Laser catheter proximal coupler with capillary assembly

Abstract

The laser catheter assembly 10 includes a laser catheter 12 containing an optical fiber bundle 14 and a coupler 16 attached to the proximal end of the laser catheter. The coupler includes a connector 18 configured to mate with an associated light source, and a retaining member 22 secured within the connector and having a through hole 24 disposed at the end of a channel, with the end of a proximal portion of the optical fiber bundle disposed within the through hole, the through hole having an optical input end 26 configured to receive light from an associated light source when the connector is mated with the associated light source, and a flared end 28 opposite the optical input end.

Description

[Technical Field]

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

[0002] In catheter-based vascular treatments, laser catheters utilize 308 nm laser light, which is transmitted down the catheter to the distal tip where the light can ablate tissue. Laser light can be used in conjunction with a contrast agent mixture. The laser light destroys the contrast agent, generating sound waves in the process. These sound waves emanate in circular or spherical waves around the tip of the laser catheter. When emitted into a calcified lesion, the sound waves can cause spallation in the calcium. However, due to the circular nature of the waves, if there is a specific section that does not have a calcified lesion completely enclosing the blood vessel, most of the generated energy from the pressure wave may 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 laser energy can be transferred to the tip of the catheter for treatment. Current laser catheter devices can also include a capillary (or "cap") tube and capillary clamp component of the assembly. The capillary tube is sized to absorb the laser beam and is made from a material that withstands the laser energy to protect adjacent coupler components. Treatments to the capillary tube surface can be applied to prevent transmission that could damage adjacent components within the coupler.

[0004] Current laser catheter capillary devices can be fabricated from fused silica with polished surfaces, which prevent transmission through light scattering at the polished surface. Channels within the capillary are used to align the fiber with the laser beam. Additionally, clamps for the capillary are currently made of stainless steel and are used to hold the capillary in place within the proximal coupler assembly. Summary of the Invention [Problem to be solved by the invention]

[0005] The following discloses specific improvements. [Means for solving the problem]

[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 coupler attached to a proximal end of the elongated device, the coupler including a connector configured to mate with an associated light source, and a retaining member secured within the connector and having a through hole positioned at an end of a channel, the end of a proximal portion of the optical fiber bundle being disposed within the through hole, the through hole having an optical input end configured to receive light from an associated light source when the connector is mated with the associated light source, and a flared end opposite the optical input end.

[0007] In some embodiments disclosed herein, a method of assembling a laser catheter assembly includes the steps of providing a slide piece having a channel formed therein; securing a retaining member to the slide piece so that a through hole of the retaining member is aligned with the channel, the through hole having a flared end; placing a proximal portion of a fiber optic bundle of the laser catheter within the channel; sliding the end of the proximal portion of the fiber optic bundle through the flared end of the through hole of the retaining member so that the end of the proximal portion of the fiber optic bundle is compressed within the through hole; and assembling first and second cover pieces of a connector onto the slide piece to surround them to form a coupler 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 fiber optic bundle and a coupler attached to a proximal end of the laser catheter, the coupler including a connector configured to mate with an associated light source and a plate or disk secured within the connector and having a through hole disposed at an end of the channel, the end of the proximal portion of the fiber optic bundle being disposed within the through hole.

[0009] One advantage is the provision of a flared end on the capillary tube within the laser catheter assembly to hold the optical fiber in place.

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

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

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

[0013] A given embodiment may provide none, one, two, more, or all of the aforementioned advantages, and / or other advantages that will become apparent to those skilled in the art upon reading and understanding this disclosure.

