Optical fiber stylet holder

Abstract

The present application relates to optical fiber stylet retainers. Disclosed herein are optical fiber stylet retainers and methods thereof for retaining an optical fiber stylet in place in a catheter or the like while preventing breakage of the optical fiber in the optical fiber stylet and maintaining the functionality of the optical fiber stylet. Retaining the optical fiber stylet in place in a catheter or the like can be important for maintaining the distal tip of an intravascularly delivered optical fiber stylet in its target anatomic location during a procedure.

Description

[0001] priority

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 115,442, filed November 18, 2020, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This application relates to the field of medical devices, and more specifically to fiber optic core retainers. Background Technology

[0004] Intravascular guidance of medical devices, including guidewires and catheters, often utilizes fluorescence microscopy to guide the distal tip of such devices through the vascular system and determine if the distal tip is properly positioned in its target anatomical location. However, fluorescence microscopy exposes patients and their physicians to harmful X-ray radiation. Furthermore, patients may be exposed to potentially harmful contrast agents required for fluorescence microscopy. For these reasons, some current medical research has shifted towards developing optical methods, such as fiber optic shape sensing (“FOSS”) methods for intravascular guidance of medical devices.

[0005] Current FOSS methods for intravascular guidance of medical devices utilize fiber optic cores with fiber Bragg grating (“FBG”) sensors along their length for shape sensing. Made of drawn glass or plastic, these fiber optic cores are prone to breakage when folded or “halved.” However, folding the core over the catheter from which it is delivered intravascularly is a common method for securing the core in place once its distal tip is properly positioned at its target anatomical location. In fact, Figure 11 This illustrates how the proximal portion of the pedicle needle 10, extending from the Luer connector 12, folds over the extension leg 14 of the catheter 16 (such as a peripherally inserted central catheter (“PICC”) or a central venous catheter (“CVC”)) to secure the pedicle needle 10 in place. However, Figure 11 It also illustrates how a fiber optic core can lead to breakage. What is needed is a fiber optic core holder to hold the fiber optic core in the proper position within a conduit or similar device while maintaining its functionality.

[0006] This article discloses a fiber optic core holder and a method thereof for holding a fiber optic core in the proper position in a conduit or the like while maintaining the function of the fiber optic core. Summary of the Invention

[0007] This document discloses a fiber optic core holder, which in some embodiments includes an integrated funnel. The integrated funnel includes a radial shoulder and a neck. The radial shoulder has a radius configured to allow the fiber optic core to be placed against the radial shoulder without damaging one or more fibers in the fiber optic core. The neck has an inner diameter sufficient to receive the fiber optic core and is configured to coincide with the lumen of an extension leg of the conduit.

[0008] In some implementations, the fiber optic core holder also includes a locking mechanism. The locking mechanism is configured to lock the fiber optic core in the fiber optic core holder.

[0009] In some implementations, the locking mechanism includes multiple notches around the mouth of the integrated funnel through the sidewall of the fiber optic core holder. Each of the multiple notches is sized to securely hold the fiber optic core when it is pressed into it.

[0010] In some implementations, the locking mechanism includes multiple side-wall petals that alternate with multiple notches around the mouth of the integrated funnel. Each of the multiple side-wall petals is configured to guide the fiber optic core into an adjacent notch when pressed against it.

[0011] In some implementations, the locking mechanism includes a cap configured to cover the mouth of the integrated funnel and the fiber optic core when extended from the mouth. The cap is connected to the sidewall of the fiber optic core holder via a movable hinge.

[0012] In some implementations, the fiber optic core retainer is integrally formed with the Luer connector of the catheter.

[0013] In some implementations, the fiber optic core retainer is a cap that includes an internal thread in the distal portion of the cap, the internal thread being configured to screw onto the external thread of the Luer connector of the conduit.

[0014] This document also discloses a fiber optic core holder, which in some embodiments includes a cap, a cylindrical washer, and a locking mechanism. The cap includes an internal thread and a cap through-hole. The internal thread is located in the distal portion of the cap's hole and is configured to screw onto a complementary external thread of an insert. The cap through-hole is located at the proximal end of the cap and has an inner diameter sufficient to receive the fiber optic core. The cylindrical washer has a compressible material. The washer includes a washer through-hole with an inner diameter not less than the inner diameter of the cap through-hole. The locking mechanism is defined by the washer, which is disposed within the cap, between the proximal end of the cap and the insert. The locking mechanism is configured to lock the fiber optic core in the fiber optic core holder by compression of the washer when the cap is screwed onto the insert with the fiber optic core in the fiber optic core holder.

[0015] In some implementations, the compression of the gasket is an axial compression between the proximal end of the cap and the insert. The axial compression then provides radial compression around the fiber optic core to lock the fiber optic core in the fiber optic core retainer.

[0016] In some implementations, the insertable element is part of the male Luer connector of the catheter.

[0017] In some implementations, the insert is part of a fiber optic core retainer. The insert has a distal portion configured as a female Luer connector.

[0018] This document also discloses a fiber optic core holder, which in some embodiments includes a pair of arms, a zigzag path for traveling the fiber optic core between the pairs of arms, and a locking mechanism. The pairs of arms are biased toward the centerline of the fiber optic core holder. The locking mechanism is defined by the zigzag path. The locking mechanism is configured to lock the fiber optic core in the fiber optic core holder by frictional force through the combination of the bias of the pairs of arms toward the centerline of the fiber optic core holder and the zigzag path formed between the pairs of arms.

[0019] In some implementations, the fiber optic core holder also includes multiple rollers mounted on paired arms. The multiple rollers alternate between the arms of the paired arms to form a tortuous path for the fiber optic core to travel.

