Medical devices and methods for managing excess lengths of medical laser fibers during medical procedures

Abstract

Disclosed herein is a laser fiber enclosed in a tubular package having a plurality of sections along its length, each of the plurality of sections being connected to an adjacent section by a circumferential tear line, and each of the plurality of sections including a length indicia.

Description

[Technical Field]

[0001] The present invention relates to medical devices, and more particularly to a package and method of use for managing excess laser fiber. [Background technology]

[0002] In medical procedures using laser systems that include a laser fiber, it can be difficult to determine the appropriate length of the laser fiber to reach from the laser module to the patient. The appropriate length can be limited by factors such as the location of the laser module in the room relative to the patient. When the laser system is located near the patient, excess laser fiber length may be present due to the short distance between the laser system and the patient. Current methods for managing this excess length include wrapping it in a wet cloth and placing it near the patient. A better method for determining the appropriate length of laser fiber needed and managing excess laser fiber length would be beneficial to the user and the patient. Disclosed herein are devices and methods of use that address the above. Summary of the Invention

[0003] A medical device disclosed herein, according to some embodiments, includes a laser fiber defining a proximal end and a distal end, the laser fiber including a connector at the proximal end, and a tubular package extending along the laser fiber, the tubular package including a plurality of sections along a length of the tubular package, adjacent sections of the plurality of sections configured to separate from one another during use of the laser fiber.

[0004] In some embodiments, the tubular package defines a coil shape. In some embodiments, the tubular package is formed from a rigid material to maintain a coiled shape during use.

[0005] In some embodiments, the tubular package is configured to be secured to the laser system during use. In some embodiments, adjacent sections are joined via frangible joints, which are configured to be separated by a clinician during use.

[0006] In some embodiments, each of the plurality of sections includes a length indication. In some embodiments, each length marking indicates the length of the laser fiber extending between the length marking and the connector.

[0007] In some embodiments, each length indicia is engraved or stamped onto the tubular package. In some embodiments, one or more of the plurality of sections includes a separable seam extending longitudinally along the tubular package.

[0008] In some embodiments, the connector is located on the exterior of the package. In some embodiments, the package is disposable. Also disclosed herein is a method for managing excess length of a medical laser fiber during a medical procedure. According to some embodiments, the method includes the steps of: (i) coupling a connector of the laser fiber to a laser system, wherein the laser fiber is disposed within a tubular package; (ii) determining a desired length of the laser fiber for use in performing the medical procedure; (iii) removing a portion of the tubular package to expose the desired length of the laser fiber; and (iv) securing the excess length of the laser fiber to the laser system and disposing the excess length within the tubular package.

[0009] In some embodiments of the method, the tubular package includes a plurality of sections, adjacent sections of the plurality of sections configured to be separated by a clinician during use of the laser fiber.

[0010] In some embodiments of the method, each of the plurality of sections includes a length indication. In some embodiments of the method, each length indication indicates a length of the laser fiber extending between the connector and the length indication.

[0011] In some embodiments of the method, determining the desired length of the laser fiber includes using the length indication to determine a portion of the tubular package to be removed from the laser fiber.

[0012] In some embodiments of the method, removing the tubular package to expose the laser fiber includes separating one or more of the adjacent sections. In some embodiments of the method, removing the tubular package to expose the laser fiber further includes threading one or more sections off a distal end of the laser fiber.

[0013] In some embodiments of the method, one or more of the plurality of sections includes a separable seam extending longitudinally along the tubular package. In some embodiments of the method, removing the tubular package to expose the laser fiber includes separating a separable seam of one or more sections of the plurality of sections to expose the laser fiber.

[0014] In some embodiments of the method, the tubular package defines a rigid coil shape, and organizing the excess length of laser fiber includes maintaining the excess length of laser fiber within the tubular package.

[0015] In some embodiments of the method, the step of securing the excess length of the laser fiber to the laser system includes hanging the tubular package on a hook of the laser system. These and other features of the concepts provided herein will become more apparent to those skilled in the art in view of the accompanying drawings and the following description, which disclose in more detail certain embodiments of such concepts.

