Catheter with textured surface
Textured catheters with protrusions and indentations address friction and vasospasm issues by reducing contact area and introducing flexibility gradients, improving navigation and reducing procedural delays.
Patent Information
- Application Number
- JP2021198338
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2020-12-08
- Filing Date
- 2021-12-07
- Publication Date
- 2025-11-18
- Estimated Expiration
- 2041-12-07
AI Technical Summary
Catheters experience friction and vasospasm during navigation through vascular anatomy, leading to tracking force issues and potential tissue damage.
Catheters with textured outer and/or luminal surfaces featuring protrusions and/or indentations to reduce friction, optionally filled with lubricants or vasodilators, and configured to rupture for fluid release, combined with a metallic tubular reinforcing layer for flexibility gradients.
Reduces tracking forces and facilitates smoother navigation, preventing tissue damage and vasospasm by minimizing friction and enhancing flexibility.
Smart Images

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Abstract
Description
[Technical Field]
[0001] The present invention relates to medical devices and procedures, and in particular to catheters. [Background technology]
[0002] Catheters serve a wide variety of functions in intravascular medical procedures. Catheters are typically tubes made of medical-grade materials that can be inserted into the body and used to deliver drugs or other devices, perform surgery, remove blockages from blood vessels, and for a variety of other purposes. By varying the materials or adjusting the method of manufacturing the catheter, it is possible to tailor different portions of the catheter for specific uses.
[0003] When navigating through vascular anatomy or through the lumen of another catheter, friction occurs due to contact between the outer surface of the catheter and the vasculature or between the outer surface of the catheter and the lumen of another catheter. The resulting friction determines the amount of tracking force required to move the catheter. Too much friction or tracking force can cause the catheter to snag, damage tissue, or kink the catheter. Additionally, vasospasm can occur when navigating a catheter through the neurovasculature, which can cause procedural delays. Summary of the Invention [Means for solving the problem]
[0004] Examples presented herein generally include catheters having a textured outer body surface with protrusions and / or indentations that can reduce friction between the outer body surface and a vascular anatomy or lumen of another catheter that contacts the outer body surface. The catheter may additionally or alternatively include protrusions and / or indentations on the luminal surface that can reduce friction between the luminal surface and the outer body surface of another catheter or a device within the exemplary catheter. The protrusions and / or indentations may be sized, shaped, positioned, and otherwise configured to affect the catheter's flexibility gradient. The protrusions may be filled with a lubricant or a vasodilator, and the protrusions may be configured to rupture to release fluid when force is applied. For example, the protrusions may rupture in response to force against the protrusions during navigation through a vascular anatomy and / or lumen of another catheter. Some exemplary catheters may include a metallic tubular reinforcing layer that may include openings through which the protrusions and / or indentations extend. Additionally or alternatively, protrusions and / or indentations may be molded into the reinforcing layer.
[0005] An exemplary catheter may include a first tubular surface, a second tubular surface opposite the first tubular surface, and deformations each including an indentation on the first surface and a corresponding protrusion on the second surface opposite the indentation.
[0006] Each indentation and corresponding protrusion of the deformation may each be hemispherical in shape.
[0007] The first surface can be an inner surface of the catheter and the second surface can be an outer surface of the catheter. Alternatively, the first surface is an outer surface of the catheter and the second surface is an inner surface of the catheter. As another alternative, the catheter can be configured such that the outer surface includes both indentations and protrusions and the inner surface includes both protrusions and indentations corresponding to the indentations and protrusions on the outer surface to form the respective deformations.
[0008] The first region of the catheter may include some or all of the deformations spaced apart in a regular pattern. The second region of the catheter may be free of deformations, may be substantially smooth at least on the outer surface of the catheter, and may have an area large enough to interrupt the regular pattern of deformations in the first region. When the outside of the catheter including the first and second regions is applied to vascular tissue, contact between the second region and the vascular tissue may result in a higher coefficient of static friction compared to the coefficient of static friction between the first region and the vascular tissue.
