Source: https://patents.google.com/patent/US9402753B2/en
Timestamp: 2018-03-23 23:07:57
Document Index: 639634315

Matched Legal Cases: ['§371', 'Application No. 07024710', 'Application No. 2013', 'Application No. 11808547', 'Application No. 11808547', 'Application No. 11808547']

US9402753B2 - Woven prosthesis and method for manufacturing the same - Google Patents
Woven prosthesis and method for manufacturing the same Download PDF
US9402753B2
US9402753B2 US13997095 US201113997095A US9402753B2 US 9402753 B2 US9402753 B2 US 9402753B2 US 13997095 US13997095 US 13997095 US 201113997095 A US201113997095 A US 201113997095A US 9402753 B2 US9402753 B2 US 9402753B2
US13997095
US20140060691A1 (en )
This application is a nationalization of International Patent Application No. PCT/US2011/067002, filed on Dec. 22, 2011, pursuant to 35 USC §371, which in turn claims benefit of priority to U.S. patent application Ser. No. 12/978,382, filed on Dec. 23, 2010, the entire disclosures of which are expressly incorporated by reference herein.
Prosthesis 10 is generally elongate, and is woven with warp yarns arranged generally parallel to an axis 34 shown in FIG. 1. First and second tubular portions 12 and 16 are shown as straight tubular portions and are continuously interwoven with the bulbous portion 14 disposed between the tubular portions 12 and 16. The prosthesis 10, 10′, 10″, 10′″, 310, 410, 510, 610, 910, and 960 depicted in FIGS. 1, 8, 16A, 16B, 17A, 17B, 20 to 23, 34A, 24B, 25A, and 25B represents just a few examples of the universe of complex contoured vascular prosthetic structures capable of being produced utilizing the techniques of the present invention, and other variations within the scope of the claimed invention are contemplated.
FIG. 4A is a magnified view of a circumferential section 35 of prosthesis 10 shown in FIG. 2. Illustrated is a cross section of the sidewall, comprising a total of fifteen warp yarns 40, and two weft passes 52. A first set of warp yarns (fifteen as illustrated) are shown, ten of which are interwoven with a first set of weft passes 52 (two weft yarns as shown), and comprise a first subset of the first set or base layer 60. The term “base” is meant to be interchangeably used with the terms “base layer,” “foundation,” “ground” or “ground layer.” The remaining warp yarns make up a second set of warp yarns, and are positioned outside the base layer 60, in a non-base layer, such as a velour layer 62. This second set comprises among the five non-base warp yarns, yarns 27′, 29′, and 31′. In this embodiment, the non-base velour layer provides a loose weave (relative to the base layer 60) allowing for tissue ingrowth into the prosthesis 10 during usage as a vascular conduit and, thus, functions as a velour layer.
Similar to FIG. 4A, FIG. 4B represents a magnified view of a circumferential section 37 of prosthesis 10 shown in FIG. 3 taken over the same arc as section 35. Illustrated is a cross section of the sidewall, including a total of thirteen warp yarns 40, and two weft passes 52. A first set of warp yarns 40 (thirteen as illustrated) are shown, ten of which are interwoven with a first set of weft passes 52 (two weft yarns as shown), and comprise a first subset of the first set or base layer 60. Two warp yarns of the first subset of the first set are warp yarns 27″ and 31″, which are the same warp yarns 27′ and 31′ illustrated in FIG. 4A, but now positioned in FIG. 4B as interwoven with weft passes 52 and in the base layer 60. The two warp yarns 27 and 31 have therefore have been shifted from a first position in a non-base layer (velour layer 62) illustrated in FIG. 4A (as warp yarns 27′ and 31′), to a base layer 60 illustrated in FIG. 4B (as warp yarns 27″ and 31″).
In an exemplary embodiment, rather than shifting both yarns 27′ and 31′ into the base layer 60, only one of yarns 27′ and 31′ may be shifted into the base layer. In this case, spacing between adjacent warp yarns will increase compared to that as shown in FIGS. 4A and 4B. This may be desirable to the extent a reduced porosity is desired in the bulbous second portion 14 as compared to, for example, the first woven tubular portion 12, while still maintaining the porosity above a level allowing for blood leakage.
On the right most side of portion 46, where warp yarn 44 is woven/incorporated into the base 60, and adopts a weave pattern consistent with the base (such as the 1/1 weave pattern shown for base warp yarns 42 a, 42 b), adjacent base warp yarns 40 are shifted apart from each other in the base layer 60 and accommodate this incorporation. This relative shifting of the base warp yarns 40 in the base layer 60 as illustrated occurs before the transition in weave pattern but may also occur at or after the transition in weave patterns. As detailed below, a warp yarn guide device (FIGS. 13A-13C and 14A-14C), such as a fan-shaped reed, may be used to adjust the spacing between the warp yarns 40. When warp yarn 44 is moved into the base layer 60, warp yarn 44 adopts the same weave pattern as one or both of base warp yarns 42 a, 42 b. Warp yarn 44, when in the base layer 60, is in-phase with base warp yarn 42 a, and out-of-phase with base warp yarn 42 b.
FIG. 8 illustrates an example embodiment of woven prosthesis 10′ of the present invention. Similar to FIG. 1, the prosthesis 10′ is illustrated as having a first tubular portion 12′, a second bulbous portion 14′, and a third portion 16′. The second tubular portion 16, 16′ has a crimped surface 17, 17′ but may also be non-crimped. The crimped surface 17, 17′ can be circularly crimped, helically crimped, or configured with combinations thereof.
