Laser catheter proximal coupler with capillary assembly

Abstract

A laser catheter assembly (10) includes: a laser catheter (12) including a bundle of optical fibers (14); and a coupler (16) attached to the proximal end of the laser catheter. The coupler comprises: a connector (18) configured for mating with an associated light source; and a retaining member (22) secured within the connector and having a through-hole (24) positioned at the end of the channel, the end of the proximal portion of the bundle of optical fibers being disposed in the through-hole, the through-hole having a light input end (26) and a flared end (28) opposite the light input end, wherein the light input is arranged for receiving light from an associated light source when the connector is mated with the associated light source.

Description

Technical Field

[0001] The following content generally relates to catheter technology, vascular treatment, lesion treatment technology and related technologies. Background Art

[0002] In catheter-based vascular treatment, laser catheters utilize a 308 nm laser that is transmitted down the catheter to the distal tip, where the light can ablate tissue. The laser can be used with a contrast agent mixture. The laser breaks down the contrast agent and, in the process, generates sound waves. Such sound waves are emitted in a circular or spherical wave around the tip of the laser catheter. When emitted in a calcified lesion, the sound waves can create breaks in the calcium. However, due to the circular nature of the wave, if there is a specific segment of a calcified lesion that does not fully encapsulate the vessel, a large portion of the energy generated from the pressure wave will bypass the target calcium.

[0003] Current laser catheter devices include a proximal coupler to align the optical fiber within the catheter with the laser system so that the laser energy can be transferred to the end of the catheter for treatment. Current laser catheter devices may also include a capillary (or "cap") tube and a capillary fixture component of the assembly. The capillary is sized to absorb the laser beam and is made of a material that withstands the laser energy, thereby protecting adjacent coupler components. The surface of the capillary can be treated to prevent transmission that could damage adjacent components within the coupler.

[0004] The capillary device of current laser catheters can be produced from fused silica with a wear surface that prevents transmission through light dispersion at the wear surface. A channel within the capillary is used to align the optical fiber with the laser beam. In addition, the clamp for the capillary is currently made of stainless steel and is used to hold the capillary in place within the proximal coupler assembly.

[0005] The following discloses some improvements. Summary of the invention

[0006] In some embodiments disclosed herein, a laser device assembly includes: an elongated device, such as a laser catheter, including a bundle of optical fibers; and a coupling attached to the proximal end of the elongated device. The coupling includes: a connector configured to be mated with an associated light source; and a retaining member fixed within the connector and having a through hole positioned at the end of a channel, an end of a proximal portion of the bundle of optical fibers being disposed in the through hole, the through hole having a light input end and a flared end opposite to the light input end, wherein the light input end is arranged to receive light from the associated light source when the connector is mated with the associated light source.

[0007] In some embodiments disclosed herein, a method of assembling a laser catheter assembly includes: providing a sliding member having a channel formed therein; fixing a retaining member to the sliding member, wherein a through hole of the retaining member is aligned with the channel and the through hole has a flared end; disposing a proximal portion of a bundle of optical fibers of the laser catheter in the channel; sliding an end of the proximal portion of the bundle of optical fibers through the flared end of the through hole of the retaining member so that the end of the proximal portion of the bundle of optical fibers is compressed into the through hole; and assembling a first cover and a second cover of a connector around the sliding member to form a connector attached to the proximal end of the laser catheter.

[0008] In some embodiments disclosed herein, a laser catheter assembly includes: a laser catheter including a bundle of optical fibers; and a coupler attached to the proximal end of the laser catheter. The coupler includes: a connector configured to mate with an associated light source; and a plate or disk fixed within the connector and having a through hole positioned at the end of the channel, the end of the proximal portion of the bundle of optical fibers being disposed in the through hole.

[0009] One advantage resides in providing a flared end on the capillary in the laser catheter assembly to hold the optical fiber in place.

[0010] Another advantage resides in the use of a disk instead of a capillary to hold the optical fiber in place.

[0011] Another advantage resides in the use of a plate instead of a capillary to hold the optical fiber in place.

[0012] Another advantage resides in the use of a malleable clamp to hold the optical fiber in place.

