Predictable textile structures for implantation
By designing textile structures with predictable lengths and tensions and incorporating markings for accurate cutting and attachment, the challenges of unpredictable implantable textile structures are addressed, enhancing surgical precision and patient safety.
Patent Information
- Application Number
- PCT/US2024/055824
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2023-11-17
- Filing Date
- 2024-11-14
- Publication Date
- 2025-05-22
AI Technical Summary
Current implantable textile structures, such as vascular conduits and grafts, have unpredictable lengths and stretchability, making it difficult for surgeons to estimate the optimal length and tension for implantation, leading to potential complications and the need for reoperation or replacement.
The development of textile structures with predictable post-implantation lengths and tensions, featuring a plurality of markings that allow for accurate cutting and attachment, ensuring the structure is implanted at the correct length and tension.
This solution enhances the consistency and accuracy of textile structure implantation, reducing the occurrence of complications related to improper tensioning and length, thereby minimizing the need for corrective surgeries and improving patient outcomes.
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Figure US2024055824_22052025_PF_FP_ABST
Abstract
Description
PREDICTABLE TEXTILE STRUCTURES FOR IMPLANTATIONCROSS-REFERENCE TO RELATED APPLICATION(S)
[0001] This application claims priority from U.S. Provisional Application No. 63 / 600,057, filed November 17, 2023, entitled “Predictable Textile Structures for Implantation”, the contents of which are incorporated by reference herein in its entirety.FIELD OF THE INVENTION
[0002] Example embodiments of the present invention generally relate to implantable textile structures, such as vascular conduits, grafts, and the like.BACKGROUND
[0003] Vascular conduits, grafts, and the like are often positioned in the human body. When implanting such structures, surgeons will often use structures with standard lengths and cut them down for the length needed for a particular patient. The structures are often configured such that, when implanted, they are stretched into place (e.g., tension from being attached to the native vessel or currently present structure likely causes some degree of stretch to occur). In this way, the structures have a first length before implantation and a second length after implantation. The length of such structures is important so that the structure is in an optimal tension within the body after implantation. In some cases, because of inconsistencies in strctch / cxpansion of the structures, the angles to position the structures, or other factors, surgeons have trouble estimating the needed length of the structure such that the tension of the implanted structure is optimal for the patient’s health. Because of these inconsistencies, even a surgeon’s best effort can lead to a structure being implanted with a tension that is not optimal for the patient’s health. This can lead to the structure having to be re-done and / or later replaced, which are undesirable results.
[0004] Further, currently used structures have unpredictable lengths. That is, the manufacturing techniques used today yield structures with varying lengths even when manufacturing is consistent. This creates further problems because the unpredictability of the lengths causes even greater unpredictability of the post-implantation realities and tensions of the structures, and the resultant variability of the post-implantation structures (e.g., leading to inconsistent post-implantation tensions) leads to errors in implantation.BRIEF SUMMARY
[0005] Embodiments of the present invention provide a medical breakthrough that enables consistent care - reducing reliance on the surgeon’s estimations and approximations. In the past, structures were different lengths, even when manufactured through the same process. Further, structures that were designed to be stretchable were, even when manufactured through the same process, stretchable to different degrees and tensions. Thus, it fell to the specific surgeon to look at the structure’s unique length, extensibility and the unique patient / implantation scenario and then estimate the desired length and tension of the structure. The surgeon would then manually pretension and cut the structure with scissors to the estimated desired length and tension. This was unpredictable because surgeons had no way to definitively gauge the expected length of the structure, much less the length of the structure at the required tension, which the surgeon estimated by merely looking at and / or stretching out the structure. Even if the surgeon were to use a ruler to measure the structure’ s length and the portion of the patient in which the structure needed to be implanted, problems would still arise because the structures all had different degrees of stretchability and planned tension during implantation. So, in many cases, a surgeon would implant a structure by estimating how far they thought it might stretch, and then would later find out that the tension of the structure was not optimal and was causing leaks or other consequences to the patient due to improper tensioning.
[0006] The present invention increases the consistency of implantation and procedures by providing a designed textile structure which removes the need for a surgeon to estimate a properly tensioned length of a textile structure when implanting the textile structure into a patient (e.g., cutting the textile structure at the proper length and / or attaching the textile structure at the proper position). Moreover, the present invention enables surgeons to be able to implant textile structures with confidence that the textile structures have a length that will achieve a proper tension. In embodiments in which textile structures are designed to stretch, the present invention enables surgeons to have confidence that the textile structures would stretch to predetermined lengths and appropriate tensions. This reduces the occurrence of textile structure implantation that have to later be replaced or adjusted because the length and tension was not estimated correctly when the textile structures were initially implanted. This may reduce surgery time, the need for corrective surgery, and / or the overall occurrences of post-implantation medical issues.
[0007] Some example embodiments of the present invention include a textile structure for implantation that has a predictable post-implantation length and an appropriate tension at that length. Further, in some embodiments, the textile structure includes a plurality of markings configured to assist a surgeon (or other user) in accurately measuring and cutting to length the textile structure and / or attaching at the proper position for implantation into, for example, a human body. For example, the current disclosure describes various textile structures, and processes for manufacturing various textile structures, that have at least a post-implantation length that is predictable. In some embodiments, a textile structure has a post-implantation length that corresponds to being in an expanded or pressurized state. Further, in some embodiments, a textile structure may have a plurality of markings on a body of the textile structure that define equivalent intervals (e.g., the spacing between consecutive intervals may be approximately equal) to enable accurate cutting and / or attachment. Notably, for structures that expand (e.g., between a relaxed length and an expanded length), the plurality of markings may be arranged so as to have equivalent intervals when in the expanded state, which allows the surgeon to be confident when cutting or attaching the structure - even when that occurs while the structure is in a relaxed state or a semi-relaxed state. Thus, the structure will be properly tensioned when implanted and pressurized with blood flow in the body.
[0008] In some embodiments, the interval corresponds to a real- world measurement interval for a length of the textile structure when it receives pressurized fluid therethrough (e.g., a length of the textile structure when it is in the expanded state at the correct tension). This allows for the surgeon (or other user) to measure the textile structure accurately and quickly such that the textile structure expands to the correct length and tension. As a specific example, a surgeon may need a textile structure that is 20 centimeters in length at an appropriate (e.g., optimal) tension. The surgeon may stretch a textile structure until markings on the textile structure are separated by 1 centimeter each, corresponding into a real-world measurement. In this regard, the surgeon may stretch the textile structure and make a cut at the 20th1 centimeter interval - which would cause the tubular body to equate to 20 real-world centimeters. Notably, however, when the textile structure is in the relaxed state, the real- world length of the relaxed textile structure (now cut) may only be 10 centimeters (and the intervals between markings may only be 0.5 centimeters). But, it will have a length of 20 centimeters at the proper tension (which is what thesurgeon was looking for) - and, in that state, the tubular body will have expanded in length 2x such that each intervals will be 1 centimeter each.
[0009] Some embodiments include textile structures with pluralities of markings that are configured to aid a surgeon (or other user) in estimating the textile structure length for implantation into, for example, a patient and / or for properly positioning the textile structure or portions thereof with respect to, for example, a medical device (e.g., another textile structure or other implanted medical device).
[0010] Some embodiments include processes and methods for manufacturing various textile structures described herein. Such processes and methods include, for example, weaving markings into a body of a textile structure during the forming of the body and / or applying markings to the body of the textile structure after the formation of the body. The processes and methods also, in some embodiments, include a crimp phase (which may be a part of the formation phase), a seal phase, and / or a test phase. The crimp phase may include applying crimps or other features to enable creation of a relaxed state, thereby introducing flexibility and aiding in the ability to change lengths. The seal phase may include sealing, for example, a tubular body to prevent fluid from flowing outwardly from within the tubular' body, and the test phase may include providing pressurized water or blood analog through the textile structure to test whether leaking will occur. In some embodiments, the test phase may be used to confirm the correct correspondence between the interval and the real world measurement interval, and correct tensioning at the expanded length, as described herein.
[0011] In an example embodiment, a textile structure for implantation is provided. The textile structure comprises a body that is transitionable between a relaxed state having a first length and an expanded state having a predetermined second length, where the second length is greater than the first length. The second length of the body in the expanded state is predictable such that the body can be accurately cut or attached for implantation at an appropriate tension.
[0012] In some embodiments, the body comprises a plurality of markings, wherein each of the plurality of markings are formed onto or into the body during manufacturing in a manner where, when the body is in the expanded state, consecutive ones of the plurality of markings are separated by equivalent intervals so as to enable accurate cutting or attaching of the textile structure for an intended implantation in which the textile structure will be in the expanded state. In some embodiments, the plurality of markings are sewn into the body. In some embodiments,the plurality of markings are woven, knitted, or braided into the body during a manufacturing of the body. In some embodiments, the plurality of markings arc added to the body after a manufacturing of the body. In some embodiments, the plurality of markings are stitched onto an outside surface of the body. In some embodiments, the plurality of markings are printed onto an outside surface of the body. In some embodiments, the plurality of markings are imprinted into an outside surface of the body.
