CATHETER SYSTEMS AND METHODS FOR ABLATING VARICOSE VEINS
20220211428 · 2022-07-07
Inventors
Cpc classification
A61B90/06
HUMAN NECESSITIES
A61B18/18
HUMAN NECESSITIES
A61B18/1492
HUMAN NECESSITIES
A61M25/0152
HUMAN NECESSITIES
International classification
A61B90/00
HUMAN NECESSITIES
Abstract
In some embodiments, the disclosure describes a catheter system for applying energy to a vessel, such as a vein. The system may include an elongate catheter shaft having a distal end and a proximal end opposite the distal end, and an energy application device coupled to the distal end of the elongate catheter shaft. The energy application device may be configured to apply energy to the vessel. The system may also include a gauge positioned relative to a working surface. The gauge may be configured to determine a distance that the elongate catheter shaft travels with respect to a treatment zone.
Claims
1. A catheter system for applying energy to a vessel, comprising: an elongate catheter shaft having a distal end and a proximal end opposite the distal end; an energy application device coupled to the distal end of the elongate catheter shaft, the energy application device configured to apply energy to the vessel; and a gauge positioned relative to a working surface, the gauge configured to determine a distance the elongate catheter shaft travels with respect to a treatment zone, the gauge slidably coupled to the working surface, and the gauge comprising a sliding object that slidably receives at least one of the elongate catheter shaft and an introducer sheath.
2. The catheter system of claim 1, wherein the energy application device defines a first length and the sliding object defines a predetermined length that is less than or equal to the first length.
3. The catheter system of claim 1, wherein the treatment zone defines a second length and the sliding object defines a predetermined length that is less than or equal to the second length.
4. The catheter system of claim 1, wherein the gauge comprises: an aperture configured to receive at least one of the introducer sheath and the elongate catheter shaft; and a slit located adjacent the aperture, the slit configured such that the aperture removably receives at least one of the elongate catheter shaft and the introducer sheath.
5. The catheter system of claim 4, wherein the gauge is coupled to the working surface, and the working surface comprises at least one of a patient drape surface, a patient leg surface, a table surface, the elongate catheter shaft, and an introducer sheath that slidably receives the elongate catheter shaft.
6. The catheter system of claim 5, wherein the gauge defines at least one of a card, sticker, label, and template.
7. The catheter system of claim 1, wherein the sliding object comprises a hollow inner portion that slidably receives the elongate catheter shaft, and the sliding object frictionally slides with respect to the elongate catheter shaft along a first direction parallel to the elongate catheter shaft, and wherein a friction between the sliding object and the elongate catheter shaft is enough such that the sliding object does not move with respect to the elongate catheter shaft under a force equal to gravity.
8. The catheter system of claim 1, wherein the sliding object comprises a hollow inner portion that slidably receives the elongate catheter shaft, and the sliding object slides along a second direction perpendicular to the elongate catheter shaft, and wherein the sliding object clippably couples to the elongate catheter shaft along the second direction.
9. The catheter system of claim 1, wherein the sliding object comprises a variable friction mechanism whereby when the variable friction mechanism is depressed the sliding object slides with respect to the elongate catheter shaft, and when the variable friction mechanism is not depressed the sliding object does not slide with respect to the elongate catheter shaft.
10. The catheter system of claim 9, wherein the variable friction mechanism comprises a spring-loaded clamping device.
11. The catheter system of claim 1, wherein the elongate catheter comprises at least one echogenic feature, and each echogenic feature of the at least one echogenic feature is spaced apart by a spacing length.
12. The catheter system of claim 11, wherein the energy application device defines a first length, and the spacing length is a predetermined multiple of the first length.
13. The catheter system of claim 11, wherein each echogenic feature of the at least one echogenic feature surrounds a portion of the elongate catheter shaft selected from the group consisting of a fully radial echogenic feature that entirely surrounds the elongate catheter shaft and a partially radial echogenic feature that partially surrounds the elongate catheter shaft.
14. The catheter system of claim 1, wherein the elongate catheter shaft further comprises: an inner tube disposed within an internal portion of the elongate catheter shaft; a middle tube that substantially surrounds the inner tube; and an outer tube that substantially surrounds the inner tube and the middle tube.