[0013] A given embodiment may provide none of the foregoing advantages, one of the foregoing advantages, two of the foregoing advantages, more of the foregoing advantages, or all of the foregoing advantages, and / or may provide other advantages that will become apparent to one of ordinary skill in the art upon reading and understanding the present disclosure. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] The disclosure may take form in various components and arrangements of components, and in various steps and arrangements of steps.The drawings are only for the purpose of illustrating the preferred embodiments and are not to be construed as limiting the disclosure.

[0015] Figure 1 A laser catheter assembly according to the present disclosure is schematically illustrated.

[0016] Figures 2 to 6 Shows Figure 1 An embodiment of a retaining member of an assembly.

[0017] Figure 7 , Fig. 8A , Figure 8B Shows Figure 1 Embodiment of a fixture for an assembly.

[0018] Fig. 9 Shows Figure 1 The sliding part of the component.

[0019] Fig.10 Schematic diagram showing the assembly Figure 1 The component method. DETAILED DESCRIPTION

[0020] The following relates to improvements to the proximal connector of a laser catheter, which is used to connect the laser catheter to an excimer laser or other type of laser used in laser catheter surgery. The following gives improvements to the basic connector described in U.S. Patent No. 7,050,692 to Harlan et al. (which is incorporated herein by reference in its entirety). The basic design has a sliding mount that is sized and shaped for connection with a laser, and the sliding mount has a channel that receives an optical fiber and positions the end of the optical fiber at the laser output hole, which is a rectangular hole in currently used commercial lasers. A clamp holds the optical fiber in the channel without the use of an adhesive. A capillary is placed at the end of the channel, and the end of the optical fiber fits into the lumen of the capillary to provide a tightly packed bundle of optical fiber ends for connection with the hole of the laser.

[0021] In the assembly sequence of the present invention, the end of the optical fiber is secured in the capillary tube, the assembly is then placed into the channel of the bottom slide and secured with a clamp, and the top slide is then secured to complete the assembly.

[0022] In one refinement, the capillary has a chamfer that widens the end into which the fiber end is inserted. In addition, the outer diameter of the chamfer is such that it is placed outside the perimeter of the sliding channel. With these modifications, the assembly process can be adjusted by first installing and securing the capillary in the channel, then placing the fiber into the channel and sliding the fiber end into the chamfered capillary.

[0023] In another refinement, the capillary can be replaced by a larger component, such as a plate or disk, having an opening having an inner diameter for the same purpose as the inner diameter of the capillary, i.e., for forming the fiber ends into a tight bundle for coupling with the aperture of the laser. This approach has advantages in terms of manufacturability because the plate or disk can be a blank plate that is machined to form the capillary opening, as opposed to the extrusion process used in the capillary.

[0024] In another improvement, the capillary opening is replaced by a rectangular opening that better matches the aspect ratio of a typical rectangular laser beam. This improvement is achieved by using a plate or disk, because machining of a blank plate can more easily form a rectangular opening; however, it can also be implemented as a capillary using suitable extrusion technology.

[0025] In another improvement, the existing metal clamp is replaced by a clamp formed of a ductile material such as plastic or rubber, which is less likely to damage the capillary (or replacement plate or disk). In a variant embodiment, the clamp is replaced by a ductile material disposed on the top slide to eliminate the need for clamp fasteners.

[0026] In another variation, the malleable clamp has a cutout or notch, referred to herein as a window, for enhanced visibility during assembly of the proximal coupler.

[0027] Reference Figure 1 , schematically illustrates an exemplary insertable laser catheter assembly 10. Figure 1 As shown, the device 10 includes an elongated device 12, such as a laser catheter, which includes at least one optical fiber 14 extending through the elongated device 12 (at Figure 1 The laser catheter 12 may also include a strain relief portion thereof.

[0028] Connector (in Figure 1 In general, it is shown as Figure 1 The element 16 in FIG. 1 is attached to the proximal end of the laser catheter 12. Figure 1 As shown, the coupling 16 includes a connector 18, which is configured to be used with an associated light source ( Figure 1 The optical fiber 14 is mated or otherwise attached to an optical fiber 14 (not shown), and the associated light source is configured to provide laser light to the optical fiber 14. A portion of the bundle of optical fibers 14 is disposed within the connector 18.

