Tube with integrated optical fiber and method of manufacture thereof - Patents.com

Abstract

Disclosed is an integrated tube comprising a tube wall, one or more lumens, and a longitudinal bead of the integrated tube having one or more optical fibers disposed therein. Each lumen of the one or more lumens is defined at least in part by the tube wall. The longitudinal bead of the integrated tube is located between opposing sides of the tube wall. Also disclosed is a medical device comprising a catheter tube and an integrated stylet. The catheter tube comprises a catheter tube wall and one or more lumens of the catheter tube. Each lumen of the one or more lumens is defined at least in part by the catheter tube wall. The integrated stylet comprises one or more optical fibers. The catheter tube also comprises a longitudinal bead between opposing sides of the catheter tube, the longitudinal bead having the one or more optical fibers disposed therein. Methods for manufacturing the above are also disclosed.

Description

Technical Field

[0001] Relates to a tube having an integrated optical fiber, a medical device, and a method thereof.

Background Art

[0002] The tip of a peripherally inserted central catheter (PICC) or a central venous catheter (CVC) may move and deviate from the ideal position in the superior vena cava (SVC) of a patient. Clinicians who believe that such a PICC or CVC has been displaced usually confirm the displacement by chest X-ray and replace the PICC or CVC if necessary. However, X-rays expose the patient to ionizing radiation. Therefore, there is a need for clinicians to easily and safely confirm the displacement of PICC and CVC and replace them if necessary.

[0003] Disclosed herein are an integrated tube, a medical device, and methods thereof that address the above, with an integrated optical fiber.

Summary of the Invention

[0004] Disclosed herein is an integrated tube, which in some embodiments, the integrated tube includes a tube wall, one or more lumens, and a longitudinal bead of the integrated tube, the longitudinal bead including one or more optical fibers disposed therein. Each lumen of the one or more lumens is at least partially defined by the tube wall. The longitudinal bead of the integrated tube is located between opposite sides of the tube wall.

[0005] In some embodiments, the integrated tube has one lumen. In some embodiments, the longitudinal bead is incorporated into the tube wall. In some embodiments, the integrated tube has two or more lumens.

[0006] In some embodiments, each of the two or more lumens has substantially the same volume as another of the two or more lumens of any length of the integrated tube. In some embodiments, at least one of the two or more lumens has a different volume from the other lumen of the two or more lumens for any length of the integrated tube.

[0007] In some embodiments, the integrated tube further includes one or more partitions of the integrated tube. Each of the two or more lumens is at least partially defined by the one or more partitions.

[0008] In some embodiments, the longitudinal bead is incorporated into the tube wall. In some embodiments, the longitudinal bead is incorporated into at least one of the one or more partitions.

[0009] In some embodiments, the longitudinal beads are incorporated into each of the one or more partition walls. In some embodiments, the longitudinal bead has one optical fiber disposed within the longitudinal bead.

[0010] In some embodiments, the longitudinal bead has a bundle of optical fibers arranged within the longitudinal bead. In some embodiments, the integrated tube is a bump tube.

[0011] In some embodiments, medical devices including a catheter tube and an integrated stylet are also disclosed herein. The catheter tube includes a catheter tube wall and one or more lumens of the catheter tube. Each of the one or more lumens is at least partially defined by the catheter tube wall. The integrated stylet includes one or more optical fibers. The catheter tube also includes a longitudinal bead between opposing sides of the catheter tube, the longitudinal bead having the one or more optical fibers disposed therein.

[0012] In some embodiments, the catheter tube has a single lumen. In some embodiments, the longitudinal bead is incorporated into the catheter tube.

[0013] In some embodiments, the catheter tube has two or more lumens. In some embodiments, each of the two or more lumens has substantially the same volume as another of the two or more lumens for any length of the catheter tube.

[0014] In some embodiments, at least one of the two or more lumens has a different volume from another of the two or more lumens for any length of the catheter tube. In some embodiments, the medical device further includes one or more partitions of the catheter tube. Each of the two or more lumens is at least partially defined by the one or more partitions.

[0015] In some embodiments, the longitudinal bead is incorporated into the catheter tube. In some embodiments, the longitudinal bead is incorporated into at least one of the one or more partitions.

[0016] In some embodiments, the longitudinal beads are incorporated into each of the one or more partition walls. In some embodiments, the longitudinal bead has one optical fiber disposed within the longitudinal bead.

