CATHETER WITH BRAID AND RADIOPAQUE SECTION
20210213250 ยท 2021-07-15
Inventors
Cpc classification
A61M2025/0059
HUMAN NECESSITIES
A61M25/0052
HUMAN NECESSITIES
A61M25/008
HUMAN NECESSITIES
A61M25/005
HUMAN NECESSITIES
A61M2025/0098
HUMAN NECESSITIES
A61M25/0053
HUMAN NECESSITIES
International classification
Abstract
In an example, a catheter assembly includes a catheter body extending from a catheter proximal portion to a catheter distal portion having a distal tip. a coil proximate to the catheter distal portion, the coil having a first section and a second section, wherein the first section has a first imaging characteristic. The second section is swaged, and the second section of the coil has a second imaging characteristic. The second imaging characteristic differs from the first imaging characteristic, and the different first and second imaging characteristics are configured to contrast and emphasize visibility of the distal tip relative to the remainder of the catheter body. In another example, a second braided layer of the catheter body is configured to constrain and brace a first braided layer.
Claims
1. A catheter assembly, comprising: a catheter body extending from a catheter proximal portion to a catheter distal portion having a distal tip; a coil proximate to the catheter distal portion, the coil having a first section and a second section, wherein: the first section of the coil extends toward the distal tip, and the first section has a first imaging characteristic; the second section is swaged and extends from the first section to the distal tip, and the second section of the coil has a second imaging characteristic; and the second imaging characteristic differs from the first imaging characteristic, and the different first and second imaging characteristics are configured to contrast and emphasize visibility of the distal tip relative to the remainder of the catheter body.
2. The catheter assembly of claim 1, wherein the second section of the coil includes a planar filar profile, and the planar filar profile includes a plurality of planar perimeter surfaces of swaged filars included in the swaged second section of the coil.
3. The catheter assembly of claim 1 comprising a tip coating applied along a planar filar profile at the distal tip, and the planar filar profile includes a plurality of planar perimeter surfaces of swaged filars included in the swaged second section.
4. The catheter assembly of claim 1, wherein the coil includes platinum.
5. The catheter assembly of claim 1, wherein the catheter does not include a marker coupled to the catheter body proximate to the distal tip.
6. The catheter assembly of claim 1, wherein the second section has a length characteristic within a range of approximately 0.02 inches to approximately 0.07 inches.
7. The catheter assembly of claim 1, wherein the second section has an outer characteristic within a range of approximately 0.015 inches to approximately 0.025 inches.
8. A catheter assembly, comprising: a catheter body extending from a catheter proximal portion to a catheter distal portion; a first braided layer within the catheter body; a second braided layer coupled along an exterior of the first braided layer; wherein the first and second braided layer include first and second, respective, filar arrays; and wherein the first and second braided layers are configured to expand to an expanded configuration with the application of axial force along a catheter longitudinal axis, and in the expanded configuration: the first braided layer is configured to expand at a first rate; the second braided layer is configured to expand at a second rate less than the first rate of expansion, and the expansion at the second rate is configured to constrain and brace the first braided layer.
9. The catheter assembly of claim 8, wherein the first braided layer has a first braid profile, the second braided layer has a second braid profile, and the second braid profile is at an angle with respect to the first braid profile.
10. The catheter assembly of claim 9, wherein the first braid profile is at an angle of approximately 45 degrees relative to a longitudinal axis of the catheter, and the second braid profile is at an angle of approximately 90 degrees relative to the longitudinal axis.
11. The catheter assembly of claim 8, further comprising: a coil proximate to the catheter distal portion, the coil having a first section and a second section, wherein: the first section of the coil extends toward the distal tip, and the first section has a first imaging characteristic; the second section is swaged and extends from the first section to the distal tip, and the second section of the coil has a second imaging characteristic; and the second imaging characteristic differs from the first imaging characteristic, and the different first and second imaging characteristics are configured to contrast and emphasize visibility of the distal tip relative to the remainder of the catheter body.
12. The catheter assembly of claim 8, wherein the second braided layer constrains and braces the first braided layer and minimizes kinking of the catheter body.
13. A catheter assembly, comprising: a catheter body extending from a catheter proximal portion to a catheter distal portion having a distal tip; a coil proximate to the catheter distal portion, the coil having a first section and a second section, wherein: the first section of the coil extends toward the distal tip, and the first section has a first imaging characteristic; the second section is swaged and extends from the first section to the distal tip, and the second section of the coil has a second imaging characteristic; and the second imaging characteristic differs from the first imaging characteristic, and the different first and second imaging characteristics are configured to contrast and emphasize visibility of the distal tip relative to the remainder of the catheter body. a first braided layer within the catheter body; a second braided layer coupled along an exterior of the first braided layer; wherein the first and second braided layer include first and second, respective, filar arrays; and wherein the first and second braided layers are configured to expand to an expanded configuration with the application of axial force along a catheter longitudinal axis, and in the expanded configuration: the first braided layer is configured to expand at a first rate; the second braided layer is configured to expand at a second rate less than the first rate of expansion, and the expansion at the second rate is configured to constrain and brace the first braided layer.
14. The catheter assembly of claim 13, wherein the second section of the coil includes a planar filar profile, and the planar filar profile includes a plurality of planar perimeter surfaces of swaged filars included in the swaged second section of the coil.
15. The catheter assembly of claim 13 comprising a tip coating applied along a planar filar profile at the distal tip, and the planar filar profile includes a plurality of planar perimeter surfaces of swaged filars included in the swaged second section.
16. The catheter assembly of claim 13, wherein the coil includes platinum.
17. The catheter assembly of claim 13, wherein the catheter does not include a marker coupled to the catheter body proximate to the distal tip.
18. The catheter assembly of claim 13, wherein the first braided layer has a first braid profile, the second braided layer has a second braid profile, and the second braid profile is at an angle with respect to the first braid profile.
19. The catheter assembly of claim 18, wherein the first braid profile is at an angle of approximately 45 degrees relative to a longitudinal axis of the catheter, and the second braid profile is at an angle of approximately 90 degrees relative to the longitudinal axis.
20. The catheter assembly of claim 13, wherein the second braided layer constrains and braces the first braided layer and minimizes kinking of the catheter body.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] In the drawings, which are not necessarily drawn to scale, like numerals may describe similar components in different views. Like numerals having different letter suffixes may represent different instances of similar components. The drawings illustrate generally, by way of example, but not by way of limitation, various embodiments discussed in the present document.
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DETAILED DESCRIPTION
[0045] In an example, a catheter includes a catheter body having a coil. The coil is proximate to a distal portion of the catheter body. The coil includes a first section having a first imaging characteristic (e.g., radiopacity, radiodensity, radiopaqueness, radiolucentness, ultrasound opacity or the like). The coil includes a second section having a second imaging characteristic. The second imaging characteristic differs from the first imaging characteristic, and the different first and second imaging characteristics contrast and emphasize visibility of the distal tip relative to the remainder of the catheter body. Accordingly, the flexibility of the distal tip is enhanced with the coil, while the coil provides enhanced visibility of the distal tip and orientation of the distal tip.
[0046] In another example, the catheter body includes a braid assembly (e.g., an assembly including the first braided layer 2500 and the second braided layer 2600) that improves the pushability of the catheter assembly and minimizes buckling or kinking, for instance by increasing an amount of axial force needed to kink the catheter body. For instance, the catheter body includes a first braided layer and a second braided layer coupled along an exterior of the first braided layer. The second braided layer optionally constrains and braces the first braided layer, for instance because the second braided layer expands at a lesser rate than the first braided layer. The constraining and bracing of the first braided layer by the second braided layer, for instance with perimeter support provided by the second braided layer, improves the pushability of the catheter assembly and minimizes buckling or kinking, for instance by increasing an amount of force needed to kink the catheter body.
