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] Tube with integrated optical fiber Buo Yobi manufacturing It concerns the method. [Background technology]

[0002] The tip of a peripherally inserted central catheter (PICC) or central venous catheter (CVC) may move and become displaced from its ideal location in a patient's superior vena cava (SVC). Clinicians who believe that such a PICC or CVC has become displaced typically confirm the displacement with a chest x-ray and replace the PICC or CVC if necessary. However, x-rays expose patients to ionizing radiation. Thus, there is a need for clinicians to easily and safely confirm the displacement of PICCs and CVCs and replace them if necessary.

[0003] SUMMARY Disclosed herein are integrated tubes with integrated optical fibers, medical devices, and methods thereof that address the above. Summary of the Invention

[0004] Disclosed herein are integral tubes, which in some embodiments include a tube wall, one or more lumens, and a longitudinal bead of the integral tube, the longitudinal bead including 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 integral tube is located between opposing sides of the tube wall.

[0005] In some embodiments, the integral tube has one lumen. In some embodiments, the longitudinal beads are embedded in the tube wall. In some embodiments, the integral tube has two or more lumens.

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

[0007] In some embodiments, the integral tube further comprises one or more bulkheads of the integral tube, each lumen of the two or more lumens being at least partially defined by the one or more bulkheads.

[0008] In some embodiments, the longitudinal beads are embedded in the tube wall. In some embodiments, the longitudinal bead is incorporated into at least one of the one or more septa.

[0009] In some embodiments, the longitudinal bead is incorporated into each septum of the one or more septums. In some embodiments, the longitudinal bead comprises one optical fiber disposed therein.

[0010] In some embodiments, the longitudinal bead comprises a fiber optic bundle disposed therein. In some embodiments, the integral tube is a bump tube.

[0011] Also disclosed herein, in some embodiments, is a medical device including a catheter tube and an integrated stylet. The catheter tube includes 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 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 one lumen. In some embodiments, the longitudinal bead is integrated into the catheter tube.

[0013] In some embodiments, the catheter tube has two or more lumens. In some embodiments, 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 catheter tube.

[0014] In some embodiments, at least one of the two or more lumens has a different volume than another of the two or more lumens along any length of the catheter tube. In some embodiments, the medical device further comprises one or more septa of the catheter tube, each lumen of the two or more lumens being at least partially defined by the one or more septa.

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

[0016] In some embodiments, the longitudinal bead is incorporated into each septum of the one or more septums. In some embodiments, the longitudinal bead comprises one optical fiber disposed therein.

[0017] In some embodiments, the longitudinal bead comprises a fiber optic bundle disposed therein. In some embodiments, a distal end portion of the catheter tube has a smaller diameter than a proximal end portion of the catheter tube, the distal end portion of the catheter tube is configured to interface with a patient's anatomy, and the proximal end portion 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. Also disclosed herein, in some embodiments, is a method for making an integrated tube, comprising passing at least one optical fiber through an extruder die, forcing molten polymer material through the die around the optical fiber to form an integrated tube with the optical fiber disposed within a longitudinal bead of the integrated tube, and cooling the integrated tube by pulling the integrated tube with a puller in a cooling bath.

[0019] In some embodiments, the method further comprises winding the integral tube with a coiler onto a spool of the integral tube. In some embodiments, the speed at which the puller pulls the integral tube is greater than or equal to the diameter of the integral tube. Multiple The integral tube may be enlarged to form a section or a larger diameter section. Multiple or reduced to form a portion.

[0020] In some embodiments, the method further comprises cutting the integral tube to 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 smaller diameter than a second end portion of the predetermined length.

[0021] In some embodiments, 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.

[0022] These and other features of the concepts provided herein will become more apparent to those of ordinary skill in the art in view of the accompanying drawings and the following description, which describe in more detail 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 integrated optical fiber according to some embodiments. [Diagram 2] FIG. 2 shows a cross section of a two lumen integrated tube with integrated optical fiber according to some embodiments. [Figure 3A] FIG. 3A shows a cross section of a three lumen integrated tube with integrated optical fiber, according to some embodiments. [Figure 3B] FIG. 3B shows a cross section of another three-lumen integrated tube with integrated optical fiber, according to some embodiments. [Figure 4A] FIG. 4A shows a CVC including a two-lumen catheter tube with integrated optical fibers, 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. [Diagram 5]FIG. 5 illustrates a method for manufacturing an integrated tube with integrated optical fiber according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0024] Before some specific embodiments are disclosed 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 can have features that can be easily separated from the specific embodiment and, optionally, combined with or substituted for features of any of the other several embodiments disclosed herein.

