Micro-molded anamorphic reflector lens for image guided therapeutic/diagnostic catheters
11627881 · 2023-04-18
Assignee
Inventors
- Himanshu N. PATEL (San Jose, CA, US)
- Manish KANKARIA (Fremont, CA, US)
- Kin F. CHAN (Los Gatos, CA, US)
Cpc classification
G01B9/02091
PHYSICS
A61B5/0084
HUMAN NECESSITIES
A61B5/02007
HUMAN NECESSITIES
A61B2562/0233
HUMAN NECESSITIES
International classification
A61B5/00
HUMAN NECESSITIES
A61B5/02
HUMAN NECESSITIES
A61B90/00
HUMAN NECESSITIES
G01B9/02091
PHYSICS
G02B27/09
PHYSICS
Abstract
A catheter system for optical coherence tomography includes an elongate catheter body, an optical fiber in the elongate catheter body, and an anamorphic lens assembly coupled with a distal end of the optical fiber. The optical fiber and the lens assembly are together configured to provide a common path for optical radiation reflected from a target and from a reference interface between the distal end of the optical fiber and the lens assembly.
Claims
1. A catheter for optical coherence tomography (OCT), comprising: an elongate catheter body; an optical fiber in the elongate catheter body; and a lens assembly, the lens assembly comprising: an elongate body having a channel extending therethrough, a distal end of the optical fiber positioned within the channel; a lens body integral with the elongate body; and an interface medium within the channel and attaching the lens body to the optical fiber; wherein the optical fiber and the lens assembly are together configured to provide a common path for optical radiation reflected from a target and from a reference interface formed by the interface medium.
2. The catheter of claim 1, wherein the lens body comprises a concave lens surface.
3. The catheter of claim 2, wherein the concave lens surface has a compound radius having a first radius along a first axis that is different from a second radius along a second axis.
4. The catheter of claim 2, wherein the concave lens surface is positioned opposite from and at an angle relative to the distal end of the optical fiber.
5. The catheter of claim 2, wherein a tangent of the concave lens surface is at an angle of between about 40 degrees and 50 degrees relative to a longitudinal axis of the optical fiber.
6. The catheter of claim 2, wherein a radius of curvature of the concave lens surface is between 0.2 mm and 1.5 mm.
7. The catheter of claim 1, further comprising a reflective coating on the lens body.
8. The catheter of claim 7, further comprising a source of optical radiation, wherein the reflective coating has a thickness of at least ⅙ of an excitation wavelength of the source of optical radiation.
9. The catheter of claim 7, wherein the reflective coating comprises gold.
10. The catheter of claim 7, wherein the reflective coating comprises a dielectric.
11. The catheter of claim 7, wherein the reflective coating has an optical density of greater than 3.0.
12. The catheter of claim 1, wherein the reference interface provides a reference reflection of between −28 and −42 dB.
13. The catheter of claim 1, further comprising a source of optical radiation, receiving electronics configured to receive optical radiation reflected from the reference interface and the target, and a processor to generate an image of the target based upon the optical radiation received by the receiving electronics.
14. The catheter of claim 1, wherein the lens assembly comprises a polycarbonate material.
15. The catheter of claim 1, wherein a secondary reflection of optical radiation from an interface between the optical fiber and the lens assembly is less than −60 dB.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) The novel features of the invention are set forth with particularity in the claims that follow. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which:
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
(12)
(13)
DETAILED DESCRIPTION
(14) Described herein are lens assemblies for use with an imaging device. Any of the lens assemblies described herein may be anamorphic lens assemblies (i.e., lens assemblies that are circularly nonsymmetric and have or produce unequal magnifications along two different axes, i.e., two different axes that are perpendicular to one another). The anamorphic lens, for example, can include two different radii along two different axes. The lens assemblies described herein may be used as part of any optical coherence tomography (OCT) device, and particularly as part of a common path OCT device, which may be included as part of a catheter or other device. The lens assembly may be, for example, placed in and/or on a distal tip of a catheter to: (1) direct the beam towards the imaging object and (2) focus the beam on the imaging object for improved image quality.