15. The catheter system of claim 14, wherein the inner tube is configured to be lubricious with respect to the middle tube, and the middle tube is configured to be lubricious with respect to the outer tube.
16. The catheter system of claim 1, wherein the energy application device further comprises a distal tip, and a movable tip is coupled to the distal tip.
17. The catheter system of claim 16, wherein the movable tip is configured to define a shape selected from the group consisting of curved, angled, and straight with respect to the elongate catheter shaft.
18. The catheter system of claim 17, further comprising a stylet disposed within an internal portion of the elongate catheter shaft, the stylet configured to move between the proximal end and the distal end of the elongate catheter shaft, and the stylet configured to adjust the shape of the movable tip by a position within the elongate catheter shaft.
19. The catheter system of claim 18, wherein the stylet is configured to lock in place with respect to the energy application device.
20. The catheter system of claim 1, further comprising a hub coupled to the proximal end of the elongate catheter shaft, the hub including a push-button communicatively coupled to the energy application device.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0034] These and other features, aspects, and advantages are described below with reference to the drawings, which are intended to illustrate, but not to limit, the invention. In the drawings, like reference characters denote corresponding features consistently throughout similar embodiments.
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DETAILED DESCRIPTION
[0063] Although certain embodiments and examples are disclosed below, inventive subject matter extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses, and to modifications and equivalents thereof Thus, the scope of the claims appended hereto is not limited by any of the particular embodiments described below. For example, in any method or process disclosed herein, the acts or operations of the method or process may be performed in any suitable sequence and are not necessarily limited to any particular disclosed sequence. Various operations may be described as multiple discrete operations in turn, in a manner that may be helpful in understanding certain embodiments; however, the order of description should not be construed to imply that these operations are order dependent. Additionally, the structures, systems, and/or devices described herein may be embodied as integrated components or as separate components.
[0064] For purposes of comparing various embodiments, certain aspects and advantages of these embodiments are described. Not necessarily all such aspects or advantages are achieved by any particular embodiment. Thus, for example, various embodiments may be carried out in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other aspects or advantages as may also be taught or suggested herein.
[0065] Additionally, reference is made to the accompanying drawings that form a part hereof, and in which the specific embodiments that may be practiced is shown by way of illustration. These embodiments are described in sufficient detail to enable those skilled in the art to practice the embodiments and it is to be understood that the logical, mechanical and other changes may be made without departing from the scope of the embodiments. The following detailed description is therefore not to be taken in a limiting sense.
LIST OF REFERENCE NUMERALS
[0066] 10—Catheter system [0067] 12—Elongate catheter shaft [0068] 14—Distal end [0069] 16—Proximal end [0070] 18—Energy application device [0071] 20—Treatment zone [0072] 21—Introducer sheath [0073] 22—Working surface [0074] 24—Gauge [0075] 26—Aperture [0076] 28—Slit [0077] 30—At least one marking interval [0078] 32—First length [0079] 34—Sliding object [0080] 36—Hollow inner portion [0081] 38—Variable friction mechanism [0082] 40—Echogenic feature [0083] 42—Spacing length [0084] 44—Inner tube [0085] 46—Middle tube [0086] 48—Outer tube [0087] 50—Hub [0088] 52—Button [0089] 54—Movable tip [0090] 56—Distal tip [0091] 60—Stylet [0092] 62—Proximal end point [0093] 64—Distal end point [0094] 66—Predetermined distance [0095] 68—Push button extension [0096] 70—Proximal connector [0097] 72—Luer port [0098] 74—One-way valve [0099] 76—Power cord
Introduction
[0100] Current catheter systems and methods for treating varicose veins have numerous shortcomings. Accordingly, the present disclosure addresses many of these problems and offers solutions to remedy the deficiencies. The solutions provided endeavor to not only enhance patients' treatment experience and improve physicians' ability to navigate and effectively treat varicose veins, but also to increase manufacturers' ability to efficiently produce the catheter systems.