[0009] The catheter may further include an inner liner, a braided wire support structure disposed about the inner liner, and an outer polymeric layer disposed about the braided wire support structure. The catheter may further include a metallic tubular reinforcing layer disposed about the braided wire support structure. The outer polymeric layer may be disposed about the metallic tubular reinforcing layer.
[0010] The deformations may be formed by the inner liner, the braided wire support structure, and the outer polymer layer. The metallic tubular reinforcing layer may have sidewall openings, through which the inner liner, the braided wire support structure, and the outer polymer layer protrude to form at least one of the deformations. Some of the sidewall openings may have a circular shape with an outer periphery. A portion of the deformations protruding through the sidewall opening may have a hemispherical shape with an outer periphery approximately equal to that of the outer periphery of the circular shape of the sidewall opening. A portion of the sidewall opening may have a helical shape that surrounds the catheter.
[0011] Some deformations may be formed by a metallic tubular reinforcing layer.
[0012] The metallic tubular reinforcing layer may be cut from a single continuous hypotube.
[0013] The deformations may be positioned to introduce a flexibility gradient in the metallic tubular reinforcing layer, increasing the flexibility of the metallic tubular reinforcing layer in a distal direction as defined by the orientation of the catheter during a procedure.
[0014] Another exemplary catheter is An inner liner, a braided wire support structure disposed about the inner liner; a metal tubular reinforcing layer disposed around the inner liner; an outer polymeric layer disposed about the metallic tubular reinforcing layer and forming the outer surface of the catheter; and a protrusion extending from the outer surface of the catheter.
[0015] The protrusions may each have a hemispherical shape. The protrusions may be regularly spaced on at least a portion of the outer surface of the catheter. The catheter may have smooth regions without hemispherical protrusions that interrupt the spaced pattern of hemispherical protrusions. The smooth regions may be on the outer surface of the catheter. The smooth regions may provide a higher coefficient of static friction when applied against vascular tissue compared to an outer surface of a catheter having a spaced pattern of hemispherical protrusions that is not interrupted by smooth regions.
[0016] The catheter may include fluid-filled cavities, each beneath one of the protrusions and shaped by the outer polymer layer. Each fluid-filled cavity may be configured to rupture to release fluid from the cavity in response to stress induced in the respective protrusion during an intravascular procedure. The fluid may include an oil and / or a drug. The fluid may include a drug for inhibiting vasospasm, and the fluid-filled cavity may be configured to rupture in response to vasospasm. [Brief explanation of the drawings]
[0017] The above and further aspects of the present invention will be further discussed with reference to the following description in conjunction with the accompanying drawings, in which like numerals indicate like structural elements and features in the various drawings. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the invention. The figures depict one or more implementations of devices of the present invention, by way of example only, and not by way of limitation. [Figure 1] 1 is a diagram of an outer surface of a portion of an exemplary catheter having protrusions in accordance with an aspect of the present invention. [Figure 2A] 2 is a cross-sectional view as shown in FIG. 1 of an exemplary catheter structure according to an embodiment of the present invention. [Figure 2B] 2 is a cross-sectional view as shown in FIG. 1 of an exemplary catheter structure according to an embodiment of the present invention. [Figure 2C] 2 is a cross-sectional view as shown in FIG. 1 of an exemplary catheter structure according to an embodiment of the present invention. [Figure 2D] 2 is a cross-sectional view as shown in FIG. 1 of an exemplary catheter structure according to an embodiment of the present invention. [Figure 3] 1 is a diagram of an exemplary catheter including a metallic tubular reinforcing layer, in accordance with an aspect of the present invention. [Figure 4A] 1 is a diagram of a smooth region of an exemplary catheter, in accordance with aspects of the present invention. [Figure 4B] 1 is a diagram of a smooth region of an exemplary catheter, in accordance with aspects of the present invention. [Figure 5] 1 is a diagram of an outer surface of a portion of an exemplary catheter having indentations, according to an aspect of the present invention. [Figure 6A] 6 is a cross-sectional view as shown in FIG. 5 of an exemplary catheter structure according to an embodiment of the present invention. [Figure 6B] 6 is a cross-sectional view as shown in FIG. 5 of an exemplary catheter structure according to an embodiment of the present invention. [Figure 6C] 6 is a cross-sectional view as shown in FIG. 5 of an exemplary catheter structure according to an embodiment of the present invention. [Figure 6D] 6 is a cross-sectional view as shown in FIG. 5 of an exemplary catheter structure according to an embodiment of the present invention. [Figure 7A] FIG. 1 is an isometric view of a portion of an exemplary catheter including an indentation on an outer surface in accordance with an aspect of the present invention. [Figure 7B] 1 is an isometric view of a portion of an exemplary catheter including an indentation on an outer surface and a corresponding protrusion on an inner surface, in accordance with an aspect of the present invention. DETAILED DESCRIPTION OF THE INVENTION
[0018] As used herein, the term "about" or "approximately" with respect to any numerical value or range of values indicates a suitable dimensional tolerance that enables a portion of a component or a collection of components to function for its intended purpose as described herein. More specifically, "about" or "approximately" may refer to a range of values of ±20% of the recited value; for example, "about 90%" may refer to a range of values of 71% to 99%.