(15) The lens assemblies described herein may be formed, e.g., using a mold. Thus, any of the lens assemblies may also be referred to as “molds” or “mold assemblies.” In some embodiments, the lens assemblies described herein may be made from polycarbonate material, such as Makrolon 2558. In some embodiments, the refractive index of the lens assembly can be close to the refractive index of the interface medium (e.g., epoxy) used to connect the lens assembly to the distal end of the imaging fiber optic.
(16) Referring to
(17) The distal surface 221 of the lens can have a compound radius (e.g., a different radius along the x-axis than along the y-axis). Further, the outer portion of the distal surface 221 can be convex (i.e., such that light hits the concave inner portion). The distal surface 221 can have a radius of curvature, for example, of between 0.2 mm and 1.5 mm.
(18) Further, the distal surface 221 can include a mirror 201 attached or coated thereon. Thus, the mirror 201 can include a coating and/or attached layer on the distal surface 221 of the lens 210. The mirror can have a thickness that is configured to reflect more than 70% (e.g., more than 75%, more than 80%, more than 85%, more than 90%, more than 95%, etc.) of light. In one example, the mirror or coating can have a thickness of greater than or equal to 100 nm, such as greater than or equal to 200 nm or greater than or equal to 250 nm in thickness. In some embodiments, the mirror or coating can have an optical density of 3.0 or greater, such as 3.5 or greater. Any appropriate reflective material may be used for the mirror or coating. For example, the reflective material may include gold, silver, or platinum. Further, the mirror 201 can be angled at approximately 45 degrees, where the angle is defined as the angle off the intersection of the fiber optical axis the second surface (i.e., the angle between the optical axis and the tangent to the compound second surface at the intersection with the second surface).
(19) In this embodiment, the proximal surface 211 of the lens 210 can be oriented substantially parallel to the distal surface 212 of the optical fiber. Further, the outer surface 217 of the lens 210 can be substantially parallel to the axis of the fiber 215 (and therefore substantially perpendicular to the proximal surface 211 of the lens and the distal surface 212 of the optical fiber). In one embodiment, surfaces 211, 217 can be substantially flat. In another embodiment, the surfaces can be slightly curved with a radius of curvature of 0.1 inches or more.
(20) In use, light from the light source can pass through the optical fiber 215. At the interface of the distal end 212 of the optical fiber and the interface medium 202, some of the light will be reflected back so as to create the reference reflection. The rest of the light can pass from the distal end 212 of the optical fiber through the interface medium 202, and through the proximal surface 211 of the lens. Because the indices of refraction of the fiber and the interface medium are closely matched, only a minimal amount (e.g., less than −55 dB) of light will be reflected back from the surface 211. The light can thus travel through the lens 210 and impinge on the mirror 201. Because of the 45 degree angle and the compound surface of the mirror 201, the light can be reflected perpendicular to the longitudinal axis of the fiber 315 with a beam profile 213 that is close to circular when it exits the outer surface 217 of the lens 210.
(21) As shown in
(22)
(23) Referring to
(24)
(25)
(26)
(27) Thus, as discussed above, the SMF-GRIN and mirror assembly required for many prior art devices can be replaced with a single anamorphic lens assembly as described herein.
(28) In some embodiments, the anamorphic lenses described herein can be made of polycarbonate.
(29) Further, in some embodiments, the lens assemblies described herein can be molded. Molding a material, such as a polycarbonate, can be relatively inexpensive and easy to make, simplifying the manufacturing process and lowering the cost for making imaging assemblies.
(30) Referring to
(31) The interface mediums described herein can be, for example, an epoxy, such as a UV-curing epoxy.
(32) As mentioned and illustrated, the use of the anamorphic lens assemblies described herein may shorten the length of the distal tip of the devices in which the assemblies are used. The length of the stripped section of the fiber may be much smaller, so the distal imaging and therapeutic housing can be made much smaller.