[0101]
Index Marking Embodiments
[0102] With reference to
[0103] The gauge 24 may comprise any type of device arranged and configured to determine distance, such as a tube, rod, and/or block. In some embodiments, the gauge 24 comprises a card, sticker, label, and/or template. The gauge 24 may include an aperture 26 and a slit 28 arranged and configured to removably receive at least one of the elongate catheter shaft 12 and the introducer sheath 21. Accordingly, the gauge 24 may slide along the introducer sheath 21 and/or elongate catheter shaft 12, via the aperture 26. In this regard, the physician may move the gauge 24 along as he or she performs various treatments whereby the gauge 24 may be used to determine how far to move the catheter system 10 for such treatments.
[0104] Now, with reference to
[0105] The sliding object 34 may slide with little to no friction or with friction along the first direction X along the elongate catheter shaft 12. The friction may be enough such that the sliding object 34 does not move with respect to the elongate catheter shaft 12 under a force greater than or equal to gravity. The sliding object 34 may also include features to control the amount of friction. Accordingly, the sliding object 34 may include a variable friction mechanism 38 that is arranged and configured to increase and/or decrease the amount of friction. In some embodiments, when the variable friction mechanism 38 is depressed the sliding object 34 may slide with respect to the elongate catheter shaft 12. When the variable friction mechanism 38 is not depressed, the sliding object 34 does not slide with respect to the elongate catheter shaft 12. In some embodiments, the variable friction mechanism 38 comprises a button and a spring-loaded clamping device that applies friction to the elongate catheter shaft 12.
[0106] In some embodiments, the sliding object 34 may engage the elongate catheter shaft 12 by clippably coupling to the elongate catheter shaft 12 along the second direction Y. Alternatively, the sliding object 34 may engage the elongate catheter shaft 12 by slideably receiving the distal end 14 or the proximal end 16 of the elongate catheter shaft 12 along the first direction X. Generally, it should be appreciated that the sliding object 34 may engage the elongate catheter shaft using any such means whereby the sliding object is able to substantially surround the elongate catheter shaft 12.
[0107] As shown in
[0108] In some embodiments, the gauge 24 is coupled to the working surface 22, while in some embodiments, the gauge 24 is decoupled from the working surface 22. It should be appreciated that in any such embodiments, the gauge 24 may be permanently or temporarily fixed to the working surface 22. For example, the gauge 24 may be configured to be coupled to the working surface 22 via a hook and loop fastener. Even still, the gauge 24 may be configured to be coupled to the working surface 22 via adhesive. However, in some embodiments, the gauge 24 is able to slide along the working surface 22. Furthermore, it should be appreciated that the working surface 22 may comprise any device or article associated with the catheter system 10 and/or the ablation process, such as a patient drape surface, a patient leg surface, a table surface, the elongate catheter shaft 12, and the introducer sheath 21.
[0109] With reference back to
[0110] In some embodiments, the first length 32, second length 33, and/or sliding object 34 are less than or equal to 7 centimeters. In some embodiments, the first length 32, second length 33, and/or sliding object 34 are greater than or equal to 7 centimeters. Generally, it should be appreciated that the first length 32, second length 33, and/or sliding object 34 may define any length.
Echogenic Feature Embodiments
[0111] As shown in
[0112] The one or more echogenic features 40 may define one or more echogenic bands that each surround a portion of the elongate catheter shaft 12. As shown in
[0113] In some embodiments, a majority of the elongate catheter shaft 12 defines a presence of echogenicity and the one or more echogenic features 40 defines an absence of echogenicity. In this regard, the one or more echogenic features 40 may be visible under ultrasound because of the presence or absence of echogenicity and the corresponding remainder of the elongate catheter shaft 12 having the opposite. In other words, if the one or more echogenic features 40 has a presence of echogenicity and the corresponding remainder of the elongate catheter shaft 12 has an absence of echogenicity, then the one or more echogenic features 40 may be visible under ultrasound because of the contrast with the remainder of the elongate catheter shaft 12. Alternatively, if the one or more echogenic features 40 has an absence of echogenicity and the corresponding remainder of the elongate catheter shaft 12 has a presence of echogenicity, then again, the one or more echogenic features 40 may be visible under ultrasound because of the contrast with the remainder of the elongate catheter shaft 12.