[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 purposes of illustrating preferred embodiments and are not to be construed as limiting the disclosure. [Brief explanation of the drawings]

[0015] [Figure 1] 1 illustrates a schematic diagram of a laser catheter assembly according to the present disclosure. [Figure 2] 2 illustrates an embodiment of a retaining member of the assembly of FIG. 1. [Figure 3] 2 illustrates an embodiment of a retaining member of the assembly of FIG. 1. [Figure 4] 2 illustrates an embodiment of a retaining member of the assembly of FIG. 1. [Figure 5] 2 illustrates an embodiment of a retaining member of the assembly of FIG. 1. [Figure 6] 2 illustrates an embodiment of a retaining member of the assembly of FIG. 1. [Figure 7] 2 illustrates an embodiment of a clamp for the assembly of FIG. 1; [Figure 8A] 2 illustrates an embodiment of a clamp for the assembly of FIG. 1; [Figure 8B] 2 illustrates an embodiment of a clamp for the assembly of FIG. 1; [Figure 9] 2 shows a slide piece of the assembly of FIG. 1; [Figure 10] 2 shows a schematic diagram of a method for assembling the assembly of FIG. 1; DETAILED DESCRIPTION OF THE INVENTION

[0016] The following relates to an improvement to a proximal end coupler of a laser catheter for coupling the laser catheter to an excimer laser or other type of laser used in laser catheterization. The following shows an improvement to the basic coupler 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 slide mount sized and shaped to receive an optical fiber and interface with the laser, with a channel that positions the fiber end at the laser output aperture, which is the rectangular aperture of currently used commercial lasers. A clamp holds the optical fiber within the channel without the use of adhesives. A capillary tube is placed at the end of the channel, and the end of the optical fiber fits within the lumen of the capillary tube to provide a tightly packed bundle of optical fiber ends for coupling with the laser aperture.

[0017] In this assembly sequence, the end of the fiber is secured in the capillary tube, then the assembly is placed into the channel of the bottom slide piece and secured with a clamp, and then the top slide piece is secured to complete the assembly.

[0018] In one improvement, the capillary has a chamfer that widens the end where the optical fiber end is inserted. Additionally, the outer diameter of the chamfer positions it outside the outer periphery of the slide channel. With these modifications, the assembly process can be modified by first mounting and securing the capillary within the channel, then placing the optical fiber within the channel and sliding the optical fiber end into the chamfered capillary.

[0019] In another improvement, the capillary tube may be replaced by a larger assembly, such as a plate or disk, with openings having an inner diameter that serves the same purpose as the capillary tube's inner diameter, i.e., forming the fiber ends into a tight bundle for mating with the laser aperture. This approach has advantages in terms of manufacturability, as the plate or disk can be a stock plate that is machined to form the capillary openings, as opposed to the extrusion process used with capillary tubes.

[0020] Another improvement is to replace the capillary opening with a rectangular opening that better matches the typically rectangular laser beam aspect ratio. This improvement is facilitated by using a plate or disk, as machining of the stock plate can more easily form a rectangular opening, but may also be implemented as a capillary tube using appropriate extrusion techniques.

[0021] In another improvement, the existing metal clamps are replaced with clamps of a malleable material, such as plastic or rubber, which is less likely to damage the capillary tubes (or exchange plate or disk). In an alternative embodiment, the clamps are replaced with a malleable material placed on the upper slide piece, eliminating the need for clamp fasteners.

[0022] In a further variation, the malleable clamp has a cutout or notch, referred to herein as a window, to enhance visibility during assembly of the proximal coupler.

[0023] Referring to Figure 1, an exemplary insertable laser catheter assembly 10 is shown schematically. As shown in Figure 1, the device 10 includes an elongate device 12, e.g., a laser catheter, that includes at least one optical fiber 14 (shown in Figure 1 as a bundle of optical fibers) extending through the elongate device 12. The laser catheter 12 may also have a strain relief portion.

[0024] A coupler (shown generally in FIG. 1 as element 16) is attached to the proximal end of the laser catheter 12. As shown in FIG. 1, the coupler 16 includes a connector 18 configured to mate with or otherwise attach to an associated light source (not shown in FIG. 1) configured to provide laser light to the optical fibers 14. A portion of the optical fiber bundle 14 is disposed within the connector 18.