[0025] With regard to the terms used herein, it should also be understood that the terms are intended to describe some particular embodiments, and that the terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps within a group of features or steps, and do not provide sequential or numerical limitations. For example, the "first", "second", and "third" features or steps do not necessarily have to appear in that order, and a particular embodiment including such features or steps is not necessarily limited to three features or steps. Labels such as terms such as "left", "right", "upper", "lower", etc. are used for convenience and do not imply, for example, a particular fixed position, orientation, or direction. Instead, such designations are used to reflect, for example, a relative position, orientation, or direction. The singular forms "one", "one", and "said" also include plural references unless the context clearly dictates otherwise.

[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 can include the proximal end of the catheter, but the proximal portion, proximal end portion, or proximal length of a catheter need not include the proximal end of the catheter. That is, unless otherwise suggested by 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, a "distal portion" or "distal end portion" of a catheter disclosed herein includes a portion of the catheter that is intended to be near or within a patient when the catheter is used with a patient. Similarly, for example, a "distal length" of a catheter includes a length of the catheter that is intended to be near or within a patient when the catheter is used with a patient. For example, a "distal end" of a catheter includes an end of the catheter that is intended to be near or within a patient when the catheter is used with a patient. A distal portion, distal end portion, or distal length of a catheter can include the distal end of the catheter, but a distal portion, distal end portion, or distal length of a catheter need not include the distal end of the catheter. That is, unless otherwise suggested by context, a distal portion, distal end portion, or distal length of a catheter is not a terminal portion or terminal length of a catheter.

[0028] 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. The tip of a PICC or CVC may move and become displaced from its ideal position in a patient's SVC. Clinicians who believe that such a PICC or CVC has become displaced typically confirm the displacement with a chest x-ray and replace the PICC or CVC if necessary. However, x-rays expose patients to ionizing radiation. Thus, there is a need for clinicians to easily and safely confirm the displacement of PICCs and CVCs and replace them if necessary.

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

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

[0031] With respect to the integral tube 100 of FIG. 1, the lumen 102 is defined, at least in part, by the tube wall 104, and in particular the inner surface of the tube wall 104. The longitudinal bead 106 of the integral tube 100 is located between opposing sides of the tube wall 104. That is, the longitudinal bead 106 is on the interior side of the integral tube 100. In fact, the longitudinal bead 106 is integrated into the tube wall 104, and in particular into the interior surface of the tube wall 104. Thus, the lumen 102 is further defined, at least in part, by the longitudinal bead 106.

[0032] With respect to the integral tube 200 of FIG. 2, each of the two lumens 202a and 202b is defined, at least in part, by the tube wall 104, and in particular by the inner surface of the tube wall 104.

[0033] The integrated tube 200 further includes a partition 208 of the integrated tube 200. Each of the two lumens 202a and 202b is further defined at least in part by a partition 208. As shown, the partition 208 separates the integrated tube 200 into two halves such that each of the two lumens 202a and 202b of the integrated tube 200 has substantially the same volume as the other of the two lumens 202a and 202b for any length of the integrated tube 200. However, the partition 208 need not separate the integrated tube 200 into two equal halves, as previously discussed. For example, instead of the partition 208 extending from the 3 o'clock to the 9 o'clock direction, as would be the case if the cross section of the integrated tube 200 of FIG. 2 were a clock face, the partition 208 could extend from the 2 o'clock to the 10 o'clock direction. With such a configuration, each of the two lumens 202a, 202b of the integrated tube 200 will have a different volume than the other of the two lumens 202a, 202b for any given length of the integrated tube 200.