[0020] In some implementations, the fiber optic core retainer is integrally formed with the Luer connector of the catheter.

[0021] In some implementations, the fiber optic core retainer is a cap that includes an internal thread in the distal portion of the cap, the internal thread being configured to screw onto the external thread of the Luer connector of the conduit.

[0022] This document also discloses a fiber optic core holder, which in some embodiments includes a clamp, a through-hole through the distal end of the fiber optic core holder conforming to the lumen of an extension leg of a conduit, and a locking mechanism defined by the clamp. The clamp includes a first jaw, a second jaw, and an elastic element configured to store mechanical energy. The first and second jaws extend longitudinally in the same direction as the centerline of the fiber optic core holder. The elastic element is coupled to the first and second jaws and configured to hold the second jaw against the first jaw. The locking mechanism is configured to lock the fiber optic core in the fiber optic core holder by frictional force of the clamp along the length of the fiber optic core.

[0023] In some implementations, the fiber optic core retainer is integrally formed with the Luer connector of the catheter.

[0024] In some implementations, the fiber optic core retainer is a cap that includes an internal thread in the distal portion of the cap, the internal thread being configured to screw onto the external thread of the Luer connector of the conduit.

[0025] This document also discloses a fiber optic core holder, which in some embodiments includes a pair of hinge plates, a hinge portion formed between the pair of hinge plates, and an elastic pad disposed on one of the hinge plates of the pair of hinge plates. Each hinge plate of the pair of hinge plates includes a fastener complementary to the other. The hinge portion formed between the pair of hinge plates utilizes a fiber optic core to provide a hinge pin for the hinge portion. The elastic pad is configured to press the fiber optic core against the other hinge plate of the pair of hinge plates when the pair of hinge plates is closed. The fiber optic core holder thus provides a locking mechanism configured to lock the fiber optic core in the fiber optic core holder and prevent distal movement of the fiber optic core when the fiber optic core is positioned in the guide tube.

[0026] In some implementations, the fiber optic core retainer is configured to be coupled to the Luer connector of the conduit.

[0027] This document also discloses a fiber optic core holder, which in some embodiments includes a pair of arms, a pair of opposing through-holes, a connecting portion between the pair of arms, and a pair of opposing resilient pads. The pair of arms includes a fixed arm and a movable arm. Each arm of the pair of arms includes a fastener complementary to the other. Each through-hole of the pair of through-holes passes through at least one arm of the pair of arms. One of the pair of resilient pads is disposed on the movable arm, and the other of the pair of resilient pads is disposed on the connecting portion. The pair of resilient pads are configured to press against a fiber optic core inserted through the through-hole when the movable arm moves toward the connecting portion. The fiber optic core holder thus provides a locking mechanism configured to lock the fiber optic core in the fiber optic core holder and prevent distal movement of the fiber optic core when it is positioned in the guide tube.

[0028] In some embodiments, the fixed arm includes a rack of teeth and the movable arm includes a pawl. The pawl is configured to move linearly through the rack as the movable arm moves toward the connecting portion.

[0029] In some implementations, the fiber optic core retainer is configured to be coupled to the Luer connector of the conduit.

[0030] This document also discloses a fiber optic core holder, which in some embodiments includes a housing, an insert, and a spring. The housing includes a housing through-hole sized to receive a fiber optic core through which it passes. The insert is partially disposed within the housing and extends from a side of the housing perpendicular to the housing through-hole, and partially as a button. The insert includes an insert through-hole that mates with the housing through-hole. The spring is configured to push or pull the insert toward a side of the housing extending from the insert. When the fiber optic core is inserted through both the housing through-hole and the insert through-hole, the fiber optic core acts as a stop to prevent the insert from being pushed or pulled toward one side of the housing. The fiber optic core holder thus provides a locking mechanism configured to lock the fiber optic core in the fiber optic core holder and prevent distal movement of the fiber optic core when it is positioned in the guide tube.

[0031] In some implementations, the fiber optic core retainer is configured to be coupled to the Luer connector of the conduit.

[0032] This document also discloses a fiber optic core holder, which in some embodiments includes a substrate and a zigzag channel on one side of the substrate. The zigzag channel is sized to receive a fiber optic core placed therein. The fiber optic core holder thus provides a locking mechanism configured to lock the fiber optic core in the fiber optic core holder and prevent distal movement of the fiber optic core when it is positioned in the guide tube.

[0033] In some implementations, the fiber optic core retainer is configured to be coupled to the Luer connector of the conduit.

[0034] This document also discloses a fiber optic core holder, which in some embodiments includes a diaphragm configured to be placed within a Luer connector of a conduit. The diaphragm includes a through-hole sized to receive a fiber optic core through which it passes and to securely retain the fiber optic core by friction when inserted therein. The fiber optic core holder thus provides a locking mechanism configured to lock the fiber optic core in the holder and prevent proximal and distal movement of the fiber optic core when it is positioned within the conduit.

[0035] In some implementations, the fiber optic core retainer also includes a retainer. The retainer includes an annular edge and a plurality of wedges extending from the edge and biased toward the center of the retainer. The retainer is configured to slide off the Luer connector and onto the fiber optic core, such that the tips of the wedges are turned inward toward the center of the retainer.

[0036] In some implementations, the retainer provides a secondary locking mechanism configured to prevent distal movement of the fiber optic core when it is positioned in the guide tube.

