Patent Application
20250195035
The present disclosure pertains to medical devices, and methods for manufacturing medical devices. More particularly, the present disclosure pertains to intravascular imaging catheters.
A wide variety of medical devices have been developed for medical use, for example, intravascular use. Some of these devices include guidewires, catheters, and the like. These devices are manufactured by any one of a variety of different manufacturing methods and may be used according to any one of a variety of methods. Of the known medical devices and methods, each has certain advantages and disadvantages. There is an ongoing need to provide alternative medical devices as well as alternative methods for manufacturing and using medical devices.
This disclosure provides design, material, manufacturing method, and use alternatives for medical devices. An intravascular imaging device is disclosed. The intravascular imaging device comprises: a catheter shaft including a hypotube region, an imaging window region, and a distal end region having a guidewire lumen formed therein; wherein the hypotube region includes a slotted section having a plurality of slots formed therein; wherein the slotted section includes a plurality of discrete zones including a first zone, a second zone disposed proximal of the first zone, a third zone disposed proximal of the second zone, a fourth zone disposed proximal of the third zone, and a fifth zone disposed proximal of the fourth zone; wherein the first zone has a constant flexural rigidity; wherein one or more of the second zone, the third zone, and the fifth zone has a flexural rigidity that varies along a length thereof; and an imaging core disposed within the catheter shaft.
Alternatively or additionally to any of the embodiments above, a pitch of the slots in one or more of the first zone and the fourth zone is constant.
Alternatively or additionally to any of the embodiments above, a pitch of the slots in one or more of the second zone, third zone, and the fifth zone varies along the length thereof.
Alternatively or additionally to any of the embodiments above, the first zone has a length of about 20-60 mm.
Alternatively or additionally to any of the embodiments above, the first zone has a flexural rigidity of about 20-40 N*mm2.
Alternatively or additionally to any of the embodiments above, the second zone has a length of about 20-60 mm.
Alternatively or additionally to any of the embodiments above, the second zone has a distal flexural rigidity adjacent to the first zone that is about 20-40 N*mm2 and a proximal flexural rigidity adjacent to the third zone that is about 40-80 N*mm2.
Alternatively or additionally to any of the embodiments above, the third zone has a length of about 50-150 mm.
Alternatively or additionally to any of the embodiments above, the third zone has a distal flexural rigidity adjacent to second zone that is about 40-80 N*mm2 and a proximal flexural rigidity adjacent to the third zone that is about 1000-1500 N*mm2.
Alternatively or additionally to any of the embodiments above, the fourth zone has a length of about 40-120 mm.
Alternatively or additionally to any of the embodiments above, the fourth zone has a flexural rigidity of about 1000-1500 N*mm2.
Alternatively or additionally to any of the embodiments above, the fifth zone has a length of about 10-50 mm.
Alternatively or additionally to any of the embodiments above, the fifth zone has a distal flexural rigidity adjacent to fourth zone that is about 1000-1500 N*mm2 and a proximal flexural rigidity that is about 2000-3000 N*mm2.
Alternatively or additionally to any of the embodiments above, the catheter shaft includes a distal end zone disposed distal of the first zone, the distal end zone being free of slots.
An intravascular imaging device is disclosed. The intravascular imaging device comprises: a catheter shaft including a hypotube region and an imaging window region; wherein the hypotube region includes a first section and a second section; wherein the second section includes a plurality of discrete zones including a first zone, a second zone disposed proximal of the first zone, a third zone disposed proximal of the second zone, a fourth zone disposed proximal of the third zone, and a fifth zone disposed proximal of the fourth zone; wherein the first zone has a constant flexural rigidity; wherein one or more of the second zone, the third zone, and the fifth zone has a flexural rigidity that varies along a length thereof; wherein one or more of the first zone, the second zone, the third zone, the fourth zone, and the fifth zone have a plurality of slots formed therein; and an imaging core disposed within the catheter shaft.