(33) The lens assemblies described herein can have significantly better focusing capability suited to the geometry of a catheter. For example, the radius of curvature of the anamorphic lens structures described herein may be such that the focus is a preferred (further) distance away from the housing.
(34) In some embodiments, the lens assemblies described herein can themselves cause the reflection of the light beam into the tissue. That is, the reflective surfaces can be uncoated, and the reflection can be caused by a total internal reflection resulting from the mismatch of the refractive indices between the lens material and the interface medium and/or air surrounding the lens. In such embodiments, the refractive index of the lens material can be high, such as 1.0 or greater, 1.2 or greater, 1.5 or greater, or 1.7 or greater. Further, in embodiments where light travels through the lens, the distal surface of the lens can be bordered by air to ensure total internal reflection.
(35) In some embodiments, the reference reflection can be made by a surface other than the optical fiber/interface medium surface. For example, the reference reflection can be made by the proximal or distal surfaces of the lens assembly and/or by the outer surface of the lens assembly. In such an embodiment, the indices of refraction of the interface medium and the core of the optical fiber can be closely matched (e.g., within 0.02) in order to provide only minimal secondary reflection at that interface.
(36) The lens assemblies described herein can be used with a variety of different imaging catheters. For example, the lens assemblies can be used with: U.S. patent application Ser. No. 12/829,277, filed Jul. 1, 2010, titled “ATHERECTOMY CATHETER WITH LATERALLY-DISPLACEABLE TIP,” now U.S. Patent Application Publication No. 2011/0004107; U.S. patent application Ser. No. 12/829,267, filed Jul. 1, 2010, titled “CATHETER-BASED OFF-AXIS OPTICAL COHERENCE TOMOGRAPHY IMAGING SYSTEM,” now U.S. Pat. No. 9,125,562; U.S. patent application Ser. No. 13/175,232, filed Jul. 1, 2011, titled “ATHERECTOMY CATHETERS WITH LONGITUDINALLY DISPLACEABLE DRIVE SHAFTS,” now U.S. Pat. No. 9,345,510; U.S. patent application Ser. No. 13/433,049, filed Mar. 28, 2012, titled “OCCLUSION-CROSSING DEVICES, IMAGING, AND ATHERECTOMY DEVICES,” now U.S. Pat. No. 8,644,913; U.S. patent application Ser. No. 14/401,175, filed Nov. 14, 2014, titled “ATHERECTOMY CATHETERS WITH IMAGING,” now U.S. Patent Application Publication No. 2016/0141816; U.S. patent application Ser. No. 14/424,277, filed Feb. 26, 2015, titled “BALLOON ATHERECTOMY CATHETERS WITH IMAGING,” now U.S. Patent Application Publication No. 2015/0208922; U.S. patent application Ser. No. 14/776,750, filed Sep. 15, 2015, titled “CHRONIC TOTAL OCCLUSION CROSSING DEVICES WITH IMAGING, now U.S. Patent Application Publication No. 2016/0029902; U.S. patent application Ser. No. 15/072,272, filed Mar. 16, 2016, titled “ATHERECTOMY CATHETERS DEVICES HAVING MULTI-CHANNEL BUSHINGS,” now U.S. Patent Application Publication No. 2016/0192962; U.S. patent application Ser. No. 15/076,568, filed Feb. 5, 2015, titled “ATHERECTOMY CATHETERS AND OCCLUSION CROSSING DEVICES;” and International Patent Application No. PCT/US2015/039585, filed Jul. 8, 2015, titled “HIGH SPEED CHRONIC TOTAL OCCLUSION CROSSING DEVICES,” now International Patent Publication No. WO 2016/007652, the entireties of which are incorporated by reference.
(37) The lens assemblies described herein can be used, for example, as part of an optical coherence tomography (OCT) system. Referring to
(38) In some embodiments, a secondary reflection of optical radiation from an interface between the optical fiber and the lens assembly is less than −60 dB. Further, in some embodiments, the reference interface provides a reference reflection of between −28 and −42 dB.