[0037] This document also discloses a method for using a fiber optic needle holder, which in some embodiments includes a needle insertion step, a first needle advancement step, a second needle advancement step, and a needle retention step. The needle insertion step includes inserting the fiber optic needle into the fiber optic needle holder. The first needle advancement step includes advancing the fiber optic needle through a catheter. The second needle advancement step includes advancing the distal tip of the fiber optic needle through the vascular system to a target anatomical location within the patient. The needle retention step includes holding the distal tip of the fiber optic needle in the target anatomical location by locking the fiber optic needle in the fiber optic needle holder, without at least any distal advancement of the distal tip.

[0038] In some embodiments, the method further includes a core placement step, a first core pressing step, and a second core pressing step. The core placement step includes placing the fiber optic core against the arcuate shoulder of the integrated funnel of the fiber optic core holder. The first core pressing step includes pressing the fiber optic core against one of a plurality of sidewall lobes surrounding the mouth of the integrated funnel to guide the fiber optic core into adjacent notches of a plurality of notches surrounding the mouth of the integrated funnel. The second core pressing step includes pressing the fiber optic core into one of the notches, thereby locking the fiber optic core in the fiber optic core holder and holding the distal tip of the fiber optic core in a target anatomical position.

[0039] In some embodiments, the method further includes a core placement step and a nozzle covering step. Again, the core placement step includes placing the fiber optic core against the arcuate shoulder of the integrated funnel of the fiber optic core holder. The nozzle covering step includes covering the nozzle of the integrated funnel with a cap connected to the sidewall of the fiber optic core holder via a movable hinge, thereby locking the fiber optic core in the fiber optic core holder and holding the distal tip of the fiber optic core in the target anatomical position.

[0040] In some implementations, the method further includes a capping step and a clamping step. The capping step includes screwing the cap of the fiber optic core retainer onto the insertable. The clamping step includes compressing a cylindrical washer disposed within the cap around the fiber optic core, between the proximal end of the cap and the insertable, wherein screwing the cap onto the insertable thereby locks the fiber optic core in the fiber optic core retainer and holds the distal tip of the fiber optic core in the target anatomical position.

[0041] In some implementations, the core insertion step includes traveling the fiber optic core along a zigzag path by multiple rollers mounted on paired arms (which are biased toward the centerline of the fiber optic core holder), thereby locking the fiber optic core in the fiber optic core holder and holding the distal tip of the fiber optic core in the target anatomical position.

[0042] In some embodiments, the method further includes a clamp opening step and a clamp closing step. The clamp opening step includes opening the clamp of the fiber optic core holder prior to the core insertion step. The clamp closing step includes closing the second jaw of the clamp onto the first jaw of the clamp, wherein the fiber optic core is located between the second jaw and the first jaw, thereby locking the fiber optic core in the fiber optic core holder and holding the distal tip of the fiber optic core in the target anatomical position.

[0043] In some embodiments, the method further includes a hinge closure step. The hinge closure step includes closing the paired hinge plates of the fiber optic core holder to press the fiber optic core against the other hinge plate of the paired hinge plates using the elastic pad of one hinge plate, thereby locking the fiber optic core in the fiber optic core holder and holding the distal tip of the fiber optic core in the target anatomical position.

[0044] In some implementations, the core insertion step includes inserting an optical fiber core into a pair of opposing through-holes through a pair of arms, including a fixed arm and a movable arm.

[0045] In some embodiments, the method further includes a pawl movement step. The pawl movement step includes moving a pawl of the movable arm against a rack of the fixed arm to press the fiber optic core between the paired arms, between an elastic pad disposed on the movable arm and another elastic pad disposed on the connecting portion of the fiber optic core holder, thereby locking the fiber optic core in the fiber optic core holder and holding the distal tip of the fiber optic core in the target anatomical position.

[0046] In some embodiments, the method further includes a button pressing step and a button releasing step. The button pressing step includes pressing a button on the insert extending from one side of the housing of the fiber optic core holder to pull or push a spring to allow free movement of the fiber optic core through the housing and insert through-hole for adjusting the position of the fiber optic core holder on the fiber optic core. The button releasing step includes releasing the button to push or pull the insert toward the side of the housing from which the insert extends by the spring, thereby locking the fiber optic core as a stop in the fiber optic core holder and holding the distal tip of the fiber optic core in the target anatomical position.

[0047] In some implementations, the core insertion step includes placing the fiber optic core into a zigzag channel on one side of the base of the fiber optic core holder, thereby locking the fiber optic core in the fiber optic core holder and holding the distal tip of the fiber optic core in the target anatomical position.

[0048] In some implementations, the core insertion step includes inserting the fiber optic core into a through-hole in the diaphragm of the fiber optic core holder, thereby locking the fiber optic core in the fiber optic core holder by friction and holding the distal tip of the fiber optic core in the target anatomical position.

[0049] These and other features of the concepts provided herein will become clearer to those skilled in the art, taking into account the accompanying drawings which describe specific embodiments of these concepts in more detail and the following description. Attached Figure Description

[0050] Figure 1 A first fiber optic core holder according to some embodiments is shown.

[0051] Figure 2 A second fiber optic core holder is shown according to some embodiments.

[0052] Figure 3 A third fiber optic core holder according to some embodiments is shown.

[0053] Figure 4 A fourth fiber optic core holder according to some embodiments is shown.

[0054] Figure 5 A fifth fiber optic core holder according to some embodiments is shown.

[0055] Figure 6A A sixth fiber optic core holder according to some embodiments is shown.

[0056] Figure 6B A sixth fiber optic core holder for use with a catheter is shown according to some embodiments.

[0057] Figure 7A A seventh fiber optic core holder is shown according to some embodiments.