Alternatively or additionally to any of the embodiments above, the second zone has a distal flexural rigidity adjacent to the first zone that is about 20-40 N*mm2 and a proximal flexural rigidity adjacent to the third zone that is about 40-80 N*mm2.
Alternatively or additionally to any of the embodiments above, the third zone has a distal flexural rigidity adjacent to second zone that is about 40-80 N*mm2 and a proximal flexural rigidity adjacent to the third zone that is about 1000-1500 N*mm2.
Alternatively or additionally to any of the embodiments above, the fifth zone has a distal flexural rigidity adjacent to fourth zone that is about 1000-1500 N*mm2 and a proximal flexural rigidity that is about 2000-3000 N*mm2.
Alternatively or additionally to any of the embodiments above, the catheter shaft includes a distal end zone disposed distal of the first zone, the distal end zone being free of slots.
A method for imaging a blood vessel is disclosed. The method comprises: disposing an intravascular imaging device within a blood vessel, the intravascular imaging device comprising: a catheter shaft including a hypotube region, an imaging window region, and a distal end region having a guidewire lumen formed therein, wherein the hypotube region includes a slotted section having a plurality of slots formed therein, wherein the slotted section includes a plurality of discrete zones including a first zone, a second zone disposed proximal of the first zone, a third zone disposed proximal of the second zone, a fourth zone disposed proximal of the third zone, and a fifth zone disposed proximal of the fourth zone, wherein the first zone has a constant flexural rigidity, wherein one or more of the second zone, the third zone, and the fifth zone has a flexural rigidity that varies along a length thereof, and an imaging core disposed within the catheter shaft; and translating the imaging core relative to the catheter shaft.
The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present disclosure. The Figures, and Detailed Description, which follow, more particularly exemplify these embodiments.
The disclosure may be more completely understood in consideration of the following detailed description in connection with the accompanying drawings, in which:
While the disclosure is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the disclosure.
For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification.
All numeric values are herein assumed to be modified by the term “about”, whether or not explicitly indicated. The term “about” generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value (e.g., having the same function or result). In many instances, the terms “about” may include numbers that are rounded to the nearest significant figure.
The recitation of numerical ranges by endpoints includes all numbers within that range (e.g. 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).
As used in this specification and the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term “or” is generally employed in its sense including “and/or” unless the content clearly dictates otherwise.
It is noted that references in the specification to “an embodiment”, “some embodiments”, “other embodiments”, etc., indicate that the embodiment described may include one or more particular features, structures, and/or characteristics. However, such recitations do not necessarily mean that all embodiments include the particular features, structures, and/or characteristics. Additionally, when particular features, structures, and/or characteristics are described in connection with one embodiment, it should be understood that such features, structures, and/or characteristics may also be used connection with other embodiments whether or not explicitly described unless clearly stated to the contrary.
The following detailed description should be read with reference to the drawings in which similar elements in different drawings are numbered the same. The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the invention.
An imaging assembly 22 (e.g., which may sometime be referred to as an imaging core) may be disposed within a lumen of the elongate shaft 12. In general, the imaging assembly 22 may be used to capture/generate images of a blood vessel. In some instances, the medical device may include devices and/or features similar to those disclosed in U.S. Patent Application Pub. No. US 2012/0059241 and U.S. Patent Application Pub. No. US 2017/0164925, the entire disclosures of which are herein incorporated by reference. In at least some instances, the medical device 10 may resemble and/or include features that resemble the OPTICROSS™ Imaging Catheter, commercially available from BOSTON SCIENTIFIC, Marlborough, MA.
The imaging assembly 22 may include a drive shaft or cable 24, a housing 26, and an imaging member or transducer 28 coupled to the drive shaft 24 and/or housing 26. In at least some instances, the transducer 28 includes an ultrasound transducer. Other transducers are also contemplated. The transducer 28 may be rotatable and/or axially translatable relative to the elongate shaft 12. For example, the drive shaft 24 may be rotated and/or translated in order to rotate and/or translate the transducer 28 (and the housing 26).