[0017] In some embodiments, the longitudinal bead has a bundle of optical fibers arranged within the longitudinal bead. In some embodiments, the distal end of the catheter tube has a smaller diameter than the proximal end of the catheter tube. The distal end of the catheter tube is configured to interface with the patient's anatomical structure. The proximal end of the catheter tube is configured to interface with a treatment device or instrument.

[0018] In some embodiments, the medical device is a PICC or CVC. Furthermore, in some embodiments, this specification discloses a method for manufacturing an integrated tube, which includes passing at least one optical fiber through the die of an extruder, forcibly extruding molten polymer material through the die around the optical fiber so as to form an integrated tube in which the optical fiber is positioned within the longitudinal bead of the integrated tube, and cooling the integrated tube by pulling it with a puller in a cooling tank.

[0019] In some embodiments, this method further includes winding the integrated tube onto a spool of the integrated tube using a coiler. In some embodiments, the speed at which the puller pulls the integrated tube is increased to form a smaller diameter portion of the integrated tube, or decreased to form a larger diameter portion of the integrated tube.

[0020] In some embodiments, this method further includes cutting the integrated tube to a predetermined length with a cutter. In some embodiments, the cutter is synchronized with the puller such that each predetermined length of the integrated tube includes a first end portion of a predetermined length having a diameter smaller than a second end portion of a predetermined length.

[0021] In some embodiments, each predetermined length of the integrated tube is a catheter tube. The first end portion of the predetermined length of the integrated tube is a distal end portion of the catheter tube configured to interface with a patient's anatomical structure. The second end portion of the predetermined length of the integrated tube is a proximal end portion of the catheter tube configured to interface with a treatment device or instrument.

[0022] 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 more particularly describe certain embodiments of such concepts.

Brief Description of the Drawings

[0023] [Figure 1] FIG. 1 shows a cross-section of a single-lumen integrated tube with an integrated optical fiber according to some embodiments. [Figure 2] FIG. 2 shows a cross-section of a two-lumen integrated tube with an integrated optical fiber according to some embodiments. [Figure 3A] FIG. 3A shows a cross-section of a three-lumen integrated tube with an integrated optical fiber according to some embodiments. [Figure 3B] FIG. 3B shows a cross-section of another three-lumen integrated tube with an integrated optical fiber according to some embodiments. [Figure 4A] FIG. 4A shows a CVC including a two-lumen catheter tube with an integrated optical fiber according to some embodiments. [Figure 4B] FIG. 4B shows a detailed view of the proximal end portion of the catheter tube of the CVC of FIG. 4A. [Figure 5]Figure 5 shows several embodiments of a method for manufacturing an integrated tube with an integrated optical fiber. [Modes for carrying out the invention]

[0024] Before certain specific embodiments are disclosed in more detail, it should be understood that certain embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that certain embodiments disclosed herein may have features that can be easily separated from a particular embodiment and which, at their discretion, can be combined with or substituted for features of any of several other embodiments disclosed herein.

[0025] With regard to the terminology used herein, it should be understood that the terms are for the purpose of describing 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 multiple features or steps and do not provide a sequential limitation or numerical limitation. For example, the "first," "second," and "third" features or steps do not necessarily have to appear in that order, and a particular embodiment containing such features or steps does not necessarily have to be limited to three features or steps. Labels such as terms like "left," "right," "up," and "down" are used for convenience and do not, for example, imply a specific fixed position, orientation, or direction. Instead, such notations are used to reflect, for example, a relative position, orientation, or direction. The singular forms "one," "one," and "the said" also include plural references unless explicitly indicated in the context.

[0026] With respect to “proximal,” for example, the “proximal portion” or “proximal end portion” of a catheter disclosed herein includes the portion of the catheter intended to be near the clinician when the catheter is used on a patient. Similarly, for example, the “proximal length” of a catheter includes the length of the catheter intended to be near the clinician when the catheter is used on a patient. For example, the “proximal end” of a needle includes the end of the catheter intended to be near the clinician when the catheter is used on a patient. The proximal portion, proximal end portion, or proximal length of a catheter may include the proximal end of the catheter, but does not necessarily include the proximal end of the catheter. That is, unless suggested by the context, the proximal portion, proximal end portion, or proximal length of a catheter is not the terminal portion or terminal length of the catheter.