[0029] The coupling 16 also includes a retaining member 22 that is secured within the connector 18. Figure 1 As best shown in inset A of , the retaining member 22 includes a through hole 24 , wherein the end of the proximal portion of a bundle of optical fibers 14 may be located in the through hole 24 of the retaining member 22 .

[0030] Figure 1 The coupling 16 is also shown to include a slider 30 configured to cooperate with the light source. The slider 30 includes a channel 32 formed therein, which is configured to receive and secure a bundle of optical fibers 14 within the slider 30. The slider 30 is configured to connect with the connector 18 so as to secure the retaining member 22 and the bundle of optical fibers 14 therebetween.

[0031] Continue to refer to Figure 1 , Figure 2 An embodiment of the retaining member 22 is shown. Figure 2 As shown, the retaining member 22 includes a capillary having a light input end 26 and a flared end 28 opposite the light input end 26, wherein the light input end 26 is arranged to receive light from the light source when the slider 30 is engaged with the light source. Figure 2 As shown, the through hole 24 includes the lumen of the capillary tube 22 having a flared end 28 .

[0032] In some embodiments, Figure 2 As shown in view A of FIG. 1 , the outer diameter of the expanded end 28 of the through hole 24 is larger than the periphery of the channel 32 of the slider 30. This allows a bundle of optical fibers 14 to extend from the through hole 24 to the laser catheter 12 and reduces the possibility of damaging the optical fibers 14. Figure 2 View B of FIG. 1 shows an opposite view of the retaining member 22 .

[0033] Now refer to Figure 3 The bottom of the inner diameter of the capillary 22 is also aligned with the bottom of the channel 32 of the slider 30 to reduce bending that may break or misalign the optical fiber 14 (which may cause breakage) and to aid in manufacturability. This allows the optical fiber 14 to slide along the channel 32 and directly enter the tapered end 28 of the through hole 24.

[0034] Continue to refer to Figure 1 and Figure 2 , Figure 4A and Figure 4B Different embodiments of the capillary 22 are shown. Figure 4A As shown, the through hole 24 has a circular cross section, and in Figure 4B In FIG. 2 , the through hole 24 has a rectangular cross section. Figure 4A The tapered end 28 of the through hole 24 is also shown.

[0035] Figure 5A , Figure 5B and Figure 6 Other embodiments of the retaining member 22 are shown. Figure 5A and Figure 5B As shown, the retaining member 22 includes a plate 22 including a through hole 24 therethrough. Figure 5B The plate 22 is shown positioned within the slide 30 . Figure 6A retaining member 22 is shown that includes a disk 22 that includes a through hole 24 therethrough. The plate / disk 22 can provide greater flexibility in making the size and shape of the through hole 24 match the shape and size of the laser beam profile provided by the light source. Costs can be reduced by using thinner materials that are compatible with various machining methods. For example, the plate / disk 22 can be water jet or diamond cut, rather than being limited to a drawing process of a cylinder. The shape of the plate / disk 22 can also be adjusted to accommodate the slide 30 so that greater coverage can be achieved to protect adjacent components from the laser energy.

[0036] Come back for reference Figure 1 The laser catheter device 10 further includes a clamp 34 configured to secure the retaining member 22 to the slide 30, wherein the through hole 24 is positioned at the end of the channel 32 of the slide 30. The clamp 34 may be secured to the slide 30 (e.g., using Figure 1 ). The clamp 34 may comprise a ductile material, such as plastic and / or rubber. The ductile material of the clamp 34 reduces the likelihood of damaging the retaining member 22. The clamp 34 may be positioned over the capillary 22 to prevent movement thereof. In some examples, the clamp 34 may be sized to allow visualization of the capillary 22 to the user during assembly of the laser catheter assembly 10. In other examples, such as Figure 1 As shown in inset A of FIG. 8 , the clamp 34 may include a notch 36 to enhance visibility during assembly.

[0037] Figure 1 The connector 18 is also shown to include a first cover 38 (ie, Figure 1 The "top" cover shown) and the second cover 40 (ie, as shown Figure 1 The slider 30 is secured between the first cover 38 and the second cover 40. The clamp 34 is secured to the slider 30 (i.e., using screws, such as Figure 1 ). In some embodiments, the clamp 34 can be secured to the first cover 38 or the second cover 40. The second cover 40 includes a slot 42 configured to receive and secure the laser catheter 12. In some embodiments, the slot 42 can be included in the first cover or in both the first cover and the second cover. In some examples, the connector 18 and the first side member 38 or the first cover can be a single component.