The proximal end region 14 of the elongate shaft 12 may be coupled to a telescoping assembly 18 as shown in
The proximal end region 14 of the elongate shaft 12 may be coupled to the telescoping assembly 18. For example, the proximal end region 14 of the elongate shaft 12 may be coupled to a distal hub 46 of the telescoping assembly 18. A proximal hub 44 may be coupled to the telescoping assembly 18 (e.g., at the proximal end of the telescoping assembly 18). The drive shaft 24 (see
The telescoping assembly 18 may include a first sheath 38 and a second sheath 40. In some instances, the first sheath 38 may be understood to be an inner telescoping tube 38 and the second sheath 40 may be understood to be an outer telescoping tube 40. Generally, the outer telescoping tube 40 may be disposed over the inner telescoping tube 38. The inner telescoping tube 38 may be coupled to or otherwise secured to the proximal hub 44. The outer telescoping tube 40 may be coupled or otherwise secured to the distal hub 46. The inner telescoping tube 38 may be axially and/or rotatably moveable relative to the outer telescoping tube 40. Because the drive shaft 24 may be secured to the proximal hub 44 and/or the inner telescoping tube 38 and because the elongate shaft 12 may be secured to the distal hub 46, movement of the proximal hub 44 relative to the distal hub 46 results in movement of the inner telescoping tube 38 and the drive shaft 24 relative to the distal hub 46 and/or the elongate shaft 12.
In use, the elongate shaft 12 may be disposed within a target region (e.g., a blood vessel) and the imaging assembly 22 may be translated within the elongate shaft 12 in order to image the blood vessel. It can be appreciated that navigating the elongate shaft 12 through the vasculature toward the target region may include navigating the elongate shaft 12 through a number of tortuous bends and turns. As such, it may be desirable for the elongate shaft 12 to be sufficiently flexible in order to navigate such anatomy. Furthermore, it may be desirable for the elongate shaft 12 to be sufficiently pushable (e.g., in a manner that resists buckling) and be capable of transmitting torque along the length of the elongate shaft 12. Disclosed herein are medical devices (e.g., such as the medical device 10) where the elongate shaft 12 is designed to have a desirable level of flexibility, pushability, torquability, and/or other characteristics.
The elongate shaft 12 may also include a hypotube region 50. The hypotube region 50 may extend proximally from the imaging window region 48 to the distal hub 46. The hypotube region 50 may include a first portion 52 a second portion 54. The first portion 52 may be free of slots. The second portion 54 may have a plurality of slots 56 formed therein. The slots 56 may help to provide a desirable level of flexibility (and/or pushability and/or torqueability) of the elongate shaft 12. Various arrangements and configurations are contemplated for slots 56. For example, in some embodiments, at least some, if not all of the slots 56 are disposed at the same or a similar angle with respect to the longitudinal axis of the hypotube region 50. In some instances, the slots 56 can be disposed at an angle that is perpendicular, or substantially perpendicular, and/or can be characterized as being disposed in a plane that is normal to the longitudinal axis of the hypotube region 50. However, in other instances, the slots 56 can be disposed at an angle that is not perpendicular, and/or can be characterized as being disposed in a plane that is not normal to the longitudinal axis of the hypotube region 50. This may include angled slots 56, slots 56 arranged in a spiral or helical pattern/arrangement, and/or the like. Additionally, a group of one or more slots 56 may be disposed at different angles relative to another group of one or more slots 56. The distribution and/or configuration of the slots 56 can also include, to the extent applicable, any of those disclosed in U.S. Pat. Publication No. US 2004/0181174, the entire disclosure of which is herein incorporated by reference.