[0058] Figure 7B A seventh fiber optic core holder for use with a catheter is shown according to some embodiments.

[0059] Figure 8 An eighth fiber optic core holder is shown according to some embodiments.

[0060] Figure 9 A ninth fiber optic core holder is shown according to some embodiments.

[0061] Figure 10 A tenth fiber optic core holder according to some embodiments is shown.

[0062] Figure 11This demonstrates a common method for holding the core in place once its distal tip is properly positioned at its target anatomical location, but this method is not applicable to fiber optic cores. Detailed Implementation

[0063] 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 can be easily separated from the specific embodiments and optionally combined with or substituted for any of the various other embodiments disclosed herein.

[0064] Regarding the terminology used herein, it should also be understood that these terms are for the purpose of describing certain specific embodiments, and that they do not limit the scope of the concepts presented herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps within a set of features or steps, and do not provide for a sequence or numerical limitation. For example, the features or steps “first,” “second,” and “third” do not necessarily appear in that order, and a particular embodiment including such features or steps is not necessarily limited to these three features or steps. Labels such as “left,” “right,” “top,” “bottom,” “front,” and “back” are used for convenience and do not imply, for example, any particular fixed position, orientation, or direction. Rather, such labels are used to reflect, for example, relative position, orientation, or direction. Unless the context clearly indicates otherwise, the singular forms of “a,” “an,” and “the” include plural references.

[0065] Regarding "proximal," for example, the "proximal portion" or "proximal part" of a catheter includes the portion of the catheter intended to be located near the clinician when used on a patient. Similarly, for example, the "proximal length" of a catheter includes the length of the catheter intended to be located near the clinician when used on a patient. For example, the "proximal end" of a catheter includes the tip of the portion of the catheter intended to be located near the clinician when used on a patient. The proximal portion, proximal part, or proximal length of a catheter may include the proximal end of the catheter; however, the proximal portion, proximal part, or proximal length of a catheter does not need to include the proximal end of the catheter. That is, unless the context otherwise requires, the proximal portion, proximal part, or proximal length of a catheter is not the distal portion or distal length of the catheter.

[0066] Regarding "distal," for example, the "distal portion" or "distal part" of a catheter includes the portion of the catheter intended to be located near or within the patient when used on a patient. Similarly, for example, the "distal length" of a catheter includes the length of the catheter intended to be located near or within the patient when used on a patient. For example, the "distal end" of a catheter includes the tip of the catheter intended to be located near or within the patient when used on a patient. The distal portion, distal part, or distal length of a catheter may include the distal end of the catheter; however, the distal portion, distal part, or distal length of a catheter does not need to include the distal end of the catheter. That is, unless the context otherwise requires, the distal portion, distal part, or distal length of a catheter is not the distal portion or distal length of the catheter.

[0067] 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.

[0068] As mentioned above, folding the cardioverter over the catheter from which it is delivered is a common method for securing the cardioverter in place once its distal tip is properly positioned at its target anatomical location. In fact, Figure 11 This illustrates how the proximal portion of the mandrel 10 extending from the Luer connector 12 folds over the extension leg 14 of the catheter 16 (such as a PICC or CVC) to secure the mandrel 10 in place. However... Figure 11 The paper also illustrates how fiber optic cores made of drawn glass or plastic can lead to breakage. What is needed is a fiber optic core holder for holding the fiber optic core in the proper position within a conduit or similar device while maintaining its functionality. This document discloses a fiber optic core holder and a method thereof for holding the fiber optic core in the proper position within a conduit or similar device while maintaining its functionality.

[0069] Figure 1 and Figure 2 A first fiber optic core holder 100 and a second fiber optic core holder 200 are shown according to some embodiments.

[0070] As shown in the figure, the fiber optic core holder 100 or 200 includes an integrated funnel 102 and a locking mechanism configured to lock a fiber optic core, such as a fiber optic core 10, in the fiber optic core holder 100 or 200, thereby preventing proximal or distal movement of the fiber optic core 10.

[0071] The integrated funnel 102 includes an arcuate shoulder 104 and a neck 106. The arcuate shoulder 104 has a radius configured to allow the fiber optic core 10 to be placed against the arcuate shoulder 104 without damaging one or more fibers in the fiber optic core 10. Advantageously, the known radius of the arcuate shoulder 104 can be used for FOSS system calibration. The neck 106 has an inner diameter sufficient to receive the fiber optic core 10. The neck is configured to conform to the lumen of an extension leg of a conduit (such as extension leg 14 of conduit 16) for advancing the fiber optic core 10 through conduit 16. The integrated funnel 102 may be formed of a semi-flexible material.

[0072] like Figure 1 As shown, the locking mechanism may include a plurality of notches 108 extending through the sidewall of the fiber optic core holder 100 around the mouth of the integrated funnel 102. Each of the plurality of notches 108 is sized to securely hold the fiber optic core 10 when pressed into it. Furthermore, the locking mechanism may include a plurality of sidewall lobes 110 alternating with the mouth of the integrated funnel 102 and the plurality of notches 108. Each of the plurality of sidewall lobes 110 is configured to guide the fiber optic core 10 into an adjacent notch when pressed against it.

[0073] like Figure 2 As shown, the locking mechanism includes a cap 212 configured to cover the mouth of the integrated funnel 102 and the fiber optic core 10 when the fiber optic core 10 extends from the mouth. The cap 212 is connected to the side wall of the fiber optic core holder 200 via a movable hinge 214.