[0013] In some embodiments, the plurality of markings are formed using at least one of radiopaque material or fluorescent material.
[0014] In some embodiments, the body is crimped in the relaxed state. In some embodiments, the body is smoother in the expanded state than in the relaxed state.
[0015] In some embodiments, the body is cylindrical.
[0016] In some embodiments, a diameter of the body is less than 50 millimeters.
[0017] In some embodiments, a change in length of the body from the relaxed state to the expanded state is at least 100 percent.
[0018] In some embodiments, a change in length of the body from the relaxed state to the expanded state is at least 50 percent.
[0019] In some embodiments, a change in length of the body from the relaxed state to the expanded state is within a range of 50 percent to 75 percent.
[0020] In some embodiments, the body is comprised of a medical fabric. In some embodiments, the medical fabric includes at least one of polytetrafluoroethylene or polyethylene terephthalate or other polymer. In some embodiments, the medical fabric includes at least some radiopaque material or some fluorescent material.
[0021] In some embodiments, the textile structure is fully sealed to prevent fluid from flowing outwardly from within the body.
[0022] In some embodiments, the textile structure is comprised of at least one synthetic material.
[0023] In some embodiments, the textile structure consists of synthetic materials.
[0024] In another example embodiment, a method of manufacturing a textile structure for implantation is provided. The method comprises constructing a body that is transitionable between a relaxed state having a first length and an expanded state having a predetermined second length, where the second length is greater than the first length. The second length of thebody in the expanded state is predictable such that the body can be accurately cut or attached for implantation at an appropriate tension.
[0025] In some embodiments, the method further comprises forming a plurality of markings on or in the body such that when the body is in the expanded state, consecutive ones of the plurality of markings are separated by equivalent intervals so as to enable accurate cutting or attaching of the textile structure for an intended implantation in which the textile structure will be in the expanded state. In some embodiments, constructing the body and forming the plurality of markings occur simultaneously. In some embodiments, forming the plurality of markings comprises at least one of stitching, printing, imprinting, weaving, knitting, or braiding the plurality of markings. In some embodiments, forming the body comprises at least one of weaving or sewing. In some embodiments, the method further comprises fully sealing the textile structure to prevent fluid from flowing outwardly from the body.
[0026] In yet another example embodiment, a textile structure for implantation is formed by the process of constructing a body that is transitionable between a relaxed state having a first length and an expanded state having a predetermined second length, wherein the second length is greater than the first length. The expanded state corresponds to an expected length of the textile structure when implanted in a human body. The second length of the body in the expanded state is predictable such that the body can be accurately cut or attached for implantation at an appropriate tension.
[0027] In some embodiments, the process further comprises forming a plurality of markings on or in the body such that when the body is in the expanded state, consecutive ones of the plurality of markings are separated by equivalent intervals so as to enable accurate cutting or attaching of the textile structure for an intended implantation in which the textile structure will be in the expanded state.
[0028] In yet another example embodiment, a textile structure for implantation is provided. The textile structure comprises a body comprising a plurality of markings, wherein each of the plurality of markings are integrally formed into the body during manufacturing in a manner where consecutive ones of the plurality of markings are separated by equivalent intervals so as to enable accurate cutting or attaching of the textile structure for relative positioning of the textile structure for an intended implantation.
[0029] In some embodiments, the body is cylindrical.
[0030] In some embodiments, the plurality of markings are sewn into the body.
[0031] In some embodiments, the plurality of markings arc woven, knitted, or braided into the body during a manufacturing of the body.
[0032] In some embodiments, the plurality of markings are added to the body after a manufacturing of the tubular body.
[0033] In some embodiments, the plurality of markings are stitched onto an outside surface of the body.
[0034] In some embodiments, the plurality of markings are formed using at least one of radiopaque material or fluorescent material.
[0035] In some embodiments, the body is comprised of a medical fabric. In some embodiments, the medical fabric includes at least one of polytetrafluoroethylene or polyethylene terephthalate or other polymer. In some embodiments, the medical fabric includes at least some radiopaque material or some fluorescent material.
[0036] In some embodiments, a diameter of the body is less than 50 millimeters.
[0037] In some embodiments, the textile structure is fully sealed to prevent fluid from flowing outwardly from within the body.
[0038] In yet another example embodiment, a method of manufacturing a textile structure for implantation is provided. The method comprises constructing a body; and forming a plurality of markings integrally on or in the body such that consecutive ones of the plurality of markings are separated by equivalent intervals so as to enable accurate cutting or attaching of the textile structure for relative positioning of the textile structure for an intended implantation.
[0039] In some embodiments, forming the body comprises at least one of weaving or sewing.
[0040] In some embodiments, constructing the body and forming the plurality of markings occur simultaneously.
[0041] In some embodiments, forming the plurality of markings comprises at least one of stitching, printing, imprinting, weaving, knitting, or braiding the plurality of markings.
[0042] In some embodiments, the method further comprises fully sealing the textile structure to prevent fluid from flowing outwardly from the body.
[0043] In yet another example embodiment, a textile structure for implantation is formed by the process of constructing a body; and forming a plurality of markings integrally on or in the body such that consecutive ones of the plurality of markings are separated by equivalent intervalsso as to enable accurate or attaching cutting of the textile structure for relative positioning of the textile structure for an intended implantation.
[0044] In some embodiments, constructing the body comprises at least one of weaving or sewing.
[0045] In some embodiments, constructing the body and forming the plurality of markings occur simultaneously.
[0046] In some embodiments, forming the plurality of markings comprises at least one of stitching, printing, imprinting, weaving, knitting, or braiding the plurality of markings.
[0047] In some embodiments, the process further comprises fully sealing the textile structure to prevent fluid from flowing outwardly from the body.BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)
[0048] Having thus described the invention in general terms, reference will now be made to the accompanying drawings, which are not necessarily drawn to scale, and wherein:
[0049] FIG. 1A illustrates an example conduit with a plurality of markings, in accordance with some embodiments discussed herein;
[0050] FIG. IB illustrates an example flat graft with a plurality of markings, the flat graft being positioned with respect to another medical device, in accordance with some embodiments discussed herein;
[0051] FIG. 1C illustrates another example flat graft with a plurality of markings, the flat graft having no crimps, in accordance with some embodiments discussed herein;
[0052] FIG. ID illustrates another example flat graft with a plurality of markings, the flat graft having no crimps, in accordance with some embodiments discussed herein;
[0053] FIG. IE illustrates another example conduit with a plurality of markings, the conduit having crimps, in accordance with some embodiments discussed herein;
[0054] FIG. IF illustrates another example conduit with a plurality of markings, the conduit having crimps, in accordance with some embodiments discussed herein;
[0055] FIG. 2A illustrates an example conduit in a relaxed state, in accordance with some embodiments discussed herein;
[0056] FIG. 2B illustrates the example conduit of FIG. 2A in an expanded state, in accordance with some embodiments discussed herein;
[0057] FIG. 3 A shows an example conduit with a kink, in accordance with some embodiments discussed herein;
[0058] FIG. 3B shows a graph illustrating example pull forces on a theoretical attached native blood vessel or currently implanted structure, based on length expansion percentages relative to a designed pressurized length for various example textile structures;
[0059] FIG. 4A illustrates an example conduit with a plurality of markings, the conduit being in a relaxed state and laying overtop a ruler, in accordance with some embodiments discussed herein;
[0060] FIG. 4B illustrates a zoomed in view of the example conduit of FIG. 4A, the conduit being in an expanded state, in accordance with some embodiments discussed herein;
[0061] FIG. 4C illustrates another example conduit with a plurality of markings, the conduit being in a relaxed state and laying overtop a ruler, in accordance with some embodiments discussed herein;
[0062] FIG. 4D illustrates a zoomed in view of the example conduit of FIG. 4C, the conduit being in an expanded state, in accordance with some embodiments discussed herein;
[0063] FIG. 5A is a block diagram of an example process for manufacturing a textile structure with a plurality of markings, in accordance with some embodiments discussed herein;
[0064] FIG. 5B is the block diagram of FIG. 5A with an additional crimper component, in accordance with some embodiments discussed herein;
[0065] FIG. 6A shows an example flat graft with a plurality of markings knit or woven into it, in accordance with some embodiments discussed herein;
[0066] FIG. 6B illustrates a zoomed-in view of another example flat graft with a plurality of markings knit in, in accordance with some embodiments discussed herein;
[0067] FIG. 7 illustrates an example conduit disposed between a water inlet and a water outlet for leak testing, in accordance with some embodiments discussed herein;
[0068] FIG. 8A is a block diagram of another example process for manufacturing a conduit with a plurality of markings, in accordance with some embodiments discussed herein;
[0069] FIG. 8B is the block diagram of FIG. 8A with an additional crimper component, in accordance with some embodiments discussed herein; and
[0070] FIG. 9 shows an example textile structure with a plurality of markings applied onto it, in accordance with some embodiments discussed herein.DETAILED DESCRIPTION
[0071] Some example embodiments now will be described more fully hereinafter with reference to the accompanying drawings, in which some, but not all example embodiments are shown. Indeed, the examples described and pictured herein should not be construed as being limiting as to the scope, applicability or configuration of the present disclosure. Rather, these example embodiments are provided so that this disclosure will satisfy applicable legal requirements. Like reference numerals refer to like elements throughout.