The slots 56 can be formed by methods such as micro-machining, saw-cutting (e.g., using a diamond grit embedded semiconductor dicing blade), electrical discharge machining, grinding, milling, casting, molding, chemically etching or treating, or other known methods, and the like. In at least some embodiments, the slots 56 may be formed in tubular member using a laser cutting process. The laser cutting process may include a suitable laser and/or laser cutting apparatus. In some embodiments, the slots 56 may have a width of about 0.005-0.04 mm (about 0.0002-0.0016 inches), or about 0.01-0.03 mm (about 0.0004-0.0012 inches), or about 0.02 mm (about 0.0079 inches). The width of the slots 56 may be constant or may be vary along the length of the hypotube region 50. The spacing between axially-adjacent slots 56 may be about 0.1-4 mm (about 0.0004-0.16inches), or about 0.2-3 mm (about 0.0008-0.12 inches), or about 0.25-2 mm (about 0.01-0.08 inches). The spacing may be constant or may vary along the length of the hypotube region 50.
In some instances, it may be desirable for the slots 56 to be arranged in the hypotube region 50 in a manner that helps to provide desirable flexibility and other characteristics. This may include arrangements of the slots 56 that are configured to provide flexibility characteristics that allow the device 10 to navigate the anatomy. For example, as indicated herein, the first portion 52 of the hypotube region 50 may be free of slots. The second portion 54 of the hypotube region 50 may include slots 56 along one or more sections/regions of its length. In some instances, the second portion 54 of the hypotube region 50 may include a plurality of discrete and/or distinct sections. For example, one or more of the different sections may include or be free of slots 56. The different sections may differ in length. The different sections may differ in the angle that the slots 56 are cut into the second portion 54. The different sections may differ in the pitch or spacing of the slots 56. These differences, which may be combined in different hypotube regions 50, may help to provide desirable characteristics.
The distal end zone 160 may be positioned at or adjacent to the distal end of the second portion 154 of the hypotube region 150 and/or distal of the first zone 162. The distal end zone 160 may have a length of about 0.1-0.8 mm (about 0.004-0.03 inches), or about 0.2-0.5 mm (about 0.008-0.02 inches), or about 0.31-0.41 mm (about 0.012-0.016 inches), or about 0.36 mm (about 0.014 inches). In this example, the distal end zone 160 may be free of slots. This may improve/enhance the ability of the hypotube region 150 to be bonded to other structures of a medical device such as the imaging window region (e.g., the imaging window region 48). In addition or in the alternative, this may improve the robustness of the hypotube region 150, which may aid in handling during assembly of the medical device. In some instances, the distal end zone 160 may represent the part of the second portion 154 of the hypotube region 150 that is uncut prior to slots 156 formed in the second portion 154 of the hypotube region 150.
The first zone 162 may be disposed proximal of the distal end zone 160. In some instances, the first zone 162 may include slots 156 and may be understood to be a “constant pitch” section (e.g., where the angle or slant that the slots 156 are oriented at relative to the longitudinal axis of the hypotube region 150 remains constant). For the purposes of this disclosure, a cut that is perpendicular to the longitudinal axis of the hypotube region 150 may form a slot 156 having a pitch of 90 degrees. In some instances, the pitch may be about 30-90 degrees, or about 60-90 degrees or about 80-90 degrees, or about 85-88 degrees. The first zone 162 may have a length of about 10-100 mm (about 0.4-4 inches), or about 20-60 mm (about 0.8-2.4 inches), or about 40 mm (about 1.6 inches). The flexural rigidity along the first zone 162 may be constant. In some instances, the flexural rigidity along the first zone 162 may be about 10-50 N*mm2, or about 20-40 N*mm2, or about 30 N*mm2.