[0027] With respect to “distal,” for example, the “distal portion” or “distal end portion” of a catheter disclosed herein includes the portion of the catheter that is near or intended to be within the patient when the catheter is used in a patient. Similarly, for example, the “distal length” of a catheter includes the length of the catheter that is near or intended to be within the patient when the catheter is used in a patient. For example, the “distal end” of a catheter includes the end of the catheter that is near or intended to be within the patient when the catheter is used in a patient. The distal portion, distal end portion, or distal length of a catheter may include the distal end of the catheter, but the distal portion, distal end portion, or distal length of a catheter does not necessarily include the distal end of the catheter. That is, unless suggested by the context, the distal portion, distal end portion, or distal length of a catheter is not the terminal portion or terminal length of the catheter.

[0028] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those generally understood by those skilled in the art. The tip of a PICC or CVC may shift, causing it to move away from the ideal position of the patient's SVC. Clinicians who believe such a PICC or CVC is displaced typically confirm the displacement with a chest X-ray and replace the PICC or CVC if necessary. However, X-rays expose the patient to ionizing radiation. Therefore, clinicians have a need for a simple and safe way to confirm PICC and CVC displacement and replace them if necessary.

[0029] Disclosed herein are integrated tubes, medical devices, and methods thereof, which have integrated optical fibers and address the issues described above. Integrated tube Figure 1 shows a cross-section of a single-lumen integrated tube 100 with an integrated optical fiber 110 according to several embodiments. Figure 2 shows a cross-section of a two-lumen integrated tube 200 with an integrated optical fiber 110 according to several embodiments. Figure 3A shows a cross-section of a three-lumen integrated tube 300A with an integrated optical fiber 110 according to several embodiments. Figure 3B shows a cross-section of another three-lumen integrated tube 300B with an integrated optical fiber 110 according to several embodiments.

[0030] As shown in Figure 1, the integrated tube 100 includes a tube wall 104, a lumen 102, and a longitudinal bead 106 of the integrated tube 100 in which one or more optical fibers 110 are arranged. Similarly, as shown in Figure 2, the integrated tube 200 includes a tube wall 104, two lumen 202a and 202b, and a longitudinal bead 206 of the integrated tube 200 in which one or more optical fibers 110 are arranged. As shown in Figure 3A, the integrated tube 300A includes a tube wall 104, three lumen 202, 302a and 302b, and a longitudinal bead 306 of the integrated tube 300A in which one or more optical fibers 110 are arranged. Similarly, as shown in Figure 3B, the integrated tube 300B includes a tube wall 104, three lumens 303a, 303b, and 303c, and a longitudinal bead 306 of the integrated tube 300B in which one or more optical fibers 110 are disposed. Thus, the integrated tube disclosed herein includes at least one tube wall, one or more lumens, and a longitudinal bead of the integrated tube in which one or more optical fibers are disposed.

[0031] With respect to the integrated tube 100 in Figure 1, the lumen 102 is defined at least partially by the tube wall 104, particularly the inner surface of the tube wall 104. The longitudinal bead 106 of the integrated tube 100 is located between the opposing sides of the tube wall 104. That is, the longitudinal bead 106 is on the inside of the integrated tube 100. In fact, the longitudinal bead 106 is incorporated into the tube wall 104, and more specifically into the inner surface of the tube wall 104. Thus, the lumen 102 is further defined, at least partially, by the longitudinal bead 106.

[0032] With respect to the integrated tube 200 in Figure 2, each of the two lumens 202a and 202b is defined at least partially by the tube wall 104, and more specifically by the inner surface of the tube wall 104.

[0033] The integrated tube 200 further includes a partition wall 208. Each of the two lumens 202a and 202b is further defined at least partially by the partition wall 208. As shown in the figure, the partition wall 208 separates the integrated tube 200 into two such that each of the two lumens 202a and 202b of the integrated tube 200 has substantially the same volume as the other lumen of the two lumens 202a and 202b for any length of the integrated tube 200. However, the partition wall 208 does not have to separate the integrated tube 200 into two equal halves, as described above. For example, if the cross-section of the integrated tube 200 in Figure 2 is a clock face, the partition wall 208 could extend from the 2 o'clock direction to the 10 o'clock direction instead of from the 3 o'clock direction to the 9 o'clock direction. With such a configuration, each of the two lumens 202a and 202b of the integrated tube 200 will have a different volume from the other lumen 202a or 202b for any length of the integrated tube 200.