[0016] A more particular description of the present disclosure will be provided by reference to specific embodiments thereof, which are illustrated in the accompanying drawings. These drawings depict only typical embodiments of the invention and therefore should not be considered limiting of its scope. Exemplary embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings. [Brief explanation of the drawings]

[0017] [Figure 1A] FIG. 1 illustrates a perspective view of a laser system including a laser fiber, according to some embodiments. [Figure 1B] 1A-1D illustrate top views of different positions of a laser system during a medical procedure, according to some embodiments. [Figure 1C] 1A-1D illustrate top views of different positions of a laser system during a medical procedure, according to some embodiments. [Figure 2A] 1 illustrates a side view of a portion of a package with a laser fiber disposed therein, according to some embodiments. [Figure 2B] 2B shows a top view of the package of FIG. 2A having a coiled shape, according to some embodiments. [Figure 2C] FIG. 2C shows a perspective view of another embodiment of the package of FIGS. 2A and 2B having a longitudinal seam, according to some embodiments. [Figure 3A] 2A and 2B and an embodiment of the package of FIG. 2C in various states of separation to expose a laser fiber, according to some embodiments. [Figure 3B]2A and 2B and an embodiment of the package of FIG. 2C in various states of separation to expose a laser fiber, according to some embodiments. [Figure 3C] 2A and 2B and an embodiment of the package of FIG. 2C in various states of separation to expose a laser fiber, according to some embodiments. [Figure 3D] 2A and 2B and an embodiment of the package of FIG. 2C in various states of separation to expose a laser fiber, according to some embodiments. [Figure 4] 1 illustrates a flowchart of an exemplary method for managing excess length of laser fiber, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0018] Before disclosing some specific embodiments in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the specific embodiments disclosed herein may have features that are readily separable from the specific embodiment and that, optionally, can be combined with or substituted for features of any of the other embodiments disclosed herein.

[0019] Regarding the terms used herein, it should also be understood that these terms are intended to describe certain specific embodiments and do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps within a group of features or steps and do not provide serial or numerical limitations. For example, "first," "second," and "third" features or steps do not necessarily have to appear in that order, and a particular embodiment including such features or steps is not necessarily limited to three features or steps. Designations such as "left," "right," "top," "bottom," "front," and "back" are for convenience and do not imply, for example, a specific fixed location, direction, or orientation. Instead, such designations are used, for example, to reflect relative location, orientation, or direction. The singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.

[0020] With respect to "proximal," for example, a "proximal portion" or "proximal end portion" of a portion disclosed herein includes a portion of the portion intended to be near a clinician when the portion is used on a patient. Similarly, for example, a "proximal length" of a laser fiber includes a length of the laser fiber intended to be near a laser system when the laser fiber is used on a patient. For example, a "proximal end" of a laser fiber includes an end of the laser fiber intended to be near a laser system when the laser fiber is used on a patient. The proximal portion, proximal end portion, or proximal length of a laser fiber can include the proximal end of the laser fiber, but the proximal portion, proximal end portion, or proximal length of a laser fiber need not include the proximal end of the laser fiber. That is, unless the context suggests otherwise, the proximal portion, proximal end portion, or proximal length of a laser fiber is not a terminal portion or terminal length of the laser fiber.

[0021] With respect to "distal," for example, a "distal portion" or "distal tip portion" of a laser fiber disclosed herein includes a portion of the laser fiber intended to be near or within a patient when the laser fiber is used on a patient. Similarly, for example, a "distal length" of a laser fiber includes a length of the laser fiber intended to be near or within a patient when the laser fiber is used on a patient. For example, a "distal tip" of a laser fiber includes an end of the laser fiber intended to be near or within a patient when the laser fiber is used on a patient. A distal portion, tip portion, or distal length of a laser fiber can include the distal tip of the laser fiber, but a distal portion, tip portion, or distal length of a laser fiber need not include the distal tip of the laser fiber. That is, unless the context suggests otherwise, a distal portion, tip portion, or distal length of a laser fiber is not a terminal portion or terminal length of the laser fiber.