[0025] Coupler 16 also includes a retention member 22 secured within connector 18. As best shown in inset A of FIG. 1, retention member 22 includes a through-hole 24 through which the end of the proximal portion of optical fiber bundle 14 can reside.

[0026] 1 also shows that coupler 16 includes a slide piece 30 configured to mate with a light source. Slide piece 30 includes a channel 32 formed therein that is configured to receive and secure fiber bundle 14 within slide piece 30. Slide piece 30 is configured to interface with connector 18 to secure retention member 22 and optical fiber bundle 14 therebetween.

[0027] Continuing with reference to Figure 1, Figure 2 illustrates an embodiment of the retaining member 22. As shown in Figure 2, the retaining member 22 has a capillary tube having a light input end 26 positioned to receive light from the light source when the slide piece 30 is mated with the light source, and a flared end 28 opposite the light input end 26. As shown in Figure 2, the through hole 24 includes the lumen of the capillary tube 22 having the flared end 28.

[0028] In some embodiments, as shown in View A of Figure 2, the outer diameter of the flared end 28 of the through-hole 24 is larger than the outer circumference of the channel 32 in the slide piece 30. This allows the bundle of optical fibers 14 to pass through the through-hole 24 and into the laser catheter 12, reducing the possibility of damage to the optical fibers 14. View B of Figure 2 shows the opposite view of the retention member 22.

[0029] 3, the bottom of the inner diameter of the capillary tube 22 is also aligned with the bottom of the channel 32 of the slide piece 30 to aid manufacturability by reducing bending that could break or misalign the optical fiber 14, which could cause breakage. This allows the optical fiber 14 to slide straight along the channel 32 and into the tapered end 28 of the through-hole 24.

[0030] Continuing with reference to Figures 1 and 2, Figures 4A and 4B show different embodiments of capillary tube 22. As shown in Figure 4A, through-hole 24 has a circular cross-section, while in Figure 4B, through-hole 24 has a rectangular cross-section. Figure 4A also shows tapered end 28 of through-hole 24.

[0031] Figures 5A, 5B, and 6 show other embodiments of the holding member 22. As shown in Figures 5A and 5B, the holding member 22 has a plate 22 with through-holes 24 extending therethrough. Figure 5B shows the plate 22 positioned within a slide piece 30. Figure 6 shows the holding member 22 with a disk 22 with through-holes 24 extending therethrough. The plate / disk 22 can provide greater flexibility in fabricating the size and shape of the through-holes 24 to match the shape and size of the laser beam profile provided by the light source. Cost reductions are possible with thinner materials that are compatible with various machining methods. For example, the plate / disk 22 can be water-jet machined or diamond-cut instead of a drawing process limited to a cylinder. The shape of the plate / disk 22 can also be tailored to the slide piece 30 to allow for greater coverage to protect adjacent components from the laser energy.

[0032] Referring back to FIG. 1 , the laser catheter device 10 further includes a clamp 34 configured to secure the retaining member 22 to the slide piece 30, with the through-hole 24 disposed at the end of the channel 32 of the slide piece 30. The clamp 34 can be secured to the slide piece 30 (e.g., using a screw as shown in FIG. 1 ). The clamp 34 can comprise a malleable material, such as plastic and / or rubber. The malleable material of the clamp 34 reduces the possibility of damage to the retaining member 22. The clamp 34 can be positioned over the capillary tube 22 to prevent its movement. In some examples, the clamp 34 can be sized to allow visualization of the capillary tube 22 to a user during assembly of the laser catheter assembly 10. In another example, shown in inset A of FIG. 1 , the clamp 34 can include a notch 36 to enhance visibility during assembly.

