Laser catheter system and proximal coupler therefor

Abstract

A laser catheter system includes a proximal coupler having multiple channels, a plurality of fiber packs positioned within the respective channels of the proximal coupler and extending into a catheter, a laser system or switch mechanism configured to direct laser energy to the fiber packs within the multiple channels of the proximal coupler, and a shielding mechanism configured activate or deactivate at least one of the fiber packs independently of the remaining fiber packs.

Description

[0001] LASER CATHETER SYSTEM AND PROXIMAL COUPLER THEREFOR

[0002] FIELD

[0003] The inventive concepts generally related to laser catheter systems, and more particularly, to laser catheter proximal couplers and other mechanisms which facilitate separate activation and deactivation of groups of fibers within a laser catheter.

[0004] BACKGROUND

[0005] Laser catheters are medical devices used in various medical procedures, including the treatment of peripheral or coronary artery disease. These catheters are designed to deliver laser energy to specific areas within the body, with the laser energy being transmitted through optical fibers within the catheter. During operation, the catheter is operatively coupled to a laser system which generates and directs the laser energy into proximal ends of the optical fibers extending within the catheter.

[0006] A proximal coupler assembly is a component of the laser catheter that may align the optical fibers with the laser system to ensure the correct amount of laser energy is accurately directed. In conventional designs, the proximal coupler is equipped with a single channel. This channel allows all the fibers within the laser catheter to be exposed to the laser energy simultaneously. The laser energy is then transmitted through the fibers to the tip of the catheter, where it is used for treatment.

[0007] The fibers within the catheter are typically grouped together in a fiber bundle. The fiber bundle is positioned within the proximal coupler assembly so that the bundle aligns with the laser energy exiting the laser system.

[0008] SUMMARY

[0009] According to an aspect of the inventive concepts, a laser catheter system is provided which may include one or more of a proximal coupler having multiple channels, a plurality of fiber packs positioned within the respective channels of the proximal coupler and extending into a catheter, a laser system configured to direct laser energy to the fiber packs within the multiple channels of the proximal coupler (switch mechanism), and a shielding mechanism configured to activate or deactivate at least one of the fiber packs independently of the remaining fiber packs.

[0010] The multiple channels within the proximal coupler may be defined by trenches, of a variety of geometries, in a surface of a fiber bundle platform or slide of the proximal coupler.

[0011] Each of the fiber packs may be a bundle of fibers or a fiber wire.

[0012] The switch mechanism / laser system may be configured to adjust the laser energy to differentially target each fiber bundle or wire within the proximal coupler during use of the laser catheter system by rotating or moving the laser energy between the fiber packs.

[0013] In other cases, the shielding mechanism may be a mechanical shield member within the proximal coupler for selectively blocking at least one channel from receiving / transmitting laser energy therethrough. The mechanical shield member may be manually operated or actuated by a motor. Other options include a spring, detent, linear actuator, or gear mechanism.

[0014] According to another aspect of the inventive concepts, a proximal coupler is provided to operatively couple a laser catheter to a laser system. A component of the proximal coupler includes a fiber support platform or slide with at least first and second fiber channels that are spaced apart and configured to align respective fiber packs of the laser catheter with laser energy emitted by the laser system. These channels may be defined by trenches formed in the fiber support platform, or slide.

[0015] The proximal coupler may further include a shield mechanism configured to shield the first fiber channel from laser energy passing therethrough. The mechanical shield member may be manually operated or actuated by a motor.

[0016] BRIEF DESCRIPTION OF DRAWINGS

[0017] The above and other aspects and features of the inventive concepts will become readily apparent from the detailed description that follows, with reference to the accompanying drawings, in which: FIG. 1 illustrates a laser catheter within a blood vessel;

[0018] FIG. 2 depicts an example of a distal end of the laser catheter of FIG. 1 ;

[0019] FIG. 3 is a simplified schematic diagram of a system for generating laser energy applied to a laser catheter;

[0020] FIG. 4 illustrates a side view of a proximal coupler according to embodiments of the inventive concepts;

[0021] FIG. 5A is a top view of a fiber bundle platform or slide of the proximal coupler of FIG. 4;

[0022] FIG. 5B is a front view of a fiber bundle platform or slide of the proximal coupler of FIG. 4;

[0023] FIGS. 6A and 6B illustrate a component of the proximal coupler and catheter fiber bundles for reference in explaining an embodiment of the inventive concepts;

[0024] FIGS. 7 A and 7B illustrate crystal prism orientations relative to an optical plane for reference in explaining another embodiment of the inventive concepts;

[0025] FIG. 8A illustrates a top view of a fiber bundle platform or slide and a first shield member in an optically open state according to an embodiment of the inventive concepts.