[0074] The fiber optic core retainer 100 or 200 can be integrated with the Luer connector 12 of the conduit 16. Alternatively, the fiber optic core retainer 100 or 200 is a cap with internal threads included in the distal portion of the cap, the internal threads being configured to screw onto the external threads of the Luer connector 12 of the conduit 16. Because Luer connectors are standardized, the latter embodiment has the advantage that the fiber optic core retainer 100 or 200 can be used with existing PICC, CVC, etc.

[0075] Figure 3 A third fiber optic core holder 300 according to some embodiments is shown.

[0076] As shown in the figure, the fiber optic core holder 300 includes a cap 316, a cylindrical washer 318, and a locking mechanism configured to lock a fiber optic core, such as a fiber optic core 10, in the fiber optic core holder 300, thereby preventing proximal or distal movement of the fiber optic core 10.

[0077] The cap includes an internal thread (not shown) and a cap through-hole 320. The internal thread is in the distal portion of the hole in the cap 316. The internal thread is configured to screw onto the complementary external thread of an insertable component. The cap through-hole 320 is located at the proximal end of the cap 316. The cap through-hole 320 has an inner diameter sufficient to receive an inserted fiber optic core 10.

[0078] Washer 318 is a compressible material, such as an elastic material. Washer 318 includes a washer through-hole (not shown) with an inner diameter not less than the inner diameter of cap through-hole 320. The washer through-hole is configured to conform to the inner cavity of an extension leg of the conduit (such as extension leg 14 of conduit 16) for advancing the fiber optic core needle 10 through conduit 16.

[0079] The locking mechanism is defined by a washer 318, which is disposed within the cap 316 between the proximal end of the cap 316 and the insert. The locking mechanism is configured to lock the fiber optic core 10 in the fiber optic core holder 300 by compression of the washer 318 when the cap 316 is screwed onto the insert with the fiber optic core 10 in the fiber optic core holder 300. The compression of the washer 318 is an axial compression between the proximal end of the cap 316 and the insert. This axial compression, in turn, provides radial compression around the fiber optic core 10 to lock it in the fiber optic core holder 300.

[0080] The insert may be part of the Luer connector 12 of the conduit 16 (e.g., a proximal portion), the Luer connector 12 being a convex Luer connector with external threads. Alternatively, the insert may be part of the fiber optic core retainer 300. In the latter embodiment, the insert may have a distal portion of a concave Luer connector configured to have internal threads complementary to the external threads of the Luer connector 12, and a proximal portion having external threads complementary to the internal threads of the cap 316. The advantage of the insert as part of the fiber optic core retainer 300 is that the pitch does not necessarily match the pitch specified for the Luer connector, which is not necessarily designed for finer-tuning movements, such as those that facilitate clamping the fiber optic core 10 in the fiber optic core retainer 300.

[0081] Figure 4 A fourth fiber optic core holder 400 according to some embodiments is shown.

[0082] As shown in the figure, the fiber optic core holder 400 includes a pair of arms 422, a plurality of rollers 424 mounted on the pair of arms 422, and a locking mechanism configured to lock a fiber optic core, such as a fiber optic core 10, in the fiber optic core holder 400, thereby preventing proximal or distal movement of the fiber optic core 10.

[0083] The paired arms 422 are biased towards the centerline of the fiber optic core holder 400. Multiple rollers 424 are mounted on the paired arms 422. The successive rollers of the multiple rollers 424 alternate between the arms of the paired arms 422, forming a zigzag path for the fiber optic core 10 to travel. Advantageously, the known zigzag path can be used for FOSS system calibration.

[0084] The fiber optic core holder 400 also includes a distal through-hole on the distal side of the plurality of rollers 424 and through the distal end of the fiber optic core holder 400, the through-hole being configured to conform to the lumen of an extension leg of the conduit (such as extension leg 14 of conduit 16) for advancing the fiber optic core 10 through conduit 16.

[0085] The locking mechanism is defined by a plurality of rollers 424 mounted on a pair of arms 422. The locking mechanism is configured to lock the fiber optic core 10 in the fiber optic core holder 400 by friction through a combination of the pair of arms 422 biased toward the centerline of the fiber optic core holder 400 and the tortuous path formed by the plurality of rollers 424.

[0086] The fiber optic core retainer 400 can be integrated with the Luer connector 12 of the conduit 16. Alternatively, the fiber optic core retainer 400 is a cap including an internal thread in the distal portion of the cap, the internal thread being configured to screw onto the external thread of the Luer connector 12 of the conduit 16. Since Luer connectors are standardized, the latter embodiment has the advantage that the fiber optic core retainer 400 can be used with existing PICC, CVC, etc.

[0087] Figure 5 A fifth fiber optic core holder 500 according to some embodiments is shown.

[0088] As shown, the fiber optic core holder 500 includes a clamp 526, a through-hole through the distal end of the fiber optic core holder 500 that conforms to the cavity of an extension leg of a conduit (such as extension leg 14 of conduit 16), and a locking mechanism defined by the clamp 526, the locking mechanism being configured to lock a fiber optic core, such as fiber optic core 10, in the fiber optic core holder 500, thereby preventing proximal or distal movement of the fiber optic core 10.

[0089] The clamp includes a first jaw 528 (such as a fixed jaw), a second jaw 530 (such as a movable jaw), and an elastic element configured to store mechanical energy (e.g., a metal spring, a molded plastic part biased on each side of the molded plastic part, etc.). The first jaw 528 and the second jaw 530 extend longitudinally in the same direction as the centerline of the fiber optic core holder 500. The elastic element is coupled to the first jaw 528 and the second jaw 530, and is configured to hold the second jaw 530 against the first jaw 528 and vice versa. In practice, both the first jaw 528 and the second jaw 530 can be moved from a common anchor point of the fiber optic core holder 500. The thumb pad 532 is configured to allow the clinician to press his or her thumb into the clamp 526 on the opposite side of the hinge pin 534 to overcome the elastic force that holds the second jaw 530 against the elastic element of the first jaw 528, thereby allowing adjustment of the fiber optic core needle 10 (e.g., proximal or distal movement).

