Patent ID: 12226591

DETAILED DESCRIPTION

As used herein, the terms “about” or “approximately” for any numerical values or ranges indicate a suitable dimensional tolerance that allows the part or collection of components to function for its intended purpose as described herein. More specifically, “about” or “approximately” may refer to the range of values ±20% of the recited value, e.g. “about 90%” may refer to the range of values from 71% to 99%.

When used herein, the terms “tubular” and “tube” are to be construed broadly and are not limited to a structure that is a right cylinder or strictly circumferential in cross-section or of a uniform cross-section throughout its length. For example, the tubular structure or system is generally illustrated as a substantially right cylindrical structure. However, the tubular system may have a tapered or curved outer surface without departing from the scope of the present invention.

The figures illustrate various example catheters100,200,300and catheter portions100a-d,300a-dhaving features that are combinable with each other to result in numerous catheter designs. A resulting catheter can vary in design along its length to achieve desired stiffness and/or trackability variations as understood by a person skilled in the pertinent art according to the teachings herein.

FIG.1is an illustration of an exterior surface of a portion of an example catheter100having protrusions (pimples)104extending from an otherwise smooth surface106. The protrusions104are arranged and shaped to reduce friction between the exterior surface of the catheter100and vascular anatomy or an inner lumen of another catheter in contact with the exterior surface. Friction is reduced by reducing area of contact to the exterior surface to peaks of the protrusions104; the smooth surface106is inhibited from contacting vascular anatomy or lumen of another catheter due to height of the protrusions104. Reduced friction can result in reduced track forces and/or better ease of trackability.

Dimensions of the protrusions104can be described in relation to pimple diameter (D1), diameter of a circular base of a hemispherical protrusion, and pimple depth (H1), height of the protrusion104measured radially from the smooth surface106. Spacing of the protrusions104in a regular pattern can be described in relation to pimple pitch (P1), distance between a center point of a base of the protrusion104. Pimple diameter (D1), pimple pitch (P1), and pimple depth (H1) can be altered to achieve desired trackability of the exterior surface of the catheter100. Additionally, or alternatively pimple diameter (D1), pimple pitch (P1), and pimple depth (H1) can be altered to achieve desired flexibility and/or flexibility gradient of the catheter100, where typically the catheter is preferably stiffer near it's proximal end and becomes gradually more flexible toward its distal end.

FIGS.2A through2Dare cross-sectional illustrations as indicated inFIG.1of example catheter constructions. Each cross-sectional illustration represents a respective catheter portion100a-100d. Features of each cross-section100a-100dcan be combined to form various cross-sectional configurations as understood by a person skilled in the pertinent art according to the teachings herein.

FIG.2Aillustrates a catheter portion100ahaving an inner liner115forming a smooth inner surface and an outer layer182shaped to form protrusions104. The catheter portion100ais illustrated including a middle braid layer102and a portion of a metallic tubular reinforcing layer110providing stability to the catheter. The metallic tubular reinforcing layer110can be configured similarly to the metallic tubular reinforcing layer210of an example catheter200illustrated inFIG.3and/or otherwise configured such as described in U.S. patent application Ser. No. 17/1147,725, filed Dec. 8, 2020, published as U.S. Patent Application Publication No. 2022/0176071 A1 dated Jun. 9, 2022. For instance, the cross-section of the metallic tubular reinforcing layer110illustrated inFIG.2Acan coincide with a ribbon cut segment240of the catheter200illustrated inFIG.3.