(39) Also described herein are carbon dioxide supply cartridges that can be used, for example, to inflate a balloon of a balloon catheter.
(40)
(41)
(42) The carbon dioxide supply devices 900, 1000 can be used with a variety of different balloon catheters. For example, the devices 900, 1000 can be used with balloon atherectomy catheters, such as those described in International Patent Application No. PCT/US2013/032494, filed Mar. 15, 2013, titled “BALLOON ATHERECTOMY CATHETERS WITH IMAGING,” and International Patent Application No. PCT/US2015/014613, filed Feb. 5, 2015, titled “ATHERECTOMY CATHETERS AND OCCLUSION CROSSING DEVICES,” incorporated by reference herein in their entireties. The carbon dioxide supply device 100 can further be used, for example, with balloon angioplasty catheters. Advantageously, the carbon dioxide supply devices 900,1000 can be a single-use sterile product.
(43) Although described as a carbon dioxide supply, other inflation gases can be used in devices 900, 1000.
(44) When a feature or element is herein referred to as being “on” another feature or element, it can be directly on the other feature or element or intervening features and/or elements may also be present. In contrast, when a feature or element is referred to as being “directly on” another feature or element, there are no intervening features or elements present. It will also be understood that, when a feature or element is referred to as being “connected”, “attached” or “coupled” to another feature or element, it can be directly connected, attached or coupled to the other feature or element or intervening features or elements may be present. In contrast, when a feature or element is referred to as being “directly connected”, “directly attached” or “directly coupled” to another feature or element, there are no intervening features or elements present. Although described or shown with respect to one embodiment, the features and elements so described or shown can apply to other embodiments. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed “adjacent” another feature may have portions that overlap or underlie the adjacent feature.
(45) Terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. For example, as used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and/or “comprising,” when used in this specification, specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof. As used herein, the term “and/or” includes any and all combinations of one or more of the associated listed items and may be abbreviated as “/”.
(46) Spatially relative terms, such as “under”, “below”, “lower”, “over”, “upper” and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as “under” or “beneath” other elements or features would then be oriented “over” the other elements or features. Thus, the exemplary term “under” can encompass both an orientation of over and under. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms “upwardly”, “downwardly”, “vertical”, “horizontal” and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.
(47) Although the terms “first” and “second” may be used herein to describe various features/elements, these features/elements should not be limited by these terms, unless the context indicates otherwise. These terms may be used to distinguish one feature/element from another feature/element. Thus, a first feature/element discussed below could be termed a second feature/element, and similarly, a second feature/element discussed below could be termed a first feature/element without departing from the teachings of the present invention.
(48) As used herein in the specification and claims, including as used in the examples and unless otherwise expressly specified, all numbers may be read as if prefaced by the word “about” or “approximately,” even if the term does not expressly appear. The phrase “about” or “approximately” may be used when describing magnitude and/or position to indicate that the value and/or position described is within a reasonable expected range of values and/or positions. For example, a numeric value may have a value that is +/−0.1% of the stated value (or range of values), +/−1% of the stated value (or range of values), +/−2% of the stated value (or range of values), +/−5% of the stated value (or range of values), +/−10% of the stated value (or range of values), etc. Any numerical range recited herein is intended to include all sub-ranges subsumed therein.
(49) Although various illustrative embodiments are described above, any of a number of changes may be made to various embodiments without departing from the scope of the invention as described by the claims. For example, the order in which various described method steps are performed may often be changed in alternative embodiments, and in other alternative embodiments one or more method steps may be skipped altogether. Optional features of various device and system embodiments may be included in some embodiments and not in others. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be interpreted to limit the scope of the invention as it is set forth in the claims.
(50) The examples and illustrations included herein show, by way of illustration and not of limitation, specific embodiments in which the subject matter may be practiced. As mentioned, other embodiments may be utilized and derived there from, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. Such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept, if more than one is, in fact, disclosed. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.