[0090] The locking mechanism is configured to lock the fiber optic core 10 in the fiber optic core holder 500 by frictional force along the length of the fiber optic core 10 using the clamp 526.

[0091] The fiber optic core retainer 500 can be integrated with the Luer connector 12 of the conduit 16. Alternatively, the fiber optic core retainer 500 is a cap including an internal thread in the distal portion of the cap, the internal thread being configured to screw onto the external thread of the Luer connector 12 of the conduit 16. Since Luer connectors are standardized, the latter embodiment has the advantage that the fiber optic core retainer 500 can be used with existing PICC, CVC, etc.

[0092] Figure 6A A sixth fiber optic core holder 600 according to some embodiments is shown. Figure 6B A sixth fiber optic core holder 600 for use with a catheter is shown according to some embodiments.

[0093] As shown in the figure, the fiber optic core holder 600 includes a pair of hinge plates 636, a hinge portion 638 formed between the pair of hinge plates 636, and an elastic pad 640 disposed on one of the hinge plates of the pair of hinge plates 636.

[0094] Each of the paired hinge plates 636 includes a fastener that is complementary to another fastener forming the paired fastener 642.

[0095] The hinge portion 638 formed between the pair of hinge plates 636 uses fiber optic core pins, such as fiber optic core pin 10, to provide the hinge pin for the hinge portion 638.

[0096] The elastic pad 640 is configured to press the fiber optic core 10 against the other hinge plate of the pair of hinge plates 636 when the pair of hinge plates 636 are closed.

[0097] The fiber optic needle holder 600 thus provides a locking mechanism configured to lock the fiber optic needle 10 in the fiber optic needle holder 600 and prevent distal movement of the fiber optic needle 10 when it is positioned in a conduit such as conduit 16. However, the fiber optic needle holder 600 can be configured to connect to a Luer connector of conduit 16 to similarly prevent proximal movement of the fiber optic needle 10.

[0098] Figure 7A A seventh fiber optic core holder 700 according to some embodiments is shown. Figure 7B A seventh fiber optic core holder 700 for use with a catheter is shown according to some embodiments.

[0099] As shown in the figure, the fiber optic core holder 700 includes a pair of arms 744, a pair of opposing through holes 746, a connecting portion 748 between the pair of arms 744, and a pair of opposing elastic pads 750.

[0100] The paired arms 744 include a fixed arm 752 and a movable arm 754. Each arm of the paired arms 744 includes a fastener complementary to the other. For example, the fixed arm 752 may include a rack and the movable arm 754 may include a pawl. When present, the pawl is configured to move linearly through the rack as the movable arm 754 moves toward the connection portion 748 of the fiber optic core holder 700.

[0101] Each of the paired through holes 746 passes through at least one arm of the paired arms 744.

[0102] One of the paired elastic pads 750 is disposed on the movable arm 754, and the other elastic pad of the pair of elastic pads 750 is disposed on the connection portion 748 of the fiber optic core holder 700. The paired elastic pads 750 are configured to press the fiber optic core, such as the fiber optic core 10 inserted through the paired through-holes 746, when the movable arm 754 moves toward the connection portion 748 of the fiber optic core holder 700.

[0103] The fiber optic needle holder 700 thus provides a locking mechanism configured to lock the fiber optic needle 10 in the fiber optic needle holder 700 and prevent distal movement of the fiber optic needle 10 when it is positioned in a conduit such as conduit 16. However, the fiber optic needle holder 700 can be configured to engage with a Luer connector of conduit 16 to similarly prevent proximal movement of the fiber optic needle 10.

[0104] Figure 8 An eighth fiber optic core holder 800 according to some embodiments is shown.

[0105] As shown in the figure, the fiber optic core holder 800 includes a housing 856, an insert 858, and a spring (not shown).

[0106] The housing 856 includes a housing through-hole 860 sized to receive fiber optic cores, such as fiber optic cores 10, passing through it.

[0107] The insert 858 is partially disposed within the housing 856 and extends from one side of the housing 856 perpendicular to the housing through-hole 860, and is partially a button. The insert includes an insert through-hole 862 that mates with the housing through-hole 860.

[0108] The spring is configured to push or pull the insert 858 toward or out of the housing 856. When the fiber optic core pin 10 is inserted through both the housing through-hole 860 and the insert through-hole 862, the fiber optic core pin 10 acts as a stop to prevent the insert 858 from being pushed or pulled toward or out of the housing 856.

[0109] The fiber optic needle holder 800 thus provides a locking mechanism configured to lock the fiber optic needle 10 in the holder and prevent distal movement of the fiber optic needle 10 when it is positioned in a conduit such as conduit 16. However, the fiber optic needle holder 800 can be configured to connect to a Luer connector of conduit 16 to similarly prevent proximal movement of the fiber optic needle 10.

[0110] Figure 9 A ninth fiber optic core holder 900 according to some embodiments is shown.

[0111] As shown in the figure, the fiber optic core holder 900 includes a substrate 964 and a tortuous channel 966 in one side (e.g., the main side) of the substrate 964.