[0047] The catheter assemblies described herein include features usable alone, or in combination with other features described herein. For instance, the catheter assembly 100 described herein optionally includes (but is not limited to) one or more of the braid assembly 112, braid assembly 608, braid assembly 808, braid assembly 814, braid assembly 1100, braid assembly 1200, strain relief fitting 110, graduated strain relief fitting 1300, braid assembly 2700, or the like.
[0048] Additionally, the catheter examples as described herein can solve the problems associated with current catheter technology by providing novel designs, construction and materials. The catheters, described herein, are optionally used in interventional procedures including access to one or more vessels or passages (e.g., arteries, veins, vessels, body passages or cavities and the like). Further, the catheters described herein facilitate enhanced deflection, torqueability and other mechanical characteristics of the catheter during navigation while at the same time minimizing kinking. For instance, where significant arterial tortuosity is encountered such with a radial artery access or a femoral approach on an obese patient, the catheters described herein are configured for navigation through such vessels. The catheters described herein include, but are not limited to, introducer sheaths, guide catheters, delivery catheters, or other typically tubular devices used in diagnostic or therapeutic procedures (e.g., including instruments, fluid delivery passages, balloons or the like).
[0049] In various embodiments, the catheters include a composite built tube fabricated using a wound metal inner layer (e.g., a braid assembly, coil or the like) and jacketed with layers of polymer inside and out, for instance an inner liner and outer sleeve, respectively. The metallic inner layer is optionally constructed with a multi-filar (6-30 filars) helically wound braid structure. In some embodiments, the filars are swaged, such that one or more of the filars is partially flat or ovular (e.g., including rectangular) in cross-section to achieve a tight wire matrix. In other examples, the braid assembly is made with one or more non-swaged, round, square or rectangular filars (optionally in combination with other filars having the swaged configuration). As described herein, the braid assembly includes filar arrays, for instance first and second filar arrays that are helically wound and interlaced.
[0050] In various embodiments, the wall thickness of the braid assembly ranges from about 0.0005 to 0.020 inches thick. The braid assembly improves the mechanical integrity of the catheter, such as compared to current guide catheters with respect to kinking, buckling, flexibility, radial strength, and maintaining circularity of the catheter lumen cross-section. This improvement is achieved in one example by varying number of filars in each of the filar arrays (e.g., in various ratios including but not limited to, 15:1, 14:2, 13:3, 12:4, 11:5, 10:6, 9:7, 8:8, 7:9, 6:10, 5:11, 4:12, 3:13, 2:14, 1:15 with a total filar count of 16 filars).
[0051] In another example, the improved mechanical characteristic (or characteristics) is achieved by varying dimensions (e.g., dimensions in cross section) of one or more of the filars in one or more of the arrays. For instance, in arrays with the ratio 14:2 the first filars (14 filars) include first filar dimensions in the cross section such as one or more of diameter, thickness or width less than corresponding dimensions of the second filars (2 filars). Stated another way, the second filars are fewer in number and are larger in at least one cross sectional dimension relative to the first filars. As described herein, the second filars structurally support the more narrow first filars in the manner of a braided brace, and thereby behave as a frame, skeleton, cage or the like that maintains the first filars in a desired configuration (e.g., without kinking or buckling during deflection). Optionally the second filars include one or more filars, such as coils, interlaced with the first filars. The coils act as a braided brace for the first filars similar to the second filars previously described. The first filars (and the second filars including the braided brace) provide improved torqueability to the catheter, while the braided brace structurally supports the braid assembly and provides at least enhanced kink resistance. The inclusion of a braided brace incorporates the profile of the brace into the braid assembly and thereby avoids coupling additional support structures over or beneath the braid assembly with attendant consumption of space (or enlargement of the catheter) avoided.
[0052] In still another example, the catheters described herein include a coil wound along the braid assembly, for instance in a guide recess provided by one of the filar arrays. The coil enhances the mechanical characteristics of the catheters. Optionally, the coil extends helically along one or more of the filars including for example the braided brace. The coil and the braided brace cooperate to capture and hold the first filars (described above) in place within the catheter. Further, infiltration of the outer sleeve (e.g., a reflowed or shrunk sleeve) into the braid assembly and the optional coils fixes each of the braided brace and the coil (optional) in place. The outer sleeve and the braided brace capture and hold the first filars in place and minimize (e.g., eliminate or decrease) kinking of the catheters. Where the coil is included along the braid assembly, the coil and the braided brace are captured within the outer sleeve (e.g., reflowed) and clamp the first filars therebetween. Kinking, buckling or the like of the first filars is thereby resisted by one or more of the braided brace or the coil in combination with the outer sleeve.
[0053] In at least some examples, the catheter of this disclosure also comprises an outer sleeve, such as an outer polymer layer and an inner liner, such as an inner polymer layer. In an embodiment, the outer polymer layer and the inner polymer layer include one or more polymers, such as PTFE, Pebax, or Polyurethane. The polymer layers are attached to the braid assembly by thermal polymer heat-shrinking or reflow. The wall thickness of the polymer layers ranges from 1.0 to 3.0 thousandths of an inch for each layer.
[0054] In various embodiments, the catheters include a pre-shaped curve, such as a curved distal end region. The catheter attains the pre-shaped curve configuration by, for instance, heat-setting the metal portion of the catheter where the curved configuration is specified. The curve retains its shape in body temperature and over time does not substantially soften (e.g., to unintentionally change shape). The guide catheter optionally includes a soft (low durometer) polymer distal tip, various distal curve shapes, a radiopaque distal marker band, a proximal luer adapter or the like.
[0055] The catheters described herein range in size from 3F to 34F and in lengths from at least 15 cm or more to 205 cm or less. As previously described, the features, elements and functions described herein as well as their equivalents are used in a variety of catheters including, but not limited to, introducer sheaths, guide catheters, catheters including one or more of instruments or delivery lumens, or the like. That is to say, the enhancements to each of torqueability, pushability, flexibility, kink-resistance or the like are readily applied to various catheter styles and types.
[0056] In reference now to the Figures,
[0057] In an embodiment, the catheter 100 includes a catheter body 102 (e.g., a main tubular shaft with an optional lumen) with a distal portion 103 (including a distal tip 104) and a proximal portion 105 (including a proximal end 106). The distal tip 104 is on the opposed end of the catheter body 102 from the proximal end 106. The distal tip 104 includes at least one layer of polymer. In another example, the distal tip 104 includes at least two layers of polymer. Optionally, the distal tip 104 includes an inner layer and an outer layer. In one example, the inner layer of the distal tip 104 includes PTFE. In another example, the outer layer of the distal tip 104 includes Pebax. In an embodiment, the distal tip 104 has a length of at least 0.05 inches. In another embodiment, the distal tip 104 has a length of at least 0.02 inches long. In yet another embodiment, the distal tip 104 is 0.2 inches long or shorter. In a further embodiment, the distal tip 104 can be is 0.5 inches long or less.