[0072] Textile structures (e.g., vascular grafts, blood carrying conduits, conduits used with left ventricular assist devices (LVADs), etc.) are often used for implantation into a body in instances in which, for example, a blood vessel needs repairing. When such textile structures are implanted, the length and the tension of the textile structure are important and are usually unique for the procedure. For example, a textile structure that is a conduit needs to have a length and a tension so that when the implantation is complete, the conduit acts as an organic blood vessel would act in allowing blood to freely flow therethrough. When a conduit is too long, the conduit may sag and / or fall into a kink (e.g., as shown in FIG. 3 A) and disrupt the flow of fluid therethrough. This can be unpredictable as well as difficult to fix. On the other hand, when a conduit is too short, the native tissue connected to the conduit will experience too much tension that can leave the connection or the native tissue itself prone to tears and leaks. This too can be unpredictable as well as difficult to fix.
[0073] It should be appreciated that the term “textile structure” is used herein to refer collectively to textile structures such as conduits, flat grafts, and non-flat grafts, among others.
[0074] Various example textile structures are manufactured with crimps that allow the textile structure to move between a relaxed state and an expanded state. Such example textile structures rest in the relaxed state prior to implantation and are stretched into the expanded state during implantation. For example, the expanded state may represent expansion and / or elongation according to a force that blood or fluid exerts against a tubular wall or a force that a tissue exerts against a textile structure after implantation. The textile structure is designed to remain in the expanded state (or a semi-expanded state) after implantation to achieve a desired tension. It is important for the textile structure to be cut correctly such that, when the textile structure is stretched into the expanded state, it is the exact right length to fit between the portions of the, e.g., blood vessel or tissue being repaired at the desired tension.
[0075] In this regard, it is important for a textile structure to have a predictable length at a desired tension and to be able to be cut to a correct length such that, when the textile structure is implanted, it is the exact right length to fit between the desired elements (e.g., between the blood vessel elements being repaired and / or between other textile structure elements being implanted) at the desired tension. As mentioned, if the textile structure is cut too short, the connecting points will be strained and cause problems (e.g., leaks and / or tears in the connection or the native tissue). If the textile structure is cut too long, the textile structure may sag and / or kink and disrupt the flow of fluid therethrough. To help illustrate this, example textile structures of differing diameters, each in the form of an unsealed graft, were tested by measuring the pull force generated by the grafts when at (i) an oversized (undertensioned) length, (ii) an optimal tensioned length, and (iii) an undersized (overtensioned) length. Notably, the corresponding pull force would equate to the pull force experienced by the native tissue on which the graft was implanted / attached. The results of these tests are shown in TABLE 1 below. Additionally, with reference to FIG. 3B, a graph 900 shows the normalized force of each of the three tested grafts at the different lengths. Notably, there is a significant increase in the pull force (e.g., on the attached tissue) when the graft is undersized and overtensioned (e.g., when the graft was cut too short and is being stretched during implantation). In contrast, there is much less force when the graft is oversized and undertensioned - which, as noted above, may lead to kinks, etc. in the connection and / or native tissue.TABLE 1
[0076] The current disclosure describes textile structures that have predictable postimplantation lengths and appropriate tensions and that, in some embodiments, include a plurality of markings that are scaled to aid a surgeon (or other user) in accurately cutting the textile structure before implantation.
[0077] FIG. 1 A illustrates an example conduit 100. The conduit 100 includes a tubular body 102, which may or may not be crimped. In some embodiments, the tubular body 102 may be cylindrical. In some embodiments, the tubular body 102 may be comprised of, or may consist of, synthetic material(s). In some embodiments, the tubular body 102 may be comprised of a medical fabric such as polytetrafluoroethylene and / or polyethylene terephthalate. In some embodiments, the medical fabric and / or synthetic material may be crimped and may enable for a consistent expansion and retraction of the material such as between a relaxed state and an expanded state. In some embodiments, the tubular body 102 may be comprised of a medical fabric that includes one or more materials that have properties designed to appear in imagery such as produced using an X-ray machine, a magnetic resonance imaging (MRI) machine, or a computed tomography (CT) machine. For example, the tubular- body 102 may include at least some radiopaque and / or fluorescent material. This may allow for a surgeon or technician to image a patient after the conduit 100 has been implanted to check the placement and / or effectiveness of the conduit 100, which would enable the surgeon or technician to make an informed decision as to whether the conduit 100 needs to be surgically altered or replaced. Further, in some other embodiments, the tubular body 102 may be comprised of any other type of material.
[0078] In some embodiments, the tubular body 102 may be designed such that the tubular body 102 is transitionable between a relaxed state and an expanded state corresponding to an expected length of the conduit 100 when implanted in a human body with fluid running therethrough. In some embodiments, in the expanded state, the crimps may be stretched to a point where a surface of the tubular body 102 is smooth. In other embodiments, in the expanded state, the crimps may be stretched to a point where a surface of the tubular body 102 is less crimped. In some embodiments, the tubular body 102 may be capable of returning back to the relaxed state after moving from the relaxed state to the expanded state (e.g., during testing). The tubular body 102 includes a plurality of markings 104a, 104b, 104c, 104d, 104e, 104f, 104g, 104h, 104i, 104j, 104k, 1041, 104m, 104n, 104o, 104p, 104q, 104r, 104s, and 104t. Each of the markings may be formed onto or into the tubular body 102 during or after manufacturing in a manner such that, when the tubular- body 102 is in the expanded state, consecutive ones of the plurality of markings are separated by equivalent intervals so as to enable accurate cutting and / or attaching of the conduit 100 for an intended implantation, such as in which the conduit100 will be in the expanded state (if the conduit 100 is designed to be expanded). This configuration enables a user to accurately cut the conduit 100 so that the conduit will be an appropriate length and tension when it is implanted. The plurality of markings 104a, 104b, 104c, 104d, 104e, 104f, 104g, 104h, 104i, 104j, 104k, 1041, 104m, 104n, 104o, 104p, 104q, 104r, 104s, and 104t may become consistent with real-world length values of the conduit 100 when the conduit 100 is stretched to a desired tension. Further, the interval and the plurality of markings 104a, 104b, 104c, 104d, 104e, 104f, 104g, 104h, 104i, 104j, 104k, 1041, 104m, 104n, 104o, 104p, 104q, 104r, 104s, and 104t may be predetermined such that the conduit 100 maintains the desired tension when the conduit 100 is in the expanded state.
[0079] For example, still referring to FIG. 1A, the markings may represent predetermined measurements in millimeters, centimeters, or any other unit. That is, the markings 104a and 104b in FIG. 1 A may be spaced apart by an interval that is 1 centimeter. In the circumstance when the conduit 100 is designed to be transitionable between a relaxed state and an expanded state (with different lengths), the space between the markings 104a and 104b may be shorter (e.g., less than 1 centimeter) in the relaxed state and longer (e.g., greater than 1 centimeter) in the expanded state. In some embodiments, continuing the example, the conduit 100 may also include a label adjacent to the marking 104a (e.g., indicating 1 centimeter) and a label adjacent to the marking 104b (e.g., indicating 2 centimeters). This allows the user to cut the conduit 100, e.g., at the marking 104b with the intention that the conduit 100 will be, for example, 2 centimeters in length once it is stretched into the expanded state. It should be appreciated that the expansion may be any other percentage within the scope of this disclosure. For example, the conduit 100 may be configured with markings representing any other lengths and may be configured to expand from the relaxed state to the expanded state at any percentage (e.g., 10 percent expansion, 20 percent expansion, 50 percent expansion, 100 percent expansion, greater than 100 percent expansion, or less than 10 percent expansion) and within any range of percentages (e.g., 10 percent - 100 percent, 25 percent - 100 percent, 50 percent - 100 percent, 75 percent - 100 percent, 25 percent - 75 percent, 50 percent - 75 percent, 10 percent - 200 percent, 10 percent - 300 percent). In some embodiments, the textile structure is formed to have a predictable nature of the expansion from the relaxed state to the expanded state that enables a change in length of the body within a range of 53 percent to 70 percent. In some embodiments, corresponding marking placement can be utilized such as described herein.
[0080] In some embodiments, the tubular body may have more markings than that shown in FIG. 1 A, and in other embodiments, the tubular body may have less markings. Further, in some embodiments, the markings may be spaced further apart than the markings shown in FIG. 1A, and, alternatively, in some embodiments, the markings may be spaced closer together along a length of the tubular’ body 102. The tubular body may be of any diameter, and the diameter may be varying or constant. For example, in some embodiments, the diameter of the tubular body may be less than 50 millimeters. In other embodiments, however, the diameter may be any other value.
[0081] For example, in some embodiments, the markings along the tubular body 102 may be configured differently so that a different result is achieved. That is, while some conduits may have markings spaced to aid a user in implanting the conduit to have a certain desired length and appropriate tension in an expanded state, some other conduits may have markings configured to aid a user in implanting the conduit to have a certain desired length and appropriate tension at any other state. Or, in some other embodiments, the conduit may not have crimps at all, and the markings may be configured to aid a user in implanting the conduit to have a certain desired length and appropriate tension in a neutral state.