The cuts forming the slots 156 in the first zone 162 may be described as angled and/or a spiral cut and/or an interrupted spiral cut. The same may be true of other zones of the second portion 154 of the hypotube region 150. In some instances, the ends of the cuts forming the slots 156 may overlap with the end of longitudinally-adjacent slots 156. The amount of overlap can vary. In some instances, the cut angle of the slots 156 in the first zone 162 may be held constant. For the purposes of this disclosure, the cut angle or arc length may be understood to be the number of degrees about the circumference of the hypotube region 150 that a cut forming a slot 156 extends about the hypotube region 150. The cut angle in the first zone 162 may be about 120-215 degrees, or about 140-175 degrees, or about or about 155 degrees. When the cuts forming the slots 156 are arranged as or form an interrupted spiral cut, it can be appreciated that the hypotube region 150 may also have an uncut angle or uncut arc length where the hypotube region 150 is uncut (e.g., uncut between slots 156 following a spiral path about the hypotube region 150). For the purposes of this disclosure, the uncut angle or uncut arc length may be understood to be the number of degrees about the circumference of the hypotube region 150 this is uncut between slots 156 (e.g., uncut between slots 156 following a spiral path about the hypotube region 150). The uncut angle in the first zone 162 may be about 30-70 degrees, or about 40-60 degrees, or about 50 degrees. Again, the same may be true of other zones of the second portion 154 of the hypotube region 150. Alternatively, different zones of the second portion 154 of the hypotube region 150 may utilize different cut angles.
The second zone 164 may be disposed proximal of the first zone 162. In some instances, the second zone 164 may include slots 156 and may be understood to be a “variable pitch” section (e.g., where the angle or slant that the slots 156 are oriented at relative to the longitudinal axis of the hypotube region 150 varies along the length of the second zone 164). In some instances, the pitch of slots 156 in the second zone 164 that are disposed adjacent to the first zone 162 may be about 30-90 degrees, or about 60-90 degrees or about 80-90 degrees, or about 85-88 degrees. The pitch of slots 156 in the second zone 164 that are disposed adjacent to the third zone 166 may be about 30-90 degrees, or about 60-90 degrees or about 75-85 degrees. The second zone 164 may have a length of about 10-100 mm (about 0.4-4 inches), or about 20-60 mm (about 0.8-2.4 inches), or about 40 mm (about 1.6 inches). The flexural rigidity along the second zone 164 may be vary along the length of the second zone 164. Adjacent the distal end of the second zone 164 (e.g., adjacent to the first zone 162), the flexural rigidity (e.g., a distal flexural rigidity) may be about 10-50 N*mm2, or about 20-40 N*mm2, or about 30 N*mm2. Adjacent the proximal end of the second zone 164 (e.g., adjacent to the third zone 166), the flexural rigidity (e.g., a proximal flexural rigidity) may be about 20-100 N*mm2, or about 40-80 N*mm2, or about 67 N*mm2. The change or transition in flexural rigidity may be constant/linear over the length of the second zone 164 or vary along the length of the second zone 164. In other words, the change or transition in flexural rigidity may be constant or it may increase at a changing rate over the length of the second zone 164.
The third zone 166 may be disposed proximal of the second zone 164. In some instances, the third zone 166 may include slots 156 and may be understood to be a “variable pitch” section. In some instances, the pitch of slots 156 in the third zone 166 that are disposed adjacent to the second zone 164 may be about 30-90 degrees, or about 60-90 degrees or about 75-85 degrees. The pitch of slots 156 in the third zone 166 that are disposed adjacent to the fourth zone 168 may be about 30-90 degrees, or about 60-90 degrees or about 65-80 degrees. The third zone 166 may have a length of about 20-200 mm (about 0.8-8 inches), or about 50-150 mm (about 2-6 inches), or about 110 mm (about 4.3 inches). The flexural rigidity along the third zone 166 may be vary along the length of the third zone 166. Adjacent the distal end of the third zone 166 (e.g., adjacent to the second zone 164), the flexural rigidity (e.g., a distal flexural rigidity) may be about 20-100 N*mm2, or about 40-80 N*mm2, or about 67 N*mm2. Adjacent the proximal end of the third zone 166 (e.g., adjacent to the fourth zone 168), the flexural rigidity (e.g., a proximal flexural rigidity) may be about 400-2000 N*mm2, or about 1000-1500 N*mm2, or about 1200 N*mm2. The change or transition in flexural rigidity may be constant/linear over the length of the third zone 166 or vary along the length of the third zone 166. In other words, the change or transition in flexural rigidity may be constant or it may increase at a changing rate over the length of the third zone 166.