The outer layer182can be constructed to retain the shape of the protrusions104during manipulation of the catheter. Alternatively, the outer layer182can be constructed so that it breaks or opens to release fluid in pimple cavities118under the protrusions104when the protrusions are pressed against by vasculature tissue and/or an interior lumen of another catheter, for example in a constricting or spasming vessel. Configured as such, the protrusions can burst as needed to facilitate tracking of the catheter portion100a. In some examples, pimple cavities118can include a drug such as nitrous oxide to inhibit blood vessel spasms. Additionally, or alternatively, pimple cavities118can include a lubricant such as oil or heparin to cause the surface of the catheter portion100ato be lubricious. Pimple cavities118having a lubricant or vasal dilator can facilitate insertion of the catheter portion100ainto a blood vessel having a smaller inner diameter than the outer diameter of the catheter portion100a. Pressure of the blood vessel against the exterior surface of the catheter portion100acan cause the outer layer182to burst, releasing lubricant and/or vasal dilator from pimple cavities118to cause the catheter portion100ato slide more easily and/or increase inner diameter of the blood vessel.

FIG.2Billustrates a catheter portion100bhaving deformations each having a protrusion104on an exterior surface of the catheter portion100band an opposite indentation122on an interior surface of the catheter portion100b. The catheter portion100bincludes an inner liner115, a middle braid layer102and an outer layer182shaped collectively to form the deformations. The indentations122on the interior surface of the catheter portion100bcan result in lower track forces for devices being navigated through the lumen of the catheter portion100bby reducing contact area between the interior surface of the catheter portion100band such devices. The indentations122on the interior surface of the catheter portion100bcan further result in the ability to aspirate or flush higher volumes of fluid through the lumen of the catheter portion100bmore efficiently by increase the overall internal volume of the catheter compared to a catheter having a similar inner diameter. This may be particularly beneficial when devices are placed in the lumen of the catheter portion100b.

FIG.2Cillustrates a catheter portion100chaving deformations each having a protrusion104on an exterior surface of the catheter portion100cand an opposite indentation122on an interior surface of the catheter portion100c. The catheter portion100cincludes an inner liner115, a middle braid layer102, and an outer layer182shaped collectively to form the deformations similar to the catheter portion100billustrated inFIG.2B. The catheter portion100cadditionally includes a metallic tubular reinforcing layer110having openings through which the deformations extend. The openings can be circular. The deformations can have a circular base with a circumference or diameter about equal to a circumference or diameter of the openings through which they respectively extend. For instance, the openings can be configured similarly to holes220in the metallic tubular reinforcing layer210of the catheter200illustrated inFIG.3. Protrusions104can have a pimple diameter (D) about equal to a diameter of the hole through which each protrusion respectively extends.

FIG.2Dillustrates a catheter portion100dhaving deformations each having a protrusion104on an exterior surface of the catheter portion100dand an opposite indentation122on an interior surface of the catheter portion100d. The catheter portion100dincludes an inner liner115, a middle braid layer102, a metallic tubular reinforcing layer110, and an outer layer182shaped collectively to form the deformations.

FIG.3is an illustration of an example catheter200including a metallic tubular reinforcing layer210. The construction of the catheter200and various configurations of the metallic tubular reinforcing layer210are described in greater detail in U.S. patent application Ser. No. 17/1147,725, filed Dec. 8, 2020, published as U.S. Patent Application Publication No. 2022/0176071 A1 dated Jun. 9, 2022. The metallic tubular reinforcing layer210is optional, as current typical catheter designs achieve stiffness by adding polymer layers in regions where increased stiffness is desired (typically increasing approaching a proximal end212of the catheter200). The metallic tubular reinforcing layer210can be a replacement for the proximal portion of many current catheter shaft designs, which are plastic. The illustrated catheter200can be modified to include additional layers as understood by a person skilled in the pertinent art.

An innermost layer of the catheter200can include an inner liner215of PTFE or other low friction material to facilitate the passage of ancillary devices through the catheter lumen. Disposed around the inner liner215can be a braided wire support structure220with braids or windings involving wires or bands of other materials. The metallic tubular reinforcing layer210can be disposed over the braid220. A polymer jacket282can be disposed over the braid220and metallic tubular reinforcing layer210. An atraumatic polymer tip230can be disposed at a distal end214of the catheter200. A radiopaque marker or band216(such as platinum) can be disposed adjacent to the tip230to mark the terminal end of the catheter200during a procedure.