[0034] The longitudinal bead 206 of the integrated tube 200 is located between the opposing sides of the tube wall 104. That is, the longitudinal bead 206 is inside the integrated tube 200. In fact, the longitudinal bead 206 is incorporated into the partition wall 208, particularly the inner portion of the partition wall 208, so that the longitudinal bead 206 is coaxial with the central axis of the integrated tube 200. However, the longitudinal bead 206 may alternatively be incorporated into the partition wall 208 between the inner portion of the partition wall 208 and the tube wall 104. That being said, the longitudinal bead 206 does not need to be incorporated into the partition wall 208 at all. Instead, the longitudinal bead 206 may be incorporated into the tube wall 104, similar to that of the integrated tube 100. Regardless of how the longitudinal bead 206 is incorporated into the integrated tube 200, at least one of the two lumens 202a and 202b of the integrated tube 200 is further defined, at least partially, by the longitudinal bead 206.

[0035] With respect to the integrated tube 300A in Figure 3A, each of the three lumens 202, 302a, and 202b is defined at least partially by the tube wall 104, and more specifically by the inner surface of the tube wall 104.

[0036] The integrated tube 300A further includes two partitions 208 and 308 of the integrated tube 300A. Each of the three lumens 202, 302a and 302b is further at least partially defined by partition 208. Each of the two lumens 302a and 302b is further at least partially defined by partition 308. As shown, partition 208 separates the integrated tube 300B into a first set of two halves, and partition 308 further separates one of the first set of two halves into a second set of two halves. As a result, each of the two lumens 302a and 302b of the integrated tube 300A has substantially the same volume as the other lumen of the two lumens 302a and 302b for any length of the integrated tube 200, and lumen 202 has at least twice the volume of the two lumens 302a and 302b for any length of the integrated tube 200. However, the partition wall 208 does not need to separate the integrated tube 300B into a first set of two halves, and the partition wall 308 does not need to further separate one of the first set of two halves into a second set of two halves as described above. For example, if the cross-section of the integrated tube 300A in Figure 3A is a clock face, the partition wall 208 can extend from the 11 o'clock direction to the 7 o'clock direction instead of from the 12 o'clock direction to the 6 o'clock direction. Similarly, instead of the partition wall 308 extending from the 3 o'clock direction to the inner portion of the partition wall 208, the partition wall 308 can extend from the 2 o'clock direction to the inner portion of the partition wall 208, or from the 2 o'clock direction to the space between the inner portion of the partition wall 208 and the tube wall 104. Such a configuration would result in each of the three lumens 202, 302a, and 302b of the integrated tube 300A having a different volume from any other lumen of the three lumens 202, 302a, and 302b for any length of the integrated tube 300A.

[0037] The longitudinal bead 306 of the integrated tube 300A is located between the opposing sides of the tube wall 104. That is, the longitudinal bead 306 is on the inside of the integrated tube 300A. In fact, the longitudinal bead 306 is incorporated into the partitions 208 and 308, particularly the inner portion of partition 208 and the end of partition 308, so that the longitudinal bead 306 is coaxial with the central axis of the integrated tube 300A. However, the longitudinal bead 306 may alternatively be incorporated into the inner portion of partition 208 or partition 308 between the inner portion of partition 208 and the tube wall 104. That being said, the longitudinal bead 306 does not need to be incorporated into any of the partitions 208 or 308 at all. Instead, the longitudinal bead 306 may be incorporated into the tube wall 104, similar to that of the integrated tube 100. Regardless of how the longitudinal bead 306 is incorporated into the integrated tube 300A, at least one of the three lumens 202, 302a, and 302b of the integrated tube 300A is further defined, at least partially, by the longitudinal bead 306.

[0038] With respect to the integrated tube 300B in Figure 3B, each of the three lumens 303a, 303b, and 303c is defined at least partially by the tube wall 104, and more specifically by the inner surface of the tube wall 104.

[0039] The integrated tube 300B further includes three partitions 309a, 309b, and 309c. Each of the three lumens 303a, 303b, and 300c is further defined at least partially by two of the three partitions 309a, 309b, and 309c. As shown in the figure, the partitions 309a, 309b, and 309c separate the integrated tube 300B into three parts such that each of the three lumens 303a, 303b, and 300c of the integrated tube 300B has substantially the same volume as another lumen of the three lumens 303a, 303b, and 300c for any length of the integrated tube 200. However, the partitions 309a, 309b, and 309c do not need to separate the integrated tube 300B into three equal parts, as previously stated. For example, see the integrated tube 300A in Figure 3A and the related explanation above. With a configuration like the example above, each of the three lumens 303a, 303b, and 303c of the integrated tube 300B will have a different volume from the other lumen of the three lumens 303a, 303b, and 303c for any length of the integrated tube 300B.