[0058] In an example, the catheter assembly 100 includes a hub 108 coupled with the catheter body 102. For instance, the hub 108 is included in a proximal portion of the catheter assembly. In another example, the proximal end 106 of the catheter body 102 is coupled with the hub 108. In yet another example, the hub 108 includes a strain relief fitting 110. For instance, in some examples, the catheter assembly 100 includes the graduated strain relief fitting 1300 (shown in
[0059] In various embodiments, the catheter body (e.g., including the catheter body 102) includes a main inner structural layer, for instance one or more of the braid assembly, discrete coil or combinations of the same as described herein. The main inner structural layer includes a helically interlaced braid assembly extending between the proximal end portion and the distal end portion (e.g., along the entire length or a portion of the length of the catheter body). In various embodiments, the braid assembly covers at least a portion of the inner liner of the catheter. The outer sleeve, for instance a shrink tube, reflowed polymer or the like surrounds the braid assembly and in at least some examples infiltrates interstitial spaces of the braid assembly (e.g., between filars, coils, opposed helixes of the braid or the like).
[0060] As described herein, the catheter body including the catheter body 102 includes an outer layer (e.g., a jacket, such as an outer sleeve). The outer layer optionally includes a polymer. The outer layer surrounds the braid assembly (e.g., jackets, coats, covers or the like). The outer layer is fixed (e.g., fixedly coupled) to the braid assembly and optionally the inner liner through one or more of shrinking of the outer layer (shrink tubing) or infiltration of the braid assembly and optionally contacting the inner liner (by reflowing).
[0061] In various embodiments, the inner liner of the catheter (e.g., the catheter body including the catheter body 102) includes a polymer. The inner layer (e.g., the inner liner) extends along and couples with an inner surface of the braid assembly (e.g., jackets, coat or covers or the like). The inner layer is coupled (e.g., fixedly coupled) to the main inner structural layer through one or more of compression of the braid assembly onto the liner (e.g., with an outer sleeve including a shrink tube), compression achieved during braiding of the braid assembly onto the liner, infiltration of the braid assembly by a reflowed outer sleeve including contact and coupling of the reflowed polymer with the inner liner.
[0062] The catheter body 102 optionally includes a curve, for instance at or near the distal end portion including the distal tip 104 (shown in
[0063] In various embodiments, the braid assembly is laminated between the inner layer (inner liner) and the outer layer (outer sleeve), such that the lamination does not fuse the outer sleeve and the inner liner together.
[0064] In an embodiment, the catheter is at least 60 cm long and not longer than 200 cm. In another embodiment, the catheter body 102 is at least 10 cm long and not longer than 300 cm. In still another embodiment, the catheter body 102 is at least 30 cm long and not longer than 250 cm. In a further embodiment, the catheter body 102 is at least 50 cm long and not longer than 225 cm.
[0065] In an embodiment, the catheter body 102 includes an outer diameter of at least 0.060 inches and not more than 0.115 inches (e.g., the outer diameter of the outer sleeve when coupled with the remainder of the catheter body). In another embodiment, the catheter body 102 includes an outer diameter of at least 0.060 inches. In a further embodiment, the catheter body 102 includes an outer diameter of at least 0.040 inches. In yet another embodiment, the catheter body 102 includes an outer diameter of at least 0.050 inches. In further embodiments, the catheter body 102 includes an outer diameter of at least 0.070 inches, at least 0.080 inches or the like. In still another embodiment, the catheter body 102 has an outer diameter of no greater than 0.115 inches. In further examples, the catheter body 102 has an outer diameter including, but not limited to, no greater than 0.095 inches, no greater than 0.105 inches, no greater than 0.125 inches, no greater than 0.135 inches.
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[0068] In various embodiments, the braid assembly 608 filars are swaged. In various embodiments, the braid assembly component filars includes include between at least 2 and 30 filars having a picks per inch (inverse of pitch) of between 30 and 180. In various embodiments, the braid assembly includes at least 4 filars and not more than 24 filars. In other embodiments, the braid assembly includes at least 8 filars and not more than 16 filars. In various embodiments, the metallic filars of the braid assembly 608 include cross sectional shapes including, but not limited to, rectangular cross-sections, circular cross-sections, ovular cross-sections, elliptical cross-sections (another example of an oval) or the like. In various embodiments, the braid assembly 608 filars are coated, for instance with PTFE, prior to braiding into the interlaced configuration of the braid.
[0069] In an embodiment, the braid assembly 608 includes welded terminations. In an embodiment, the braid assembly 608 includes a distal end having a gold coating. In various embodiments, the gold coating ranges from about 0.5 mm to 2 mm thick. In other embodiments, the gold coating ranges from about 0.4 mm to 2.5 mm thick. In still other embodiments, the gold coating ranges from 0.25 mm to 3 mm thick.
[0070] In an embodiment, the braid assembly 608 includes thickness (e.g., from the braid assembly exterior to the braid assembly interior) that ranges from about 0.0015 inches to 0.010 inches. In another embodiment, the braid assembly 608 includes a thickness of at least 0.0010 inches. In still another embodiment, the braid assembly 608 includes a thickness of at least 0.0005 inches. In other embodiments, the main inner braid assembly 608 includes a thickness of no greater than 0.015 inches. In still other embodiments, the braid assembly 608 includes a thickness of no greater than 0.020 inches.
[0071] As described herein, the catheter body including the catheter body 102 includes an outer layer 610, such as an outer sleeve. The outer layer 610 includes a polymer in at least one example. The outer layer 610 extends around (e.g., jackets, covers, coats or the like) at least a portion of the braid assembly 608. In an embodiment, the outer layer 610 is at least about 0.001 inches thick and not more than about 0.005 inches thick. In another embodiment, the outer layer 610 is least about 0.0007 inches thick. In still another embodiment, the outer layer 610 is at least about 0.0005 inches thick. In yet another embodiment, the outer layer 610 is no more than about 0.007 inches thick. In further embodiments, the outer layer is no more than about 0.01 inches thick.
[0072] Optionally, the outer layer 610 includes one or more of polymers including, but not limited to, Pebax, PTFE, shrink tubing or the like. In another example, the outer layer 610 includes nylon. In an embodiment, the outer layer 610 is coated with a hydrophilic polymer. In another example, the outer layer 610 includes at least two layers. Optionally, each of the two layers includes Pebax or one or more of the polymers described herein. In another example, the outer layer 610 is heat shrinkable to snugly couple form the outer layer 610 onto the braid assembly 608. In yet another example, the outer layer 610 includes a reflowable polymer that is heated and reflows around the braid assembly 608. Optionally, the reflowed outer layer 610 infiltrates and captures one or more of the filars (including the braided brace) within the outer layer 610. As described herein, the outer layer 610 in cooperation with the braided brace (e.g., a coil, filars as described herein or the like) and an optional discrete coil maintain the braid assembly 608 in a specified (unkinked) configuration even with significant deflection of the catheter 100 (relative to a braid assembly without the structural support described herein).
[0073] In an embodiment, the catheter body including the catheter body 102 includes an inner liner, such as an inner layer 612. The inner layer 612 includes a polymer including, but not limited to, a lubricious polymer such as PTFE (e.g., to provide strength and facilitate passage of instruments through an optional center lumen as shown in
[0074] In an embodiment, the inner layer 612 is at least about 0.001 inches and not more than about 0.005 inches thick. In another embodiment, the inner layer 612 is at least about 0.0007 inches thick. In yet another embodiment, the inner layer 612 is at least about 0.0005 inches thick. In another example, the inner layer 612 is no more than about 0.007 inches thick. In still another example, the inner layer is no more than about 0.01 inches thick. Optionally, the inner layer 612 includes one or more polymers including, but not limited to, PTFE (described above), nylon, and coated polymers (e.g., coated with a hydrophilic polymer).