[0033] FIG. 1 also shows that the connector 18 further includes a first cover piece 38 (i.e., the “top” cover piece shown in FIG. 1 ) and a second cover piece 40 (i.e., the “bottom” cover piece shown in FIG. 1 ). The slide piece 30 is secured between the first cover piece 38 and the second cover piece 40. The clamp 34 is secured to the slide piece 30 (i.e., by a screw, as shown in FIG. 1 ). In some embodiments, the clamp 34 can be secured to the first cover piece 38 or the second cover piece 40. The second cover piece 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 piece or in both the first and second cover pieces. In some examples, the connector 18 and the first side piece 38 or the first cover piece can be a single component.

[0034] Continuing with reference to FIG. 1, FIGS. 7, 8A, and 8B show different embodiments of the clamp 34. As shown in FIG. 7, the clamp 34 is secured to a portion of the first cover piece 38. The clamp 34 is configured to apply a compressive force to the capillary tube 22 to hold the capillary tube 22 in place within the channel 32 of the slide piece 30. FIGS. 8A and 8B show embodiments in which the clamp 34 has a spring configured to engage and hold the capillary tube 22 in place within the channel 32 of the slide piece 30. FIG. 8A shows the clamp 34 prior to engagement with the capillary tube 22, and FIG. 8B shows the clamp 34 engaged with the capillary tube 22.

[0035] FIG. 9 shows a diagram of the slide piece 30. As shown in FIG. 9, the slide piece 30 includes a channel 32 for receiving a bundle of optical fibers 14. The slide piece 30 can also include a recess 44 configured to receive a retaining member 22 (i.e., either a capillary tube 22 or a plate / disk 22). The recess 44 can be machined into the slide piece 30 with a desired setback based on the size of the laser catheter 12 and the number of optical fibers 14. The laser beam profile is larger with a larger setback; therefore, smaller fiber packs have a smaller setback (i.e., closer to the edge of the slide piece 30) and larger fiber packs have a larger setback (further from the edge of the slide piece 30). In some examples, the recess 44 can have a "dogbone" shape, V-channel, or similar structure that holds the capillary tube 22 in place. The recess 44 is machined in a manner that allows the capillary tube 22 to align with the channel 32 of the slide piece 30 for greater manufacturability and reduced risk of fiber breakage. To hold the capillary tube 22 within this feature, a clamp 34 is placed over the capillary tube 22 .

[0036] 10 , an exemplary embodiment of a method or process 100 for assembling the laser catheter assembly 10 is shown generally as a flow chart. In operation 102, the retaining member 22 is secured to the slide piece 30 such that the through-hole 24 of the retaining member 22 is aligned with the channel 32 of the slide piece 30. In some embodiments, the securing operation 102 can include clamping the retaining member 22 to the slide piece 30 using a clamp 34.

[0037] In operation 104, the proximal portion of the optical fiber bundle 14 is placed in the channel 32 of the slide piece 30. In operation 106, the end of the proximal portion of the optical fiber bundle 14 is slid through the flared end 28 of the through hole 24 of the retaining member 22, and the end of the proximal portion of the optical fiber bundle 14 is compressed within the through hole 24. The outer diameter of the flared end 28 of the through hole 24 is larger than the outer circumference of the channel 32 of the slide piece 30. During the sliding operation 106, the flared end 28 guides the end of the proximal portion of the optical fiber bundle 14 into the through hole 24.

[0038] In operation 108, the first cover piece 38 and the second cover piece 40 are assembled on opposite ends of the slide piece 30 to form the coupler 16. In some embodiments, the securing operation 102 is performed by securing a clamp 34 to the first cover piece 38 during the assembly operation 108, which clamp 34 presses the retaining member 22 against the slide piece 30 during the assembly operation 108. Once formed, the coupler 16 can be attached to a laser source, and a laser beam can be delivered to the optical fiber 14.

[0039] The present disclosure has been described with reference to the preferred embodiment. Modifications and alterations may occur to others upon reading and understanding the preceding detailed description. It is intended that the exemplary embodiments be construed as including all such modifications and alterations insofar as they come within the scope of the appended claims or the equivalents thereof.