FIG. 9 is a magnified view of a portion of the prosthesis 10′ of FIG. 8 taken about a dashed line border 240. As can be seen in FIG. 9, circumferentially spaced velour warp yarns 44′ are woven into the prosthesis 10′ and extend longitudinally along the prosthesis 10′. The circumferential center-to-center spacing of the velour warp yarns 44′ is adjustable. Also adjustable is the pattern, sequence, or rate in which the velour warp yarns 44′ are longitudinally transitioned into and out of the base layer 60 (FIGS. 12A-12C).
A plurality of groups of velour warp yarns (250, 254, 258, 262, 266, and 270) are shown in FIG. 9. Each group is representative of a plurality of warp yarns that share a characteristic relating to the positioning of the groups of warp yarns. Shown for example in FIG. 9 are a plurality of groups, three of which are illustrated with suffixes a through c for the groups of velour warp yarn 250, 254, 258, 262, 266, and 270. A first group of velour warp yarns 250 is represented by velour warp yarns (or sets of velour warp yarns) 250 a, 250 b, and 250 c. These yarns may be brought into the base and adopt a weave pattern consistent with the base at the same or similar time during the weaving process. Subsequent to velour warps yarns 250 a, 250 b, and 250 c being moved into the base, additional velour warp yarns such as a second group of warp yarns 254 comprised of velour warp yarns 254 a, 254 b, and 254 c may be brought into the base. The process of moving one or more groups of velour warp yarns into the base can intentionally be arranged to correlate to the vertical positioning of a reed 120 and can be used to maintain base warp yarn density, and control the diameter of the prosthesis such as to increase or decrease the diameter. This process as applied to groups of velour warp yarns 250 and 254 can be subsequently adapted to additional groups, such as 258, 262, 266, and 270. This process, therefore, can be used to controllably expand the diameter of the woven prosthesis.
FIG. 10 is a magnified view of a portion of the bulbous section 14′ shown in FIG. 9 and circumscribed by dashed line border 242 for illustration purposes. The portion circumscribed by dashed border 242 includes one of the many velour warp yarns 44′ spaced about and woven into prosthesis 10′. In the magnified view of FIG. 10, it can be seen that the portion circumscribed by border 242 actually may include two velour warp yarns 272 b′, 272 b″ that are closely spaced. For added clarity, FIG. 11 is a magnified view of the portion of the prosthesis 10′ circumscribed by dashed border 244 in FIG. 10.
FIGS. 12A, 12B, 12C are sectional views shown in FIG. 10 taken along lines 12A-12A, 12B-12B, and 12C-12C, respectively. For illustrative clarity, the weft yarns are not shown. As the prosthesis 10′ is woven, and as further detailed below, velour warp yarns 272 b′, 272 b″ are progressively shifted from the velour layer 62′, 62″, 62′″ into the base layer 60′, 60″, 60′″, e.g., so as to maintain a warp yarn density of the base layer 60 while increasing a width 108′, 108″, 108′″ defined by a first set of warp yarns 84, 88, 90, 92. This pattern or technique can be used in a repetitive manner throughout a prosthesis, to thereby produce a large diameter bulbous portion (such as bulbous portions 14, 14′ illustrated in FIGS. 1 and 8), as well as manage porosity, warp yarn density, or other properties of a prosthesis. The technique may also be used to construct varied diameter embodiments of other shapes and geometries such as those illustrated in FIGS. 20-23, 24A and 25A.
Shown in FIG. 12A are a first set of warp yarns 112′ with six warp yarns in the set, however other quantities are possible. First set of warp yarns 112′ has a plurality of base warp yarns 84, 88, 90, 92 in a base 60′ thereby defining a first subset 106′. Additionally shown in a non-base layer, such as a velour layer 62′, are one or more velour warp yarns 272 b′, 272 b″. Flanking or adjacent to each side of the first set of warp yarns within border 112′ are additional base warp yarns 100, 102. Two warp yarns within the first subset of warp yarns circumscribed by border 106′ are spaced apart from each other a first distance 108′, a distance greater than the distance of any other pair of base warp yarns in the first subset circumscribed by border 106′.
Pertaining to the warp yarns of FIG. 12A, a warp yarn guide device, such as a fan-shaped reed 120′, may be used to control warp yarn spacing. As shown in FIG. 14A, fan shaped reed 120′ has three positions (e.g., 122, 124, and 126) where warp yarns intersect the reed 120′ to control spacing during weaving. Correlating to the warp yarns arranged in FIG. 14A, the position of fan shaped reed 120′ is used to help achieve the weave pattern of FIG. 12A and is shown to be in a “high” position whereby the reed 120′ engages warp yarns at a low location 126. The reed 120′ is progressively lowered (or raised depending on its orientation) so as to shift the base warp yarns 84, 88, 90, 92 apart making space for the velour warp yarns 272 b′, 272 b″ to be incorporated into the base layer 60′, 60″, 60′″.
Shown in FIG. 12B is the first set of warp yarns from FIG. 12A with a different arrangement and circumscribed by dashed border 112″. The first set of warp yarns in FIG. 12B differs from that of FIG. 12A in that velour warp yarn 272 b′ has been shifted into the first subset 106″ or base layer 60″. Therefore, in the first subset 106″ of the first set of warp yarns circumscribed by dashed border 112″, there are now five base warp yarns instead of four. Reed 120″ may be shifted to the middle position to shift the base warp yarns sufficiently to accommodate velour warp yarn 272 b′ in the base layer 60″.