[0019] As used herein, the terms "tubular" and "pipe / tube" are intended to be broadly construed and are not limited to right cylindrical structures, structures that are strictly circular in cross section, or structures that have a uniform cross section along their entire length. For example, tubular structures or tubular systems are generally depicted as substantially right cylindrical structures. However, tubular systems may have tapered or curved outer surfaces without departing from the scope of the present invention.
[0020] The figures illustrate various exemplary catheters 100, 200, 300 and catheter segments 100a-100d, 300a-300d having features that can be combined with one another to produce a multitude of catheter designs. The resulting catheters may vary in design along their length to achieve desired stiffness and / or compliance variations, as will be understood by those skilled in the art following the teachings herein.
[0021] 1 is a diagram of the outer surface of a portion of an exemplary catheter 100 having protrusions 104 extending from an otherwise smooth surface 106. The protrusions 104 are positioned and shaped to reduce friction between the outer surface of the catheter 100 and the vascular anatomy or lumen of another catheter that contacts the outer surface. Friction is reduced by reducing the contact area of the outer surface relative to the apex of the protrusions 104. The smooth surface 106 is prevented from contacting the vascular anatomy or lumen of another catheter due to the height of the protrusions 104. Reduced friction may reduce tracking forces and / or facilitate better trackability.
[0022] The dimensions of the protrusions 104 can be described in terms of the protrusion diameter (D1), the diameter of the circular base of the hemispherical protrusions, and the protrusion depth (H1), the height of the protrusions 104 measured radially from the smooth surface 106. The spacing of the regular pattern of protrusions 104 can be described in terms of the protrusion pitch (P1), the distance between the center points of the bases of the protrusions 104. The protrusion diameter (D1), the protrusion pitch (P1), and the protrusion depth (H1) can be varied to achieve a desired conformability of the outer surface of the catheter 100. Additionally or alternatively, the protrusion diameter (D1), the protrusion pitch (P1), and the protrusion depth (H1) can be varied to achieve a desired flexibility and / or flexibility gradient of the catheter 100, typically with the catheter being stiffer, preferably near the proximal end, and gradually becoming more flexible toward the distal end of the catheter.
[0023] 2A-2D are cross-sectional views of exemplary catheter structures as shown in FIG. 1. Each cross-sectional view represents a respective catheter section 100a-100d. As will be understood by those skilled in the art following the teachings herein, the features of each cross-section 100a-100d can be combined to form a variety of cross-sectional configurations.
[0024] FIG. 2A shows a catheter section 100a having an inner liner 115 forming a smooth inner surface and an outer layer 182 shaped to form protrusions 104. The catheter section 100a is shown to include an intermediate braided layer 102 and a portion of a metallic tubular reinforcing layer 110 that provides stability to the catheter. The metallic tubular reinforcing layer 110 may be configured similarly to the metallic tubular reinforcing layer 210 of the exemplary catheter 200 illustrated in FIG. 3 and / or may be configured otherwise as described in U.S. patent application having attorney docket number 243382.000291, filed concurrently herewith. For example, the cross section of the metallic tubular reinforcing layer 110 illustrated in FIG. 2A may correspond to the ribbon cut segment 240 of the catheter 200 illustrated in FIG. 3.