[0022] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. 1A shows a perspective view of a laser system 100 including a laser fiber 110 (medical device), according to some embodiments. The laser system 100 can be used in performing medical procedures, including laser lithotripsy. The laser fiber 110 includes an optical fiber for transmitting a laser from the laser system 100 to a patient. The laser fiber 110 includes a connector 112 at a proximal end, the connector 112 being configured to operably couple the laser fiber 110 to the laser system 100. A distal end portion of the laser fiber 110 is configured to engage a patient.

[0023] The laser fiber 110 can be placed in a package configured to organize the laser fiber 110 before and during use, as shown and described below. The package can also define a microbial barrier to maintain the sterility of the laser fiber 110 before use. During use, the entire length of the laser fiber 110, or a portion thereof, can be removed from the package. As shown, in some instances, the entire length of the laser fiber 110 exceeds the length necessary to extend from the laser system 100 to the patient location. In such cases, the excess length 113 of the laser fiber 110 can be coiled and placed on or near the patient's bed 105 or near the laser system 100.

[0024] 1B and 1C show plan views of different placements of laser system 100 during a medical procedure, according to some embodiments. During a medical procedure, laser system 100 can be positioned in various locations within operating room 160, depending on the physician's preference and the location of available electrical outlets. In some embodiments, laser system 100 can be positioned close to the patient, as shown in FIG. 1B, resulting in excess length of laser fiber 110 that must be managed. In some embodiments, laser system 100 can be positioned farther from the patient, as shown in FIG. 1C, resulting in little or no excess length of laser fiber 110.

[0025] FIG. 2A shows a perspective view of a laser fiber package (package) 130, according to some embodiments. The package 130 can be configured to protect and organize the laser fiber 110 during shipping and handling. The package 130 can also be configured to manage excess length of the laser fiber 110 during use. The package 130 can also be configured to define a microbial barrier to maintain sterility of at least a distal portion of the laser fiber 110. The package 130 includes an elongate body 132 defining a lumen 134 configured to receive the laser fiber 110. The laser fiber 110 can be slidably disposed within the package 130. In some embodiments, the package 130 can define a closed distal end (not shown). In some embodiments, a proximal portion of the package 130 can be configured to receive the connector 112.

[0026] The package 130 can include several (e.g., one, two, three, four, five, or more) separable sections 136 along the length of the package 130. By way of example, the package 130 can include three sections 136A-136C extending along the length of the package 130. Each of the sections 136A-136C defines a length of the elongated body 132. The elongated body 132 can define any suitable cross-section, such as, for example, a circular cross-section or a polygonal cross-section. Each of the sections 136A-136C is connected to an adjacent section by a separable joint 140 (e.g., a circumferential tear line). The joint 140 defines a weakened portion configured to allow a clinician to separate the adjacent sections by applying a separation force. The force to separate the sections 136 can include a pulling force, a pushing force, a twisting force, or a combination thereof. The splice 140 may include score lines, grooves, laser cut lines, perforations, thinned sections, or similar structures to facilitate separation of the splice 140. Each of the sections 136A-136C may be configured to separate from the adjacent section along a splice 140A-140C. Once separated, each of the multiple sections 136A-136C may be distally threaded off the laser fiber 110 to expose a portion of the laser fiber 110 for use. Similarly, the laser fiber 110, or a portion thereof, may be proximally removed from the package 130.

[0027] In some embodiments, each of sections 136A-136C may include length indicia 144. The length indicia may indicate, for example, the length of the respective section or some other length, such as the distance between length indicia 144 and connector 112. In some embodiments, length indicia 144 may indicate the distance of each indicia 144A-144C from connector 112. Length indicia 144A-144C may be applied to package 130 via any suitable process, such as, for example, engraving, stamping, printing, etc.