Reed 120′″ may be shifted even further to the low position illustrated in FIG. 14C so as to allow for velour yarn 272 b″ to be incorporated in base layer 60′″, as illustrated in FIG. 12C. In this state, the base layer 60′″ circumscribed by dashed line 106′″ holds six base warp yarns.
The distance 108′″ shown in FIG. 12C has increased to be greater than distances 108′ and 108″ shown in FIGS. 12A and 12B, respectively. Even though the distance 108′″ has increased, the warp yarn density of the base layer 106′″ is maintained relatively consistent with the warp yarn densities of one or both of the arrangements depicted in FIGS. 12A and 12B. Additionally, the velour warp yarn density in terms of velour warp yarns per given length, has decreased in FIG. 12C, i.e., to a magnitude of zero) when compared to one or both of FIGS. 12A and 12B. Warp yarn 272 b″ adopts the weave pattern of the base warp yarns circumscribed by border 106′″ depicted in FIG. 12C.
The warp yarns are guided by reed 120 through a variety of spacings (or dents) within the reed used to influence the woven width (or diameter) of the prosthesis 10″. As illustrated in FIG. 18, the spacings correlate with locations 800, 802, 804, 806, 808, 810, and 812, each location having a different offset (816, 818, 820, 822, 824, 826, and 828) respectively, from a datum 814 on the reed 120. For example, since warp yarn group 250 is shown to enter the base layer first (from the bottom or distal end 20′ in FIG. 9), the portion of the prosthesis woven prior to group 250 being moved into the base relates to location 800 of fan shaped reed 120 spaced from a datum 814 on the reed a distance 816. When warp yarn group 250 moves into the base layer, the fan shaped reed moves to a second position causing warp yarns to engage a second location 802 on the fan shaped reed 120, spaced a distance 818 from the datum 814 on the reed. This relationship may continue for the remaining groups 254, 258, 262, 266, and 270 such that portions of the bulbous profile 230′ in FIG. 9 can be controllably and repeatably formed.
Prosthesis 10′ of FIG. 8 has a length 220 between twelve and thirty centimeters, although other lengths may be appropriate depending on the intended use. The second tubular portion 16′ has a first length 218 greater than ten centimeters, preferably fifteen centimeters, but other lengths may be used. The first tubular portion 12′ has a first tubular diameter 222 and a length 212, and the second tubular portion 16′ has a second tubular diameter 224. A maximum diameter 226 is greater than the diameters of the first and second tubular portions 12′ and 16′ respectively, and is positioned within the bulbous portion 14′. The maximum diameter 226 is larger than the diameters 222 and 224 by four to sixteen millimeters, preferably six to ten millimeters, and most preferably by about eight millimeters, but this difference may be varied.
As further illustrated in FIG. 8, the maximum diameter 226 of bulbous portion 14′ may be positioned to be closer to a first transition region 22′ than a second transition region 24′, hence further from the second transition region 24′ than the first transition region 22′. For example, the maximum diameter 226 may be positioned at a distance 216 from second transition region 24′, such that the distance 216 is between 50% and 75%, or between 60% and 70%, or between 65% and 70% of the length 214 of the bulbous portion 14′. The woven length 214 of the bulbous portion 14′ is configured to approximate the diameter 224 within a tolerance of plus or minus two millimeters, preferably one millimeter. The first tubular portion 12′ is configured to have a length 212 measured from the first transition region 22′ to the proximal end 18′, greater or equal to one centimeter. All of these dimensions are provided as examples, for they may vary and are not intended to limit the scope of the invention.
The first transition region 22′ represents the transition from the first tubular portion 12′ to the bulbous portion 14′, while the second transition region 24′ represents the transition from the bulbous portion 14′ to the second tubular portion 16′. The bulbous portion 14′ is woven to have a varied diameter profile and is configurable to have varying degrees of flaring and tapering, to mimic the natural anatomy, shape, dimensions, and intended blood flow dynamics of the aortic root for cardiothoracic surgery pertaining to the ascending aorta.
FIG. 9 illustrates a partial view of a woven prosthesis 10′ embodiment representative of elements of the present disclosure, taken about border 240 of FIG. 8. Illustrated in FIG. 9 is a bulbous portion 14′, and adjacent thereto portions of the first tubular portion 12′ and the second tubular portion 16′. Preferably, the first tubular portion 12′ and the second tubular portion 16′ have warp yarns continuously woven throughout the bulbous portion 14′ into one, preferably both of the first and second tubular portions 12′ and 16′. Other elements such as first transition region 22′ and second transition region 24′ are illustrated as well. The second transition region 24′ may correlate with the sinotubular junction common to the anatomy of the ascending aorta.
Optionally, both the first transition region 22′ and second transition region 24′ may be visually differentiated from other regions of the prosthesis through the use of a diameter transition reference indicator 27′, 29′. The diameter transition reference indicator may include the use of a weft yarn of a color different from the color of the weft yarn used in other regions of the prosthesis. For example, the entire prosthesis can be woven with two or more weft yarns of different colors, wherein the color of the weft yarn used for all or a portion of a transition region (e.g., one or both of 22′ and 24′ in FIG. 9) may be chosen to be a first color while the weft yarn used for the other regions may be chosen from a second color. In an example embodiment, the first color is dark, and is preferably green, blue or even black while the second color is lighter than the dark color, and is optionally white. The second weft yarn can be woven in addition to or instead of a first weft yarn to form the transition reference indicator. The second weft yarn can have an over and under (1/1) interlacing or may optionally float over a plurality of warp yarns. Variations are shown in FIG. 9 as 29′ (having two weft passes of a 1/1 interlacing) and 27′ (having one weft pass with a plurality of floats). Other arrangements are of course possible and are shown for example in FIGS. 16A, 16B, 17A, and 17B as reference numerals 27″ and 29″. The diameter transition reference indicators can be used in all embodiments shown within the present application, including those of FIGS. 1, 20-23, 24A, 24B, 25A, and 25B.
