two sets of openings, a set of openings 531′ and another set of openings (not shown), along each of first edge 553′ and second edge 557′ of indentations 54′. Openings 531′ and the other set of openings are configured to receive a respective steering wire, thereby allowing for articulation/steering along the single plane, as discussed above, and two directions (e.g., up and down, or left and right, depending on the orientation of articulation joint 50′).
It will be apparent to those skilled in the art that various modifications and variations can be made to the disclosed device without departing from the scope of the disclosure. For example, although embodiments of the disclosure focus mainly on articulation in two planes, as discussed above, embodiments may be modified to articulate in a single plane, or in more than two planes. Accordingly, embodiments of the disclosure are intended to articulate in at least one plane. Other embodiments of the disclosure will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims.
This application claims the benefit of priority from U.S. Provisional Application No. 63/267,700, filed on Feb. 8, 2022, which is incorporated by reference herein in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 63267700 | Feb 2022 | US |