[0082] Notably, the expansion is predictable such that the length of the conduit 100 in the expanded state, as shown in FIG. 1A, is a predetermined length. That is, a plurality of conduits manufactured in the same way as conduit 100 would have the same length in the expanded state as the conduit 100. This is important because many conduits manufactured today have inconsistent lengths even when manufactured through the same process, and as such, the conduits manufactured today would not be able to be implanted correctly even if a plurality of markings were disposed thereon. For example, in some of the embodiments disclosed herein, the tubular body 102 may be formed to have a pre-determined length in the expanded state. The predetermined length of the tubular body 102 in the expanded state may be predictable such that the tubular body 102 can be accurately cut to length and implanted at a desired tension.
[0083] FIG. IB illustrates an example textile structure 200 that includes a body 202 (e.g., a Hat body). The body 202 may or may not be crimped and may be any shape. For example, the body 202 may be a nontubular body in some embodiments and may be a tubular embodiment in other embodiments. For example, in some embodiments, the body 202 may be cylindrical, but in other embodiments, the body 202 may be a rectangular sheet of material, as shown, or any othershape. As another example, the body may have a first portion that is crimped and a second portion that is not crimped in the relaxed state. In some embodiments, the body 202 may be comprised of a medical fabric such as polypropylene, polytetrafluoroethylene and / or polyethylene terephthalate. Additionally or alternatively, in some embodiments, the body 202 may be comprised of a medical fabric that includes one or more materials that have properties designed to appear in imagery such as an X-ray, an MRI, or a CT-scan. For example, the body 202 may include at least some radiopaque and / or fluorescent material. This may allow for a surgeon or technician to image a patient after the textile structure 200 has been implanted to check the placement and / or effectiveness of the textile structure 200, which would enable the surgeon or technician to make an informed decision as to whether the textile structure 200 needs to be surgically altered or replaced. Additionally or alternatively, in some embodiments, the body 202 may be comprised of any other type of material. The body 202 may include a plurality of markings 204a, 204b, 204c, 204d, 204e, 204f, 204g, 204h, 204i, 204j, 204k, and 2041. The markings may additionally or alternatively be formed using radiopaque and / or fluorescent material such that the markings themselves appear in medical imaging after implantation. For example, a first portion of markings may be formed using radiopaque and / or fluorescent material, and a second portion of markings may be formed using material that is viewable in a normal (e.g., surgical) environment. This may enable a surgeon to correctly tension (or evaluate) the textile structure 200 in both visual surgical conditions and in medical imaging conditions. As another example, all of the markings may be formed using radiopaque and / or fluorescent material. The markings may be integrally formed into the body 102 during manufacturing in a manner where consecutive ones of the markings are separated by an interval. The interval may be determined for the body 102 so as to enable accurate cutting and / or attaching of the textile structure 200 for relative positioning of the textile structure 200 for an intended implantation. Moreover, this configuration enables a user to accurately cut and / or attach the textile structure 200 when it is placed in a desired position, such as within the opening 208 of the object 206, so that the textile structure 200 will be an appropriate length and / or shape and / or be in an appropriate position when it is implanted. The object 206 may be any object. For example, the object 206 may be another textile structure, a piece of metal, or even a body part such as tissue or bone. Other objects are also contemplated.
[0084] As mentioned, textile structures described herein may take on any shape, size, or length. As an example, FIG. 1C shows a textile structure 210 with an uncrimpcd body 212. Either disposed on or incorporated within the body 212 are a first marking 214a, a second marking 214b, a third marking 214c, a fourth marking 214d, a fifth marking 214e, a sixth marking 214f, and a seventh marking 214g. Also disposed on or incorporated within the body 212 is a surgical line 216, which may be optional. The textile structure 210 has a diameter DI. As another example, FIG. ID shows a textile structure 218 with an uncrimped body 220. Either disposed on or incorporated within the body 220 are a first marking 222a, a second marking 222b, a third marking 222c, a fourth marking 222d, a fifth marking 222e, a sixth marking 222f, and a seventh marking 222g. Also disposed on or incorporated within the body 220 is a surgical line 224, which may be optional. The textile structure 218 has a diameter D2. As shown, the diameter DI of the textile structure 210 is smaller than the diameter D2 of the textile structure 218. It should be appreciated that the diameters DI and D2 may be any value. For example, the diameter DI may be 10 millimeters, and the diameter D2 may be 20 millimeters. Other values are also contemplated.
[0085] As another example, FIG. IE shows a conduit 226 with a crimped body 228. Either disposed on or incorporated within the body 228 are a first marking 230a, a second marking 230b, a third marking 230c, a fourth marking 230d, a fifth marking 230e, a sixth marking 230f, a seventh marking 230g, an eighth marking 230h, and a ninth marking 230i. Also disposed on or incorporated within the body 228 is a surgical line 232, which may be optional. The conduit 226 has a diameter D3. As another example, FIG. IF shows a conduit 234 with a crimped body 236. Either disposed on or incorporated within the body 236 are a first marking 238a, a second marking 238b, a third marking 238c, a fourth marking 238d, a fifth marking 238e, a sixth marking 238f, a seventh marking 238g, and an eighth marking 238h. Also disposed on or incorporated within the body 236 is a surgical line 240, which may be optional. The conduit 234 has a diameter D4. As shown, the diameter D3 of the conduit 226 is smaller than the diameter D4 of the conduit 234. It should be appreciated that the diameters D3 and D4 may be any value. For example, the diameter D3 may be 10 millimeters, and the diameter D4 may be 20 millimeters. Other values are also contemplated. Notably, while the markings appear consistently spaced by a same interval in FIGs. IE and IF, in some cases, the spacing in the relaxed state (e.g., the crimps are not expanded) may be inconsistent between consecutive markings. In this regard, in somecases, the markings may be applied prior to application of the crimps and reduction of the length (c.g., due to application of the crimps). Since the crimps introduce bumps and changes in the surface, this may cause inconsistency in the spacing of the already applied markings. Notably, however, as detailed herein the markings may be otherwise applied relative to crimping (e.g., after crimping, to account for crimping, etc.).
[0086] FIG. 2A illustrates an example conduit 110 in a relaxed state with a pre-implantation length LI . The conduit 110 has a first end 114 and a second end 116. As shown in FIG. 2A, the conduit 110 has crimps 112 in the relaxed state. FIG. 2B illustrates the conduit 110 in an expanded state. A user may, for example, grab the first end 114 of the conduit 110 and the second end 116 of the conduit 110 and pull the first end 114 and the second end 116 apart to move the conduit 110 from the relaxed state shown in FIG. 2A to the expanded state shown in FIG. 2B. In some embodiments, the conduit 110 may be stretched and then implanted in a way such that the conduit remains in the expanded state (or a semi-expanded state) after the implantation has been completed. In the embodiment shown in FIGs. 2A-2B, the conduit 110 has been expanded from the length LI to a length L2, and when in the expanded state, the conduit 110 no longer has crimps 112. The predictability of the length L2 allows for a plurality of markings, such as those described above with respect to FIG. 1A, to be integrated into or disposed onto the conduit 110 in a way that enables greater accuracy of estimating length for implantation. In some embodiments, the change in length from the length LI to the length L2 may be approximately 50 percent. Further, in some embodiments, the change in length from the length LI to the length L2 may be more than 50 percent. In other embodiments, the change in length from the length LI to the length L2 may be any other value, such as less than 50 percent. For example, the change in length from the length LI to the length L2 may be between 45 percent and 55 percent, between 40 percent and 60 percent, between 35 percent and 65 percent, between 0 percent and 5 percent, between 0 percent and 20 percent, between 20 percent and 35 percent, between 60 and 80 percent, between 80 percent and 100 percent, above 100 percent, or any other percent.
[0087] FIG. 3 A shows an example tubular body 122 that has been implanted within a first portion 123 and a second portion 125 of a blood vessel 120. In the embodiment shown in FIG. 3 A, the tubular body 122 has been implanted incorrectly such that a kink 124 has formed. That is, the tubular body 122 was estimated incorrectly before implantation, so it is too long (e.g.,having an incorrect tension) in the implanted state. Since the tubular body 122 is too long, it sags and forms the kink 124. The kink 124 can disrupt the flow of pressurized fluid (c.g., blood) therein and cause problems with the patient.
[0088] FIG. 4A illustrates an example conduit 130 laying on top of a ruler 136. The conduit 130 has a diameter of 6 millimeters. In FIG. 4A, the conduit 130 is in a relaxed state. The conduit 130 includes a plurality of markings 132. For example, the plurality of markings 132 include a first marking 132a, a second marking 132b, a third marking 132c, a fourth marking 132d, a fifth marking 132e, a sixth marking 132f, a seventh marking 132g, an eighth marking 132h, a ninth marking 132i, a tenth marking 132j, an eleventh marking 132k, a twelfth marking 1321, a thirteenth marking 132m, a fourteenth marking 132n, and a fifteenth marking 132o. The ruler 136 includes a plurality of labels 131 representing real-world measurements. For example, the plurality of labels 131 include a first label 131a indicating 0 centimeters, a second label 131b indicating 1 centimeter, a third label 131c indicating 2 centimeters, a fourth label 13 Id indicating 3 centimeters, a fifth label 131e indicating 4 centimeters, a sixth label 13 If indicating 5 centimeters, a seventh label 131g indicating 6 centimeters, an eighth label 13 lh indicating 7 centimeters, a ninth label 13 li indicating 8 centimeters, and a tenth label 13 Ij indicating 9 centimeters.