In embodiment 10′ of FIG. 9, the velour warp yarn density (quantity of velour warp yarns per given length of woven fabric) is shown to decrease when moving towards the maximum diameter portion of the bulbous portion 14′, and away from either the first or second transition regions 22′ and 24′.
Additionally shown in FIG. 9, the second tubular portion 16′ has a crimped surface 17′. This is shown more specifically in FIG. 15, taken about border 19 shown in FIG. 8. The crimped surface can be circularly or helically crimped.
FIG. 11 illustrates the behavior of the velour warp yarns 272 b′ and 272 b″ circumscribed by border 244 in FIG. 10. Velour warp yarns 272 b′ and 272 b″ are shown to adopt a 5/1 weave pattern in portion 780. The velour warp yarns 272 b′ and 272 b″ float over a plurality of weft passes 752 (depicted as yarns extending from left to right in FIG. 11). After floating over weft pass 765 and under weft pass 766, velour warp yarn 272 b′ is shown to adopt the weave pattern of base layer 60″, 60′″, which in this example may be represented as a 1/1 weave pattern. Thereafter, velour warp yarn 272 b′ engages each of the weft passes 769 through 773. Fan shaped reed 120 adjusts from a first position 121′ illustrated in FIG. 13A while weaving portion 780 to a second position 121″ illustrated in FIG. 13B while weaving a portion at or near transition point 786 (illustrated by a dashed horizontal line). In the first position (FIG. 13A) where the reed 121′ has been moved to a top position, warp yarns engage the reed at a low portion 136 of the reed, and in the second position 121″ (FIG. 13B), the reed has been moved to a middle position whereby warp yarns engage the reed at the middle portion 134 of the reed 121″. Therefore, when velour warp yarn 272 b′ adopts the base weave pattern 60″, 60′″, the warp yarn spacing in the base layer 60″, 60′″ may be maintained.
Further illustrated in FIG. 11, velour warp yarn 272 b″ is shown to first adopt a 5/1 weave pattern in portion 780 and part of portion 781, and then adopt a weave pattern consistent with the base weave pattern in portion 782. This behavior is similar to that of velour warp yarn 272 b′, but begins at a different weft pass. After floating over weft pass 766 and under weft pass 767, velour warp yarn 272 b″ is shown to adopt the weave pattern of a base layer 60′″, which in this example may be represented as a 1/1 weave pattern. Similar to velour warp yarn 272 b′, velour warp yarn 272 b″ engages each of the weft passes 769 through 773. Fan shaped reed 120 adjusts from a second position 121″ illustrated in FIG. 13B to a third position 121′″ illustrated in FIG. 13C at or near transition point 788 (illustrated by a dashed horizontal line). In the second position 121″ (FIG. 13B), where the reed 121″ has been moved to a middle position, warp yarns engage the reed at a middle portion 134 of the reed, and in the third position 121′″ (FIG. 13C), the reed 121′″ has been moved to a bottom position whereby warp yarns engage the reed 121′″ at the top portion 132 of the reed 121′″. Therefore, when velour warp yarn 272 b″ adopts the base weave pattern, the warp yarn spacing in the base layer 60′″ may be maintained, and the overall width achieved by the same quantity of warp yarns from portion 780 has increased to increasingly wider portions 781 and 782.
Prosthesis 310 is configured to have a size and shape in accordance with the bulbous portion of prosthesis 10′. Unlike prosthesis 10′, prosthesis 310 does not have first and second tubular portions 12′, 16′. Prosthesis 310 may be woven in a manner generally consistent with prosthesis 10′. Prosthesis 310 may be formed, for example, by cutting the bulbous portion 14′ from prosthesis 10′, and utilizing the woven bulbous portion alone.
Prosthesis 410 is configured to have a size and shape in accordance with the bulbous portion of prosthesis 10′, as well as the first tubular portion 12′ of prosthesis 10′. Unlike prosthesis 10′, prosthesis 410 does not have a second tubular portion 16′. Prosthesis 410 may be woven in a manner generally consistent with prosthesis 10′. Prosthesis 410 may be formed by removing through cutting for instance, second tubular portion 16′ from prosthesis 10′, and utilizing the remaining portion of prosthesis 10′ not removed.
Prosthesis 510 is configured to have a size and shape in accordance with the bulbous portion of prosthesis 10′, as well as the first tubular portion 12′ of prosthesis 10′. Unlike prosthesis 10′, prosthesis 510 does not have a second tubular portion 16′. Prosthesis 510 may be woven in a manner generally consistent with prosthesis 10′. Prosthesis 510 may be formed by removing through cutting for instance, second tubular portion 16′ from prosthesis 10′, and utilizing the remaining portion of prosthesis 10′ not removed.
