The present disclosure relates to a warp knit fabric and related methods of manufacturing various embodiments of the warp knit fabric for medical use and for various technical textile applications. In one application, this disclosure relates to an implantable mesh of a Raschel warp knit construction that distributes tensile stress over a larger area between the implantable mesh and the surrounding tissue and, thereby, provides increased durability and better surgical outcomes for patients compared to currently-available devices and methods.
Meshes are used in many medical applications, including as implants to repair or restructure tissue, such as skin, fat, fascia, and/or muscle. One common application for such meshes is in hernia repair, such as abdominal wall hernia repairs. A hernia is a protrusion of an organ or tissue through an opening or weakness in the walls that normally retain the organ or tissue within a confined space. Most commonly, hernias occur in the abdominal region; however, hernias may occur in many locations throughout the body, including but not limited to the head, thorax/chest, pelvis, groin, axilla, and upper and lower extremities. Traditionally, there are two main types of surgical hernia repairs: open and laparoscopic hernioplasty. In both types, the hernia defect is closed and reinforced by surrounding tissues.
This Summary is provided to introduce a selection of concepts that are further described below in the Detailed Description. This Summary is not intended to identify key or essential features of the claimed subject matter, nor is it intended to be used as an aid in limiting the scope of the claimed subject matter.
In one embodiment, a warp knitted fabric formed by a warp knitting machine includes a first knitted portion formed using a first knitting sequence in a machine direction, and a second knitted portion formed using a second knitting sequence in the machine direction, the second knitted portion comprises at least two strips extending lengthwise in the machine direction, the at least two strips being detached from one another along their lengthwise edges. The second knitted portion has the same width as the first knitted portion, and the first knitted portion and the second knitted portion alternate sequentially in the machine direction and are formed of a single set of continuous textile strands.
In one embodiment, a method of manufacturing a warp knitted fabric includes knitting a set of textile strands in a first knitting sequence in a machine direction on a warp knitting machine to form a first knitted portion, the first knitted portion having a width, and then knitting the set of textile strands in a second knitting sequence in the machine direction on the warp knitting machine to form a second knitted portion, the second knitted portion having the same width as the first knitted portion. The second knitted portion comprises at least two strips extending lengthwise in the machine direction, wherein the at least two strips are detached from one another along their lengthwise edges. The first knitting sequence and the second knitting sequence are alternately knitted sequentially in the machine direction to form a length of fabric.
In one embodiment, an implantable mesh comprises a mesh body formed using a first knitting sequence in a machine direction, the mesh body having a width. The implantable mesh further includes a first set of two mesh extensions extending parallel to one another in the machine direction from a first side of the mesh body, the at least two mesh extensions formed using a second knitting sequence, wherein the first knitted portion and the second knitted portion are formed continuously from a single set of textile strands.
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee. The present disclosure is described with reference to the following Figures.
The current recommendation for ventral hernia repair includes the use of mesh. Various factors contribute to the hernia recurrence; however, the inventors have recognized that failure of the mesh—either through degradation or mechanical failure—remains a significant problem. The inventors have recognized that one source of the problem of hernia repair failures is the construction of the mesh, as prior art meshes are typically a woven piece of material that gets sewn in to the repaired area with sutures. This causes problems, as the material can become unraveled and/or the connections between the sutures and the material can slip. Similar issues occur with other types of mesh or fabric implants.
Upon recognition of the problems and challenges in the relevant field, the inventors developed a warp knit fabric from which an implantable mesh of unitary construction can be created. The implantable mesh of the present disclosure minimizes possible failure points by minimizing the number of separate and/or cut strands in the fabric and by eliminating the need for sutures to fasten the mesh to the affected area. The inventors have further recognized that the developed warp knit fabric has multiple possible embodiments and possible applications, including various medical applications and industrial textile applications. Exemplary industrial textile applications include, but are not limited to, industrial netting for shipping and/or cargo restraint applications, netting for marine or aquatic applications, agricultural and hydroponic applications, or the like.
As illustrated in the figures, the warp knit fabric 100 has two different knitted portions 21 and 22 created using strategically differing knitting sequences, each knitted portion 21 and 22 extending across the width W of the fabric 100. The first knitted portion 21 is formed using a first knitting sequence 31 and the second knitted portion 22 is formed using a second knitting sequence 32, wherein the same textile strands are used in both the first and second sequences 31 and 32. The two knitted portions are alternated in the machine direction along the length L of the fabric 100, and may be alternated at various interval lengths along the fabric as required based on the particular application of use for the fabric 100. Whereas the first knitted portion 21 is constructed to form a fabric portion that is continually connected across the width W, the second knitted portion 22 is characterized by forming at least two strips 23 extending parallel and lengthwise in the machine direction. The strips 23 are detached from one another along their lengths L″, such that the fabric 100 has slits 26 or holes between the strips 23 and that run the length L″ of the strips 23, which is approximately or nearly the length of the second knitted portion 22.