The metallic tubular reinforcing layer210can extend from the proximal end212of the catheter200and terminate at a distal end224at some point proximal of the distal end214of the catheter200, running at least a portion of the length of the catheter200. The metallic tubular reinforcing layer210can be cut from a single continuous Nitinol hypotube or other suitable material.

Stiffness transitions along the axial length of the catheter200can be affected by cut patterns in the metallic tubular reinforcing layer210and/or positioning of protrusions104and/or indentations122along the catheter200. The catheter200can include protrusions104, indentations122, and combinations thereof to achieve cross-sections similar to those illustrated inFIGS.2A through2D. Hemispherical or other atraumatic shaped deformations can be positioned to introduce a flexibility gradient in the metallic tubular reinforcing layer with increasing flexibility of the metallic tubular reinforcing layer210in a distal direction as defined by orientation of the catheter200during treatment. Pimple diameter (D), pimple pitch (P), and pimple depth (H) can be altered to achieve desired stiffness and stiffness gradient of the catheter200. The cut pattern of the metallic tubular reinforcing layer210can define sidewall openings (e.g. holes220, space between ribbon segment240) through which some or all of the remaining layers280,202,215of the catheter200can extend to form protrusions104and/or indentations122. Additionally, or alternatively, the metallic tubular reinforcing layer210can be shaped to form protrusions104and/or indentations122.

FIGS.4A and4Bare illustrations of smooth regions126on the exterior surface of the example catheter100. The exterior surface includes a first region124having protrusions104spaced in a pattern and a second region lacking protrusions104, being substantially smooth, and having an area sufficiently large to interrupt the pattern of the portion of the deformations in the first region124. When applied to vascular tissue, the smooth second region126can result in a higher coefficient of friction compared to the first region124having protrusions104. The protrusions104can be spaced in the first region124in a regular pattern as illustrated and/or an irregular pattern.

The smooth regions126can provide higher friction anchor patches to allow the catheter100to anchor in place. When the catheter100is positioned within vasculature and devices or smaller catheters are pushed through the lumen of the catheter100, friction between the anchor patches126and vascular walls can prevent the catheter100from shifting or backing out.

Additionally, or alternatively, the smooth regions126can define controlled bend locations of the catheter100.

FIG.4Bis an isometric view of a catheter portion100ahaving a smooth inner lumen surface.

FIG.5is an illustration of an exterior surface of a portion of an example catheter300having indentations (dimples)304extending into an otherwise smooth surface306. The indentations304are arranged and shaped to reduce friction between the exterior surface of the catheter300and vascular anatomy or an inner lumen of another catheter in contact with the exterior surface. Friction is reduced by reducing area of contact to the smooth surface306, A portion of the indentations304are inhibited from contacting vascular anatomy or lumen of another catheter due to depth of the indentations304. Reduced friction can result in reduced track forces and/or better ease of trackability.

Dimensions of the indentations304can be described in relation to dimple diameter (D2), diameter of a circular base of a hemispherical indentation, and dimple depth (H2), depth of the indentation304measured radially inward from the smooth surface306. Spacing of the indentations304in a regular pattern can be described in relation to dimple pitch (P2), distance between a center point of a base of the indentation304. Dimple diameter (D2), dimple pitch (P2), and dimple depth (H2) can be altered to achieve desired trackability of the exterior surface of the catheter300. Additionally, or alternatively dimple diameter (D2), dimple pitch (P2), and dimple depth (H2) can be altered to achieve desired flexibility and/or flexibility gradient of the catheter300, where typically the catheter is preferably stiffer near it's proximal end and becomes gradually more flexible toward its distal end.