[0075] In an embodiment, the outer layer 610 (outer sleeve) and the inner layer 612 (inner liner) are fused together, for instance through the braid assembly 608 (shown in
[0076] In an embodiment, the filars of the braid assembly 814 includes metal or a polymer including, but not limited to, stainless steel, Nitinol or the like. In one embodiment, the braid assembly 814 is at least about 0.0005 inches thick and not more than about 0.010 inches thick. In another embodiment, the braid assembly 814 is at least about 0.005 inches thick and not more than about 0.010 inches thick. In still another embodiment, the braid assembly 814 is at least about 0.0004 inches thick. In a further embodiment, the braid assembly 814 is at least about 0.0003 inches thick. In other embodiments, the braid assembly 814 no more than about 0.015 inches thick, no more than about 0.020 inches thick or the like.
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[0078] The catheters described herein include a catheter body including a braid assembly having at least first and second interlaced filar arrays, with each of the filar arrays including one or more respective first and second filars extending in opposed helixes. The braid assembly is between an inner liner and an outer sleeve. In at least one example, the braid assembly including interstitial spaces between filars, filar arrays and the like, is infiltrated by the outer sleeve.
[0079] The braid assembly is constructed with a multi-filar (e.g., 6-30 filars) helically wound interlaced braid structure. In some embodiments, the filars are swaged, such that one or more of the filars is partially flat or ovular (e.g., including rectangular and elliptical) in cross-section to achieve a tight wire matrix. In other examples, the braid assembly is made with one or more non-swaged, round, square or rectangular filars (optionally in combination with other filars having the swaged configuration). In one example, the one or more filars one or both of the first and second filar arrays include filars approximating the dimensions and characteristics of a coil (e.g., a circular or ovular cross section, material characteristics such as Young's modulus, flexural modulus or the like). One example of a braided brace 1102 is shown in
[0080] In various embodiments, the wall thickness of the braid assembly 1100 ranges from about 0.0005 to 0.020 inches thick. The braid assembly 1100 improves the mechanical characteristics of the catheter 1101, such as compared to current guide catheters with respect to kinking, buckling, flexibility, radial strength, and maintaining circularity of the catheter lumen 1109 cross-section. The braid assembly 1100 of the catheter also improves characteristics of the catheter including, but not limited to, one or more torqueability, flexibility, pushability or kink resistance. This improvement is achieved in one example by varying number of filars (e.g., filars, coils or the like) in each of the filar arrays 1104, 1106 (e.g., in various ratios including but not limited to, 15:1, 14:2, 13:3, 12:4, 11:5, 10:6, 9:7, 8:8, 7:9, 6:10, 5:11, 4:12, 3:13, 2:14, 1:15 with a total filar count of 16 filars). One example of a braid assembly 1200 including an unbalanced ratio is shown in
[0081] In another example, the one or more improved mechanical characteristics are achieved by varying dimensions (e.g., dimensions in cross section) of one or more of the filars in one or more of the arrays. For instance, in arrays with the ratio 14:2 the first filars (14 filars of a first filar array) include first filar dimensions in the cross section such as one or more of diameter, thickness or width less than corresponding dimensions of the second filars (2 filars of a second filar array). Stated another way, the second filars are fewer in number and are larger in at least one cross sectional dimension relative to the first filars. The second filars structurally support the more narrow first filars in the manner of a braided brace, and thereby provide a frame, skeleton, cage or the like that maintains the first filars in a desired configuration (e.g., without kinking or buckling during deflection). One example of a braid assembly 1200 including filars having different dimensions between the first and second filar arrays 1202, 1204 is shown in
[0082] Optionally, the second filars include one or more filars, such as coils, interlaced with the first filars. An example of second filars including coils (including filars having coil shapes and dimensions) is provided in
[0083] In still another example, the catheters described herein include a coil 1206 wound along the braid assembly 1200, for instance in a guide recess 1208 provided by one of the filar arrays 1202, 1204. One example of discrete coils is shown in
[0084] As further shown in
[0085] As previously described herein one or more of the ratio of filars, dimensions of filars and components included with the braid assembly 1100, 1200 and along the braid assembly are varied to provide specified mechanical characteristics for a catheter 1101, 1201. For instance, various ratios and dimensions of filars are used to provide a specified torqueability for the catheter 1101, 1201 and at the same time enhance kink-resistance. One or more optional discrete coils 1206 are optionally provided along the braid assembly 1100, 1200, for instance within guide recesses 1208 of the braid assembly 1200, to further enhance the mechanical characteristics of the catheter. Tables 1, 2 and 3 provided herein describe each of the various features of an example braid assembly including, but not limited to, filar ratios between first and second filar arrays, filar dimensions, filar shapes, discrete coils and positioning of the same. These features are chosen and implemented in the catheter to provide the specified characteristics for a therapeutic or diagnostic procedure.
[0086] Table 1 (below) provides one example of a braid assembly including a filar count of 16 total filars. As shown, the ratios between the first and second filar arrays, and in some examples their cross sectional shapes, are varied between each of the example braid configurations. Although the smaller filar arrays (e.g., six and under) include the option for circular filars (e.g., coils or the like), circular filars are also included in some examples with filar array having larger filar counts, for instance greater than six filars.
TABLE-US-00001 TABLE 1 Structural Braid Configuration (example of 16 filar count between arrays, but total filar count is higher or lower in examples such as 6, 8, 10, 12, 14, 18, 20, 22, 24, 26, 28, 30 or the like) First Filar Second Filar Array - Filar Array - Filar Braid Count (e.g., First Filar Count (e.g., Second Filar Config- left hand Array - Filar right hand Array - uration helix) Shape helix) Filar Shape X1 15 flat or ovular 1 circular (e.g., coil), flat or ovular X2 14 flat or ovular 2 circular (e.g., coil), flat or ovular X3 13 flat or ovular 3 circular (e.g., coil), flat or ovular X4 12 flat or ovular 4 circular (e.g., coil), flat or ovular X5 11 flat or ovular 5 circular (e.g., coil), flat or ovular X6 10 flat or ovular 6 circular (e.g., coil), flat or ovular X7 9 flat or ovular 7 flat or ovular X8 8 flat or ovular 8 flat or ovular X9 7 flat or ovular 9 flat or ovular X10 6 circular 10 flat or ovular (e.g., coil), flat or ovular X11 5 circular 11 flat or ovular (e.g., coil), flat or ovular X12 4 circular 12 flat or ovular (e.g., coil), flat or ovular X13 3 circular 13 flat or ovular (e.g., coil), flat or ovular X14 2 circular 14 flat or ovular (e.g., coil), flat or ovular X15 1 circular 15 flat or ovular (e.g., coil), flat or ovular
[0087] Table 2 describes filar configurations including dimensions for each of the first and second filar arrays. In some examples, larger filar dimensions (e.g., of the second filar array) are paired with smaller filar dimensions of the other filar array (e.g., the first filar array). Examples of filars having circular cross sections are also provided including dimensions between about 0.001 to 0.01 inches. Table 2 further qualitatively shows the relative difference between dimensions of the first and second filar arrays in the Order of Magnitude column. As shown, at least some the filar configurations provide one or more of the filars of one array as at least one order of magnitude larger in a dimension, such as width or diameter, relative to the corresponding dimension of the other filars of the other (e.g., second) filar array.