[0040] The longitudinal bead 306 of the integrated tube 300B is located between the opposing sides of the tube wall 104. That is, the longitudinal bead 306 is on the inside of the integrated tube 300B. In fact, the longitudinal bead 306 is incorporated into the partitions 309a, 309b, and 309c, and in particular into the ends of each partition of partitions 309a, 309b, and 309c, so that the longitudinal bead 306 is coaxial with the central axis of the integrated tube 300B. However, the longitudinal bead 306 may alternatively be incorporated into the inner portion of any partition of partitions 309a, 309b, and 309c. That being said, the longitudinal bead 306 does not need to be incorporated into any of partitions 309a, 309b, and 309c. Instead, the longitudinal bead 306 may be incorporated into the tube wall 104, similar to that of the integrated tube 100. Regardless of how the longitudinal bead 306 is incorporated into the integrated tube 300B, at least one of the three lumens 203a, 303b, and 303C of the integrated tube 300B is further defined, at least partially, by the longitudinal bead 306.

[0041] Integrated tubes 100, 200, 300A, or 300B may be integrated bump tubes having a diameter that varies along their length. When an integrated bump tube is cut to a predetermined length depending on how its diameter varies along its length, each predetermined length of the integrated bump tube may have a first end having a smaller diameter than the second end, such that the first end of the predetermined length of the integrated bump tube is configured to interface with, for example, the anatomical structure of a mammal, and the second end of the predetermined length of the integrated bump tube is configured to interface with a medical device or instrument.

[0042] Integrated tubes 100, 200, 300A, or 300B, including tube walls 104, partitions 208, 308, or 309a-c, and longitudinal beads 106, 206, or 306, are made of either an inorganic polymer such as silicone or an organic polymer such as polyurethane.

[0043] The optical fibers 110 arranged in the longitudinal beads 106, 206, or 306 of the integrated tubes 100, 200, 300A, or 300B include one optical fiber or bundles of two or more optical fibers made of silica glass or organic polymer, and are optionally coated with a cladding of another silica glass or organic polymer having a lower refractive index than that of the optical fiber, a buffer coating of yet another organic polymer, or a combination thereof. Each of the aforementioned optical fibers has a diameter between approximately 8 μm and approximately 25 μm.

[0044] Medical devices Figure 4A shows a CVC400 including a two-lumen catheter tube 402 with an integrated optical fiber stylet 110, according to several embodiments. Figure 4B shows a detailed view of the proximal end portion of the catheter tube 402 of the CVC400 in Figure 4A. Again, Figure 2 shows a cross-section of a two-lumen integrated tube 200 having an integrated optical fiber 110, according to several embodiments, but since the catheter tube 402 is a predetermined length of the integrated tube 200, the features of the integrated tube 200 are incorporated into the catheter tube 402 as shown below.

[0045] As shown in Figure 4A, the CVC400 includes a catheter tube 402, which, as will be described in more detail below, includes two catheter tube lumens 202a and 202b, a branched hub having two hub lumens fluidly connected to the two catheter tube lumens 202a and 202b, two extension legs, each extension leg fluidly connected to one of the two hub lumens, and Luer connectors connected to each of the two extension legs. The CVC400 optionally includes a stylet extension 404 extending from the hub of the CVC400 to interface the integrated fiber optic stylet 110 of the catheter tube 402 with a treatment device or instrument. The stylet extension 404 may be a cut-off portion of the catheter tube 402 containing the fiber optic stylet 110, or a cut-off portion of the catheter tube 402 placed on another tube (e.g., an extension tube).

[0046] With respect to the integrated tube 402 in Figures 2, 4A, and 4B, each of the two catheter tube lumens 202a and 202b is defined at least partially by the catheter tube wall 104, and more specifically by the inner surface of the tube wall 104.