[0114] The one or more echogenic features 40 may define any type of material and/or define any type of surface finish. In some embodiments, the one or more echogenic features 40 includes a coiled material. Additionally, in some embodiments, the one or more echogenic features 40 includes a roughened surface. Even still, the one or more echogenic features 40 may include a solid material, while in some embodiments the one or more echogenic features 40 includes a porous material.
[0115] This disclosure also includes methods of using the echogenic features 40 to determine a position of the catheter system 10 with respect to a second treatment zone of a vessel. It should be appreciated that the second treatment zone occurs after a first treatment zone. The methods may include inserting an elongate catheter shaft 12 into a vessel of a patient (at step 1500) and determining a position of the energy application device 18 with respect to a second treatment zone of the vessel via one or more echogenic features 40 viewed under ultrasound (at step 1502). Methods may also include positioning the energy application device 18 in the second treatment zone of the vessel (at step 1504) and applying energy to the second treatment zone of the vessel via the energy application device 18 (at step 1506). Accordingly, methods may include moving the energy application device 18 away from the second treatment zone of the vessel (at step 1508).
[0116] Methods may thereby include determining a third position of the energy application device 18 with respect to a third treatment zone of the vessel via the one or more echogenic features 40 viewed under ultrasound (at step 1510). As well, methods may include positioning the energy application device 18 in the third treatment zone of the vessel (at step 1512) and applying energy to the third treatment zone of the vessel via the energy application device 18 (at step 1514).
Coil and Catheter Tube Embodiments
[0117] As shown in
[0118] Such materials may allow the elongate catheter shaft 12 and the tubes 44, 46, 48 to be more lubricious to thereby improve guide wire movement within the internal portion of the elongate catheter shaft 12. As well, the thermoplastic, PTFE, and/or Pebax may result in improved flexibility and improved manufacturability because the materials may be more bondable.
[0119] As illustrated in
Movable Tip Embodiments
[0120] With reference to
[0121] The catheter system 10 may also include a stylet 60 disposed within an internal portion of the elongate catheter shaft 12. The stylet 60 may be arranged and configured to move between a proximal end point 62 and a distal end point 64 within the elongate catheter shaft 12. The proximal end point 62 and the distal end point 64 may be located a predetermined distance from each other, whereby the stylet 60 is free to move within the elongate catheter shaft 12 between the proximal end point 62 and the distal end point 64. Accordingly, when the stylet 60 is moved towards the distal end point 64 the movable tip 54 becomes straightened. When the stylet 60 is moved towards the proximal end point 62 the movable tip 54 may thereby define a curved and/or an angled shape.
[0122] The stylet 60 may also be arranged and configured to lock into place with respect to the energy application device 18 and/or the hub 50. In this regard, the movable tip 54 may thereby be locked in its straight, curved, or angled shape when the stylet 60 is also locked in place. Furthermore, in some embodiments, when the stylet 60 is moved to the proximal end point 62 the stylet 60 is completely detached from the internal portion of the elongate catheter shaft 12.
[0123] In some embodiments, the energy application device 18 and/or the movable tip 54 may be coated with polymers, or other materials to aid lamination and/or create spacing for wraps. Even still, the energy application device 18 and/or the movable tip 54 may define a longer length (e.g. 15 centimeters, 20 centimeters, and the like) than prior art energy application devices to thereby result in shorter procedure times due to fewer cycles needed to be run. In some embodiments, the stylet 60 may be arranged and configured to allow the elongate catheter shaft 12 to be pushed into and pulled out of the vessel.
Hub and Proximal Connector Embodiments
[0124] With reference to
[0125] The catheter system 10 may also include a push button 52 communicatively coupled to the energy application device 18. The push button 52 may be configured to activate the energy application device 18. As shown in
[0126] In some embodiments, the catheter system 10 includes a push button extension 68 communicatively and/or electrically coupled to the energy application device 18, hub 50, and/or push button 52. The push button extension 68 may be located remotely with respect to the hub 50 and push button 52. In some embodiments, the push button extension 68 comprises a wireless remote control. The push button extension 68 may assist the physician because the push button extension 68 may remain in place and not be moved during every movement of the catheter, thus making the treatment faster and easier for the physician. In other words, when the hub 50 and push button 52 move, the push button extension 68 may be arranged and configured to remain in a fixed position with respect to the hub 50 and push button 52. Stated differently, the push button extension 68 may be arranged and configured to move independently with respect to the hub 50 and push button 52.