Claims

1. In the laser catheter device, the laser catheter device comprises: a laser catheter including a bundle of optical fibers; a coupler attached to the proximal end of the laser catheter; and the coupler comprises: a connector configured to mate with an associated light source; a retaining member secured within the connector and having a through hole disposed at an end of a channel, the through hole having an end of a proximal portion of the optical fiber bundle disposed within the through hole, the through hole having a light input end disposed to receive light from the associated light source when the connector is mated with the associated light source, and a flared end opposite the light input end; Including, Laser catheter device.

2. The laser catheter device of claim 1 , wherein the retaining member includes a capillary tube, and the through-hole includes a lumen of the capillary tube having the flared end.

3. The laser catheter device according to claim 1 , wherein the through-hole of the holding member has a rectangular cross section.

4. The laser catheter device according to claim 1 or 2, wherein the retaining member comprises a plate or a disk, and the through-hole passes through the plate or the disk.

5. The connector of the coupler has a slide piece configured to mate with the associated light source, the slide piece having a channel formed therein, the coupler further comprising: a clamp for fixing the retaining member to the slide piece, the through hole being disposed at an end of the channel; Including, 5. The laser catheter device according to claim 1.

6. The laser catheter device according to claim 6 , wherein the outer diameter of the flared end of the through-hole is larger than the outer periphery of the channel of the slide piece.

7. The laser catheter device of claim 6 or 7, wherein the clamp comprises plastic or rubber.

8. The laser catheter device of claim 6 , wherein the clamp includes a notch.

9. 9. The laser catheter device according to claim 6, wherein the connector further includes a first cover piece and a second cover piece, the slide piece being fixed between the first cover piece and the second cover piece, and the clamp being fixed to the first cover piece.

10. 1. A method of assembling a laser catheter assembly, comprising: providing a slide piece having a channel formed therein; securing a retaining member to the slide piece, the retaining member having a through hole aligned with the channel, the through hole having a flared end; placing a proximal portion of a laser catheter fiber optic bundle within the channel; sliding the end of the proximal portion of the optical fiber bundle through the flared end of the through hole of the retention member such that the end of the proximal portion of the optical fiber bundle is compressed within the through hole; assembling first and second cover pieces of the connector over and surrounding the slide piece to form a coupler attached to the proximal end of the laser catheter; A method having the following.

11. The method of claim 10, wherein the outer diameter of the flared end of the through hole is larger than the outer circumference of the channel of the sliding piece, whereby during sliding, the flared end guides the end of the proximal portion of the optical fiber bundle into the through hole of the holding member.

12. 12. The method of claim 10, wherein the step of securing the retaining member to the sliding piece includes clamping the retaining member to the sliding piece using a clamp comprising plastic or rubber.

13. 12. The method of claim 10, wherein the step of securing the retaining member to the slide piece is performed during assembly of the first and second cover pieces by a clamp secured to the first cover piece that presses the retaining member against the slide piece during assembly.

14. a laser catheter including a bundle of optical fibers; a coupler attached to the proximal end of the laser catheter, a connector configured to mate with an associated light source; and a plate or disk fixed within the connector and having a through hole disposed at an end of a channel, the end of the proximal portion of the optical fiber bundle being disposed within the through hole; a coupler including: A laser catheter device having:

15. 15. The laser catheter device of claim 14, wherein the connector of the coupler has a sliding piece configured to mate with the associated light source, the sliding piece having a channel formed therein.

16. The coupler further comprises: a clamp for fixing the retaining member to the slide piece, the through hole being disposed at an end of the channel; 16. The laser catheter device of claim 15, comprising:

17. The laser catheter device of claim 16 , wherein the clamp comprises plastic or rubber.

18. The laser catheter device of claim 16 or 17, wherein the clamp includes a notch.

19. 18. The laser catheter device of claim 16, wherein the connector further includes a first cover piece and a second cover piece, and the slide piece is fixed between the first cover piece and the second cover piece.

20. 20. The laser catheter of claim 19, wherein the clamp is secured to the first cover piece.

Images