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

[0035] With respect to the integral tube 300A of FIG. 3A, each of the three lumens 202, 302a and 202b is defined, at least in part, by the tube wall 104, and in particular 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 defined at least in part by a partition 208. Each of the two lumens 302a and 302b is further defined at least in part by a partition 308. As shown, partitions 208 separate 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 of the two lumens 302a and 302b for any length of the integrated tube 200, and the 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 208 need not separate the integrated tube 300B into a first set of two halves, and the partition 308 need not further separate one of the first set of two halves into a second set of two halves as described above. For example, instead of the partition 208 extending from the 12 o'clock to the 6 o'clock direction, as in the case where the cross section of the integrated tube 300A of FIG. 3A is a clock face, the partition 208 could extend from the 11 o'clock to the 7 o'clock direction. Similarly, instead of the septum 308 extending from the 3 o'clock direction to the inner portion of the septum 208, the septum 308 can extend from the 2 o'clock direction to the inner portion of the septum 208, or from the 2 o'clock direction to between the inner portion of the septum 208 and the tube wall 104. With such a configuration, each of the three lumens 202, 302a, 302b of the integrated tube 300A will have a different volume than another of the three lumens 202, 302a, 302b for any given length of the integrated tube 300A.

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

[0038] With respect to the integral tube 300B of FIG. 3B, each of the three lumens 303a, 303b and 303c is defined, at least in part, by the tube wall 104, and in particular by the inner surface of the tube wall 104.

[0039] The integrated tube 300B further includes three partitions 309a, 309b, and 309c of the integrated tube 300B. Each of the three lumens 303a, 303b, and 300c is further defined at least in part by two of the three partitions 309a, 309b, and 309c. As shown, the partitions 309a, 309b, and 309c separate the integrated tube 300B into three such that each of the three lumens 303a, 303b, and 300c of the integrated tube 300B has substantially the same volume as another of the three lumens 303a, 303b, and 300c for any length of the integrated tube 200. However, the partitions 309a, 309b, and 309c need not separate the integrated tube 300B into three equal portions, as previously described. See, for example, integrated tube 300A in Figure 3A and the associated discussion above. With the above example configuration, each of the three lumens 303a, 303b, and 303c of integrated tube 300B will have a different volume than another of the three lumens 303a, 303b, and 303c for any given length of integrated tube 300B.

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

[0041] The integrated tube 100, 200, 300A, or 300B may be an integrated bump tube having a diameter that varies along its length. When cutting the integrated bump tube to predetermined lengths according to how the diameter of the integrated bump tube varies along its length, each predetermined length of 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 integrated bump tube is configured to interface with, for example, a mammalian anatomy, and the second end of the predetermined length of integrated bump tube is configured to interface with a medical device or instrument.

[0042] The integral tube 100, 200, 300A, or 300B, including the tube wall 104, the septa 208, 308, or 309a-c, and the longitudinal beads 106, 206, or 306, are either an inorganic polymer, such as silicone, or an organic polymer, such as polyurethane.

[0043] The optical fibers 110 disposed in the longitudinal bead 106, 206, or 306 of the integral tube 100, 200, 300A, or 300B may comprise one optical fiber or a bundle of two or more optical fibers made of silica glass or an organic polymer, 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 optical fiber of said optical fibers has a diameter between about 8 μm and about 25 μm.

[0044] Medical Devices Figure 4A shows a CVC 400 including a two-lumen catheter tube 402 with an integrated fiber optic stylet 110, according to some embodiments. Figure 4B shows a detailed view of a proximal end portion of the catheter tube 402 of the CVC 400 of Figure 4A. Again, Figure 2 shows a cross section of a two-lumen integrated tube 200 with integrated optical fiber 110, according to some embodiments, but the catheter tube 402 is a length of integrated tube 200 such that features of the integrated tube 200 are incorporated into the catheter tube 402, as described below.

[0045] 4A, the CVC 400 includes a catheter tube 402 having two catheter tube lumens 202a and 202b, a bifurcated 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 a luer connector connecting each of the two extension legs, as described in more detail below. The CVC 400 optionally includes a stylet extension 404 extending from the hub of the CVC 400 to interface the integrated fiber optic stylet 110 of the catheter tube 402 with a treatment device or instrument. The stylet extension 404 can be a skived portion of the catheter tube 402 that includes the fiber optic stylet 110, or a skived portion of the catheter tube 402 that is disposed in another tube (e.g., an extension tube).

[0046] With respect to the integral tube 402 of FIGS. 2, 4A and 4B, each of the two catheter tube lumens 202a and 202b is defined, at least in part, by the catheter tube wall 104, and in particular by the inner surface of the tube wall 104.