[0026] FIG. 8B is a side view of FIG. 8A;

[0027] FIG. 9A illustrates a top view of a fiber bundle platform or slide and the first shield member in an optically closed state according to an embodiment of the inventive concepts;

[0028] FIG. 9B is a side view of FIG. 9A;

[0029] FIG. 10A illustrates a top view of a fiber bundle platform or slide and a second shield member in an optically open state according to an embodiment of the inventive concepts;

[0030] FIG. 1 OB is a side view of FIG. 8A;

[0031] FIG. 11 A illustrates a top view of a fiber bundle platform or slide and the second shield member in an optically closed state according to an embodiment of the inventive concepts; and

[0032] FIG. 1 IB is a side view of FIG. 11 A. DETAILED DESCRIPTION

[0033] In the following detailed description, for purposes of explanation and not limitation, representative embodiments disclosing specific details are set forth m order to provide a thorough understanding of the present teachings. However, it will be apparent to one having ordinary skill m the art having had the benefit of the present disclosure that other embodiments according to the present teachings that depart from the specific details disclosed herein remain within the scope of the appended claims. Moreover, descriptions of well-known apparatuses and methods may be omitted to avoid obscuring the description of the example embodiments. Such methods and apparatuses are clearly within the scope of the present teachings. Further, throughout the drawings, like reference numbers refer to the same or similar elements. It is noted that elements of the figures may not be drawn to scale, and that relative sizes of elements may be exaggerated for clarity.

[0034] The terminology used herein is for purposes of describing particular embodiments only, and is not intended to be limiting. The defined terms are m addition to the technical and scientific meanings of the defined terms as commonly understood and accepted m the technical field of the present teachings. As used m the specification and appended claims, the terms ‘a’, ‘an’ and ‘the’ include both singular and plural referents, unless the context clearly dictates otherwise. Thus, for example, ‘a device’ includes one device and plural devices. Further, for example, when one element is described as being “connected to” another element, the one element may be directly connected to the other element, or indirectly connected to the other element m an operative manner.

[0035] The inventive concepts are directed a laser catheter system that may enhance the flexibility and precision of laser energy delivery during medical procedures. The system may include a proximal coupler designed with multiple channels, each capable of housing a distinct fiber bundle or fiber wire. This multi-channel design, together with a switching or shielding mechanism as discussed in embodiments below, or with multiple setbacks of the fibers, allows for the separate activation or separate laser energy out of different fiber bundles, thus enabling a variety of treatment modalities within a single catheter device. In some embodiments, the positioning of the fiber bundles within the proximal coupler may be adjustable during use. This feature may provide the user with the ability to control which fiber bundles are exposed to the laser energy at any given time, thereby offering a dynamic and customizable approach to laser energy delivery.

[0036] In other embodiments, the laser catheter system may incorporate a laser system that can direct laser energy to selected fiber bundles within the multiple channels of the proximal coupler. For example, a crystal prism component that can be manipulated to rotate or move the laser beam may be utilized, thereby directing the energy between different channels.

[0037] In still other embodiments, the laser catheter system may include a mechanical shield member within the proximal coupler. This shield member is capable of selectively preventing one channel from receiving laser energy, thereby controlling which fiber bundles are activated.

[0038] As background, attention is directed to FIGS. 1 and 2 for reference in describing a laser catheter generally.

[0039] Referring to FIGS. 1 and 2, a guide wire 101 may be used to navigate catheter 104 within a blood vessel inner lumen 102. The laser catheter 104 may include an a guide wire lumen 201, and multiple optical fibers 203. In operation, the laser catheter 104 may be positioned in proximity to an obstruction 103 within the blood vessel wall for ablation of the obstruction 103. This may be achieved by directing laser energy from the laser system towards the obstruction 103 via the fiber bundle 203 within the laser catheter 104. As is known in the art, the laser energy may be used to ablate or otherwise modify the obstruction 103, thereby facilitating its removal or reduction.