[0025] The outer layer 182 may be configured to maintain the shape of the protrusions 104 during catheter manipulation. Alternatively, the outer layer 182 may be configured to rupture or open to release fluid within the protrusion cavities 118 beneath the protrusions 104 when the protrusions are pressed against vasculature tissue and / or the lumen of another catheter, for example, in a constricted or spasming blood vessel. Thus, the protrusions may rupture as needed to facilitate tracking of the catheter portion 100a. In some examples, the protrusion cavities 118 may contain a drug, such as nitrous oxide, to prevent vasospasm. Additionally or alternatively, the protrusion cavities 118 may contain a lubricant, such as oil or heparin, to lubricate the surface of the catheter portion 100a. A protrusion cavity 118 containing a lubricant or vasodilator may facilitate insertion of the catheter portion 100a into a blood vessel having an inner diameter smaller than the outer diameter of the catheter portion 100a. Pressure of the blood vessel against the outer surface of the catheter portion 100a may cause the outer layer 182 to rupture, releasing the lubricant and / or vasodilator from the protrusion cavities 118, allowing the catheter portion 100a to slide more easily and / or increase the inner diameter of the blood vessel.
[0026] 2B illustrates a catheter portion 100b having a deformation having a protrusion 104 on the outer surface of the catheter portion 100b and an opposing indentation 122 on the inner surface of the catheter portion 100b. The catheter portion 100b includes an inner liner 115, an intermediate braided layer 102, and an outer layer 182, which are collectively molded to form the deformation. The indentation 122 on the inner surface of the catheter portion 100b reduces the contact area between the inner surface of the catheter portion 100b and a device navigated through the lumen of the catheter portion 100b, thereby providing a lower compliance force for such a device. The indentation 122 on the inner surface of the catheter portion 100b increases the overall internal volume of the catheter, further providing a more efficient ability to aspirate or flush a larger volume of fluid through the lumen of the catheter portion 100b compared to a catheter having a similar inner diameter. This feature can be particularly beneficial when the device is placed within the lumen of catheter portion 100b.
[0027] FIG. 2C illustrates a catheter section 100c having a deformation, each having a protrusion 104 on the outer surface of the catheter section 100c and an opposing indentation 122 on the inner surface of the catheter section 100c. The catheter section 100c includes an inner liner 115, an intermediate braided layer 102, and an outer layer 182, which are collectively molded to form a deformation similar to that of the catheter section 100b illustrated in FIG. 2B. The catheter section 100c further includes a metallic tubular reinforcing layer 110 having an opening through which the deformation extends. The opening may be circular. The deformation may have a circular base with a circumference or diameter approximately equal to the circumference or diameter of the opening through which the deformation extends. For example, the opening may be configured similar to the hole 220 in the metallic tubular reinforcing layer 210 of the catheter 200 illustrated in FIG. 3. The protrusions 104 may have a projection diameter (D) that is approximately equal to the diameter of the hole through which each respective protrusion extends.
[0028] 2D illustrates a catheter section 100d having a deformation with a protrusion 104 on the outer surface of the catheter section 100d and an opposing indentation 122 on the inner surface of the catheter section 100d. The catheter section 100d includes an inner liner 115, an intermediate braided layer 102, a metallic tubular reinforcement layer 110, and an outer layer 182, which are collectively molded to form the deformation.
[0029] FIG. 3 is a diagram of an exemplary catheter 200 including a metallic tubular reinforcing layer 210. The structure of the catheter 200 and various configurations of the metallic tubular reinforcing layer 210 are described in more detail in U.S. patent application Ser. No. 243382.000291, filed concurrently herewith. The metallic tubular reinforcing layer 210 is optional; typical current catheter designs achieve stiffness by adding polymer layers in areas where increased stiffness is desired (typically, stiffness increases toward the proximal end 212 of the catheter 200). The metallic tubular reinforcing layer 210 can be a replacement for the proximal portion of many current catheter shaft designs, which is plastic. The exemplary catheter 200 may be modified to include additional layers, as will be understood by those skilled in the art.