Prosthesis 610 is configured to have a size and shape in accordance with a portion of the bulbous portion 14′ of prosthesis 10′, as well as the second tubular portion 16′ of prosthesis 10′. Unlike prosthesis 10′, prosthesis 610 does not have a first tubular portion 12′, nor does it have a proximal portion of the bulbous portion 14′ of prosthesis 10′. Therefore, the bulbous portion of prosthesis 610 only expands outward in an increasing diameter configuration, such as a “flared” manner, flaring from the second tubular portion 616 towards the proximal portion 618. Prosthesis 610 may be woven in a manner generally consistent with prosthesis 10′. Prosthesis 610 may be formed by removing through cutting for instance, the proximal portion of the bulbous portion 14′, through cutting for instance at the location of the maximum diameter 226 of prosthesis 10′ (FIG. 8), as well as the first tubular portion 12′ of prosthesis 10′, thereby utilizing the remaining portions of prosthesis 10′ not removed.
FIGS. 24A and 24B illustrate a prosthesis 910 which comprises a proximal end 918, a distal end 920, and a sidewall disposed therebetween, preferably constructed through a weaving process. The sidewall may be woven with a base layer and velour layer, as illustrated for example in FIGS. 12A through 12C. Such weaving processes used to provide prosthesis 910 may be consistent with the weaving of portions of prosthesis 10′ described herein.
Prosthesis 910 is configured to have a flared shape expanding from a minor diameter 938 at the proximal end to a larger diameter at the distal end 920. As illustrated in FIG. 24A, the flared shape of prosthesis 910 is not continuously flared throughout the length 930. Instead, prosthesis 910 has a proximal region 912, a distal region 916, and a flared region 914. The flared region 914 utilizes the weaving technique disclosed throughout this specification and incorporates more warp yarns as velour warp yarns towards the proximal end 918 than towards the distal end 920. The velour density change per unit length within the flared region 914 is greater than one or more adjacent regions 912, 916. For instance, proximal region 912 is shown to have a generally consistent diameter 938 throughout its length 932. Similarly, distal region 916 may have a generally consistent diameter 940 throughout its length 936. The proximal region 912 transitions to the flare region 914 at a proximal transition zone 922, while flared region 926 transitions to the distal region 916 at a distal transition zone 924. In the proximal and distal transition zones 922, 924 the rate increase and decrease of the velour warp yarns transitioning to base warp yarns and vice versa is at a maximum. In the flared region 926, the rate of change of velour yarns transitioning to base warp yarns is a constant non-zero value, while in the proximal and distal regions 912 and 916 the rate may be a constant value of zero (representing no change of velour warp yarns to base warp yarns).
FIGS. 25A and 25B illustrate a prosthesis 960 similar to the embodiment of prosthesis 910, but instead the prosthesis 960 has a generally or substantially constant flare between its proximal end 964 and distal end 966. The sidewall of prosthesis 960 may be woven with a base layer and velour layer, as illustrated for example in FIGS. 12A through 12C. Such weaving processes used to fabricate prosthesis 960 may be consistent with the weaving of portions of prosthesis 10′ and 910 as described herein.
It should be noted that embodiments of the invention may involve the movement of all velour warp yarns to the base layer as illustrated for example for prosthesis 10″ in FIGS. 16A and 16B prior to emerging from the base layer to return as velour warp yarns. In other embodiments, such as the prosthesis 10′″ illustrated in FIGS. 17A and 17B, less than all of the velour warp yarns are moved into the base.
Prostheses consistent with and resulting from the methods of manufacture of the embodiments of the present invention may be constructed in a variety of specific ways. In certain embodiments, examples of the present invention may be manufactured in four steps comprising (i) a flat weaving step, (ii) a cutting step, (iii) a heat setting step, and (iv) a sterilization step. The heat setting step may be achieved in a two-step manner, first involving the application of heat through a crimping mandrel to crimp and corrugate certain portions of the surface of portions of the prosthesis, as well as a shaping step in which heat is applied to the prosthesis, whereby the prosthesis takes a “set” or “shape memory” in an expanded state through the usage of an expandable bladder configured to provide a shape consistent with the desired final shape of the prosthesis. Furthermore, an optional step (v) of inserting one or more reference lines at diameter transition regions could be employed. Such a step would demarcate through a change in color of the weft yarn passes at diameter transition regions to enhance the visual identification of such transitions. Such a step may occur through the use of a multi-colored weft insertion mechanism wherein a secondary weft yarn of a different color than the yarn chosen for a primary weft yarn is visually different (colored differently, preferably darker) and used in conjunction with or instead of the primary weft yarn.
An example prosthesis according to the present invention, including prosthesis 10, 10′, 10′″, 910, and 960 may be woven with a loom, e.g., a Jacquard-type loom 136, and a warp yarn guide device, e.g., fan-shaped reed 120, as shown in FIGS. 18, 19A, and 19B. The warp yarns or threads (i.e., those yarns extending in the longitudinal direction) and one or more weft or fill yarns or threads (i.e., those yarns extending generally transverse to the longitudinal direction of the portion to be woven) are interlaced with one another in one or multiple predetermined weaving patterns. When weaving a conduit, as employed in various embodiments of the present invention, at the weaving station of the loom, the warp yarns are fed individually through heddles aligned transverse to the longitudinal direction on one of four or more shafts. The upward and downward movement of the shafts moves a preselected pattern of the warp yarns up and then down. In such an arrangement, two of the shafts move the warp yarns for forming the upper surface of the tubular conduit, and two of the shafts move the warp yarns for forming the lower surface of the tubular conduit. As the warp yarns on one shaft are drawn upwardly and the warp yarns on another shaft are drawn downwardly, the weft thread is shuttled in a first direction between those groups of warp yarns to weave the upper surface of the tubular conduit, thereby providing a weft pass of the weft yarn, also known as a machine pick. The weft yarn is then shuttled in a reverse direction between another group of upwardly and downwardly drawn warp yarns to weave the lower surface of the tubular conduit, thereby creating an additional weft pass or machine pick. The position of the shafts and thus the position of the warp yarns is then reversed and the weft thread is again shuttled between the groups of warp yarns, creating a plurality of weft passes, wherein the process continues resulting in a woven tubular shape.