TABLE-US-00002 TABLE 2 Filar Configurations (example flat/ovular or coil dimensions used in some examples with the braid configuration of Table 1) Order of First Second Magnitude Filar First Filar Filar Second Filar Difference Filar Array - Array - Filar Array - Array - Filar (e.g., of Config- Filar Dimensions Filar Dimensions width or uration Shape (inches) Shape (inches) diameter) Y1 flat or 0.0005 0.003 flat or 0.002 0.015 Yes ovular ovular Y2 flat or 0.0005 0.003 flat or 0.002 0.010 Yes ovular ovular Y3 flat or 0.002 0.015 flat or 0.002 0.015 No ovular ovular Y4 flat or 0.002 0.015 circular 0.001 No ovular (e.g., coil) Y5 flat or 0.005 0.015 circular 0.003 No ovular (e.g., coil) Y6 flat or 0.0005 0.003 circular 0.004 Yes ovular (e.g., coil) Y7 flat or 0.0005 0.003 circular 0.005 Yes ovular (e.g., coil) Y8 flat or 0.0005 0.003 circular 0.008 Yes ovular (e.g., coil) Y9 flat or 0.0005 0.003 circular 0.01 Yes (2 ovular (e.g., coil) orders of magnitude) Table 2 provides an array of example dimensions. Filar Dimensions (flat or ovular) vary between thicknesses of 0.0005 to 0.005 and widths of 0.001 to 0.030 As described herein, in one example, a filar array with fewer filars has relatively larger filar dimensions relative to a companion filar array having a greater number of filars
[0088] Table 3 describes the placement of one or more discrete coils with the braid assembly. Further, the table describes options for positioning of the coils within guide recesses, for instance along the one or more guide recesses 1208 previously shown in
TABLE-US-00003 TABLE 3 Discrete Coil (example coils optionally used in some examples with the braid configurations of Tables 1 and 2) Placement Coil Proximal or of Coil Positioning Distal Guide Relative in Braid Recess (Relative Coil to Braid Guide to braid filar or Number Config- (Exterior Recess or filars providing of uration or Interior) Recesses guide recesses) Coils Z1 Exterior Yes Proximal 1 Z2 Exterior Yes Proximal and 2 Distal Z3 Exterior Yes Distal 1 Z4 Exterior No NA 1 Z5 Exterior No NA 2 Z6 Interior No NA 1 Z7 Interior No NA 2 Coil Dimensions: Various including 0.001 to 0.010 inches.
[0089] A variety of prophetic example catheter configurations are provided herein. The configurations are drawn by assembling one or more of the configurations provided in Tables 1, 2 and 3 and provide variation in mechanical characteristics based on the configurations chosen (e.g., the inclusion of a braided brace, such as larger filars in one of the arrays, a coil or the like improve kink-resistance).
[0090] The catheter of example 1 includes a braid assembly provided over a PTFE inner liner with an intermediate tie layer provided between the PTFE and the braid assembly (e.g., to facilitate coupling of the braid assembly and optionally an outer sleeve with the inner liner). The inner liner has an outer diameter of about 0.255 to 0.256 inches; the tie layer outer diameter (over the inner liner) is about 0.260 to 0.2605 inches; and the braid assembly outer diameter (over the tie layer) is about 0.270 to 0.271 inches. An outer sleeve, such as Pebax or the like, is provided along the catheter and over the braid assembly.
[0091] The catheter of example 2 includes a braid assembly with a discrete coil extending along the braid assembly exterior. The braid assembly includes an 8:8 ratio of first filars to second filars. In one example, the first filars have cross sectional dimensions of about 0.002 (thickness) by about 0.015 (width) inches. The 25 second filars have the same dimensions. In another example, the second filars have the previously described dimensions (e.g., 0.0020.015 inches) while the first filars have cross sectional dimensions of about 0.0005 inches by 0.003 inches. In this example, the second filars have dimensions an order of magnitude greater than the first filars. The braid assembly is provided over a PTFE inner liner with an intermediate tie layer. The inner liner has an outer diameter of about 0.2555 to 0.2565 inches; the tie layer outer diameter (over the inner liner) is about 0.2585 to 0.259 inches; and the braid assembly outer diameter (over the tie layer) is about 0.261 to 0.2615 inches. The coil is loaded over the braid assembly and retained therealong with the outer sleeve, such as Pebax or the like. In one example, the outer sleeve has a durometer of 55D and an outer diameter of between about 0.280 inches to 0.285 inches. Optionally, an end of the coil is fixed near the corresponding end of the braid assembly and the coil is wound around the braid assembly in the same direction (e.g., from proximal to distal). In another example, the coil is would along one or more guide recesses of one of the filar arrays as described herein.
[0092] The catheter of example 3 includes a braid assembly having an 8:8 ratio of eight filars for the first filar array and eight filars for the second filar array. The braid assembly is provided over a PTFE inner liner and an intermediate tie layer is provided between the PTFE and the braid assembly (e.g., to facilitate coupling of the braid assembly and optionally an outer sleeve with the inner liner). The inner liner has an outer diameter of about 0.255 to 0.266 inches; the tie layer outer diameter is about 0.258 to 0.259 inches; and the braid assembly outer diameter is about 0.263 to 0.264 inches. The first filars have cross sectional dimensions of 0.0005 (thickness) by 0.003 (width) inches. The second filars have cross section dimensions of 0.002 (thickness) by 0.015 (width) inches. The second filars have dimensions an order of magnitude greater than the first filars. The braid assembly is braided at 50 picks per inch, and is encapsulated with a polymer having a durometer of 55D and an outer diameter of about 0.280 to 0.285 inches.
[0093] In other examples (related to example 3), the braid assembly has a 14:2 or 12:4 ratio with the first filars having the same dimensions. In this example, the picks per inch are optionally increased (e.g., greater than 50, for instance to 180 PPI). In still another example, the braid assembly has a 15:1 ratio of first filars to second filars. Each of the first and second filars include the same dimensions as those for the 8:8 example provided immediately above.
[0094] In either of the examples (e.g., ratios of 8:8, 14:2, 12:4, 15:1) the catheter optionally includes a discrete coil. For instance, in the last example including the 15:1 ratio the coil is positioned within a guide recess formed along the second filar array (e.g., including the single second filar). The guide recess appears in the examples as one or more rifled grooves extending along the braid assembly. In addition to providing increased kink-resistance, the inclusion of the coil enhances the radial strength of the catheter (resistance to collapsing).
[0095] The catheter of example 4 includes a braid assembly having a 14:2 ratio of fourteen first filars for the first filar array and two second filars for the second filar array. In a similar manner to the previous examples, the braid assembly is provided over a PTFE inner liner (e.g., inner sleeve 1107 in
[0096] The catheter of example 5 includes a braid assembly having a 15:1 ratio of fifteen first filars for the first filar array and one second filar for the second filar array. The filars are provided at 160 PPI. In a similar manner to the previous examples, the braid assembly is provided over a PTFE inner liner and an intermediate tie layer is provided between the PTFE and the braid assembly. The inner liner has an outer diameter of about 0.2555 to 0.256 inches; the tie layer outer diameter is about 0.258 to 0.259 inches; and the braid assembly outer diameter is about 0.2625 to 0.2635 inches. The first filars have cross sectional dimensions of 0.0005 (thickness) by 0.003 (width) inches. The second filar has cross sectional dimensions of 0.002 (thickness) by 0.015 (width) inches and is an order of magnitude greater than the first filars.
[0097] The second filar array in this example provides at least one guide recess (e.g., along the proximal or distal faces of the filar array) and a coil is wound along the filar array and positioned within the guide recess (the recess serves as a guide for placement of the coil). The coil is at least partially received within the guide recess and the profile of the coil is thereby decreased because it is partially absorbed by the filar array and its guide recess. In one example, where the coil is wound in a particular direction (e.g., left hand) the second filar array is also wound left handed (and the first filar array wound right handed) to ensure placement of the coil within the guide recess.