The fourth zone 168 may be disposed proximal of the third zone 166. In some instances, the fourth zone 168 may include slots 156 and may be understood to be a “constant pitch” section. The pitch of slots 156 in the fourth zone 168 may be about 30-90 degrees, or about 60-90 degrees or about 65-80 degrees. The fourth zone 168 may have a length of about 20-200 mm (about 0.8-8 inches), or about 40-120 mm (about 1.6-4.8 inches), or about 80 mm (about 3.2 inches). The flexural rigidity along the fourth zone 168 may be constant. In some instances, the flexural rigidity along the fourth zone 168 may be about 400-2000 N*mm2, or about 1000-1500 N*mm2, or about 1200 N*mm2.
The fifth zone 170 may be disposed proximal of the fourth zone 168. In some instances, the fifth zone 170 may include slots 156 and may be understood to be a “variable pitch” section. In some instances, the pitch of slots 156 in the fifth zone 170 that are disposed adjacent to the fourth zone 168 may be about 30-90 degrees, or about 60-90 degrees or about 65-80 degrees. The pitch of slots 156 in the fifth zone 170 that are disposed adjacent to the first portion 152 of the hypotube region 150 may be about 30-90 degrees, or about 55-80 degrees or about 60-75 degrees. The fifth zone 170 may have a length of about 5-75 mm (about 0.2-3 inches), or about 10-50 mm (about 0.4-5 inches), or about 30 mm (about 1.2 inches). The flexural rigidity along the fifth zone 170 may be vary along the length of the fifth zone 170. Adjacent the distal end of the fifth zone 170 (e.g., adjacent to the fourth zone 168), the flexural rigidity (e.g., a distal flexural rigidity) may be about 400-2000 N*mm2, or about 1000-1500 N*mm2, or about 1200 N*mm2. Adjacent the proximal end of the fifth zone 170 (e.g., adjacent to the first portion 152 of the hypotube region 150), the flexural rigidity (e.g., a proximal flexural rigidity) may be about 1500-3500 N*mm2, or about 2000-3000 N*mm2, or about 2600 N*mm2. The change or transition in flexural rigidity may be constant/linear over the length of the fifth zone 170 or vary along the length of the fifth zone 170. In other words, the change or transition in flexural rigidity may be constant or it may increase at a changing rate over the length of the fifth zone 170.
In some instances, the overall flexibility characteristics of the hypotube region 150 may aid in navigating a medical device (e.g., such as the medical device 10 with the hypotube region 150 utilized therein) to a target region. For example, when using a radial approach to coronary vessels, the flexibility characteristics of the hypotube region 150 may aid in navigating the tortuous anatomy. It can be appreciated that other hypotube regions are contemplated that may include differing numbers and/or arrangements of zones. Such variations may aid in navigating a medical device (e.g., such as the medical device 10 with the hypotube region 150 utilized therein) to a target region with other approaches (e.g., such as a femoral approach and/or other non-radial approaches).
The materials that can be used for the various components of the medical device 10 (and/or other devices disclosed herein) and the various tubular members disclosed herein may include those commonly associated with medical devices. For simplicity purposes, the following discussion refers to the elongate shaft 12 and other components of the medical device 10. However, this is not intended to limit the devices and methods described herein, as the discussion may be applied to other similar tubular members and/or components of tubular members or devices disclosed herein.