[0038] Continue to refer to Figure 1 , Figure 7 , Fig. 8A and Figure 8B Different embodiments of the clamp 34 are shown. Figure 7As shown, the clamp 34 is secured to a portion of the first cover 38. The clamp 34 is configured to apply a compressive force to the capillary 22 so as to hold the capillary 22 in place within the channel 32 of the slider 30. Fig. 8A and Figure 8B An embodiment is shown in which the clamp 34 includes a spring configured to engage and hold the capillary 22 in position within the channel 32 of the slider 30 . Fig. 8A The fixture 34 is shown prior to engagement with the capillary 22, and Figure 8B A clamp 34 is shown engaged with the capillary 22 .

[0039] Fig. 9 A view of the slide 30 is shown. Fig. 9 As shown, the slider 30 includes a channel 32 for receiving a bundle of optical fibers 14. The slider 30 may also include a recess 44 configured to receive a holding member 22 (i.e., a capillary 22 or a plate / disk 22). The recess 44 may be machined into the slider 30 at a desired indentation based on the size of the laser catheter 12 and the number of optical fibers 14. The laser beam profile becomes larger at a larger indentation, so a smaller group of optical fibers has a smaller indentation (i.e., closer to the edge of the slider 30) and a larger group of optical fibers has a larger indentation (farther away from the edge of the slider 30). In some examples, the recess 44 may have a "dog bone" shape, a V-shaped channel, or a similar structure that holds the capillary 22 in place. The recess 44 is machined in a manner that allows the capillary 22 to align with the channel 32 of the slider 30 for easier manufacturing and reduced risk of fiber breakage. To hold the capillary 22 within this feature, a clamp 34 is placed on top of the capillary 22.

[0040] Reference Fig.10 , an illustrative embodiment of a method or process 100 of assembling a laser catheter assembly 10 is schematically shown as a flow chart. At operation 102, a retaining member 22 is secured to a slide 30 such that a through hole 24 of the retaining member 22 is aligned with a channel 32 of the slide 30. In some embodiments, the securing operation 102 may include clamping the retaining member 22 to the slide 30 using a clamp 34.

[0041] At operation 104, the proximal portion of the bundle of optical fibers 14 is disposed within the channel 32 of the slider 30. At operation 106, the end of the proximal portion of the bundle of optical fibers 14 is slid through the flared end 28 of the through hole 24 of the retaining member 22, so that the end of the proximal portion of the bundle of optical fibers 14 is compressed into the through hole 24. The outer diameter of the flared end 28 of the through hole 24 is larger than the periphery of the channel 32 of the slider 30. During the sliding operation 106, the flared end 28 guides the end of the proximal portion of the bundle of optical fibers 14 into the through hole 24.

[0042] At operation 108, the first cover 38 and the second cover 40 are assembled on opposite ends of the slide 30 to form the coupler 16. In some embodiments, during the assembly operation 108, the securing operation 102 is performed by securing the clamp 34 to the first cover 38, and during the assembly operation 108, the clamp 34 presses the retaining member 22 against the slide 30. Once formed, the coupler 16 can be attached to a laser source, and the laser beam can be supplied to the optical fiber 14.

[0043] The present disclosure has been described with reference to preferred embodiments. Modifications and changes may occur to others once the foregoing detailed description is read and understood. It is intended that the exemplary embodiments be interpreted as including all such modifications and changes as long as they fall within the scope of the appended claims or their equivalents.

Claims

1. A laser catheter assembly (10), comprising: A laser catheter (12) comprising a bundle of optical fibers (14); as well as A coupler (16) attached to the proximal end of the laser catheter, the coupler comprising: a connector (18) configured to mate with an associated light source; as well as a retaining member (22) fixed within the connector and having a through hole (24) positioned at the end of the passage, the end of the proximal portion of the bundle of optical fibers being disposed in the through hole, the through hole having a light input end (26) and a flared end (28) opposite the light input end, wherein the light input end is arranged to receive light from the associated light source when the connector is mated with the associated light source.