[0030] The innermost layer of the catheter 200 may include an inner liner 215 made of PTFE or other low-friction material to facilitate passage of auxiliary devices through the lumen of the catheter. A braided wire support structure 202 having a braid or winding with wires or bands of other materials may be disposed around the inner liner 215. A metallic tubular reinforcing layer 210 may be disposed over the braid 220. The polymer jacket 28 0 may be disposed over the braid 202 and metallic tubular reinforcement layer 210. An atraumatic polymeric tip 230 may be disposed at the distal end 214 of the catheter 200. A radiopaque marker or band 216 (e.g., platinum) may be disposed adjacent to the tip 230 for marking the end of the catheter 200 during the procedure.
[0031] The metallic tubular reinforcing layer 210 may span at least a portion of the length of the catheter 200, extending from the proximal end 212 of the catheter 200 and terminating at a distal end 224 at a point proximal to the distal end 214 of the catheter 200. The metallic tubular reinforcing layer 210 may be cut from a single continuous piece of nitinol hypotube or other suitable material.
[0032] The transition in stiffness along the axial length of the catheter 200 can be affected by the cut pattern in the metallic tubular reinforcing layer 210 and / or the positioning of the protrusions 104 and / or indentations 122 along the catheter 200. The catheter 200 may include protrusions 104, indentations 122, and combinations thereof to achieve cross sections similar to those illustrated in FIGS. 2A-2D. Hemispherical or other atraumatic shaped deformations may be positioned to introduce a flexibility gradient in the metallic tubular reinforcing layer 210, increasing its flexibility in the distal direction as defined by the orientation of the catheter 200 during a procedure. The protrusion diameter (D), protrusion pitch (P), and protrusion depth (H) can be varied to achieve a desired stiffness and stiffness gradient in the catheter 200. The cut pattern in the metallic tubular reinforcing layer 210 may define sidewall openings (e.g., holes 220, spaces between ribbon segments 240) through which some or all of the remaining layers 280, 202, 215 of the catheter 200 may extend to form the protrusions 104 and / or the indentations 122. Additionally or alternatively, the metallic tubular reinforcing layer 210 may be molded to form the protrusions 104 and / or the indentations 122.
[0033] 4A and 4B are illustrations of a smooth region 126 on the outer surface of an exemplary catheter 100. The outer surface includes a first region 124 having protrusions 104 spaced in a pattern, and a second region 126 that is substantially smooth without protrusions 104 and has an area large enough to interrupt the pattern of deformations in the first region 124. When applied to vascular tissue, the smooth second region 126 may provide a higher coefficient of friction compared to the first region 124 having protrusions 104. The protrusions 104 may be spaced in the first region 124 in a regular pattern as shown, and / or in an irregular pattern.
[0034] The smooth region 126 can provide a higher friction fixation patch to secure the catheter 100 in place. When the catheter 100 is positioned within the vasculature and a device or smaller catheter is pushed through the lumen of the catheter 100, friction between the fixation patch 126 and the vessel wall can prevent the catheter 100 from moving or backing out.
[0035] Additionally or alternatively, the smooth regions 126 can define controlled bending positions for the catheter 100 .
[0036] FIG. 4B is an isometric view of a catheter portion 100a having a smooth lumen surface.
[0037] 5 is a diagram of the outer surface of a portion of an exemplary catheter 300 having indentations 304 extending into an otherwise smooth surface 306. The indentations 304 are positioned and shaped to reduce friction between the outer surface of the catheter 300 and the vascular anatomy or lumen of another catheter that contacts the outer surface. By reducing the contact area with the smooth surface 306, friction is reduced, and portions of the indentations 304 are prevented from contacting the vascular anatomy or lumen of another catheter due to the depth of the indentations 304. Reducing friction may reduce tracking forces and / or better facilitate trackability.