The elongate shaft 12 and/or other components of the medical device 10 may be made from a metal, metal alloy, polymer (some examples of which are disclosed below), a metal-polymer composite, ceramics, combinations thereof, and the like, or other suitable material. Some examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, for example, DELRIN® available from DuPont), polyether block ester, polyurethane (for example, Polyurethane 85A), polypropylene (PP), polyvinylchloride (PVC), polyether-ester (for example, ARNITEL® available from DSM Engineering Plastics), ether ester based copolymers (for example, butylene/poly(alkylene ether) phthalate and/or other polyester elastomers such as HYTREL® available from DuPont), polyamide (for example, DURETHAN® available from Bayer or CRISTAMID® available from Elf Atochem), elastomeric polyamides, block polyamide/ethers, polyether block amide (PEBA, for example available under the trade name PEBAX®), ethylene vinyl acetate copolymers (EVA), silicones, polyethylene (PE), high-density polyethylene, low-density polyethylene, linear low density polyethylene (for example REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly paraphenylene terephthalamide (for example, KEVLAR®), polysulfone, nylon, nylon-12 (such as GRILAMID® available from EMS American Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (for example, SIBS and/or SIBS 50A), polycarbonates, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers thereof, polymer/metal composites, and the like. In some embodiments the sheath can be blended with a liquid crystal polymer (LCP). For example, the mixture can contain up to about 6 percent LCP.
Some examples of suitable metals and metal alloys include stainless steel, such as 304V, 304L, and 316LV stainless steel; mild steel; nickel-titanium alloy such as linear-clastic and/or super-elastic nitinol; other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625 such as INCONEL® 625, UNS: N06022 such as HASTELLOY® C-22®, UNS: N10276 such as HASTELLOY® C276®, other HASTELLOY® alloys, and the like), nickel-copper alloys (e.g., UNS: N04400 such as MONEL® 400, NICKELVAC® 400, NICORROS® 400, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such as MP35-N® and the like), nickel-molybdenum alloys (e.g., UNS: N10665 such as HASTELLOY® ALLOY B2®), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, and the like; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R30003 such as ELGILOY®, PHYNOX®, and the like); platinum enriched stainless steel; titanium; combinations thereof; and the like; or any other suitable material.
In at least some embodiments, portions or all of the medical device 10 may also be doped with, made of, or otherwise include a radiopaque material. Radiopaque materials are understood to be materials capable of producing a relatively bright image on a fluoroscopy screen or another imaging technique during a medical procedure. This relatively bright image aids the user of the medical device 10 in determining its location. Some examples of radiopaque materials can include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloy, polymer material loaded with a radiopaque filler, and the like. Additionally, other radiopaque marker bands and/or coils may also be incorporated into the design of the medical device 10 to achieve the same result.
In some embodiments, a degree of Magnetic Resonance Imaging (MRI) compatibility is imparted into the medical device 10. For example, the medical device 10, or portions thereof, may be made of a material that does not substantially distort the image and create substantial artifacts (e.g., gaps in the image). Certain ferromagnetic materials, for example, may not be suitable because they may create artifacts in an MRI image. The medical device 10, or portions thereof, may also be made from a material that the MRI machine can image. Some materials that exhibit these characteristics include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R30003 such as ELGILOY®, PHYNOX®, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such as MP35-N® and the like), nitinol, and the like, and others.
It should be understood that this disclosure is, in many respects, only illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps without exceeding the scope of the disclosure. This may include, to the extent that it is appropriate, the use of any of the features of one example embodiment being used in other embodiments. The invention's scope is, of course, defined in the language in which the appended claims are expressed.
This application claims the benefit of priority under 35 U.S.C. § 119 of U.S. Provisional Application No. 63/609,408, filed Dec. 13, 2023, the entire disclosure of which is hereby incorporated by reference.
| Number | Date | Country | |
|---|---|---|---|
| 63609408 | Dec 2023 | US |