As they approach the weaving station, the warp yarns are fed between the fingers of a fan-shaped reed 120, which aligns the yarns for weaving and which thus determines the ultimate shape of the woven article. Whereby weaving tubular articles having a substantially constant diameter is performed utilizing a conventional front reed which is fixed in place and which has evenly spaced fingers used to produce constant spacing between the warp yarns, reeds with varying spacing will be beneficial for carrying out the present invention but are not required. An example of such a reed has spacing between the fingers which is narrow at a first end or bottom end, and gradually increases toward the top end. In contrast to conventional reeds, the fan-shaped reed 120 is not held in a fixed position, but rather is moved upward or downward with respect to the warp yarns to alter yarn to yarn spacing in all or portions of the of the article being woven. For example, fan shaped reed 120′, 120″ 120′″ as shown in FIGS. 14A-14C, may be moved upwards and downwards, causing warp yarns to engage the fan shaped reed 120′, 120″, 120′″ at a plurality of elevations represented by dimensions 816 through 828 in FIG. 18, all with respect to a datum 134. When the fan shaped reed is at its highest position, the warp yarns engage the reed at a low position such as that represented by location 800 in FIG. 18. Likewise, when the fan shaped reed is at its lowest position, the warp yarns engage the reed at a high location such as that represented by location 812 in FIG. 18. In the context of fabricating a tubular article consistent with certain embodiments of the present disclosure, the movement of the fan-shaped reed 120 provides for an adjustable diameter.
During further processing of the prosthesis, all or portions of the prosthesis of the present invention may be crimped to provide for “self-supporting” qualities of the finished prosthesis, adding rigidity to the tubular prosthesis wherein the strength is needed to ensure proper cross sectional area for assured flow of blood through the conduits. Examples are disclosed by example in U.S. Pat. No. 3,945,052 herein incorporated by reference. As illustrated in all the figures, neither the bulbous portion nor the collar or first woven portion 12, 12′ are crimped but they may be crimped in other embodiments. A benefit to not crimping these sections include, for example, being able to provide a surgeon locally flat or slightly curved surfaces beneficial for anastomosis and suturing. Providing a surface that has crimps, pleats, or corrugations in the bulbous portion 14, 14′ and/or a collar, e.g., the proximal tubular woven portion 12, 12′, may complicate suturing and anastomosis procedures as it is understood to be more convenient to suture and perform a proximal anastomosis on a flat or slightly curved surface rather than a non-uniform crimped, pleated, or corrugated surface.
The woven fabric or prosthesis 10, 10′, 10″, 10′″, 910, 960 may be coated with a collagen or gel coating applied to entire length of the prosthesis for sealing purposes. Therefore, in addition to a uniform textile structural porosity capable of being achieved in a base layer (between warp yarns, weft yarns, and interwoven combinations thereof), a uniform functional porosity impacting permeability of the woven fabric to a fluid may additionally be achieved.
The prosthesis 10, 10′, 10′, 10′″, 910, 960 may be sterilized from any of the sterilization process suitable for woven grafts, including gamma radiation or cobalt 60 radiation, ethylene oxide gas, or e-beam radiation as commonly known to one skilled in the art.
The following four examples are to be illustrative of embodiments that relate to the present invention. The first two relate to the formation of a bulbous prosthesis, consistent with prosthesis 10, 10′ shown in FIGS. 1 and 8 respectively. The second two relate to the formation of a prosthesis tapering generally from a small diameter end to a larger diameter end. Unless otherwise noted, the vascular prosthesis of all of the following examples were fabricated through flat-woven processes, arranged to achieve a tubular configuration using an electronic Jacquard weaving machine and a variable reed such as a fan-shaped reed.
When weaving the first portion 12, 12′ and the third portions 16, 16′ (both collar and crimped/corrugated sections respectively), the position of the reed 120 is set to its narrowest width in order to achieve a woven fabric tubular diameter of approximately 32 mm (or flat width 50.3 mm), and the total of 703 warp yarns are so divided into two groups. The first group includes 469 warp yarns to form the base layer, and the second group includes 234 warp yarns to form the velour layer of the first portion. Therefore, to achieve the intended tubular diameter of 32 millimeters, the warp spacing for the base layer is 118 yarns per inch (46 yarns per centimeter) when a 32 millimeter diameter portion is to be woven, and 59 velour warp yarns per inch (23 yarns per centimeter) for the velour layer. The average fabric warp spacing including both velour and base warp yarns is the sum of both layers, i.e., 177 yarns per inch (70 yarns per centimeter). The first tubular portion 12, 12′ is woven with warp yarns acting as both base warp yarns and velour warp yarns to establish the first tubular portion 12, 12′.
The fan shaped reed 120 is gradually repositioned in steps during the weaving process to achieve the desired profile of the bulbous portion 14, 14′. This occurs in combination with the conversion of velour warp yarns into base warp yarns, until the maximum desired diameter is achieved.