2. The laser catheter device (10) according to claim 1, wherein: The retaining member (22) comprises a capillary tube, and the through hole (24) comprises a lumen of the capillary tube having the flared end.

3. The laser catheter device (10) according to any one of claims 1 and 2, wherein: The through hole (24) of the retaining member (22) has a rectangular cross section.

4. The laser catheter device (10) according to any one of claims 1 and 2, wherein: The retaining member (22) comprises a plate or disc having a through hole (24) therethrough.

5. The laser catheter device (10) according to any one of claims 1 to 4, wherein: The connector (18) of the coupler (16) includes a slide (30) configured to mate with the associated light source, the slide having the channel (32) formed therein, the coupler further comprising: A clamp (34) secures the retaining member to the slide, wherein the through hole (24) is located at the end of the channel.

6. The laser catheter device (10) according to claim 6, wherein: The flared end (28) of the through hole (24) has an outer diameter that is larger than the periphery of the passage (32) of the sliding member (30).

7. The laser catheter device (10) according to any one of claims 6 and 7, wherein: The clamp (34) comprises plastic or rubber.

8. The laser catheter device (10) according to any one of claims 6 to 8, wherein: The clamp (34) includes a notch (36).

9. The laser catheter device (10) according to any one of claims 6 to 8, wherein: The connector (18) further comprises a first cover (38) and a second cover (40), the slide (30) being fixed between the first cover and the second cover, and the clamp (34) being fixed to the first cover.

10. A method (100) of assembling a laser catheter assembly (10), the method comprising: providing a slide (30) having a channel (32) formed therein; securing a retaining member (22) to the slide, wherein a through hole (24) of the retaining member is aligned with the passage, the through hole having a flared end (28); placing a proximal portion of a bundle of optical fibers (14) of a laser catheter (12) in the channel; sliding an end of the proximal portion of the bundle of optical fibers through the flared end of the through hole of the retaining member such that the end of the proximal portion of the bundle of optical fibers is compressed into the through hole; as well as A first cover (38) and a second cover (40) of a connector (18) are assembled around the slide to form a coupler (16) that is attached to the proximal end of the laser catheter.

11. The method (100) according to claim 10, wherein: The flared end (28) of the through hole (24) has an outer diameter greater than the periphery of the channel (32) of the slider (30), whereby during the sliding, the flared end guides the end of the proximal portion of the bundle of optical fibers (14) into the through hole of the retaining member (22).

12. The method (100) according to any one of claims 10 and 11, wherein: Securing the retaining member (22) to the slide (30) includes clamping the retaining member to the slide using a clamp (34) comprising plastic or rubber.

13. The method (100) according to any one of claims 10 and 11, wherein: During assembly of the first cover (38) and the second cover (40), the retaining member (22) is secured to the slide (30) by a clamp (34) secured to the first cover, wherein the clamp (34) presses the retaining member (22) against the slide during the assembly.

14. A laser catheter assembly (10), comprising: A laser catheter (12) comprising a bundle of optical fibers (14); as well as A coupler (16) attached to the proximal end of the laser catheter, the coupler comprising: a connector (18) configured to mate with an associated light source; as well as A plate or disk (22) is secured within the connector and has a through hole (24) positioned at the end of the passageway, the end of the proximal portion of the bundle of optical fibers being disposed in the through hole.

15. The laser catheter device (10) according to claim 14, wherein: The connector (18) of the coupler (16) includes a slide (30) configured to mate with the associated light source, the slide having the channel (32) formed therein.

16. The laser catheter device (10) according to claim 15, wherein: The coupling (16) further comprises: A clamp (34) secures the retaining member to the slide, wherein the through hole (24) is located at the end of the channel (22).

17. The laser catheter device (10) according to claim 16, wherein: The clamp (34) comprises plastic or rubber.

18. The laser catheter device (10) according to any one of claims 16 and 17, wherein: The clamp (34) includes a notch (36).

19. The laser catheter device (10) according to any one of claims 16 and 17, wherein: The connector (18) further comprises a first cover member (38) and a second cover member (40), and the sliding member (30) is fixed between the first cover member and the second cover member.

20. The laser catheter (10) according to claim 19, wherein: The clamp (34) is fixed to the first cover (38).

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