[0047] The catheter tube 402 further includes a partition 208 of the catheter tube 402. Each of the two catheter tube lumens 202a and 202b is further defined at least in part by the partition 208. As shown, the partition 208 separates the catheter tube 402 into two halves such that each of the two catheter tube lumens 202a and 202b of the catheter tube 402 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 need not separate the catheter tube 402 into two equal halves, as previously described. For example, instead of the partition 208 extending from the 3 o'clock direction to the 9 o'clock direction, as in the case where the cross section of the catheter tube 402 of FIG. 2 is a clock face, the partition 208 could extend from the 2 o'clock direction to the 10 o'clock direction. With such a configuration, each of the two catheter tube lumens 202a, 202b of the catheter tube 402 will have a different volume than the other of the two catheter tube lumens 202a, 202b for any given 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 disposed is between the opposing sides of the catheter tube wall 104. That is, the longitudinal bead 206 is inside the catheter tube 402. In fact, the longitudinal bead 206 is incorporated into the septum 208, particularly the inner portion of the septum 208, such 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 septum 208 between the inner portion of the septum 208 and the tube wall 104. That said, the longitudinal bead 206 does not have to be incorporated into the septum 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 202 a and 202 b of the catheter tube 402 is further defined, at least in part, by the longitudinal bead 206 .

[0049] The catheter tube 402 is a cut to length portion of the integral tube 200 such that the distal end portion of the catheter tube 402 has a smaller diameter than the proximal end portion of the catheter tube 402. The distal end portion of the catheter tube 402 is configured to interface with a patient's anatomy. The proximal end portion of the catheter tube 402 is configured to interface with a treatment device or instrument.

[0050] Like the integral tubes 100, 200, 300A, or 300B, the catheter tube 402, including the tube wall 104, the septum 208, and the longitudinal beads 206, is either an inorganic polymer, such as silicone, or an organic polymer, such as polyurethane.

[0051] The integrated optical fiber 110 disposed in the longitudinal bead 206 of the catheter tube 402 includes one optical fiber or two or more optical fiber bundles made of silica glass or an organic polymer, optionally coated with a cladding made of another silica glass or an 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 optical fiber of said optical fibers has a diameter between about 8 μm and about 25 μm.

[0052] The CVC 400 shown above is a two-lumen CVC having a two-lumen catheter tube 402, but may be other medical devices such as a two-lumen PICC similar to the CVC 400. Additionally, one-lumen or three-lumen CVCs or PICCs are possible, with each one-lumen CVC or PICC having a catheter tube and integrated fiber optic stylet 110 corresponding to integrated tube 100, and each three-lumen CVC or PICC having a catheter tube and integrated fiber optic stylet 110 corresponding to integrated tube 300A or 300B.

[0053] manufacturing FIG. 5 illustrates a method of manufacturing an integrated tube 100, 200, 300A or 300B with an integrated optical fiber 110 according to some embodiments.

[0054] A method of manufacturing the 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, forcing a molten polymer material 504, such as silicone or polyurethane, through the die 502 around the optical fiber 110 to form an integrated tube in which the optical fiber 110 is disposed within the longitudinal bead 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 the integrated tube 100, 200, 300A or 300B with a puller in a cooling bath. The speed at which the puller pulls the integral tube 100, 200, 300A or 300B shall be the smaller of the diameter of the integral tube 100, 200, 300A or 300B. Multiple or the diameter of the integral tube 100, 200, 300A or 300B is increased to form a portion of the Multiple or reduced to form a portion.

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

[0056] The 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 the puller such that each predetermined length of the integrated tube 100, 200, 300A or 300B includes a first end portion of a 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 the catheter tube 402, formed from the predetermined length of the integrated tube 200. Such a first end portion of the integrated tube 200 of the predetermined length is a distal end portion of the catheter tube 402 configured to interface with a patient's anatomy. Such a second end portion of the integrated tube 200 of the predetermined length is a proximal end portion of the catheter tube 402 configured to interface with a treatment device or instrument.

[0057] Although some specific embodiments are disclosed herein, and the specific embodiments are disclosed in some detail, the specific embodiments are not intended to limit the scope of the concepts provided herein. Those skilled in the art will appreciate that additional adaptations and / or modifications may be made in the broader aspects, and these adaptations and / or modifications are also encompassed. Thus, deviations from the specific embodiments disclosed herein may be made without departing from the scope of the concepts provided herein.

Claims

1. A hot melt extruded integral tube, 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 integral 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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