[0089] In the relaxed state, the plurality of markings 132 are separated by intervals that are not equal to the intervals represented by the plurality of labels 131 on the ruler 136. For example, as shown in FIG. 4 A, there are fourteen of the plurality of markings 132 between the first label 131a and the tenth label 13 Ij .
[0090] FIG. 4B illustrates a zoomed in view of the example conduit 130 laying on top of the ruler 136. In FIG. 4B, the conduit 130 is in an expanded state. As shown, the conduit 130 has been expanded to a desired tension such that the intervals between the plurality of markings 132 correspond to the intervals between the plurality of labels 131, which represent real-world measurements in centimeters. For example, although not shown, the conduit 130 may be tensioned such that the first marking 132a lines up with the first label 131a, the second marking 132b lines up with the second label 131b, the third marking 132c lines up with the third label 131c, and the fourth marking 132d lines up with the fourth label 13 Id. Further, as shown in the zoomed in view of FIG. 4B, the fifth marking 132e lines up with the fifth label 13 le, the sixth marking 132f lines up with the sixth label 13 If, the seventh marking 132g lines up with theseventh label 131g, the eighth marking 132h lines up with the eighth label 131 h, the ninth marking 132i lines up with the ninth label 13 li, and so on.
[0091] This configuration in which the conduit 130 is made to expand to have intervals between its plurality of markings 132 that correspond to real-world measurement intervals between the plurality of labels 131 on the ruler 136 when the conduit 130 is in the expanded state corresponds to the tension level the conduit 130 is designed to undergo when implanted in the user with blood flowing therethrough. Thus, by a user pre-tensioning the conduit 130 to align the markings with the labels (as shown in FIG. 4B), the user may accurately understand the proper marking to utilize for cutting the conduit 130 for an intended implantation in which the conduit 130 will be in the expanded state. For example, upon pre-tensioning the conduit 130 to the expanded state in FIG. 4B, the user may now realize that they need to cut the conduit at or in proximity to marking 132h in order of the conduit 130 to have an anticipated implantation length of 7 cm. The conduit 130 can thus be easily implanted at an exact desired tension. Cuts can be made when the conduit 130 is in the relaxed state, when the conduit 130 is in the expanded state, or when the conduit 130 is anywhere in between the relaxed state and the expanded state.
[0092] FIG. 4C illustrates another example conduit 133 laying on top of a ruler 137. The conduit 133 has a diameter of 22 millimeters. In FIG. 4C, the conduit 133 is in a relaxed state. The conduit 133 includes a plurality of markings 134. For example, the plurality of markings 134 include a first marking 134a, a second marking 134b, a third marking 134c, a fourth marking 134d, a fifth marking 134e, a sixth marking 134f, a seventh marking 134g, an eighth marking 134h, a ninth marking 134i, a tenth marking 134j, an eleventh marking 134k, a twelfth marking 1341, a thirteenth marking 134m, a fourteenth marking 134n, and a fifteenth marking 134o. The ruler 137 includes a plurality of labels 135 representing real-world measurements. For example, the plurality of labels 135 include a first label 135a indicating 0 centimeters, a second label 135b indicating 1 centimeter, a third label 135c indicating 2 centimeters, a fourth label 135d indicating 3 centimeters, a fifth label 135e indicating 4 centimeters, a sixth label 135f indicating 5 centimeters, a seventh label 135g indicating 6 centimeters, and an eighth label 135h indicating 7 centimeters.
[0093] In the relaxed state, the plurality of markings 134 are separated by intervals that are not equal to the intervals represented by the plurality of labels 135 on the ruler 137. For example,as shown in FTG. 4C, there are fourteen of the plurality of markings 134 between the first label 135a and the eighth label 135h.
[0094] FIG. 4D illustrates a zoomed in view of the example conduit 133 laying on top of the ruler 137. In FIG. 4D, the conduit 133 is in an expanded state. As shown, the conduit 133 has been expanded to a desired tension such that the intervals between the plurality of markings 134 correspond to the intervals between the plurality of labels 135, which represent real-world measurements in centimeters. For example, although not shown, the conduit 133 may be tensioned such that the first marking 134a lines up with the first label 135a, the second marking 134b lines up with the second label 135b, the third marking 134c lines up with the third label 135c, and the fourth marking 134d lines up with the fourth label 135d. Further, as shown in the zoomed in view of FIG. 4D, the fifth marking 134e lines up with the fifth label 135e, the sixth marking 134f lines up with the sixth label 135f, the seventh marking 134g lines up with the seventh label 135g, the eighth marking 134h lines up with the eighth label 135h, the ninth marking 134i lines up with the ninth label 135i, and so on.
[0095] As with conduit 130 in FIGs. 4A-B, this configuration in which the conduit 133 is made to expand to have intervals between its plurality of markings 134 that correspond to real- world measurement intervals between the plurality of labels 135 on the ruler 137 when the conduit 133 is in the expanded state enables accurate cutting and / or attaching of the conduit 133 for an intended implantation in which the conduit 133 will be in the expanded state. The conduit 133 can thus be easily implanted at an exact desired tension. Cuts can be made when the conduit 133 is in the relaxed state, when the conduit 133 is in the expanded state, or when the conduit 133 is anywhere in between the relaxed state and the expanded state.
[0096] A surgeon may use a ruler such as shown in FIGs. 4A-4D to achieve a desired tension of a textile structure in various ways. For example, in one approach, a surgeon may calibrate a desired tension to be placed on a textile structure by expanding the textile structure overtop a ruler such that markings on the textile structure align with the labels on the ruler, and then the surgeon may move the textile structure to the patient and simulate the same calculated desired tension before cutting or attaching the textile structure to the desired length (e.g., utilizing the appropriate marking). In another approach, a surgeon may first determine a real- world measurement of a portion of the patient in which a textile structure needs to be implanted, and then the surgeon may choose the label on the ruler that corresponds to that real-worldmeasurement to determine the corresponding marking on the textile structure for where to cut or attach / position accordingly. Other approaches arc also contemplated within the scope of this disclosure.
[0097] It should be appreciated that, although the embodiments shown and discussed with respect to FIGs. 4A-4D are in units of centimeters, any other scale of measurement may be used within the scope of this disclosure (e.g., micrometers, millimeters, inches, feet, or any other unit of measurement). For example, the plurality of labels and / or the plurality of markings may be further apart or closer together (and may or may not be labeled accordingly). Further, the plurality of labels and / or the plurality of markings may be numbered (as are the plurality of labels in FIGs. 4A-4D), the plurality of labels and / or the plurality of markings may be color coded, the plurality of labels and / or the plurality of markings may be simply marked (as are the plurality of markings in FIGs. 4A-4D), or any other system may be used. In some embodiments, the system(s) may additionally or alternatively include different yarn colors or different percentage colorants. Further, markings may be included on only a portion of a conduit (e.g., only on one side or in a portion of a middle of the conduit), and only that portion may be usable to achieve a certain tension of the conduit. In this regal’d, any marking method may be used.
[0098] FIG. 5A is a block diagram showing a process 140 for manufacturing a textile structure for implantation. The process 140 comprises a textile structure formation phase 141, a seal phase 146, and a test phase 149. In the embodiment shown in FIG. 5A, the textile structure formation phase 141 has a thread supply 142 and a marker supply 143 that both feed into a textile structure former 144. For example, the textile structure former 144 may be a machine configured to weave threads together. Specifically, in some embodiments, the textile structure former 144 may be a machine configured to weave a first plurality of threads from the thread supply 142 into a body and then, during the weaving of the first plurality of threads, weave a second plurality of threads from the marker supply 143 to create a plurality of markings within the body such that the plurality of markings are woven into the body. For example, in some embodiments, the first plurality of threads may include both warp and weft threads, and the second plurality of threads may include additional or substitute weft threads. In other embodiments, the plurality of markings may be pre-dyed or pre-configured into the weft threads that are used to form the textile structure (e.g., the second plurality of threads may be the weft threads, but portions of the weft threads corresponding specifically to the markings may be dyedor otherwise differentiable to provide the markings when the textile structure is formed). Other configurations arc also contemplated. The cutter 145 may then be used to cut the body from the textile structure former 144. The cutter 145 may be optional, though, depending on the type of textile structure former 144 used. Alternatively, the cutter 145 may be integrated into the textile structure former 145 (e.g., the textile structure former 144 may include the cutter 145 in the same mechanism).
[0099] In some embodiments, the textile structure former 144 and / or the cutter 145 may be further configured to tuck, remove, or otherwise hide extraneous threads into / from the body that is formed such that there are no extraneous threads to be dealt with after the textile structure formation phase 141. Additionally or alternatively, another mechanism may be incorporated within the textile structure formation phase 141 to accomplish such.