FIGS.6A through6Dare cross-sectional illustrations as indicated inFIG.5of example catheter constructions. Each cross-sectional illustration represents a respective catheter portion300a-300d. Features of each cross-section300a-300dcan be combined to form various cross-sectional configurations. Further, features of each cross-section100a-100dillustrated inFIGS.2A through2Dcan be combined with features of each cross-section inFIGS.6A through6Dto result in various cross-sections as understood by a person skilled in the pertinent art according to the teachings herein.

FIG.6Aillustrates a catheter portion300ahaving an inner liner315forming a smooth inner surface and an outer layer382shaped to form indentations304. The catheter portion300ais illustrated including a middle braid layer302and a portion of a metallic tubular reinforcing layer310providing stability to the catheter. The metallic tubular reinforcing layer310can be configured similarly to the metallic tubular reinforcing layer210of an example catheter200illustrated inFIG.3and/or otherwise configured such as described in U.S. patent application Ser. No. 17/1147,725, filed Dec. 8, 2020, published as U.S. Patent Application Publication No. 2022/0176071 A1 dated Jun. 9, 2022. For instance, the cross-section of the metallic tubular reinforcing layer310illustrated inFIG.6Acan coincide with a ribbon cut segment240of the catheter200illustrated inFIG.3. As illustrated, the indentations304are formed exclusively by the outer layer382while the reinforcing layer310and braid layer302are smooth. The outer layer382therefore has a greater thickness than the other layers310,302,315and the indentations304are inset into the outer layer382.

FIG.6Billustrates a catheter portion300bhaving deformations each having an indentation304on an exterior surface of the catheter portion300band an opposite protrusion322on an interior surface of the catheter portion300b. The catheter portion300bincludes an inner liner315, a middle braid layer302and an outer layer382shaped collectively to form the deformations. The protrusions322on the interior surface of the catheter portion300bcan result in lower track forces for devices being navigated through the lumen of the catheter portion300bby reducing contact area between the interior surface of the catheter portion300band such devices and therefore friction.

FIG.6Cillustrates a catheter portion300chaving deformations each having an indentation304on an exterior surface of the catheter portion300cand an opposite protrusion322on an interior surface of the catheter portion300c. The catheter portion300cincludes an inner liner315, a middle braid layer302, and an outer layer382shaped collectively to form the deformations similar to the catheter portion300billustrated inFIG.6B. The catheter portion300cadditionally includes a metallic tubular reinforcing layer310having openings through which the deformations extend. The openings can be circular. The deformations can have a circular base with a circumference or diameter about equal to a circumference or diameter of the openings through which they respectively extend. For instance, the openings can be configured similarly to holes220in the metallic tubular reinforcing layer210of the catheter200illustrated inFIG.3.

FIG.6Dillustrates a catheter portion600dhaving deformations each having an indentation304on an exterior surface of the catheter portion300dand an opposite protrusion322on an interior surface of the catheter portion300d. The catheter portion300dincludes an inner liner315, a middle braid layer302, a metallic tubular reinforcing layer310, and an outer layer382shaped collectively to form the deformations.

FIG.7Ais an isometric view of a portion of an example catheter portion300aincluding indentations304on the exterior surface and a smooth interior lumen surface315.

FIG.7Bis an isometric view of a portion of an example catheter portion300bincluding indentations 3-4 on the exterior surface and corresponding protrusions322on an interior surface315. The catheter portion300bfurther includes an anchor patch region326configured similarly to anchor patch regions126illustrated inFIGS.4A and4B.

The descriptions contained herein are examples of embodiments of the invention and are not intended to limit the scope of the invention. As described herein, the invention contemplates many variations and modifications of the catheter, including alternative materials, alternative geometries, alternative structures, combinations with compatible structures, etc. For instance, protrusions and indentations drawn herein as hemispherical can have an arbitrary atraumatic shape including dome, ridge, or trough. Methods of treatment using an example catheter and methods of construction of an example catheter are within the scope of the present disclosure. Modifications apparent to those skilled in the pertinent art are intended to be within the scope of the claims which follow.