[0127] In some embodiments, the energy application device 18 is electrically coupled to the hub 50. Embodiments may also include a proximal connector 70 that is electrically coupled to the energy application device 18 and the hub 50. The energy application device 18 and the proximal connector 70 may be electrically coupled via a continuous uninterrupted electrical connection, such as a continuous wire.
Luer Port Embodiments for Prepping the Inner Lumen
[0128] The present disclosure also includes embodiments arranged and configured to allow a catheter system 10 to be prepped with saline from a syringe. Accordingly, as shown in
[0129] Some embodiments may also include a one-way valve 74 in fluid communication with the luer port 72. The one-way valve 74 may be coupled to the stylet 60 whereby the one-way valve 74 is arranged and configured to allow a fluid (e.g. saline) to be discharged into the internal portion of the elongate catheter shaft 12.
[0130] Accordingly, the disclosure also includes methods for prepping an inner lumen located within an elongate catheter shaft 12. Methods may include coupling a syringe to a luer port 72 in fluid communication with the inner lumen (at step 3500) and pushing saline, via the syringe, into the inner lumen to remove air from the inner lumen (at step 3502). Methods may also include maintaining fluid stasis, via a one-way valve 74 within the luer port 74, between the syringe and the inner lumen (at step 3504).
[0131] Embodiments may also include inserting the stylet 60 into the luer port 72 and into the elongate catheter shaft 12 (at step 3506) and fixing the stylet 60 with respect to the luer port 72 (at step 3508). Fixing the stylet 60 with respect to the luer port 72 may comprise rotating a portion of the luer port 72 to thereby lock the stylet 60 with respect to the luer port 72 (at step 3510). Methods may thereby include pushing saline through the one-way valve 74 into the inner lumen while the stylet 60 is fixed with respect to the luer port 72 (at step 3512).
Power Cord Embodiments
[0132] As shown in
Interpretation
[0133] None of the steps described herein is essential or indispensable. Any of the steps can be adjusted or modified. Other or additional steps can be used. Any portion of any of the steps, processes, structures, and/or devices disclosed or illustrated in one embodiment, flowchart, or example in this specification can be combined or used with or instead of any other portion of any of the steps, processes, structures, and/or devices disclosed or illustrated in a different embodiment, flowchart, or example. The embodiments and examples provided herein are not intended to be discrete and separate from each other.
[0134] The section headings and subheadings provided herein are nonlimiting. The section headings and subheadings do not represent or limit the full scope of the embodiments described in the sections to which the headings and subheadings pertain. For example, a section titled “Topic 1” may include embodiments that do not pertain to Topic 1 and embodiments described in other sections may apply to and be combined with embodiments described within the “Topic 1” section.
[0135] Some of the devices, systems, embodiments, and processes use computers. Each of the routines, processes, methods, and algorithms described in the preceding sections may be embodied in, and fully or partially automated by, code modules executed by one or more computers, computer processors, or machines configured to execute computer instructions. The code modules may be stored on any type of non-transitory computer-readable storage medium or tangible computer storage device, such as hard drives, solid state memory, flash memory, optical disc, and/or the like. The processes and algorithms may be implemented partially or wholly in application-specific circuitry. The results of the disclosed processes and process steps may be stored, persistently or otherwise, in any type of non-transitory computer storage such as, e.g., volatile or non-volatile storage.
[0136] The various features and processes described above may be used independently of one another, or may be combined in various ways. All possible combinations and subcombinations are intended to fall within the scope of this disclosure. In addition, certain method, event, state, or process blocks may be omitted in some implementations. The methods, steps, and processes described herein are also not limited to any particular sequence, and the blocks, steps, or states relating thereto can be performed in other sequences that are appropriate. For example, described tasks or events may be performed in an order other than the order specifically disclosed. Multiple steps may be combined in a single block or state. The example tasks or events may be performed in serial, in parallel, or in some other manner. Tasks or events may be added to or removed from the disclosed example embodiments. The example systems and components described herein may be configured differently than described. For example, elements may be added to, removed from, or rearranged compared to the disclosed example embodiments.