[0040] As discussed below, a proximal coupler is used to couple the laser catheter 104 to a laser system. In current proximal couple designs, all fibers 203 are exposed to the laser beam generated by the laser system at the same time. As such, all fibers 203 are turned “on” and “off’ at the same time. In some aspects of the inventive concepts, a proximal coupler that has the ability to direct or block the laser energy to activate different fiber packs within the same catheter is provided. This allows for the laser energy to hit different portions of the fiber pack, and could be used for a variety of applications in which the catheter is used for multiple modalities such as having a laserwire couple to the catheter and wanting to activate the laser wire separately. This could also be used for ISR (in stent restenosis) or other applications that have front facing fibers and side facing fibers in which there is a need to activate each of these fiber groups separately within the catheter.

[0041] FIG. 3 is a simplified schematic view for reference in describing an example of a laser system that is configured to generate and direct laser energy to multiple fiber bundles 309 within the multiple channels (described below) of a proximal coupler 308.

[0042] Referring to FIG. 3, the laser system may include an optical rail 301 that supports a laser source 302. The laser source 302 may generate laser energy L, which may then be directed along the optical rail 301. The laser energy may pass through various miscellaneous optical components 303, which may serve to condition, shape, or otherwise modify the laser energy for transmission to the fiber bundles 309. It is noted here that the term optical rail also refers to the assembly of components 301-304.

[0043] The laser system may include a crystal prism 304 positioned along the optical rail 301. The crystal 304 may serve to further condition or direct the laser energy towards the fiber bundles 309.

[0044] The laser system may also include a optical rail coupler 306. A proximal coupler 308 of the catheter is configured for connection to the optical rail coupler 306, thereby operatively aligning and exposing the fiber bundles 309 to the laser energy L generated by the laser system.

[0045] FIG. 4 is a diagram illustrating an example of proximal coupler 308 according to embodiments of the inventive concepts.

[0046] Referring to FIG. 4, the proximal coupler 308 may be designed with multiple channels (described below), each capable of housing a distinct fiber bundle. In the example of FIG. 4, the proximal coupler 308 accommodates two fiber bundles, i.e., a first fiber bundle 309a and a second fiber bundle 309b. However, the inventive concepts are not limited to two fiber bundles. Instead, three or more fiber bundles may be accommodated. The proximal coupler 308 may include coding pins 401. These coding pins 401 may be positioned on the proximal coupler 308 to ensure proper alignment and functionality. The coding pins 401 may serve as a mechanical interface between the proximal coupler 308 and the laser system. The presence or absence of a coding pin 401 at a particular location may correspond to a binary code, which may be used to identify the type of catheter connected to the laser system. This may allow the laser system to adjust its operation based on the specific characteristics of the catheter, thereby enhancing the precision and effectiveness of the laser energy delivery.

[0047] In some cases, the proximal coupler 308 may be designed to accommodate multiple fiber bundles 309 with different characteristics or functionalities. For example, the proximal coupler 308 may include a first channel for a first fiber bundle 309a designed for front-facing laser energy delivery, and a second channel for a second fiber bundle 309b designed for side-facing laser energy delivery. As discussed herein, one or more mechanisms are provided to facilitate the separate activation of the different fiber bundles 309a and 309b. This may involve the use of a mechanical shield member, a movable crystal component, or other mechanisms for controlling the direction and distribution of laser energy.

[0048] FIG. 5A is a top view of an example of a fiber bundle platform or slide of the proximal coupler of FIG. 4, and FIG. 5B is a front view of the fiber bundle platform or slide, according to embodiments of the inventive concepts.

[0049] Referring to Figs. 5A-5B, the fiber bundle platform, or slide, 501 may be machined to include multiple channels, each capable of housing a distinct fiber bundle. These channels may be represented as fiber bundle trenches, such as channel one fiber bundle trench CHI and channel two fiber bundle trench CH2, formed in a surface of the fiber bundle platform 501.

[0050] The fiber bundle platform 501 may be designed to facilitate the alignment and positioning of the fiber bundles within the proximal coupler 308. In embodiments, the fiber bundle trenches CH 1 , CH2, which may serve as guides or receptacles for the fiber bundles. The fiber bundle platform 501 may include a channel 502. The channel 502 may serve as a manufacturing aid to align the fibers within the laser beam .

[0051] While two channels CHI and CH2 are shown and described above in connection with FIGS. 5 A and 5B, the inventive concepts are not limited in this manner. That is, three or more channels may instead be provided.

[0052] Further, while the illustrated channels of FIGS. 5B are shown as being rectangular, the inventive concepts are not limited in this matter. Other shapes may be adopted instead, such as triangular trenches and curved trenches.