[0098] The braid assembly and the coil are encapsulated with a polymer (outer sleeve) having a durometer of 55D and an outer diameter of about 0.280 to 0.285 inches. Optionally, the outer sleeve is reflowed multiple time (e.g., at least twice) to remove gas bubbles in the sleeve. The catheter of example 5 has enhanced radial strength and flexibility relative to at least some of the other examples.
[0099] Example 6 includes a selection of catheters including braid assemblies having ratios of 15:1, 14:2, 12:4 and so on. The braid assemblies include second filars having dimensions approaching or equaling those of a coil. For instance, filar (coil) diameters of about 0.003 to 0.005 inches (e.g., larger than the 0.0020.015 filars described herein). The second filars of the second filar array are interlaced with the first filar array. In one example, the second filars are staggered around the catheter body, for instance according to the count of the second filars (4 second filars at 90 degree intervals, 3 at 120 degree intervals, 2 at 180 degree intervals or the like). Optionally, these catheters and the second filar arrays of each are paired with discrete coils that are positioned within one or more guide recesses of the second filar array.
[0100]
[0101] As further shown in
[0102] Referring again to
[0103] Additionally, and as described herein, the graduated strain relief fitting 1300 minimizes (e.g., lowers, decreases or eliminates) stress risers at the interfaces between the fitting proximal portion 1304 and the hub 108 (a hub interface) as well as at the fitting distal portion 1306 and the catheter shaft 102 (a fitting interface). The graduated strain relief fitting 1300 includes one or more flexure joints 1312 configured to modulate (e.g., control, tune, graduate or the like) one or more support characteristics, such as flexural modulus, of the graduated strain relief fitting 1300 to provide a specified flexibility to the graduated strain relief fitting 1300 that maintains the support provided to the catheter shaft 102 at the interfaces with the fitting distal portion 1306 as well as the interface with the hub 108, for instance, at the fitting proximal portion 1304. Accordingly, the graduated strain relief fitting 1300, including the flexure joints 1312, provides a specified modulated flexural modulus at each of these interfaces and along the graduated strain relief fitting 1300 to control the one or more support characteristics (e.g., flexural modulus, elastic modulus, tensile modulus or the like) to minimize kinking, buckling or the like of the catheter shaft 102, for instance, when deflected.
[0104] In the view shown in
[0105]
[0106] The catheter assembly 1400 in
[0107]
[0108] As shown in
[0109] In one example, the strain relief profile 1500 is a consistent profile extending between the fitting proximal and distal portions 1304, 1306. In another example, the strain relief profile 1500 changes from the fitting proximal portion 1304 to the fitting distal portion 1306. For instance, one or more of the shape, size, frequency or the like of the flexure joint 1312 changes between the proximal and distal portions 1304, 1306. In the example shown in
[0110] In another example, the graduated strain relief fitting 1300 includes a fitting frame 1508 between the one or more flexure joints 1312. The fitting frame 1508 is, in one example, a portion of the graduated strain relief fitting 1300 having a wall thickness greater than the corresponding wall thickness proximate to the flexure joints 1312. Accordingly, the fitting frame 1508 provides enhanced support to one or more portions of the graduated strain relief fitting 1300 while the flexure joints 1312 modulate the support provided by the graduated strain relief fitting 1300. Changes in one or more of the frequency of the fitting frame 1508, frequency of the flexure joints 1312 or the like are used in various examples to provide one or more specified support characteristics, such as flexural modulus, at one or more locations of the graduated strain relief fitting 1300 to correspondingly support the catheter shaft 102 during deflection while at the same time minimizing stress risers, kinking, buckling or the like.
[0111] In the example shown in
[0112] In another example, the graduated strain relief fitting 1300 includes a taper between the fitting proximal and distal portions 1304, 1306. As shown in
[0113]
[0114] As further shown in
[0115] In the example shown in
[0116]
[0117] As further shown in this example, the graduated strain relief fitting 1610 includes one or more fitting materials, such as a first fitting material 1612 and a second fitting material 1614. The first fitting material 1612 includes a higher support characteristic (e.g., flexural modulus, tensile modulus, rigidity or the like) relative to the second fitting material 1614 associated with a fitting distal portion 1306. Accordingly, the second fitting material 1614 provides a more flexible distal portion 1306 to correspond and flexibly support the shaft proximal portion 106 at the fitting interface 1516. Conversely, the first fitting material 1612 associated with the fitting proximal portion 1304 has a higher support characteristic (e.g., flexural modulus, tensile modulus, rigidity or the like) than the fitting distal portion 1306. Accordingly, additional support is provided at the hub interface 1514 to the catheter shaft 102 to maintain the catheter shaft 102 in a relatively linear configuration relative to the hub 108 at the hub interface 1514.
[0118] In another example, the graduated strain relief fitting 1610 includes one or more supplemental materials including, for instance, a third fitting material 416, for instance, interposed between the first and second fitting materials 1612, 1614. In one example, the third fitting material 416 is a more flexible material than that used in the first fitting material 1612 and a less flexible material than the second fitting material 1614. For instance, the third fitting material 416 provides an intermediate support characteristic (e.g., flexural modulus or the like) relative to the flexural moduli of the fitting proximal and distal portions 1304, 1306. In still other examples, the fitting materials 1612, 1614, 416 include the same material, and the material is selectively doped or treated to provide differing support characteristics. For instance, the first fitting material 1612 includes a fitting filler including, but not limited to, metallic particles, glass fibers or the like configured to enhanced the support characteristic of the first fitting material 1612 and the associated fitting proximal portion 1304. In this example, the second fitting material 1614 includes a lesser amount of the fitting filler (including no filler) to provide a flexible fitting distal portion 1306 to conform or provide a complementary profile of the graduated strain relief fitting 1610 to the catheter shaft (see
[0119]
[0120] As previously described, the graduated strain relief fitting 1300 includes one or more of flexure joints 1312, a fitting frame 1508, variations in material or the like. The fitting 1300, including one or more of these features, is configured to provide one or more supporting characteristics to the catheter shaft 102, for instance at the hub interface 1514 between the graduated strain relief fitting 1300 and the hub 108, and the fitting interface 1516 between the fitting distal portion 1306 of the strain relief fitting 1300 and the shaft proximal portion 106. As shown in
[0121] The fitting distal portion 1306 includes a support characteristic configured to provide flexibility in the fitting distal portion 1306 while at the same time supporting the shaft proximal portion 106 in the deflected configuration 1700. For example, the flexure joints 1312, joint pitch, fitting frame 1508, frame pitch, materials or the like are configured to provide a specified support characteristic at the fitting distal portion 1306 including the fitting interface 1516. The support characteristic (e.g., a second flexural modulus) is modulated proximate to the fitting distal portion 1306 relative to a first higher flexural modulus of the fitting proximal portion 1304 with one or more of variations in the flexure joints 1312, fitting frame 1508, their respective pitches, materials of the fitting or the like. The modulated support characteristic of the fitting distal portion 1306 permits deflection of the catheter shaft 102 and the fitting distal portion 1306 into a configuration and respective complementary profile 1702 like that shown in
[0122] Conversely, the fitting proximal portion 1304 including, for instance, one or more of a thicker wall, an increased frame pitch 1510 relative to the frame pitch 1512, decreased joint pitch 1504 relative to the joint pitch 1506, variations in material or the like provides enhanced support to the catheter shaft 102 proximate to the hub interface 1514. Accordingly, the catheter shaft 102 remains in a substantially linear configuration relative to the hub 108 even in the deflected configuration 1700. In one example, the support characteristic of the fitting proximal portion 1304, such as a first flexural modulus, is greater than the second flexural modulus at the fitting distal portion 1306. Optionally, the flexural modulus of the proximal portion 1304 approaches a corresponding flexural modulus of the hub 108.