[0038] The dimensions of the dimples 304 can be described in terms of a dimple diameter (D2), the diameter of the circular base of the hemispherical dimples, and a dimple depth (H2), the depth of the dimples 304 measured radially inward from the smooth surface 306. The spacing of the regular pattern of dimples 304 can be described in terms of a dimple pitch (P2), the distance between the center points of the bases of the dimples 304. The dimple diameter (D2), dimple pitch (P2), and dimple depth (H2) can be varied to achieve a desired conformability of the outer surface of the catheter 300. Additionally or alternatively, the dimple diameter (D2), dimple pitch (P2), and dimple depth (H2) can be varied to achieve a desired flexibility and / or flexibility gradient of the catheter 300, typically with the catheter being stiffer, preferably near the proximal end, and gradually becoming more flexible toward the distal end of the catheter.
[0039] 6A-6D are cross-sectional views of exemplary catheter structures as shown in FIG. 5. Each cross-sectional view represents a respective catheter section 300a-300d. Features of each cross-section 300a-300d can be combined to form various cross-sectional configurations. Furthermore, as will be understood by those skilled in the art following the teachings herein, features of each cross-section 100a-100d illustrated in FIGS. 2A-2D can be combined with features of each cross-section in FIGS. 6A-6D to provide various cross-sections.
[0040] FIG. 6A shows a catheter section 300a having an inner liner 315 forming a smooth inner surface and an outer layer 382 shaped to form a dimple 304. The catheter section 300a is shown to include an intermediate braided layer 302 and a portion of a metallic tubular reinforcing layer 310 that provides stability to the catheter. The metallic tubular reinforcing layer 310 may be configured similarly to the metallic tubular reinforcing layer 210 of the exemplary catheter 200 illustrated in FIG. 3 and / or may be configured otherwise as described in concurrently filed U.S. patent application having attorney docket number 243382.000291. For example, the cross section of the metallic tubular reinforcing layer 310 illustrated in FIG. 6A may correspond to the ribbon cut segment 240 of the catheter 200 illustrated in FIG. 3. As shown, the dimple 304 is formed exclusively by the outer layer 382, while the reinforcing layer 310 and braided layer 302 are smooth. Thus, the outer layer 382 is thicker than the other layers 310 , 302 , 315 , and the recess 304 is inset into the outer layer 382 .
[0041] 6B illustrates a catheter portion 300b having a deformation with an indentation 304 on the outer surface of the catheter portion 300b and an opposing protrusion 322 on the inner surface of the catheter portion 300b. The catheter portion 300b includes an inner liner 315, an intermediate braided layer 302, and an outer layer 382, which are collectively molded to form the deformation. The protrusion 322 on the inner surface of the catheter portion 300b reduces the contact area between the inner surface of the catheter portion 300b and a device navigated through the lumen of the catheter portion 300b, thereby allowing for lower compliance forces on such devices.
[0042] FIG. 6C illustrates a catheter section 300c having a deformation, each having a depression 304 on the outer surface of the catheter section 300c and an opposing protrusion 322 on the inner surface of the catheter section 300c. The catheter section 300c includes an inner liner 315, an intermediate braided layer 302, and an outer layer 382, which are collectively molded to form a deformation similar to the catheter section 300b illustrated in FIG. 6B. The catheter section 300c further includes a metallic tubular reinforcing layer 310 having an opening through which the deformation extends. The opening may be circular. The deformation may have a circular base with a circumference or diameter approximately equal to the circumference or diameter of the opening through which the deformation extends. For example, the opening may be configured similar to the hole 220 in the metallic tubular reinforcing layer 210 of the catheter 200 illustrated in FIG. 3.
[0043] 6D illustrates a catheter section 600d having a deformation having an indentation 304 on the outer surface of the catheter section 300d and an opposing protrusion 322 on the inner surface of the catheter section 300d. The catheter section 300d includes an inner liner 315, an intermediate braided layer 302, a metallic tubular reinforcement layer 310, and an outer layer 382 that are collectively molded to form the deformation.