When reaching the maximum diameter portion, the reed 120 is at its widest to help fabricate the maximum fabric tubular diameter of 40 mm (or flat width 62.8 mm), and the total of 703 warp yarns are so divided into two groups that 584 yarns now form the fabric base layer (for example, the inner surface), and 119 yarns form the velour layer or layers. As a result, the warp spacing for the ground layer 60, 60′ is maintained as 118 yarns per inch (46), while the velour layer is reduced to 24 yarns per inch (9 yarns per centimeter) for the velour layer 62, 62″.
A weft yarn material chosen for the present example is comprised of polyethylene terephthalate (PET) and is configured from two plies of 70 denier per ply, thereby having a final denier of 140. A warp yarn material chosen for the present example is comprised of polyethylene terephthalate (PET) and is configured from two plies of 70 denier per ply, thereby having a final denier of 140. Either or both of the warp and weft yarn materials may be texturized or untexturized. A base weave pattern is chosen to be a plain weave pattern. The velour layer 62, 62″ can be woven to the outside of the base layer 60, 60′. The weave pattern chosen for the velour layer is a 5/1 pattern.
A constant weft yarn spacing is chosen to be used for the weaving of all woven portions of the prosthesis 10, 10′. Specifically, a weft yarn spacing (or density) of 66 yarns per inch (26 weft yarns per centimeter) is determined to be used for all woven portions of the prosthesis 10, 10′. Although a goal spacing of 66 yearns per inch is chosen, one will appreciate that tolerances throughout the woven prosthesis will be expected. Preferably, such a spacing will be within a range of plus or minus 30% of the targeted average, more preferably 20% of the targeted average, and most preferably 10% of the targeted average.
When weaving the first portion 12, 12′ and the third portion 16, 16′ (both corrugated and collar portions), the position of the reed 120 is set to narrowest width in order to achieve a woven fabric tubular diameter of approximately 24 mm (or flat width 37.7 mm), and the total of 550 warp yarns are so divided into two groups. The first group includes 367 warp yarns to form the base layer 60, 60′, and the second group includes 183 warp yarns to form the velour layer 62, 62′ of the first portion 12, 12′. Therefore, to achieve the intended tubular diameter of 24 millimeters, the warp spacing for the base layer 60, 60′ is 124 yarns per inch (49 yarns per centimeter) when a 24 millimeter diameter portion is to be woven, and 62 velour warp yarns per inch (24 yarns per centimeter) for the velour layer 62, 62′. The average fabric warp spacing including both velour and base warp yarns is the sum of both layers, (i.e., 177 yarns per inch, or 70 yarns per centimeter). The first tubular portion 12, 12′ is woven with warp yarns acting as both base warp yarns and velour warp yarns to establish the first tubular portion 12, 12′. Again, the reed 120 is gradually repositioned in steps during the weaving process to achieve the desired profile of the bulbous portion 14, 14′. This occurs in combination with the conversion of velour warp yarns into base warp yarns, until the maximum desired diameter is achieved.
When reaching the maximum diameter portion, the reed 120 is at its widest to help achieve the maximum fabric tubular diameter of 32 mm (or flat width 50.3 mm), and the total of 550 warp yarns are so divided into two groups that 491 yarns now form the fabric base layer 60, 60′ (for example, the inner surface), and 59 yarns form the velour layer or layers 62, 62′. As a result, the warp spacing for the ground layer 60, 60′ is maintained as 124 yarns per inch (49 yarns per centimeter), while the velour layer 62, 62″ is reduced to 15 yarns per inch (6 yarns per centimeter) for the velour layer.
After the maximum desired diameter is achieved, the diameter of the prosthesis 10, 10′ is intentionally reduced or tapered by reversing the steps used to create the increased diameter. Specifically, warp yarns now in the base 60, 60′ of the prosthesis 10, 10′ are adjusted and moved out of the base 60, 60′ to behave and perform as velour warp yarns. The spacing of the base warp yarns still within the base 60, 60′ are adjusted to accommodate the removal of the warp yarn from the base layer 60, 60′ to the velour layer 62, 62′, without significantly impacting the warp yarn spacing within the base 60, 60′.
1. A method for manufacturing an implantable medical prosthesis, the medical prosthesis comprising a first end and a second end, the method comprising:
weaving a woven base from a set of warp yarns and at least one weft yarn pass, the set of warp yarns comprises warp yarns woven as base warp yarns and warp yarns woven as non-base warp yarns, wherein the base warp yarns and weft yarn passes are woven into a base weave pattern, and the non-base warp yarns are woven with at least one weft yarn pass with a smaller frequency of interlacing when not woven into a base weave pattern; and
incorporating into the woven base one or more of the non-base warp yarns through an increase in the frequency of interlacing of the non-base warp yarns along the longitudinal direction of the base warp yarns.
2. The method of claim 1, wherein the non-base warp yarns are velour yarns.
3. The method of claim 2, wherein the woven base is configured to establish a smaller and larger diameter portion, the larger diameter portion capable of achieving a larger diameter than the smaller diameter portion, wherein the larger diameter of the larger diameter portion is achieved by the step of incorporating into the woven base one or more velour yarns.
4. The method of claim 2, wherein the incorporating into the woven base one or more velour yarns exclusively utilizes velour yarns utilized as velour prior to being incorporated into the woven base.
5. The method of claim 2, wherein a variable reed is moved during the weaving step to provide for a varied diameter profile of the medical prosthesis.