[0100] Referring now to FIG. 5B, in some embodiments, the textile structure formation phase 141 may include a crimper 152 that may be used either after the cutter 145 is used or at any other position within the process 140. In some embodiments, a textile structure may be formed with the textile structure former 144, and while the textile structure is being formed, the plurality of markings may be incorporated therewithin. The plurality of markings may be precalculated and spaced apart along the textile structure before the crimper 152 is used so that, once the crimper 152 is used to crimp the textile structure and then the textile structure is transitioned to the expanded state, the plurality of markings represents real world interval values that correspond to the desired tension of the textile structure when it is implanted. In other embodiments, the crimper 152 may be positioned before the cutter 145 or positioned at any other place throughout the process 140.
[0101] Referring to FIGs. 5A-5B, the seal phase 146, which may be optional within process 140, may include a seal supply 147 which may be connected to one or more seal devices 148. During the seal phase 146, when the textile structure being formed is a conduit, for example, the tubular body may go through a sealing process to prevent fluid from flowing outwardly from within the tubular- body. For example, the seal supply 147 may contain a sealant and provide the sealant to the seal device(s) 148. The sealant may be applied to the tubular body by seal device(s) 148 in any number of ways, such as by spraying the sealant onto the tubular body, for example. In other embodiments, the sealant may be applied in any other way (e.g., dipping the textile structure into the sealant, etc.).
[0102] The process 140 may also include test phase 149, which is also optional. In the test phase 149, a fluid supply 150 may be connected to one or more test devices 151. In some embodiments, the test phase 149 may involve connecting the tubular body to a water inlet and a water outlet and transferring water and / or other fluid through the tubular body to make sure that no fluid flows outwardly from within the tubular body during the passing of the water and / or other fluid. The test phase 149 may additionally or alternatively include stretching the tubular body from a first length (e.g., in the relaxed state) to a predetermined second length (e.g., in the expanded state), measuring the second length of the tubular body, and then comparing the second length to a desired length that corresponds to the interval of the textile structure. This testing method may be used to make sure that the markings displayed on the tubular body correspond to accurate measurements of the textile structure at the desired tension (e.g., when it is stretched into the expanded state). In some embodiments, the markings may also be used for quality control purposes. Notably, while described as being utilized for a tubular’ body, any other textile structure (e.g., a flat graft) may utilize the length quality testing described herein.
[0103] It should be appreciated that each of the elements of the process 140 may be optional or may be integrated with other elements of the process 140. Further, certain elements may be in a different order in embodiments other than that shown in FIGs. 5A-5B. For example, the seal phase 146 may be integrated in the textile structure formation phase 141 (e.g., a sealant may be applied to the tubular body while it is being formed).
[0104] FIG. 6A shows a zoomed-in view of a portion of a flat graft 160 with a plurality of markings 162a, 162b, 162c, and 162d woven into the threads 161 of the tubular body 160. FIG. 6B shows another view of a portion of another example flat graft 164 that has a plurality of markings 166, 167, and 168 woven into threads 165, 169, and 163 of the flat graft 164. FIGs. 6A and 6B both show examples of how a plurality of markings may be woven, braided, knitted, or sewn into a body of a textile structure during a manufacturing of the body. In this regard, in some embodiments, the plurality of markings may be formed of a same material as a remaining portion of the textile structure (e.g., the flat graft 160 or the flat graft 164), but may have different colors, densities, and / or weave patterns to enable distinctive identification. Alternatively, in some embodiments, the plurality of markings may be formed of different material than some of the remaining portions of the textile structure. Along these lines, in some beneficial embodiments, the plurality of markings may be formed of one or more materials that have properties designedto appear in imagery such as an X-ray, an MRI, or a CT-scan. For example, such material may include at least some radiopaque and / or fluorescent material. This may allow for a surgeon or technician to image a patient after the textile structure has been implanted to check the placement and / or effectiveness of the textile structure, including the length and / or position of the textile structure based on the visible markings.
[0105] Further, whether the plurality of markings is formed during the weaving of the body (e.g., the flat graft 160 or the flat graft 164) or whether the plurality of markings is added after the forming of the body, the plurality of markings represents measurements that correlate to real- world measurements of the body when the body is correctly tensioned. For example, the body may have no crimps, and the plurality of markings may represent real world measurements of the body with no extension of the body at all. In other embodiments, the body may be crimped, and the plurality of markings may be added before or after the body is crimped. For example, the plurality of markings may be added to the body before crimping in a pre-calculated manner such that the plurality of markings represents real- world measurements of the body when the body has been crimped and then expanded to a correct tension. As another example, the plurality of markings may be added after the body is crimped (e.g., by expanding the crimped body to the correct tension and then adding the plurality of markings accordingly). Other processes are also contemplated within the scope of this disclosure.
[0106] FIG. 7 illustrates a conduit 170 with a crimped tubular body 173 that is being tested. The tubular body 173 is connected to a water inlet 171 and a water outlet 172. In the testing configuration shown, the crimped tubular body 173 is in an expanded state. That is, the crimped tubular body 173 is connected to the water inlet 171 and the water outlet 172 in a way that mimics implantation into a body to, e.g., repair a blood vessel. Pressurized water and / or blood analog is pushed through the crimped tubular body 173 from the water inlet 171 to the water outlet 172, and testing is performed on the crimped tubular body 173 to ensure that no leaking occurs. That is, the crimped tubular body 173 is tested to make sure that it is fully sealed to prevent fluid from flowing outwardly from within the crimped tubular- body 173. It should be appreciated that the conduit 170 could be tested in any other way with any other fluid. For example, other conduits such as those without crimps or such as conduits configured to be implanted in a relaxed state may be tested in the same or similar manner as demonstrated in FIG.7. Further, the conduit 170 may be tested either before or after sealing of the conduit 170, or the conduit 170 may not be tested at all, in some embodiments.
[0107] FIG. 8A is a block diagram showing another example process 180 for manufacturing a textile structure for implantation. The process 180 comprises a textile structure formation phase 181, a seal phase 187, and a test phase 190. In the embodiment shown in FIG. 8A, the textile structure formation phase 181 has a thread supply 182 that feeds into a textile structure former 184. In some embodiments, the textile structure former 184 may be a machine configured to weave threads together. Specifically, in some embodiments, the textile structure former 184 may be a machine configured to weave a plurality of threads from thread supply 182 into a body. The textile structure formation phase 181 may also have a marker supply 183 that feeds into a marker applicator 185 that is configured to apply a plurality of markings to the body after it is formed by the textile structure former 184. The plurality of markings may be applied by the marker applicator 185 by, for example, stitching, printing, imprinting, weaving, knitting, or braiding the plurality of markings onto the body after the body has been formed. Further, in some embodiments, the marker applicator 185 may be configured for use with certain materials such that the plurality of markings illuminate or otherwise show up in medical imaging processes after implantation. The cutter 186 may then be used to cut the body from the textile structure former 184. The cutter 186 may be optional, though, depending on the type of textile structure former 184 used. Alternatively, the cutter 186 may be integrated into the textile structure former 184 (e.g., the textile structure former 184 may include the cutter 186 in the same mechanism) and / or the cutter 186 may be positioned upstream (relatively) of the marker applicator 185 such that the body may be cut from the textile structure former 184 before the marker applicator 185 is used to apply the plurality of markings onto the body. Further, in some embodiments, a textile structure former 184 may be used to create a body, a separate cutter 186 may be used to cut the body from the textile structure former 184, and then a marker applicator 185 may be used to apply a plurality of markings onto the body.
[0108] In some embodiments, the textile structure former 184, the marker applicator 185, and / or the cutter 186 may be further configured to tuck, remove, or otherwise hide extraneous threads into / from the body that is formed such that there are no extraneous threads to be dealt with after the textile structure formation phase 181. Additionally or alternatively, anothermechanism may be incorporated within the textile structure formation phase 181 to accomplish such.
[0109] Referring now to FIG. 8B, in some embodiments, the textile structure formation phase 181 may include a crimper 193 that may be used either after the cutter 186 is used or at any other position within the process 180. For example, in some embodiments, a textile structure may be formed with the textile structure former 184, and then the plurality of markings may be applied with the marker applicator 185 onto or into the textile structure before it is crimped. The plurality of markings may be pre-calculated and spaced apart along the uncrimped textile structure before the crimper 193 is used so that, once the crimper 193 is used to crimp the textile structure, the plurality of markings represents real world interval values that correspond to the desired tension of the crimped textile structure when it is expanded to the desired tension and implanted. In other embodiments, the crimper 193 may be positioned before the cutter 145 or positioned at any other place throughout the process 180. For example, the crimper 193 may be positioned in between the textile structure former 184 and the marker applicator 185 such that the plurality of markings is added after the crimper 193 has crimped the textile structure. In that example, the crimped textile structure would be expanded to the correct length and tension and then the markings would be applied with intervals that match real world intervals of the textile structure at that desired length and tension.