[0044] FIG. 7A is an isometric view of a portion of an exemplary catheter portion 300 a including indentations 304 on the outer surface and a smooth lumen surface 315 .
[0045] Figure 7B is an isometric view of a portion of an exemplary catheter portion 300b, including indentations 3-4 on the outer surface and corresponding protrusions 322 on the inner surface 315. The catheter portion 300b further includes a fixed patch region 326 configured similarly to the fixed patch region 126 illustrated in Figures 4A and 4B.
[0046] The descriptions contained herein are examples of embodiments of the present invention and are not intended to limit the scope of the present invention. As described herein, the present invention contemplates many variations and modifications of catheters, including alternative materials, alternative geometries, alternative structures, combinations with compatible structures, and the like. For example, protrusions and depressions illustrated herein as hemispheres may have any atraumatic shape, including domes, ridges, or troughs. Methods of treatment using the exemplary catheters and methods of constructing the exemplary catheters are within the scope of the present disclosure. Variations obvious to those skilled in the art are intended to be within the scope of the following claims.
[0047] [Embodiment] (1) a first tubular surface; a second tubular surface opposite the first tubular surface; and a plurality of deformations, each including an indentation on the first surface and a corresponding protrusion on the second surface opposite the indentation. (2) A catheter as described in embodiment 1, wherein the depression and the corresponding protrusion of each of the multiple deformation portions are each hemispherical in shape. (3) A catheter as described in embodiment 1, wherein the first surface is an inner surface of the catheter and the second surface is an outer surface of the catheter. (4) A catheter as described in embodiment 1, wherein the first surface is an outer surface of the catheter and the second surface is an inner surface of the catheter. (5) a first region of the catheter including at least some of the plurality of deformations spaced apart in a regular pattern; a second region free of deformations, the second region being substantially smooth on at least the outer surface of the catheter and including an area large enough to interrupt the regular pattern of the portions of the deformations in the first region; A catheter as described in embodiment 1, wherein when the outside of the catheter including the first region and the second region is applied to vascular tissue, contact between the second region and the vascular tissue results in a higher coefficient of static friction compared to the coefficient of static friction between the first region and the vascular tissue.
[0048] (6) an inner liner; a braided wire support structure disposed around the inner liner; an outer polymer layer disposed about the braided wire support structure; A catheter as described in embodiment 1, wherein the deformation portion is formed by the inner liner, the braided wire support structure, and the outer polymer layer. (7) The catheter of embodiment 6, further comprising a metallic tubular reinforcing layer disposed around the braided wire support structure, the outer polymer layer disposed around the metallic tubular reinforcing layer. (8) A catheter as described in embodiment 7, wherein the metallic tubular reinforcement layer includes a sidewall opening, and the inner liner, the braided wire support structure, and the outer polymer layer protrude through the sidewall opening to form at least one of the deformation portions. (9) The sidewall opening includes a circular shape including an outer periphery; A catheter as described in embodiment 8, wherein each of the at least one deformed portion protruding through the side wall opening comprises a hemispherical shape having an outer circumference approximately equal to that of the outer circumference of the circular shape of the side wall opening. (10) The catheter of embodiment 8, wherein the side wall opening comprises a spiral shape surrounding the catheter.
[0049] (11) A catheter according to embodiment 7, wherein at least one of the deformation portions is further formed by the metal tubular reinforcing layer. (12) A catheter as described in embodiment 7, wherein the metallic tubular reinforcing layer is cut from a single continuous hypotube. (13) The catheter of embodiment 7, wherein the deformation portion is positioned to introduce a flexibility gradient in the metallic tubular reinforcing layer while increasing the flexibility of the metallic tubular reinforcing layer in a distal direction as defined by the orientation of the catheter during a procedure. (14) A catheter, An inner liner, a braided wire support structure disposed around the inner liner; a metallic tubular reinforcing layer disposed around the braided wire support structure; an outer polymeric layer disposed about the metallic tubular reinforcing layer and forming an outer surface of the catheter; a protrusion extending from the outer surface of the catheter. (15) The protrusions each include a hemispherical shape; 15. The catheter of claim 14, wherein the protrusions are regularly spaced on at least a portion of the outer surface of the catheter.