The strips 23 extend from the first knitted portion 21 and may generally continue the knitting sequence, or pattern, of the first knitted portion 21, with only a change in the pattern along the lengthwise edges 27 of the strips 23. Thus, portions of the second knitting sequence 32 may be the same as the first knitting sequence 31—i.e., the pattern executed by certain guide bars may remain the same for both the first knitting sequence 31 and the second knitting sequence 32 (
Since the warp knit fabric 100 is knitted from a single set of textile strands, and the strands are not cut anywhere along their lengths, the disclosed fabric 100 has excellent durability and avoids fraying or failures, including at the juncture between the knitted portions 21 and 22 where the warp knit fabric 100 changes from having a unitary width to forming two or more strips 23. Depending on the intended application of use, the disclosed warp knit fabric 100 may be constructed using any number of warp knitting patterns, or sequences, using any type of textile strand, including any filament, filament yarn (including single filament or multi-filament yarns), or spun yarn. Likewise, the textile strands may be of a synthetic or natural material. For example, in certain embodiments of the warp knit fabric 100 for medical applications, the textile strands 17 may be of a synthetic biocompatible material such as, but not limited to, polypropylene, polyethylene terephthalate polyester, expanded polytetrafluroethylene (ePTFE), polyglactin, polyglycolic acid, trimethylene carbonate, poly-4-hydroxybutyrate (P4HB), polyglycolide, polyactide, and trimethylene carbonate (TMC). In other embodiments, the textile strands 17 may be from biocompatible and biological materials, including, but not limited to, human dermis, porcine dermis, porcine intestine, bovine dermis, and bovine pericardium. The textile strands 17 may also comprise a combination of synthetic and biologic materials.
The warp knit fabric 100 may be a tightly knitted, solid-looking fabric, or may be an openwork knit, such as a mesh, having openings, or pores, throughout.
Referring to
The lengths of the respective first and second knitted portion 21 and 22 may vary. In the embodiment of
The color ledger at the bottom of
The implantable mesh is formed by cutting the fabric 100 widthwise along the second knitted portion 22, such as along dashed lines 36a and 36b. For example, cuts may be made across the entire width W of the fabric 100, thereby cutting each of the strips 23. For example, the cuts may be made half way along the length L″ of each second knitted portion 21, such as with a heated knife so that the ends 12 of each extension do not fray. Thereby, the fabric 100 is cut into several implantable meshes 1.
The mesh body 7 has a surrounding edge 9 from which the mesh extensions 3 extend. At least two mesh extensions 3 extend from the mesh body 7, and, in various embodiments, the implantable mesh 1 may have any number of additional mesh extensions 3. In the embodiment of
The mesh extensions 3 of the implantable mesh 1 have sufficient length L′ to permit multiple anchor points with surrounding tissue upon implantation. An anchor point is a position where the mesh extension passes through some portion of the surrounding tissue in order to provide a force against migration or dehiscence. Multiple anchor points refers to more than one anchor point. For example, each mesh extension 3 may be passed through the surrounding tissue multiple times, such as by weaving or sewing the mesh extensions 3 into the tissue with the fixation device 5. Additionally, in some embodiments the distal end 12 of the mesh extension 3 may be secured to bone. Thereby, the implantable mesh 1 of the present disclosure is configured such that, upon implantation, it can withstand substantial forces, including tensile stress, without failure. This device and implantation method is especially applicable for providing a durable reconstruction or repair of a tissue defect, such as a repair of an abdominal hernia or a breast reconstruction.
A properly implantable mesh 1 is able to withstand increased tensile stress compared to prior art devices that are sutured to surrounding tissue by conventional anchoring methods. One force distribution mechanism at play is frictional resistance, which is distributed across numerous points of contact between the implantable mesh 1 and the surrounding tissue. The amount of frictional resistance between the implantable mesh 1 and the tissue may depend on numerous factors, including, but not limited to, the area over which the tensile stress is distributed, forces that press the mesh into the tissue, the relative roughness of the mesh and the tissue, the method of fixation, and the extent of bioincorporation of the mesh into the tissue. As long as frictional resistance exceeds tensile stress at each of the anchor points, or points of contact, the mesh will not migrate or dehisce.
In an exemplary embodiment, the length L′ of the mesh extensions 3 is at least 10 cm. In another embodiment, the length L″ of the mesh extensions 3 is at least 16 cm, 18 cm or 20 cm long and may be up to 25, 30, 35 or 40 cm long; and in still other embodiments the mesh extensions 3 may be even longer than 40 cm to allow for fixation to certain tissues or for the distal end 12 of the mesh extension 3 to be fixed to bone. However, in certain applications, the mesh extensions may be less than 10 cm, such as where the implantable mesh 1 is small and/or intended for repair or reconstruction of tissue that does not withstand significant forces. The mesh extensions 3 of the implantable mesh do not need to all be the same length. In one embodiment, at least one mesh extension is at least 18, 20 or 22 cm long, but the implantable mesh may include additional mesh extensions that are less than 18 cm long or longer than 22 cm long.