[0137] Conditional language used herein, such as, among others, “can,” “could,” “might,” “may,” “e.g.,” and the like, unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements and/or steps. Thus, such conditional language is not generally intended to imply that features, elements and/or steps are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without author input or prompting, whether these features, elements and/or steps are included or are to be performed in any particular embodiment. The terms “comprising,” “including,” “having,” and the like are synonymous and are used inclusively, in an open-ended fashion, and do not exclude additional elements, features, acts, operations and so forth. Also, the term “or” is used in its inclusive sense (and not in its exclusive sense) so that when used, for example, to connect a list of elements, the term “or” means one, some, or all of the elements in the list. Conjunctive language such as the phrase “at least one of X, Y, and Z,” unless specifically stated otherwise, is otherwise understood with the context as used in general to convey that an item, term, etc. may be either X, Y, or Z. Thus, such conjunctive language is not generally intended to imply that certain embodiments require at least one of X, at least one of Y, and at least one of Z to each be present.
[0138] The term “and/or” means that “and” applies to some embodiments and “or” applies to some embodiments. Thus, A, B, and/or C can be replaced with A, B, and C written in one sentence and A, B, or C written in another sentence. A, B, and/or C means that some embodiments can include A and B, some embodiments can include A and C, some embodiments can include B and C, some embodiments can only include A, some embodiments can include only B, some embodiments can include only C, and some embodiments include A, B, and C. The term “and/or” is used to avoid unnecessary redundancy.
[0139] Although the embodiments herein are described with various specific embodiments, it will be obvious for a person skilled in the art to practice the invention with modifications. However, all such modifications are deemed to be within the scope of the claims. While certain example embodiments have been described, these embodiments have been presented by way of example only, and are not intended to limit the scope of the inventions disclosed herein. Thus, nothing in the foregoing description is intended to imply that any particular feature, characteristic, step, module, or block is necessary or indispensable. Indeed, the novel methods and systems described herein may be embodied in a variety of other forms; furthermore, various omissions, substitutions, and changes in the form of the methods and systems described herein may be made without departing from the spirit of the inventions disclosed herein.
[0140] Furthermore, the foregoing description of the specific embodiments will so fully reveal the general nature of the embodiments herein that others can, by applying current knowledge, readily modify and/or adapt for various applications such specific embodiments without departing from the generic concept, and, therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments. It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. Therefore, while the embodiments herein have been described in terms of preferred embodiments, those skilled in the art will recognize that the embodiments herein can be practiced with modification within the spirit and scope of the appended claims.
Implementation
[0141] The aforementioned embodiments can be implemented, for example, using a machine-readable medium or article which is able to store an instruction or a set of instructions that, if executed by a machine, can cause the machine to perform a method and/or operations described herein. Such machine can include, for example, any suitable processing platform, computing platform, computing device, processing device, electronic device, electronic system, computing system, processing system, computer, processor, or the like, and is able to be implemented using any suitable combination of hardware and/or software.
[0142] The machine-readable medium or article can include, for example, any suitable type of memory unit, memory device, memory article, memory medium, storage device, storage article, storage medium and/or storage unit; for example, memory, removable or non-removable media, erasable or non-erasable media, writeable or re-writeable media, digital or analog media, hard disk drive, floppy disk, Compact Disk Read Only Memory (CD-ROM), Compact Disk Recordable (CD-R), Compact Disk Re-Writeable (CD-RW), optical disk, magnetic media, various types of Digital Versatile Disks (DVDs), a tape, a cassette, or the like. The instructions can include any suitable type of code, for example, source code, compiled code, interpreted code, executable code, static code, dynamic code, or the like, and is able to be implemented using any suitable high-level, low-level, object-oriented, visual, compiled and/or interpreted programming language, e.g., C, C#, C++, Java, BASIC, Pascal, Fortran, Cobol, assembly language, machine code, or the like. Functions, operations, components and/or features described herein with reference to one or more embodiments, is able to be combined with, or is able to be utilized in combination with, one or more other functions, operations, components and/or features described herein with reference to one or more other embodiments, or vice versa.