[0047] The catheter tube 402 further includes a partition 208. Each of the two catheter tube lumens 202a and 202b is further defined, at least partially, by the partition 208. As shown in the figure, the partition 208 separates the catheter tube 402 into two such that each of the two catheter tube lumens 202a and 202b has substantially the same volume as the other of the two catheter tube lumens 202a and 202b for any length of the catheter tube 402. However, the partition 208 does not have to separate the catheter tube 402 into two equal halves, as described above. For example, if the cross-section of the catheter tube 402 in Figure 2 is a clock face, the partition 208 could extend from the 2 o'clock position to the 10 o'clock position instead of from the 3 o'clock position to the 9 o'clock position. With such a configuration, each of the two catheter tube lumens 202a and 202b of the catheter tube 402 will have a different volume from the other of the two catheter tube lumens 202a and 202b for any length of the catheter tube 402.

[0048] The longitudinal bead 206 of the catheter tube 402 in which the integrated fiber optic stylet 110 is located is between the opposing sides of the catheter tube wall 104. That is, the longitudinal bead 206 is on the inside of the catheter tube 402. In fact, the longitudinal bead 206 is incorporated into the partition wall 208, particularly the inner portion of the partition wall 208, so that the longitudinal bead 206 is coaxial with the central axis of the catheter tube 402. However, the longitudinal bead 206 may alternatively be incorporated into the partition wall 208 between the inner portion of the partition wall 208 and the tube wall 104. That being said, the longitudinal bead 206 does not need to be incorporated into the partition wall 208 at all. Instead, the longitudinal bead 206 may be incorporated into the catheter tube wall 104, similar to that of the integrated tube 100. Regardless of how the longitudinal bead 206 is incorporated into the catheter tube 402, at least one of the two catheter tube lumens 202a and 202b of the catheter tube 402 is further defined, at least partially, by the longitudinal bead 206.

[0049] The catheter tube 402 is formed by cutting the integrated tube 200 to a predetermined length such that the distal end of the catheter tube 402 has a smaller diameter than the proximal end of the catheter tube 402. The distal end of the catheter tube 402 is configured to interface with the patient's anatomical structure. The proximal end of the catheter tube 402 is configured to interface with a treatment device or instrument.

[0050] Catheter tubes 402, including tube walls 104, septa 208, and longitudinal beads 206, such as integrated tubes 100, 200, 300A, or 300B, are made of either an inorganic polymer such as silicone or an organic polymer such as polyurethane.

[0051] The integrated optical fiber 110, positioned in the longitudinal bead 206 of the catheter tube 402, comprises one optical fiber or two or more optical fiber bundles made of silica glass or organic polymer, and is optionally coated with a cladding made of another silica glass or organic polymer having a lower refractive index than that of the optical fiber, a buffer coating of yet another organic polymer, or a combination thereof. Each of the aforementioned optical fibers has a diameter between approximately 8 μm and approximately 25 μm.

[0052] The CVC400 described above is a two-lumen CVC having a two-lumen catheter tube 402, but other medical devices similar to the CVC400, such as a two-lumen PICC, may also be used. Furthermore, one-lumen or three-lumen CVCs or PICCs are possible, each one-lumen CVC or PICC having a catheter tube and integrated fiber optic stylet 110 corresponding to an integrated tube 100, and each three-lumen CVC or PICC having a catheter tube and integrated fiber optic stylet 110 corresponding to an integrated tube 300A or 300B.

[0053] manufacturing Figure 5 shows several embodiments of manufacturing integrated tubes 100, 200, 300A, or 300B equipped with an integrated optical fiber 110.

[0054] A method for manufacturing an integrated tube 100, 200, 300A, or 300B includes passing at least one optical fiber 110 (either individually or wound on a spool) through a die 502 of an extruder 500; forcibly extruding a molten polymer material 504 such as silicone or polyurethane through the die 502 around the optical fiber 110 so that the optical fiber 110 is positioned within the longitudinal beads 106, 206, or 306 of the integrated tube 100, 200, 300A, or 300B; and cooling the integrated tube 100, 200, 300A, or 300B by pulling it with a puller in a cooling tank. The speed at which the puller pulls the integrated tube 100, 200, 300A, or 300B is increased to form a smaller diameter portion of the integrated tube 100, 200, 300A, or 300B, or decreased to form a larger diameter portion of the integrated tube 100, 200, 300A, or 300B.

[0055] This method may further include winding the integrated tube 100, 200, 300A or 300B onto the spool of integrated tube 100, 200, 300A or 300B using a coiler.