[0028] FIG. 2B shows a perspective view of a package 130 having a laser fiber 110 disposed therein, according to some embodiments. The package 130 can define a coil shape having multiple windings. The package 130 can be rigid to maintain the coiled shape during use. In some embodiments, the proximal end of the laser fiber 110 can include a connector 112, which can be disposed external to the package 130. During use, a clinician can determine the length of the laser fiber 110 to perform a treatment. The clinician can remove a portion of the package 130 from the determined length of the laser fiber 110, leaving an excess length of the laser fiber 110 within the remaining portion of the package 130. Leaving the excess length of the laser fiber 110 within the package 130 allows the excess length of the laser fiber 110 to be organized and protected by the package 130. The package 130 is configured to secure the excess length of the laser fiber 110 to the laser system 100, for example, by hanging the excess length of the laser fiber 110 on a housing of the laser system 100. Sections 136A-136C defining joints 140A-140D may be evenly spaced along the length of package 130. In some embodiments, sections 136A-136C may be more closely spaced toward the distal end of package 130 and more widely spaced toward the proximal end of package 130. In some embodiments, sections 136A-136C may be spaced a defined distance (e.g., 6 inches, 12 inches, 18 inches, etc.). In some embodiments, package 130 may be constructed of a hardened plastic (e.g., PEEK, PTFE, PPSU, PSU, PU, ​​Nylon, PEBAX, PP, PE, ABS, EVA, PETG, PVDF, etc.). In some embodiments, the windings of package 130 or sections 136A-136C may be coupled to one another via fixtures 146 to help maintain the coiled shape, which may include, for example, adhesive or adhesive tape.In other words, portions of the package 130 are combined to manage excess lengths of the laser fiber 110 disposed within the package 130. In some embodiments, the package 130 may be disposable.

[0029] 2C shows a perspective view of another embodiment of the package 130. In such an embodiment, the package 130 can include a splice 140 and can further include a seam 150 extending longitudinally along the package 130 to laterally separate the laser fiber 110 from the package 130. The seam 150 can include a tear line, or the seam 150 can include a slit that is biased toward a closed configuration. In some embodiments, the seam 150 can extend along one or more of the sections 136 or along the entire length of the package 130. For example, the seam 150 can extend along a section 136 that is disposed along a distal portion of the package 130, because such a distally disposed section 136 is more likely to be dislodged during use. Advantageously, splice 150 allows a user to laterally separate section 136 from laser fiber 110 without longitudinally threading the section 136 off the distal end of the laser fiber 110, thereby saving the clinician time in setting up the laser fiber 110.

[0030] 3A-3D are perspective views illustrating separating the package 130 to expose the laser fiber 110, according to some embodiments. The proximal end of the laser fiber 110 is coupled to the laser system 100 (see FIGS. 1A-1C), and the laser fiber 110 is housed within the package 130, as shown in FIG. 3A. In some embodiments, the package 130 includes sections 136A-136D that define splices 140A-140C. A user can determine a desired length of the laser fiber 110. Once the user determines the desired length of the laser fiber 110, the user can remove section 130A of the package 130 to expose the laser fiber 110. The user can remove section 136A by separating section 136A from section 136B along splice 140A and sliding section 136A distally along the laser fiber 110, as shown in FIG. 3B. In some embodiments, a user can remove section 136A from section 136B by separating section 136A along joint 140A, and further remove section 136A from laser fiber 110 by separating section 136A along seam 150 to expose laser fiber 110, as shown in FIG. 3C. The remaining sections 136B-136D of package 130 remain on laser fiber 110 and may be organized into a coil and secured to laser system 100.

[0031] 4 shows a flowchart of an exemplary method 200 for managing excess length of laser fiber 110, according to some embodiments. In some embodiments, method 200 includes coupling laser fiber 110 in package 130 to laser system 100 (block 202). In some embodiments, the coupling includes coupling a connector 112 of laser fiber 110 to laser system 100, with the remaining portion of laser fiber 110 disposed within package 130. Method 200 further includes determining a desired length of laser fiber 110 (block 204). In some embodiments, the determining may include using length indicia 144 on package 130 to determine a portion of package 130 to be removed from laser fiber 110. Method 200 further includes removing a portion of package 130 to expose the desired length of laser fiber 110 (block 206). In some embodiments, removing package 130 includes separating adjacent sections 136 of package 130 at splice 140. In some embodiments, the removing step includes sliding the separated section 136 distally along the longitudinal axis to expose the laser fiber 110. In some embodiments, the removing step includes separating the section 136 along the seam 150 to expose the laser fiber 110. The method 200 further includes configuring and securing the package 130 to the laser system 100, wherein the excess length of laser fiber 110 is disposed within the package 130 (block 208). In some embodiments, organizing the excess laser fiber 110 includes coiling the excess laser fiber 110. In some embodiments, securing the excess laser fiber 110 to the laser system 100 includes hanging the package 130 on a hook of the laser system 100.