[0123] The graduated strain relief fitting 1300, including one or more of the flexure joints 1312 (e.g., grooves, scallops, scoring, flutes, notches, recesses, dimples or the like), the fitting frame 1508, modulation of their respective profiles or pitch, as well as variations in material are used separately or together to modulate the support characteristics of the graduated strain relief fitting 1300 to accordingly provide enhanced support characteristics at one or more locations while permitting deflection of the catheter shaft (and optionally assuming the complementary profile 1702).
[0124] In one example, the second flexural modulus of the fitting distal portion 1306 includes a flexural modulus less than or equal to the flexural modulus of the catheter shaft 102 to support the catheter shaft and assume the complementary profile 1702. In another example, the second flexural modulus of the fitting distal portion 1306 approaches the flexural modulus of the catheter shaft 102. For instance, the second flexural modulus substantially matches the modulus of the catheter shaft (e.g., is equal to or within 1 to 5 percent above or below the modulus, within 1,000, 7,000, 10,000 psi or the like). In another example, the fitting proximal portion 1304 includes a first flexural modulus greater than the flexural modulus of the fitting distal portion 1306 and accordingly greater than the flexural modulus of the catheter shaft 102. The first flexural modulus optionally approaches the modulus of the hub 108 (e.g., is equal to or within 20 to 25 percent of the hub modulus, within 10,000, 20,000 or 50,000 psi or the like). In one example, with these modulated support characteristics the graduated strain relief fitting 1300 is configured to assume the complementary profile 1702 in the deflected configuration 1700 and support the catheter shaft 102 while at the same time minimizing one or more of kinking, buckling or the like. Optionally, flexural modulus as used herein is used interchangeably with similar mechanical characteristics, such as modulus of elasticity (Young's modulus), tensile strength or the like.
[0125]
[0126] Referring again to
[0127] As shown in
[0128] As further shown in
[0129] Conversely, the graduated strain relief fitting 1800 provides enhanced support proximate to the fitting proximal portion 1304 according to the first frame pitch 1810 (and counterpart first joint pitch 1806) relative to the second frame pitch 1812 (and counterpart second joint pitch 1808) at the fitting distal portion 1306. Accordingly, the fitting distal portion 1306 provides a support characteristic for the shaft proximal portion 106 configured to facilitate bending of the shaft proximal portion 106 but at the same time support the shaft proximal portion 106 and minimize (e.g., decrease, eliminate or the like), kinking, buckling or the like of the shaft. One example of the deformation is shown in the deflected configuration 1700 in
[0130] Optionally, the fitting distal portion 1306, including variations in the flexure joints 1802 and fitting frame 1804, provide a support characteristic, such as flexural modulus, approximating the flexural modulus of the catheter shaft 102. In another example, the flexural modulus of the fitting distal portion 1306 of the graduated strain relief fitting 1800 includes a flexural modulus less than or equal to the flexural modulus of the catheter shaft 102. The flexural modulus of the fitting distal portion 1306, when approximating the catheter shaft 102 (equal to or less than, within 1 to 5 percent of the catheter shaft or the like) facilitates the supported deformation of the catheter shaft 102 while the fitting 1800 assumes a supporting complementary profile, such as the profile 1702, shown in
[0131]
[0132] As further shown in
[0133]
[0134]
[0135] Conversely, the pitch of the fitting frame 1864 interposed between the flexure joints 1862 decreases between the fitting distal and proximal portions 1306, 1304. Accordingly, the first frame pitch 1870 (e.g., frame area per unit length, ratio of frame area to the joint area or the like) proximate to the fitting proximal portion 1306 is greater than the second frame pitch 1872 proximate to the fitting distal portion 1306. In a similar manner to the other graduated strain relief fittings described herein, the flexure joints 1862 and the fitting frame 1864 cooperate to modulate the support characteristics of the graduated strain relief fitting 1860, for instance, at the fitting interface 1516 and the hub interface 1514.
[0136] As shown in
[0137]
[0138]
[0139]
[0140]
[0141] The distal portion 103 of the catheter assembly 100 has varying imaging characteristics to facilitate identification of the distal portion 103 relative to other portions of the catheter assembly 100, for example identification of the distal portion 103 relative to the proximal portion 105 or intermediate portions of the catheter. In an example, a first section 2200 of the coil 2100 has a first imaging characteristic 2202 (e.g., radiopacity, radiodensity, radiopaqueness, radiolucentness, ultrasound opacity or the like). The coil 2100 includes a second section 2204, and the second section 2204 of the coil 2100 has a second imaging characteristic 2206. In an example, the first imaging characteristic 2022 differs from the second imaging characteristic 2206, for instance to provide contrast to the distal tip 104 relative to the remainder of the catheter body 102 (e.g., the proximal portion 103 of the catheter body 102). In some examples, the variation of characteristics, profiles of the sections or the like facilitate identification of the catheter including the location of the distal portion 103, its orientation or the like. In an example, the difference between the first imaging characteristic 2202 and the second imaging characteristic 2206 emphasizes visibility (e.g., observation, classification, discernment, distinguishing, determination of orientation or the like) of the distal tip 104 relative to the remainder of the catheter body 102. In another example, the difference between the first imaging characteristic 2202 and the second imaging characteristic 2206 contrasts the first section 2200 of the coil 2100 from the second section 2204 of the coil 2100. For instance, the first section 2200 is radiopaque based on the first imaging characteristic 2202, and the second section 2204 is radiolucent based on the second imaging characteristic 2206.
[0142] In yet another example, the difference between the first imaging characteristic 2202 and the second imaging characteristic 2206 emphasizes visibility of the first section 2200 of the coil 2100 as distinct from the second section 2204 of the coil 2100. Accordingly, the difference between the imaging characteristic 2202 of the first section 2200, and the imaging characteristic 2206 of the section 2204 facilitates identification of the distal tip 104 relative to other portions of the catheter body 102, such as the proximal portion 105 (shown in
[0143]
[0144] Referring to
[0145]
[0146] In an example, the second section 2204 of the coil 2100 has a first characteristic 2408 (e.g., length, width, radius, diameter, perimeter, area or the like). In another example, the second section 2204 of the coil 2100 has a second characteristic 2410 (e.g., length, width, radius, diameter, perimeter, area or the like). In one example, the first characteristic 2408 is in this example a length within a range of approximately 0.02 inches to approximately 0.07 inches (however the present subject matter is not so limited). In yet another example, the second characteristic 2410 is in this example a length within a range of approximately 0.015 inches to approximately 0.025 inches (however the present subject matter is not so limited).
[0147]
[0148]
[0149]
[0150] In an example, the expansion of the second braided layer 2600 at the second rate is less than the expansion of the first braided layer 2500 at the first rate. For instance, the first rate of expansion for the first braided layer 2500 is greater than the second rate of expansion of the second braided layer 2600 because of the angle of the first filar 2502 of the first braided layer 2500. Conversely, the angle of the second filar 2602 is less than the angle of the first filar 2502 and the second filar 2602 and the associate second braided layer 2600 more slowly expand with axial loading of the catheter 100. In one example, the second braided layer 2600 surrounds and engages with the first braided layer 2500, and thereby braces the first braided layer 2500 in the manner of a belt, girdle or ring. Accordingly, the second braided layer 2600 constrains and braces the first braided layer 2500, for instance due to the difference in rate of expansion between the first braided layers 2500 and the second braided layer 2600 when axially loaded. For instance, the constraint or bracing of the first braided layer 2500 by the second braided layer 2600 minimizes the risk of one or more of buckling, kinking or the like of the catheter body 102 during axial loading of the catheter assembly 100 (e.g., with compression, deflection or the like).