[0053] Further, instead of bundles of fibers being provided in each channel, the combination of a fiber bundle and a laser wire may be provided in the respective channels. In the description that follows, it is assumed that two fiber bundles are provided. But it will be understood that one of the fiber bundles may be replaced with a laser wire. For purposes of definition, the term fiber “pack” means either one of a fiber bundle or a fiber wire.

[0054] In some aspects of the inventive concepts, a selected one of the fiber bundles is deactivated, while the other remains active, by physically separating an end of the to-be- deactivated bundle from the laser system. An example of this is represented in FIGS. 6A and 6B. For convenience of the illustration, the bundle fiber platform 501 is omitted from the figures.

[0055] Referring to Figs. 6A, a proximal coupler 308 is shown connected on one side to catheter 104. In this example, the catheter 104 includes two fiber bundles which extend into the proximal coupler 308. The fiber bundles of this example are sheathed together and are optically coupled to the laser system as described above.

[0056] As represented in FIG. 6A, one of the fiber bundles (labeled 601) is able to form a visible loop. The proximal end of the fiber bundle 601 is denoted by reference number 602 in the figure, which as mentioned above is optically coupled to the laser system.

[0057] Referring now to FIG. 6B, fiber bundle 601 can be deactivated by pulling the loop to retract proximal end 602 away from the laser energy and towards the proximal coupler housing. This movement places the group of fiber 601 further distal of the laser beam and ensures that the concentrated laser energy is only hitting the remaining fibers.

[0058] The adjustment of the fiber bundle positioning within the proximal coupler 308 may be performed manually by the user. Alternatively, the adjustment may be performed automatically by a motor or other actuating mechanism. This may provide a high degree of control over the distribution of laser energy within the catheter device, potentially enhancing the precision and effectiveness of the laser treatment.

[0059] The adjustable positioning of the fiber bundles 309 within the proximal coupler 308 may allow for the selective activation of different fiber bundles during a single treatment session. This may enable a variety of treatment modalities within a single catheter device, potentially improving the versatility and efficiency of the laser catheter system. For example, the user may activate a first fiber bundle for a first treatment modality, adjust the positioning of the fiber bundles within the proximal coupler 308, and then activate a second fiber bundle for a second treatment modality.

[0060] Reference is now made to FIGS. 7 A and 7B in connection with another embodiment for selectively activating and deactivating fiber bundles.

[0061] In this embodiment, the laser system is configured to generate and direct laser energy to selected fiber bundles 309 within the multiple channels of the proximal coupler 308 (not pictured in Fig 7A and 7B). The laser system may include a crystal component 304 that can be manipulated to rotate or move the laser beam L, thereby directing the energy between different fiber bundles at the optical rail coupler 306. For instance, as shown in FIG. 7A, the crystal component 304 may be rotated or moved to direct the laser beam L towards a first fiber bundle 309a at an optical rail coupler 306. Then, as shown in FIG. 7B, the crystal component 304 may be rotated or moved again to direct the laser beam L towards a second fiber bundle 309b at the optical rail coupler 306. As with the previous embodiment, this may enable a variety of treatment modalities within a single catheter device, potentially improving the versatility and efficiency of the laser catheter system.

[0062] The rotation or movement of the crystal component 304 may be controlled by a motor or other actuating mechanism. The motor may be configured to rotate the crystal component 304 about a rotational axis, thereby changing the direction of the laser beam L. Alternatively, the motor may be configured to move the crystal component 304 linearly, thereby changing the position of the laser beam L relative to the optical rail coupler 306.

[0063] In some cases, the rotation or movement of the crystal component 304 may be controlled based on feedback from the laser catheter system or user input. For example, the laser catheter system may include sensors or other feedback mechanisms that provide information about the position or orientation of the fiber bundles 309 within the proximal coupler 308. This information may be used to control the rotation or movement of the crystal component 304, thereby ensuring that the laser energy is directed towards the desired fiber bundles 309a or 309b.

[0064] In some cases, the rotation or movement of the crystal component 304 may be used in conjunction with other features of the laser catheter system, such as the multi-channel design of the proximal coupler 308, the adjustable positioning of the fiber bundles 309 within the proximal coupler 308, and / or the mechanical shield member (described next) within the proximal coupler 308. These features may work together to provide a comprehensive and adaptable solution for delivering laser energy in a variety of medical applications.

[0065] Yet another embodiment of the inventive concepts will be described with reference to FIGS. 8A through 9B. In this embodiment, a mechanical blocking shield is used to deactivate one or more of the fiber bundles.