6. A method for manufacturing an implantable medical prosthesis comprising:
weaving a woven base comprising base warp yarns interwoven with weft yarn passes, the base at least partially forming smaller and larger diameter portions, one or more velour yarns forming part of both the smaller and larger diameter portions, weaving in at least a portion of the larger diameter portion at least one of the one or more velour yarns of the smaller diameter portion into the woven base to adopt the base weave pattern, and;
sterilizing the woven base and the one or more velour yarns forming part of both the smaller and larger diameter portions.
7. The method for manufacturing an implantable prosthesis as claimed in claim 6, wherein the at least one of the one or more velour yarns woven into the woven base of the larger diameter portion and exhibiting the base weave pattern is not woven into the base of the smaller diameter portion.
8. A method for weaving a variable diameter generally elongate graft configured for implantation and/or anastomosis by a surgeon, the elongate graft having a velour layer on at least a portion of the graft, the method comprising the step of:
changing a weave pattern of a warp yarn used to form the velour layer in a smaller diameter portion of the elongate graft such that in the larger diameter portion of the graft, said warp yarn (i) takes on a different weave pattern than the weave pattern said warp yarn utilizes in the smaller diameter portion and (ii) forms part of a base layer of the larger diameter portion of the elongate graft.
9. The method as claimed in claim 8, further comprising the step of changing the weave pattern of the warp yarn as it transitions from the larger diameter portion to a second smaller diameter portion so as to form a velour layer on at least a portion of the second smaller diameter portion which is smaller in diameter than the larger diameter portion.
10. The method as claimed in claim 6, further comprising the step of shifting at least a pair of adjacent warp yarns used to form a base layer of the smaller diameter portion so as to increase a spacing between said adjacent warp yarn in the larger diameter portion.
11. The method as claimed in claim 6, wherein a spacing between base warp yarns used to form the smaller diameter portion is within 30% of the size of a corresponding spacing between the same base warp yarns in the larger diameter portion.
12. A method for weaving a medical prosthesis, comprising the steps of:
(i) forming a first portion of the prosthesis by interweaving base warp yarns, velour warp yarns, and one or more weft yarn passes;
(ii) shifting at least a pair of adjacent base warp yarns so as to increase or decrease a spacing between them; and
(iii) forming a base layer of a second portion of the prosthesis by weaving the one or more weft yarn passes with the at least a pair of shifted base warp yarns together with one or more of the velour warp yarns;
wherein the medical prosthesis is configured as a conduit, and the first portion is capable of establishing a diameter of a first magnitude and the second portion is capable of establishing a diameter of a second magnitude greater than the first magnitude, and wherein an average base warp yarn density is maintained within a predetermined range in both the first and second portions of the medical prosthesis, while the velour warp yarn density is decreased in the second portion as compared to the first portion of the medical prosthesis.
13. The method as claimed in claim 12, wherein the velour warp yarn exhibits a float in the first portion and no float or less of a float in the second portion.
14. The method as claimed in claim 12, wherein the shifting is accomplished using a warp yarn guide device.
15. The method as claimed in claim 14, wherein the warp yarns pass through gaps in the warp yarn guide device, the spaces are spaced apart a distance greater than the spacing between the warp yarns in the first portion of the prosthesis.
16. The method as claimed in claim 12, wherein the medical prosthesis is generally tubular.
17. The method as claimed in claim 12, wherein the shifting is incrementally increased or decreased along a longitudinal axis of the graft so as to effect a change in diameter of the prosthesis.
18. The method as claimed in claim 12, wherein a spacing between the base warp yarns in the first portion is within a plus or minus range of 30% of the size of a corresponding spacing between the same base warp yarns in the second portion.
19. The method as claimed in claim 12, further comprising the step of using at least one of the base warp yarns from the first portion in the second portion as a velour warp yarn and not as part of the base layer of the second portion.
20. The method as claimed in claim 12, wherein the medical prosthesis is woven from a total quantity of warp yarns including base warp yarns and velour warp yarns, the total quantity of the base warp yarns and velour warp yarns is the same for both the first portion and the second portion.
21. A method for manufacturing an implantable medical prosthesis comprising:
weaving a tubular prosthesis with at least one weft yarn and a plurality of warp yarns, all or a portion of the warp yarns are woven as base warp yarns, velour warp yarns, or both velour and base warp yarns, and wherein the weaving occurs in a longitudinal direction from a smaller diameter portion to a larger diameter portion while maintaining within a predetermined range an average base warp yarn density while decreasing a velour warp yarn density.
22. The method of claim 21, wherein a quantity of warp yarns is maintained constant during the step of weaving.
23. The method of any of claim 21, wherein during the step of weaving, the total warp yarn density decreases.
24. The method of claim 1, wherein in the step of incorporating into the woven base the one or more of the non-base warp yarns through an increase in the frequency of interlacing of the non-base warp yarns along the longitudinal direction of the warp yarns, the non-base warp yarns assume the base weave pattern.
25. The method of claim 1, wherein the weaving of the medical prosthesis occurs in a flat-woven manner between two edges of the medical prosthesis, and the set of warp yarns is located away from and intermediately disposed between the edges of the medical prosthesis.
26. The method of claim 1, wherein between the first end and the second end the set of warp yarns are not cut.
27. The method of claim 21 comprising: sterilizing the medical prosthesis.
cutting the tubular prosthesis to form a first end and a second end;
wherein between the first end and the second end the plurality of warp yarns are not cut.
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