[0112] The zigzag channel 966 is sized to receive fiber optic cores, such as fiber optic core 10 placed therein. Advantageously, the known zigzag channel 966 can be used for FOSS system calibration.

[0113] The fiber optic needle holder 900 thus provides a locking mechanism configured to lock the fiber optic needle 10 in the fiber optic needle holder 900 and prevent distal movement of the fiber optic needle 10 when it is positioned in a conduit such as conduit 16. However, the fiber optic needle holder 900 can be configured to connect to a Luer connector of conduit 16 to similarly prevent proximal movement of the fiber optic needle 10.

[0114] Figure 10A tenth fiber optic core holder 1000 according to some embodiments is shown.

[0115] As shown in the figure, the fiber optic core holder includes a diaphragm 1068 configured to be disposed in a Luer connector (such as Luer connector 12 of conduit 16) of a conduit.

[0116] The diaphragm 1068 includes a through-hole 1070, which is sized to receive a fiber optic core, such as a fiber optic core 10, passing through it and to hold the fiber optic core 10 securely by friction when inserted therein. The diaphragm 1068 may be formed of an elastic material.

[0117] The fiber optic core retainer 1000 may further include a retainer 1072. The retainer 1072 includes an annular edge 1074 and a plurality of wedges 1076 extending from the edge 1074 and biased toward the center of the retainer 1072. The retainer 1072 is configured to slide off the Luer connector 12 and onto the fiber optic core 10, such that the tips of the wedges 1076 are directed inward toward the center of the retainer 1072.

[0118] The retainer 1072 provides a secondary locking mechanism configured to prevent distal movement of the fiber optic core 10 when it is positioned in a conduit such as conduit 16. In practice, distal movement of the fiber optic core 10 is prevented because the wedge 1076 of the retainer 1072 is in close contact with the fiber optic core 10.

[0119] The fiber optic core holder thus provides a primary locking mechanism in the diaphragm 1068, configured to lock the fiber optic core 10 in the fiber optic core holder 1000 and prevent proximal and distal movement of the fiber optic core 10 when it is positioned in the conduit 16. The fiber optic core holder thus also provides a secondary locking mechanism configured in the retainer 1072, configured to lock the fiber optic core 10 in the fiber optic core holder 900 and prevent distal movement of the fiber optic core 10 when it is positioned in the conduit 16.

[0120] method

[0121] The methods include those using the fiber optic pin holders 100-1000 disclosed herein. For example, the methods for fiber optic pin holders 100, 200, 300, 400, 500, 600, 700, 800, 900, or 1000 include a pin insertion step, a first pin advancement step, a second pin advancement step, and a pin holding step.

[0122] The needle insertion step includes inserting a fiber optic needle, such as fiber optic needle 10, into a fiber optic needle holder 100, 200, 300, 400, 500, 600, 700, 800, 900, or 1000. A first needle advancement step includes advancing the fiber optic needle 10 through a catheter, such as catheter 16. A second needle advancement step includes advancing the distal tip of the fiber optic needle 10 through the vascular system to a target anatomical location within the patient. The needle retention step includes retaining the distal tip of the fiber optic needle 10 in the target anatomical location by locking the fiber optic needle in the fiber optic needle holder 100, 200, 300, 400, 500, 600, 700, 800, 900, or 1000, without at least distal advancement of the distal tip.

[0123] again, Figure 1 A first fiber optic core holder 100 is shown according to some embodiments.

[0124] The method may also include a core needle placement step, a first core needle pressing step, and a second core needle pressing step.

[0125] The core placement step includes placing the fiber optic core 10 against the arcuate shoulder 104 of the integrated funnel 102 of the fiber optic core holder 100.

[0126] The first core pressing step includes pressing the fiber optic core 10 against one of the sidewall lobes 110 surrounding the mouth of the integrated funnel 102 to guide the fiber optic core 10 into adjacent notches of the plurality of notches 108 surrounding the mouth of the integrated funnel 102.

[0127] The second core pressing step includes pressing the fiber optic core 10 into one of the plurality of notches 108, thereby locking the fiber optic core 10 in the fiber optic core holder 100 and holding the distal tip of the fiber optic core 10 in the target anatomical position.

[0128] again, Figure 2 A second fiber optic core holder 200 is shown according to some embodiments.

[0129] The method may also include a core needle placement step and a mouthpiece covering step.

[0130] Next, the core placement step includes placing the fiber optic core 10 against the arcuate shoulder 104 of the integrated funnel 102 of the fiber optic core holder 200.

[0131] The mouth covering step includes covering the mouth of the integrated funnel 102 with a cap 212 that is connected to the side wall of the fiber optic core holder 200 via a movable hinge 214, thereby locking the fiber optic core 10 in the fiber optic core holder 200 and holding the distal tip of the fiber optic core 10 in the target anatomical position.

[0132] again, Figure 3 A third fiber optic core holder 300 according to some embodiments is shown.

[0133] The method may also include a screw-on step and a tightening step.

[0134] The tightening step involves tightening the cap 316 of the fiber optic core retainer 300 onto the insert.

[0135] The compression step includes compressing the fiber optic core 10 within a cap 316, and a cylindrical washer 318 between the proximal end of the cap 316 and the insert, wherein the cap 316 is screwed onto the insert, thereby locking the fiber optic core 10 in the fiber optic core holder 300 and holding the distal tip of the fiber optic core 10 in the target anatomical position.

[0136] again, Figure 4 A fourth fiber optic core holder 400 according to some embodiments is shown.

[0137] The core insertion step may also include using multiple rollers 424 mounted on paired arms 422 (which are biased toward the centerline of the core holder 400) to travel a tortuous path, thereby locking the core 10 in the core holder 400 and holding the distal tip of the core 10 in the target anatomical position.