[0110] Referring to FIGs. 8A-8B, the seal phase 187, which may be optional within process 180, may include a seal supply 188 which may be connected to one or more seal devices 189. During the seal phase 187, a tubular body may be utilized and the tubular’ body may go through a sealing process to prevent fluid from flowing outwardly from within the tubular body. For example, the seal supply 188 may contain a sealant and provide the sealant to the seal device(s) 189. The sealant may be applied to the tubular’ body by seal device(s) 189 by any application method, such as spraying the sealant onto the tubular body, for example. In other embodiments, the sealant may be applied in any other way.
[0111] The process 180 may also include test phase 190, which is also optional. In the test phase 190, a fluid supply 191 may be connected to one or more test devices 192. In some embodiments, the test phase 190 may involve connecting the tubular body to a water inlet and a water outlet and transferring water and / or other fluid through the tubular body to make sure that no fluid flows outwardly from within the tubular body during the passing of the water and / orother fluid. The test phase 190 may additionally or alternatively include stretching the body (whether tubular or flat, for example) from a first length (e.g., in the relaxed state) to a predetermined second length (e.g., in the expanded state), measuring the second length of the body, and then comparing the second length to a desired length that corresponds to the interval of the textile structure. This testing method may be used to make sure that the markings displayed on the body correspond to accurate measurements of the textile structure at the desired tension (e.g., when it is stretched into the expanded state). In some embodiments, the markings may also be used for quality control purposes.
[0112] It should be appreciated that each of the elements of the process 180 may be optional or may be integrated with other elements of the process 180. Further, certain elements may be in a different order in embodiments other than that shown in FIGs. 8A-8B. For example, the seal phase 187 may be integrated in the textile structure formation phase 181 (e.g., a sealant may be applied to the tubular body while it is being formed).
[0113] FIG. 9 shows a zoomed-in view of a marking 195 on a body 196 of a textile structure 194. The marking 195 could, for example, be stitched, glued, imprinted, or printed on the body 196 after the body 196 has been formed, such as in accordance with some example embodiments of the processes shown in FIGs. 8A-8B. It should be appreciated, however, that the marking 195 may be created in any other way while the body 196 is being formed or after the body 196 has been formed, as well as at any other time in the process.
[0114] As detailed herein, various example structures are contemplated. For example, in an example embodiment, a conduit for implantation is provided. The conduit includes a tubular body including a plurality of markings. The tubular body is transitionable between a relaxed state and an expanded state corresponding to an expected length of the conduit when implanted in a human body with fluid running therethrough. Each of the plurality of markings are formed onto or into the tubular body during manufacturing in a manner where, when the tubular body is in the expanded state, the consecutive ones of the plurality of markings are separated by an interval that corresponds to a real- world measurement interval so as to enable accurate cutting and / or attaching (e.g., suturing) of the conduit for an intended implantation in which the conduit will be in the expanded state.
[0115] In some embodiments, the plurality of markings may become consistent with real- world length values of the conduit when the conduit is stretched to a desired tension.
[0116] In some embodiments, the interval and the plurality of markings may be predetermined such that the conduit is at the desired tension and the expected length when the conduit is in the expanded state.
[0117] In some embodiments, the conduit may be comprised of at least one synthetic material.
[0118] In some embodiments, the conduit may consist of synthetic materials.
[0119] In some embodiments, the conduit may be cut while in the expanded state.
[0120] In some embodiments, the conduit may be cut while in the relaxed state.
[0121] In some embodiments, the conduit may be cut while in a semi-expanded state.
[0122] In some embodiments, the tubular body may be crimped in the relaxed state.
[0123] In some embodiments, the tubular body may be smoother in the expanded state than in the relaxed state.
[0124] In some embodiments, the tubular body may have a first portion that is crimped and a second portion that is not crimped in the relaxed state.
[0125] In some embodiments, the tubular body may change in length when the tubular body transitions between the relaxed state and the expanded state.
[0126] In some embodiments, the tubular body may be cylindrical.
[0127] In some embodiments, the plurality of markings may represent predetermined measurements in centimeters or inches when the tubular body is in the expanded state.
[0128] In some embodiments, the plurality of markings may be sewn into the tubular body.
[0129] In some embodiments, the plurality of markings may be woven, knitted, or braided into the tubular body during a manufacturing of the tubular body.
[0130] In some embodiments, the plurality of markings may be added to the tubular body after a manufacturing of the tubular body.
[0131] In some embodiments, the plurality of markings may be stitched onto an outside surface of the tubular body.
[0132] In some embodiments, the plurality of markings may be printed onto an outside surface of the tubular body.
[0133] In some embodiments, the plurality of markings may be imprinted into an outside surface of the tubular body.
[0134] In some embodiments, the plurality of markings may be formed using at least one of radiopaque material or fluorescent material.
[0135] In some embodiments, the tubular body may be capable of returning back to the relaxed state after transitioning from the relaxed state to the expanded state during testing.
[0136] In some embodiments, the diameter of the tubular body may be less than 50 millimeters.
[0137] In some embodiments, a change in length of the tubular body from the relaxed state to the expanded state may be at least 100 percent.
[0138] In some embodiments, a change in length of the tubular body from the relaxed state to the expanded state may be at least 10 percent.
[0139] In some embodiments, a change in length of the tubular body from the relaxed state to the expanded state may be at least 60 percent.
[0140] In some embodiments, the tubular body may be comprised of a medical fabric.
[0141] In some embodiments, the medical fabric may be at least one of polytetrafluoroethylene or polyethylene terephthalate or other polymer.
[0142] In some embodiments, the medical fabric may include at least some radiopaque material or some fluorescent material.
[0143] In some embodiments, the conduit may be fully sealed to prevent fluid from flowing outwardly from within the tubular body.
[0144] In some embodiments, the length of the tubular body may be adjustable before implantation.
[0145] In some embodiments, the plurality of markings may include a plurality of labels that correspond to measurements associated with the interval.
[0146] In another example embodiment, a method of manufacturing a conduit for implantation is provided. The method includes constructing a tubular body, and the tubular body is configured to transition between a relaxed state and an expanded state corresponding to an expected length of the conduit when implanted in a human body with fluid running therethrough. The method also includes forming a plurality of markings on or in the tubular body such that when the tubular body is in the expanded state, consecutive ones of the plurality of markings are separated by an interval that corresponds to a real-world measurement interval so as to enableaccurate cutting and / or attaching of the conduit for an intended implantation in which the conduit will be in the expanded state.
[0147] In some embodiments, the plurality of markings may become consistent with real- world length values of the conduit when the conduit is stretched to a desired tension.
[0148] In some embodiments, the interval and the plurality of markings may be predetermined such that the conduit is at the desired tension and the expected length when the conduit is in the expanded state.
[0149] In some embodiments, the conduit may be comprised of at least one synthetic material.
[0150] In some embodiments, the conduit may consist of synthetic materials.
[0151] In some embodiments, the conduit may be cut while in the expanded state.
[0152] In some embodiments, the conduit may be cut while in the relaxed state.
[0153] In some embodiments, the conduit may be cut while in a semi-expanded state.
[0154] In some embodiments, forming the tubular body may include at least one of weaving or sewing.
[0155] In some embodiments, the tubular body may be comprised of a medical fabric.
[0156] In some embodiments, the medical fabric may include at least one of polytetrafluoroethylene or polyethylene terephthalate or other polymer.
[0157] In some embodiments, the medical fabric may include at least some radiopaque material or some fluorescent material.
[0158] In some embodiments, constructing the tubular body and forming the plurality of markings may occur simultaneously.
[0159] In some embodiments, the method may further include stretching the tubular body from a first length to a second length. The tubular’ body may define the second length in the expanded state. The method may further include measuring the second length of the tubular body and comparing the second length to a desired length that corresponds to the interval.
[0160] In some embodiments, forming the plurality of markings may include at least one of stitching, printing, imprinting, weaving, knitting, or braiding the plurality of markings.
[0161] In some embodiments, the plurality of markings may include a plurality of labels that correspond to measurements associated with the interval.
[0162] In some embodiments, the method may further include fully sealing the conduit to prevent fluid from flowing outwardly from the tubular body.
[0163] In another example embodiment, a conduit for implantation is formed by the process of weaving a plurality of first textile threads to at least partially form a tubular body and weaving a plurality of second textile threads into the tubular’ body as the tubular body is being formed. The plurality of second textile threads form a plurality of markings on or in the tubular- body at positions that are separated by an interval when the tubular- body is in an expanded state. The interval corresponds to a real-world measurement interval so as to enable accurate cutting and / or attaching of the conduit for an intended implantation in which the conduit will be in the expanded state.
[0164] In some embodiments, the process may further include applying a sealant to the tubular conduit to prevent fluid from flowing outwardly from within the tubular body.
[0165] In some embodiments, the plurality of markings may include a plurality of labels that correspond to measurements associated with the interval.
[0166] In another example embodiment, a conduit for implantation is formed by the process of constructing a tubular body. The tubular body is transitionable between a relaxed state and an expanded state corresponding to an expected length of the conduit when implanted into a human body with fluid miming therethrough. The process further includes forming a plurality of markings on or in the tubular body such that when the tubular body is in the expanded state, consecutive ones of the plurality of markings are separated by an interval. The interval corresponds to a real-world measurement interval so as to enable accurate cutting and / or attaching of the conduit for an intended implantation in which the conduit will be in the expanded state.