[0066] Referring collectively to FIGS. 8 A, 8B, 9 A, and 9B, the laser catheter system may include a first shield member 901 at the proximal end of the fiber bundle platform or slide 501 of the proximal coupler 308. The first shield member 901 may be configured to selectively block laser energy from reaching specific fiber bundles within the multiple channels of the proximal coupler 308.

[0067] The first shield member 901 may be positioned at the proximal end of the fiber bundle platform or slide 501 in such a way that it can be moved horizontally to block or unblock the channels. This may be accomplished manually or by using a mechanical actuator, for example by spring-loaded locking mechanism. The actuator may be configured to move the first shield member 901 between an optically open state (FIGS. 8 A and 8B), in which laser energy can pass through the channel, and an optically closed state (FIGS. 9A and 9B), in which the channel is blocked from receiving laser energy.

[0068] The first shield member 901 may be constructed from a material that can diffuse or not be affected by laser light energy. This is to ensure that the first shield member 901 remains intact and functional even when exposed to high-intensity laser energy. In some cases, the material may be fused silica or another suitable material.

[0069] As one skilled in the art will appreciate, there are myriad of potential configurations of the shield member and the mechanism used to move the shield member between open and closed positions. For example, there may be more than one shielding mechanism to selectively control each channel, if desired. FIGS. 10A through 11B illustrates another example in which the shield member is rotated into and out of the optical channel.

[0070] Specifically, FIGS. 10A and 10B illustrate a shield member 1001 in an open or activated state. Here, the shield member 1001 is fixed to a rotatable shaft 1002, which in turn is coupled to a motor M.

[0071] Upon rotation of the shield member 1001 by the motor M, as shown in FIGS. 11 A and 11B, the shield memory 1001 is positioned at the end of the second channel CH2, thereby blocking or deactivation the fiber bundle associated with the second channel CH2.

[0072] While the invention has been illustrated and described in detail in the drawings and foregoing description, such illustration and description are to be considered illustrative or exemplary and not restrictive; the invention is not limited to the disclosed embodiments. Other variations to the disclosed embodiments can be understood and effected by those skilled in the art in practicing the claimed invention, from a study of the drawings, the disclosure, and the appended claims. While representative embodiments are disclosed herein, one of ordinary skill in the art will appreciate that many variations that are in accordance with the present teachings are possible and remain within the scope of the appended claim set. The invention therefore is not to be restricted except within the scope of the appended claims.

Claims

WHAT IS CLAIMED:

1. A laser catheter system, comprising: a proximal coupler with a slide or fiber support platform having multiple channels; a plurality of fiber packs positioned within the respective channels of the slide or fiber support platform and extending into a catheter; a laser system or switch mechanism configured to direct laser energy to the fiber packs within the multiple channels of the proximal coupler; and a shielding mechanism configured to activate or deactivate at least one of the fiber packs independently of the remaining fiber packs.

2. The laser catheter system of claim 1, wherein the multiple channels within the proximal coupler are defined by trenches in a surface of a fiber bundle platform or slide of the proximal coupler.

3. The laser catheter system of claim 1, wherein each of the fiber packs is at least one of a bundle of fibers or a fiber wire.

4. The laser catheter system of claim 1, wherein the shielding mechanism is configured to allow at least one the fiber packs within the proximal coupler to be retracted out of optical engagement with of the laser catheter system, while the remaining fiber packs remain in optical engagement with the laser catheter system.

5. The laser catheter system of claim 1, wherein the shielding mechanism is configured to rotate or move the laser energy between the fiber packs.

6. The laser catheter system of claim 1, wherein the shielding mechanism is a mechanical shield member within the proximal coupler for selectively blocking at least one channel from transmitting laser energy therethrough.

7. The laser catheter system of claim 6, wherein the mechanical shield member is manually operated.

8. The laser catheter system of claim 6, wherein the mechanical shield member is actuated by a motor.

9. A proximal connector, comprising: a connector body configured to operatively couple a laser catheter to a laser system, the connector body including at least first and second fiber channels that are spaced apart and configured to align respective fiber packs of the laser catheter with laser energy emitted by the laser system.

10. The proximal connector of claim 9, wherein the connector body includes a fiber support platform or slide, and the first and second fiber channels are defined by trenches formed in the fiber support platform or slide.

11. The proximal connector of claim 9, further comprising a shield mechanism configured to shield the first fiber channel from laser energy passing therethrough.

12. The proximal connector of claim 11, wherein the mechanical shield member is manually operated.

13. The proximal connector of claim 11, wherein the mechanical shield member is actuated by a motor.

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