[0151] Referring to
[0152]
Various Notes & Examples
[0153] Example 1 is a catheter assembly, comprising: a catheter body extending from a catheter proximal portion to a catheter distal portion having a distal tip; a coil proximate to the catheter distal portion, the coil having a first section and a second section, wherein: the first section of the coil extends toward the distal tip, and the first section has a first imaging characteristic; the second section is swaged and extends from the first section to the distal tip, and the second section of the coil has a second imaging characteristic; and the second imaging characteristic differs from the first imaging characteristic, and the different first and second imaging characteristics are configured to contrast and emphasize visibility of the distal tip relative to the remainder of the catheter body.
[0154] In Example 2, the subject matter of Example 1 optionally includes wherein the second section of the coil includes a planar filar profile, and the planar filar profile includes a plurality of planar perimeter surfaces of swaged filars included in the swaged second section of the coil.
[0155] In Example 3, the subject matter of any one or more of Examples 1-2 optionally include a tip coating applied along a planar filar profile at the distal tip, and the planar filar profile includes a plurality of planar perimeter surfaces of swaged filars included in the swaged second section.
[0156] In Example 4, the subject matter of any one or more of Examples 1-3 optionally include wherein the coil includes platinum.
[0157] In Example 5, the subject matter of any one or more of Examples 1-4 optionally include wherein the catheter does not include a marker coupled to the catheter body proximate to the distal tip.
[0158] In Example 6, the subject matter of any one or more of Examples 1-5 optionally include inches.
[0159] In Example 7, the subject matter of any one or more of Examples 1-6 optionally include inches.
[0160] Example 8 is a catheter assembly, comprising: a catheter body extending from a catheter proximal portion to a catheter distal portion; a first braided layer within the catheter body; a second braided layer coupled along an exterior of the first braided layer; wherein the first and second braided layer include first and second, respective, filar arrays; and wherein the first and second braided layers are configured to expand to an expanded configuration with the application of axial force along a catheter longitudinal axis, and in the expanded configuration: the first braided layer is configured to expand at a first rate; the second braided layer is configured to expand at a second rate less than the first rate of expansion, and the expansion at the second rate is configured to constrain and brace the first braided layer.
[0161] In Example 9, the subject matter of Example 8 optionally includes wherein the first braided layer has a first braid profile, the second braided layer has a second braid profile, and the second braid profile is at an angle with respect to the first braid profile.
[0162] In Example 10, the subject matter of Example 9 optionally wherein the first braid profile is at an angle of approximately 45 degrees relative to a longitudinal axis of the catheter, and the second braid profile is at an angle of approximately 90 degrees relative to the longitudinal axis.
[0163] In Example 11, the subject matter of any one or more of Examples 8-10 optionally include a coil proximate to the catheter distal portion, the coil having a first section and a second section, wherein: the first section of the coil extends toward the distal tip, and the first section has a first imaging characteristic; the second section is swaged and extends from the first section to the distal tip, and the second section of the coil has a second imaging characteristic; and the second imaging characteristic differs from the first imaging characteristic, and the different first and second imaging characteristics are configured to contrast and emphasize visibility of the distal tip relative to the remainder of the catheter body.
[0164] In Example 12, the subject matter of any one or more of Examples 8-11 optionally include wherein the second braided layer constrains and braces the first braided layer and minimizes kinking of the catheter body.
[0165] Example 13 is a catheter assembly, comprising: a catheter body extending from a catheter proximal portion to a catheter distal portion having a distal tip; a coil proximate to the catheter distal portion, the coil having a first section and a second section, wherein: the first section of the coil extends toward the distal tip, and the first section has a first imaging characteristic; the second section is swaged and extends from the first section to the distal tip, and the second section of the coil has a second imaging characteristic; and the second imaging characteristic differs from the first imaging characteristic, and the different first and second imaging characteristics are configured to contrast and emphasize visibility of the distal tip relative to the remainder of the catheter body.
[0166] In Example 14, the subject matter of Example 13 optionally includes wherein the second section of the coil includes a planar filar profile, and the planar filar profile includes a plurality of planar perimeter surfaces of swaged filars included in the swaged second section of the coil.
[0167] In Example 15, the subject matter of any one or more of Examples 13-14 optionally include a tip coating applied along a planar filar profile at the distal tip, and the planar filar profile includes a plurality of planar perimeter surfaces of swaged filars included in the swaged second section.
[0168] In Example 16, the subject matter of any one or more of Examples 13-15 optionally include wherein the coil includes platinum.
[0169] In Example 17, the subject matter of any one or more of Examples 13-16 optionally include wherein the catheter does not include a marker coupled to the catheter body proximate to the distal tip.
[0170] In Example 18, the subject matter of any one or more of Examples 13-17 optionally include wherein the first braided layer has a first braid profile, the second braided layer has a second braid profile, and the second braid profile is at an angle with respect to the first braid profile.
[0171] In Example 19, the subject matter of Example 18 optionally includes wherein the first braid profile is at an angle of approximately 45 degrees relative to a longitudinal axis of the catheter, and the second braid profile is at an angle of approximately 90 degrees relative to the longitudinal axis.
[0172] In Example 20, the subject matter of any one or more of Examples 13-19 optionally include wherein the second braided layer constrains and braces the first braided layer and minimizes kinking of the catheter body.
[0173] Example 21 may include or use, or may optionally be combined with any portion or combination of any portions of any one or more of Examples 1 through 20 to include or use, subject matter that may include means for performing any one or more of the functions of Examples 1 through 20.
[0174] Each of these non-limiting examples can stand on its own, or can be combined in various permutations or combinations with one or more of the other examples.
[0175] The above detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the disclosure can be practiced. These embodiments are also referred to herein as examples. Such examples can include elements in addition to those shown or described. However, the present inventors also contemplate examples in which only those elements shown or described are provided. Moreover, the present inventors also contemplate examples using any combination or permutation of those elements shown or described (or one or more aspects thereof), either with respect to a particular example (or one or more aspects thereof), or with respect to other examples (or one or more aspects thereof) shown or described herein.
[0176] In the event of inconsistent usages between this document and any documents so incorporated by reference, the usage in this document controls.
[0177] In this document, the terms a or an are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of at least one or one or more. In this document, the term or is used to refer to a nonexclusive or, such that A or B includes A but not B, B but not A, and A and B, unless otherwise indicated. In this document, the terms including and in which are used as the plain-English equivalents of the respective terms comprising and wherein. Also, in the following claims, the terms including and comprising are open-ended, that is, a system, device, article, composition, formulation, or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms first, second, and third, etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.
[0178] The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) may be used in combination with each other. Other embodiments can be used, such as by one of ordinary skill in the art upon reviewing the above description. The Abstract is provided to comply with 37 C.F.R. 1.72(b), to allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features may be grouped together to streamline the disclosure. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter may lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description as examples or embodiments, with each claim standing on its own as a separate embodiment, and it is contemplated that such embodiments can be combined with each other in various combinations or permutations. The scope of the disclosure should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.