[0167] In some embodiments, constructing the tubular body may include at least one of weaving or sewing.
[0168] In some embodiments, the tubular body may be constructed using a medical fabric.
[0169] In some embodiments, the medical fabric may include at least one of polytetrafluoroethylene or polyethylene terephthalate or other polymer.
[0170] In some embodiments, the medical fabric may include at least some radiopaque material or some fluorescent material.
[0171] In some embodiments, constructing the tubular body and forming the plurality of markings may occur simultaneously.
[0172] In some embodiments, forming the plurality of markings may include at least one of stitching, printing, imprinting, weaving, knitting, or braiding the plurality of markings.
[0173] In some embodiments, the plurality of markings may include a plurality of labels that correspond to measurements associated with the interval.
[0174] In some embodiments, the process may further include fully sealing the conduit to prevent fluid from flowing outwardly from the tubular- body.Conclusion
[0175] Many modifications and other embodiments of the inventions set forth herein may come to mind to one skilled in the ait to which these inventions pertain having the benefit of the teachings presented in the foregoing descriptions and the associated drawings. Therefore, it is to be understood that the embodiments of the invention are not to be limited to the specific embodiments disclosed and that modifications and other embodiments are intended to be included within the scope of the invention. Moreover, although the foregoing descriptions and the associated drawings describe example embodiments in the context of certain example combinations of elements and / or functions, it should be appreciated that different combinations of elements and / or functions may be provided by alternative embodiments without departing from the scope of the invention. In this regard, for example, different combinations of elements and / or functions than those explicitly described above are also contemplated within the scope of the invention. Although specific terms are employed herein, they are used in a generic and descriptive sense only and not for purposes of limitation.
Claims
THAT WHICH IS CLAIMED:
1. A textile structure for implantation, the textile structure comprising: a body that is transitionable between a relaxed state having a first length and an expanded state having a predetermined second length, wherein the second length is greater than the first length, and wherein the second length of the body in the expanded state is predictable such that the body can be accurately cut or attached for implantation at an appropriate tension.
2. The textile structure of claim 1, wherein the body comprises a plurality of markings, wherein each of the plurality of markings are formed onto or into the body during manufacturing in a manner where, when the body is in the expanded state, consecutive ones of the plurality of markings are separated by equivalent intervals so as to enable accurate cutting or attaching of the textile structure for an intended implantation in which the textile structure will be in the expanded state.
3. The textile structure of claim 2, wherein the plurality of markings are sewn into the body.
4. The textile structure of claim 2, wherein the plurality of markings are woven, knitted, or braided into the body during a manufacturing of the body.
5. The textile structure of claim 2, wherein the plurality of markings are added to the body after a manufacturing of the body.
6. The textile structure of claim 5, wherein the plurality of markings are stitched onto an outside surface of the body.
7. The textile structure of claim 5, wherein the plurality of markings are printed onto an outside surface of the body.
8. The textile structure of claim 5, wherein the plurality of markings are imprinted into an outside surface of the body.
9. The textile structure of claim 1, wherein the plurality of markings arc formed using at least one of radiopaque material or fluorescent material.
10. The textile structure of claim 1, wherein the body is crimped in the relaxed state.
11. The textile structure of claim 10, wherein the body is smoother in the expanded state than in the relaxed state.
12. The textile structure of claim 1, wherein the body is cylindrical.
13. The textile structure of claim 1, wherein a diameter of the body is less than 50 millimeters.
14. The textile structure of claim 1, wherein a change in length of the body from the relaxed state to the expanded state is at least 100 percent.
15. The textile structure of claim 1, wherein a change in length of the body from the relaxed state to the expanded state is at least 50 percent.
16. The textile structure of claim 1, wherein a change in length of the body from the relaxed state to the expanded state is within a range of 50 percent to 75 percent.
17. The textile structure of claim 1, wherein the body is comprised of a medical fabric.
18. The textile structure of claim 17, wherein the medical fabric includes at least one of polytetrafluoroethylene or polyethylene terephthalate or other polymer.
19. The textile structure of claim 17, wherein the medical fabric includes at least some radiopaque material or some fluorescent material.
20. The textile structure of claim 1 , wherein the textile structure is fully sealed to prevent fluid from flowing outwardly from within the body.
21. The textile structure of claim 1, wherein the textile structure is comprised of at least one synthetic material.
22. The textile structure of claim 1, wherein the textile structure consists of synthetic materials.
23. A method of manufacturing a textile structure for implantation, the method comprising: constructing a body that is transitionable between a relaxed state having a first length and an expanded state having a predetermined second length, wherein the second length is greater than the first length, and wherein the second length of the body in the expanded state is predictable such that the body can be accurately cut or attached for implantation at an appropriate tension.
24. The method of claim 23, wherein the method further comprises forming a plurality of markings on or in the body such that when the body is in the expanded state, consecutive ones of the plurality of markings are separated by equivalent intervals so as to enable accurate cutting or attaching of the textile structure for an intended implantation in which the textile structure will be in the expanded state.
25. The method of claim 24, wherein constructing the body and forming the plurality of markings occur simultaneously.
26. The method of claim 23, wherein forming the plurality of markings comprises at least one of stitching, printing, imprinting, weaving, knitting, or braiding the plurality of markings.
27. The method of claim 23, wherein forming the body comprises at least one of weaving or sewing.
28. The method of claim 23, wherein the method further comprises fully sealing the textile structure to prevent fluid from flowing outwardly from the body.
29. A textile structure for implantation formed by the process of: constructing a body that is transitionable between a relaxed state having a first length and an expanded state having a predetermined second length, wherein the second length is greater than the first length, and wherein the expanded state corresponds to an expected length of the textile structure when implanted in a human body, wherein the second length of the body in the expanded state is predictable such that the body can be accurately cut or attached for implantation at an appropriate tension.
30. The textile structure of claim 29, wherein the process further comprises: forming a plurality of markings on or in the body such that when the body is in the expanded state, consecutive ones of the plurality of markings are separated by equivalent intervals so as to enable accurate cutting or attaching of the textile structure for an intended implantation in which the textile structure will be in the expanded state.
31. A textile structure for implantation, the textile structure comprising: a body comprising a plurality of markings, wherein each of the plurality of markings are integrally formed into the body during manufacturing in a manner where consecutive ones of the plurality of markings are separated by equivalent intervals so as to enable accurate cutting or attaching of the textile structure for relative positioning of the textile structure for an intended implantation.
32. The textile structure of claim 31, wherein the body is cylindrical.
33. The textile structure of claim 31, wherein the plurality of markings are sewn into the body.
34. The textile structure of claim 31, wherein the plurality of markings are woven, knitted, or braided into the body during a manufacturing of the body.
35. The textile structure of claim 31, wherein the plurality of markings arc added to the body after a manufacturing of the tubular body.
36. The textile structure of claim 31, wherein the plurality of markings are stitched onto an outside surface of the body.
37. The textile structure of claim 31, wherein the plurality of markings are formed using at least one of radiopaque material or fluorescent material.
38. The textile structure of claim 31, wherein the body is comprised of a medical fabric.
39. The textile structure of claim 38, wherein the medical fabric includes at least one of polytetrafluoroethylene or polyethylene terephthalate or other polymer.
40. The textile structure of claim 38, wherein the medical fabric includes at least some radiopaque material or some fluorescent material.
41. The textile structure of claim 31, wherein a diameter of the body is less than 50 millimeters.
42. The textile structure of claim 31, wherein the textile structure is fully sealed to prevent fluid from flowing outwardly from within the body.
43. A method of manufacturing a textile structure for implantation, the method comprising: constructing a body; and forming a plurality of markings integrally on or in the body such that consecutive ones of the plurality of markings are separated by equivalent intervals so as to enable accurate cutting or attaching of the textile structure for relative positioning of the textile structure for an intended implantation.
44. The method of claim 43, wherein forming the body comprises at least one of weaving or sewing.
45. The method of claim 43, wherein constructing the body and forming the plurality of markings occur simultaneously.
46. The method of claim 43, wherein forming the plurality of markings comprises at least one of stitching, printing, imprinting, weaving, knitting, or braiding the plurality of markings.
47. The method of claim 43 further comprising fully sealing the textile structure to prevent fluid from flowing outwardly from the body.
48. A textile structure for implantation formed by the process of: constructing a body; and forming a plurality of markings integrally on or in the body such that consecutive ones of the plurality of markings are separated by equivalent intervals so as to enable accurate or attaching cutting of the textile structure for relative positioning of the textile structure for an intended implantation.
49. The textile structure of claim 48, wherein constructing the body comprises at least one of weaving or sewing.
50. The textile structure of claim 48, wherein constructing the body and forming the plurality of markings occur simultaneously.
51. The textile structure of claim 48, wherein forming the plurality of markings comprises at least one of stitching, printing, imprinting, weaving, knitting, or braiding the plurality of markings.
52. The textile structure of claim 48, wherein the process further comprises fully sealing the textile structure to prevent fluid from flowing outwardly from the body.
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