[0032] Some specific embodiments are disclosed herein, and although the specific embodiments are disclosed in some detail, the specific embodiments are not intended to limit the scope of the concepts provided herein. Additional adaptations and / or modifications may be apparent to those skilled in the art, and the broader aspects also encompass these adaptations and / or modifications. Thus, one can deviate from the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. A medical device comprising: a laser fiber defining a proximal end and a distal end, the laser fiber having a connector at the proximal end; a tubular package extending along the laser fiber, the laser fiber being disposed within the tubular package; the tubular package includes a plurality of sections along its length; A medical device wherein adjacent sections of the plurality of sections are configured to be separable from one another during use of the laser fiber.

2. The medical device of claim 1 , wherein the tubular package defines a coil shape.

3. The medical device of claim 2 , wherein the tubular package is formed from a rigid material to maintain the coiled shape during use.

4. The medical device of any one of claims 1 to 3, wherein the tubular package is configured to be secured to a laser system module during use.

5. the adjacent sections are joined together via weakened joints; The medical device of any one of claims 1 to 3, wherein the frangible joint is configured to be separated by a clinician during use.

6. The medical device of claim 1 , wherein each of the plurality of sections includes a length indicia.

7. The medical device of claim 6 , wherein each length marking indicates a length of the laser fiber extending between the length marking and the connector.

8. 8. The medical device of claim 6 or 7, wherein each length indicia is engraved or stamped onto the tubular package.

9. The medical device of any one of claims 1 to 3, wherein one or more of the plurality of sections includes a separable seam extending longitudinally along the tubular package.

10. The medical device of any one of claims 1 to 3, wherein the connector is disposed externally of the tubular package.

11. The medical device of any one of claims 1 to 3, wherein the tubular package is disposable.

12. 1. A method for managing excess length of a medical laser fiber during a medical procedure, comprising: coupling a connector of a laser fiber to a laser system, the laser fiber being disposed within a tubular package; determining a desired length of a laser fiber for use in performing a medical procedure; removing a portion of the tubular package to expose a desired length of the laser fiber; and securing the excess length of the laser fiber to a laser device included in the laser system and placing the excess length within a tubular package.

13. 13. The method of claim 12, wherein the tubular package includes a plurality of sections, adjacent sections of the plurality of sections configured to be separated by a clinician during use of the laser fiber.

14. The method of claim 13 , wherein each of the plurality of sections includes a length indication.

15. The method of claim 14 , wherein each length marking indicates a length of the laser fiber extending between the connector and the length marking.

16. 16. The method of claim 15, wherein determining a desired length of the laser fiber includes using the length indication to determine a portion of the tubular package to be removed from the laser fiber.

17. The method of any one of claims 13 to 16, wherein removing the tubular package to expose the laser fiber comprises separating one or more of the adjacent sections.

18. 20. The method of claim 17, wherein removing the tubular package to expose the laser fiber further comprises detaching one or more of the plurality of sections from a distal end of the laser fiber.

19. 20. The method of claim 18, wherein one or more of the plurality of sections includes a separable seam extending longitudinally along the tubular package.

20. 20. The method of claim 19, wherein removing the tubular package to expose the laser fiber comprises separating a separable seam of one or more sections of the plurality of sections to expose the laser fiber.

21. the tubular package defining a rigid coil shape; 13. The method of claim 12, further comprising organizing the excess length of laser fiber, the method comprising maintaining the excess length of laser fiber within the tubular package.

22. The method of claim 12 , wherein the step of securing the excess length of the laser fiber to a laser system includes hanging the tubular package on a hook of a laser system.

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