[0056] This method may further include cutting the integrated tube 100, 200, 300A, or 300B to a predetermined length with a cutter. The cutter may be synchronized with a puller so that each predetermined length of the integrated tube 100, 200, 300A, or 300B includes a first end portion of the predetermined length having a smaller diameter than a second end portion of the predetermined length. As described above, each predetermined length of the integrated tube 100, 200, 300A, or 300B may be a catheter tube, such as a catheter tube 402 formed from an integrated tube 200 of the predetermined length. The first end portion of the integrated tube 200 of the predetermined length is the distal end portion of the catheter tube 402 configured to interface with the patient's anatomical structure. The second end portion of the integrated tube 200 of the predetermined length is the proximal end portion of the catheter tube 402 configured to interface with a treatment device or instrument.

[0057] While several specific embodiments are disclosed herein, and some embodiments are disclosed in some degree of detail, no particular embodiment is intended to limit the scope of the concepts provided herein. Those skilled in the art will understand that in broader embodiments, additional adaptations and / or modifications are possible, and these adaptations and / or modifications are also included. Thus, it is possible to implement these embodiments outside of the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. 1. A hot melt extruded integral tube, comprising: a tube wall of the integral tube, the integral tube being comprised of a first organic polymer; one or more lumens of the integrated tube, each lumen of the one or more lumens being defined at least in part by the tube wall; a plurality of sections having varying diameters along a length of the integral tube, each section of the plurality of sections being within a predetermined length of the integral tube; a longitudinal bead of the integrated tube, the longitudinal bead being a cooled hot melt of the first organic polymer extruded around the one or more optical fibers such that the longitudinal bead integrates the one or more optical fibers into the longitudinal bead, the longitudinal bead being located between opposing sides of the tube wall; An integrated tube comprising:

2. The integral tube of claim 1 , wherein the integral tube has one lumen and the longitudinal bead is integrated into the tube wall.

3. The integrated tube of claim 1 , wherein the integrated tube has two or more lumens.

4. The integrated tube of claim 3 , wherein each lumen of the two or more lumens has substantially the same volume as another lumen of the two or more lumens for any length of the integrated tube.

5. The integrated tube of claim 3 , wherein at least one lumen of the two or more lumens has a different volume than another lumen of the two or more lumens over any length of the integrated tube.

6. The integrated tube of any one of claims 3 to 5, further comprising one or more bulkheads of the integrated tube, each lumen of the two or more lumens being at least partially defined by the one or more bulkheads.

7. The integral tube of claim 6 , wherein the longitudinal beads are embedded in the tube wall.

8. 7. The integrated tube of claim 6, wherein the longitudinal bead is incorporated into at least one of the one or more septa.

9. 7. The integral tube of claim 6, wherein the longitudinal bead is incorporated into each septum of the one or more septums.

10. 10. The integrated tube of claim 1, wherein the integrated tube is cut into a plurality of catheter tubes, each catheter tube having a portion between a distal end of the catheter tube and a proximal end of the catheter tube that has a varying diameter along a length of the integrated tube.

11. 1. A method for manufacturing an integral tube, comprising: passing one or more optical fibers through an extruder die; forcing a molten polymer material of a first polymer material through the die around the one or more optical fibers to form an integrated tube with a longitudinal bead around the one or more optical fibers to integrate the one or more optical fibers into the longitudinal bead; cooling the integral tube by pulling the integral tube with a puller in a cooling bath, a speed at which the integral tube is pulled with the puller being varied to form a plurality of sections having varying diameters along a length of the integral tube, each of the plurality of sections being formed within a predetermined length of the integral tube; The method includes:

12. The method of claim 11 further comprising winding the integral tube onto a spool of the integral tube with a coiler.

13. 12. The method of claim 11, wherein a speed at which the puller pulls the integral tube is increased to form smaller diameter sections of the integral tube or decreased to form larger diameter sections of the integral tube.

14. The method of claim 13 further comprising cutting the integral tube to length with a cutter.

15. 15. The method of claim 14, wherein the cutter is synchronized with the puller such that each predetermined length of the integrated tube includes a first end portion of the predetermined length having a smaller diameter than a second end portion of the predetermined length.

16. 16. The method of claim 15, wherein each predetermined length of integrated tubing is a catheter tubing, the first end portion of the predetermined length of integrated tubing is a distal end portion of the catheter tubing configured to interface with a patient's anatomy, and the second end portion of the predetermined length of integrated tubing is a proximal end portion of the catheter tubing configured to interface with a treatment device or instrument.

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