[0050] (16) The catheter of embodiment 15, further comprising a plurality of smooth regions that are free of hemispherical protrusions and that interrupt the spacing pattern of the hemispherical protrusions. (17) The smooth region is on an outer surface of the catheter; 17. A catheter as described in embodiment 16, wherein the smooth region provides a higher coefficient of static friction when applied to vascular tissue compared to the outer surface of the catheter having the spaced pattern of hemispherical protrusions uninterrupted by the smooth region. (18) The catheter of embodiment 14, further comprising a plurality of fluid-filled cavities, each of which is located under one of the protrusions and is formed by the outer polymer layer. (19) The catheter of embodiment 18, wherein each of the fluid-filled cavities is configured to rupture to release fluid from the cavity in response to stress induced in the respective protrusion during an intravascular procedure, the fluid comprising an oil and / or a drug. (20) The catheter of embodiment 19, wherein the fluid includes a drug for inhibiting vasospasm, and each of the fluid-filled cavities is configured to rupture in response to vasospasm.
Claims
1. An inner liner; a braided wire support structure disposed around the inner liner; a metallic tubular reinforcing layer disposed around the braided wire support structure; an outer polymeric layer disposed about the metallic tubular reinforcing layer, the catheter comprising: a first tubular surface; and a second tubular surface opposite the first tubular surface; and a plurality of hemispherical deformations each including a hemispherical depression on the first tubular surface and a corresponding hemispherical protrusion on the second tubular surface opposite the hemispherical depression; the plurality of hemispherical deformations are formed by the inner liner, the braided wire support structure, and the outer polymer layer; the metallic tubular reinforcement layer includes a plurality of circular sidewall openings, and the inner liner, the braided wire support structure, and the outer polymeric layer protrude through corresponding ones of the plurality of circular sidewall openings to form each of the plurality of hemispherical deformations.
2. The catheter of claim 1 , wherein the first tubular surface is an inner surface of the catheter and the second tubular surface is an outer surface of the catheter.
3. The catheter of claim 1 , wherein the first tubular surface is an outer surface of the catheter and the second tubular surface is an inner surface of the catheter.
4. A catheter as described in claim 1, wherein the metal tubular reinforcing layer is a nitinol hypotube.
5. A catheter as described in claim 1, wherein the inner liner is the innermost layer of the catheter, and the inner liner is made of PTFE.
6. a first region of the catheter including at least a portion of the plurality of hemispherical deformations spaced in a regular pattern; a second region free of the plurality of hemispherical deformations, the second region being substantially smooth on at least the outer surface of the catheter and including an area large enough to interrupt the regular pattern of the portion of the plurality of hemispherical deformations in the first region; 2. The catheter of claim 1, wherein when the exterior of the catheter including the first region and the second region is applied to vascular tissue, contact between the second region and the vascular tissue results in a higher coefficient of static friction compared to the coefficient of static friction between the first region and the vascular tissue.
7. each of the plurality of circular sidewall openings includes a circular shape including a perimeter; 2. The catheter of claim 1, wherein the plurality of hemispherical deformations protruding through the plurality of circular sidewall openings each include a hemispherical shape that includes a perimeter approximately equal to the perimeter of the circular shapes of the plurality of circular sidewall openings.
8. The catheter of claim 1 , wherein the metallic tubular reinforcing layer further includes a helical shaped opening that surrounds the circumference of the catheter.
9. A catheter as described in claim 1, further comprising at least one deformed portion including a depression and a protrusion formed by the metal tubular reinforcing layer.
10. The catheter of claim 1 , wherein the metallic tubular reinforcing layer is cut from a single continuous hypotube.
11. 10. The catheter of claim 1, wherein the plurality of hemispherical deformations are positioned to introduce a flexibility gradient in the metallic tubular reinforcing layer, increasing the flexibility of the metallic tubular reinforcing layer in a distal direction as defined by the orientation of the catheter during a procedure.
Citation Information
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