[0138] again, Figure 5 A fifth fiber optic core holder 500 according to some embodiments is shown.

[0139] The method may also include a clamp opening step and a clamp closing step.

[0140] The clamp opening step includes opening the clamp 526 of the fiber optic core holder 500 before the core insertion step.

[0141] The clamp closing step includes closing the second jaw 530 of the clamp 526 onto the first jaw 528 of the clamp 526, wherein the fiber optic core 10 is located between the second jaw 530 and the first jaw 528, thereby locking the fiber optic core 10 in the fiber optic core holder 500 and holding the distal tip of the fiber optic core 10 in the target anatomical position.

[0142] again, Figure 6AA sixth fiber optic core holder 600 according to some embodiments is shown.

[0143] The method may also include a hinge closure step.

[0144] The hinge closure step includes closing the paired hinge plates 636 of the fiber optic core holder 600 to press the fiber optic core 10 against the other hinge plate of the paired hinge plate 636 using the elastic pad 640 of one hinge plate, thereby locking the fiber optic core 10 in the fiber optic core holder 600 and holding the distal tip of the fiber optic core 10 in the target anatomical position.

[0145] again, Figure 7A A seventh fiber optic core holder 700 according to some embodiments is shown.

[0146] The core insertion step may also include inserting the fiber optic core 10 into a pair of opposing through holes 746 through a pair of arms 744, including a fixed arm 752 and a movable arm 754.

[0147] The method may also include a ratchet movement step.

[0148] The pawl movement step includes moving the pawl of the movable arm 754 against the rack of the fixed arm 752 to press the fiber optic core 10 between the paired arms 744, between an elastic pad provided on the movable arm 754 and another elastic pad provided on the connecting portion 748 of the fiber optic core holder 700, thereby locking the fiber optic core 10 in the fiber optic core holder 700 and holding the distal tip of the fiber optic core 10 in the target anatomical position.

[0149] again, Figure 8 An eighth fiber optic core holder 800 according to some embodiments is shown.

[0150] The method may also include a button press step and a button release step.

[0151] The button pressing step includes pressing a button on the insert 858 extending from one side of the housing 856 of the fiber optic core holder 800 to pull or push a spring to allow the fiber optic core 10 to move freely through the housing and insert through-holes 860 and 862 for adjusting the position of the fiber optic core holder 800 on the fiber optic core 10.

[0152] The button release procedure includes releasing the button to push or pull the insert 858 toward the side of the housing 856 from which it extends by means of a spring, thereby locking the fiber optic core 10 as a stop in the housing and insert through holes 860 and 862 in the fiber optic core holder 800 and holding the distal tip of the fiber optic core 10 in the target anatomical position.

[0153] again, Figure 9 A ninth fiber optic core holder 900 according to some embodiments is shown.

[0154] The core insertion step may further include placing the fiber optic core 10 into a zigzag channel 966 on one side of the base 964 of the fiber optic core holder 900, thereby locking the fiber optic core 10 in the fiber optic core holder 900 and holding the distal tip of the fiber optic core 10 in the target anatomical position.

[0155] again, Figure 10 A tenth fiber optic core holder 1000 according to some embodiments is shown.

[0156] The core insertion step may further include inserting the fiber optic core 10 into the through hole 1070 of the diaphragm 1068 of the fiber optic core holder 1000, thereby locking the fiber optic core 10 in the fiber optic core holder 1000 by friction and holding the distal tip of the fiber optic core 10 in the target anatomical position.

[0157] While specific embodiments have been disclosed herein, and while these specific embodiments have been disclosed in detail, the intent of these specific embodiments is not intended to limit the scope of the concepts provided herein. Other adaptations and / or modifications will likely occur to those skilled in the art, and are included in a broader sense. Therefore, deviations from the specific embodiments disclosed herein are permissible without departing from the scope of the concepts provided herein.

Claims

1. A fiber optic core holder, characterized in that, include: An integrated funnel, the integrated funnel comprising: An arcuate shoulder having a radius configured to allow a fiber optic core to be placed against the arcuate shoulder without damaging one or more fibers in the fiber optic core; and A neck configured to conform to the lumen of an extension leg of the catheter, the neck having an inner diameter sufficient to receive the fiber optic core needle; and A locking mechanism configured to lock the fiber optic core pin in the fiber optic core pin holder.

2. The fiber optic core holder according to claim 1, characterized in that, The locking mechanism includes a plurality of notches around the mouth of the integrated funnel through the sidewall of the fiber optic core holder, each of the plurality of notches being sized to securely hold the fiber optic core when it is pressed into it.

3. The fiber optic core holder according to claim 2, characterized in that, The locking mechanism includes a plurality of sidewall lobes that alternate with the plurality of notches around the mouth of the integrated funnel, each of the plurality of sidewall lobes being configured to guide the fiber optic core into an adjacent notch when pressed against it.

4. The fiber optic core holder according to claim 1, characterized in that, The locking mechanism includes a cap configured to cover the mouth and the fiber optic core when extending from the mouth of the integrated funnel, the cap being connected to the sidewall of the fiber optic core holder via a movable hinge.

5. The fiber optic core holder according to claim 1, characterized in that, The fiber optic core retainer is integrally formed with the Luer connector of the catheter.

6. The fiber optic core holder according to claim 1, characterized in that, The fiber optic core retainer is a cap that includes an internal thread in the distal portion of the cap, the internal thread being configured to screw onto the external thread of the Luer connector of the conduit.

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