The mesh extensions 3 may have any of various widths. For the embodiment of
In
The use herein of the terms “including,” “comprising,” or “having,” and variations thereof, is meant to encompass the elements listed thereafter and equivalents thereof, as well as additional elements. Embodiments recited as “including,” “comprising,” or “having” certain elements are also contemplated as “consisting essentially of” and “consisting of” those certain elements.
Recitation of ranges of values herein are merely intended to serve as a shorthand method of referring individually to each separate value falling within the range, unless otherwise indicated herein, and each separate value is incorporated into the specification as if it were individually recited herein. For example, if a concentration range is stated as 1% to 50%, it is intended that values such as 2% to 40%, 10% to 30%, or 1% to 3%, etc., are expressly enumerated in this specification. These are only examples of what is specifically intended, and all possible combinations of numerical values between and including the lowest value and the highest value enumerated are to be considered to be expressly stated in this disclosure.
This patent application is a national stage filing under 35 U.S.C. 371 of International Application No. PCT/US2017/037023, filed Jun. 12, 2017, which claims the benefit of priority of U.S. Provisional Patent Application No. 62/348,211, filed Jun. 10, 2016, both of which are incorporated herein by reference in their entirety.
Filing Document | Filing Date | Country | Kind |
---|---|---|---|
PCT/US2017/037023 | 6/12/2017 | WO | 00 |
Publishing Document | Publishing Date | Country | Kind |
---|---|---|---|
WO2017/214620 | 12/14/2017 | WO | A |
Number | Name | Date | Kind |
---|---|---|---|
752033 | Clewley | Feb 1904 | A |
1139342 | Clewley | May 1915 | A |
1139343 | Clewley | May 1915 | A |
1803476 | Kappler | May 1931 | A |
2233664 | Deri | Mar 1941 | A |
2369651 | Amidon | Feb 1945 | A |
2691286 | Cooper | Oct 1954 | A |
2992550 | Frith, Jr. | Jul 1961 | A |
3084529 | Scheibe | Apr 1963 | A |
4074543 | Schmidt | Feb 1978 | A |
4133191 | Blore | Jan 1979 | A |
4215453 | Matsuda | Aug 1980 | A |
4497187 | Yamaguchi | Feb 1985 | A |
4753088 | Harrison | Jun 1988 | A |
5797283 | Kaczmarczyk | Aug 1998 | A |
5894743 | Bredemeyer | Apr 1999 | A |
6305875 | Matsumoto | Oct 2001 | B1 |
6374643 | Orima | Apr 2002 | B2 |
7587915 | Kaneda | Sep 2009 | B2 |
7775170 | Zafiroglu | Aug 2010 | B2 |
7892377 | Lais | Feb 2011 | B2 |
9884140 | Shalaby | Feb 2018 | B2 |
10178991 | Bailly | Jan 2019 | B2 |
20010042388 | West | Nov 2001 | A1 |
20030100954 | Schuldt-Hempe et al. | May 2003 | A1 |
20040049260 | Dong | Mar 2004 | A1 |
20080208360 | Meneghin | Aug 2008 | A1 |
20100192638 | Wall et al. | Aug 2010 | A1 |
20100197999 | Deegan et al. | Aug 2010 | A1 |
20110130774 | Crioscuolo et al. | Jun 2011 | A1 |
20130055765 | De Ridder | Mar 2013 | A1 |
20140190215 | Schmitz | Jul 2014 | A1 |
20140237747 | Torri | Aug 2014 | A1 |
20180110605 | Couderc | Apr 2018 | A1 |
20190309449 | Chikada | Oct 2019 | A1 |
Number | Date | Country |
---|---|---|
2503497 | Sep 1975 | DE |
2727218 | Dec 1978 | DE |
1 172 785 | Jan 2002 | EP |
1172785 | Jan 2002 | EP |
2340769 | Jul 2011 | EP |
1319508 | Mar 1963 | FR |
198793 | Jun 1923 | GB |
1284937 | Aug 1972 | GB |
2511484 | Sep 2014 | GB |
02074649 | Mar 1990 | JP |
Entry |
---|
“Implantable Material Selection: Nonresorbable Biocompatible Materials: Resorbable Biocompatible Polymers.” ATEX, 2016, www.atextechnologies.com/medical-textile-process/improve-innovative-ideas/implantable-material-selection/. (Year: 2016). |
Office Action issued Mar. 2, 2020 in counterpart China patent application 201780041014.X. |
PCT International Search Report and Written Opinion dated Oct. 31, 2017 in counterpart PCT Application No. PCT/US/17/37023. |
European search report dated Jul. 17, 2020 in counterpart European Patent Application 17811156.3. |
Number | Date | Country | |
---|---|---|---|
20190153640 A1 | May 2019 | US |
Number | Date | Country | |
---|---|---|---|
62348211 | Jun 2016 | US |