Patent Application
20090036996
Mesh fabric prostheses are used in various surgical procedures including repair of anatomical defects of abdominal wall, diaphragm, and chest wall, correction of defects in the genitourinary system, and repair of traumatically damaged organs such as the spleen, liver, or kidney. Hernia repairs are among the more common surgical operations that employ such prostheses.
Surgical repair mesh fabrics are constructed from a variety of synthetic fibers in the form of knitted and woven fabrics.
Ventral hernias can be repaired using open or laparoscopic techniques that include intraperitoneal or preperitoneal placement of a prosthetic biomaterial (e.g., mesh or patch). In the US it is estimated that about 16% (US Markets for Soft Tissue Repair 2006, Millennium Research Group) of ventral hernias are repaired using an open preperitoneal technique while in Europe the percentage is much higher, approximately 69% (European Markets for Soft Tissue Repair 2006, Millennium Research Group). In these cases, open knit meshes of polypropylene comprise the material of choice, providing high in-growth, the ability to treat if infected, and sufficient initial stiffness to enable ease of use during implantation of the prosthetic. However, it is reported in the literature that meshes constructed from polypropylene elicit a prolonged inflammatory response (Klosterhalfen et al., Expert Rev Med Devices (2005); January 2(1): 103-17) (Klinge et al., Eur J Surg (1999); 165: 665-673) or chronic foreign body response (FBR). This tissue response may lead to potentially serious long-term complications such as mesh erosion, mesh migration, fistulas, aggressive adhesions when in contact with the viscera and a reduction in postoperative compliance leading to patient discomfort. Studies within the literature have evaluated methods to reduce these responses. The solution most commonly pursued is the use of monofilament, large pore, reduced material polypropylene meshes. These meshes present a reduced surface area for biological interaction thereby reducing the foreign body response. An improved solution is through substitution of polypropylene with a more biocompatible material such as polytetrafluoroethylene (PTFE). PTFE knit mesh currently exists in the market, for example one such brand is Bard® PTFE Mesh, however it lacks the appropriate monofilament, reduced material, large pore structure. Even so, due to the inherently lower modulus of the material, PTFE knit articles have inferior handling (stiffness), compared to the preferred characteristics of polypropylene mesh. Conventional methods of raising the stiffness of the knit article result in increased foreign body and or the introduction of an additional material that takes away from the biocompatibility of the construct. The ideal PTFE knit prosthetic mesh should be constructed such that it combines the ideal structure and material without sacrificing the desired handling. The present invention addresses this limitation and enables the creation of a highly biocompatible, monofilament, reduced material, large pore prosthetic mesh with appropriate handling for the reconstruction of hernias and other soft tissue deficiencies.
In one embodiment of the invention is provided a knitted article with a knitted structure having at least one PTFE fiber with oriented fibrils forming multiple fiber cross-over points wherein the PTFE fiber is self-bonded in at least one of the cross-over points. The fibrils in the knitted structure are able to self-bond while oriented essentially non-parallel to each other. In another embodiment the PTFE fiber is a monofilament PTFE fiber.
A knitted PTFE surgical mesh is provided which exhibits both a desirable material and unique handling features, without the need of a bonding additive. The unique ability of the PTFE knit to form articles without the addition of bonding additives, to achieve tissue integration, favorable anti-inflammation results, and good biomechanical resistance for soft tissue repair is an unexpected result derived from the present invention.
A knitted article is constructed of a yarn having at least one PTFE fiber. The term PTFE is meant to be inclusive of expanded polytetrafluorethylene (ePTFE). The PTFE fiber comprises oriented fibrils. The PTFE fiber may be microporous or non-microporous. In one aspect the PTFE fiber 4 is a monofilament PTFE fiber. In another aspect, the PTFE fiber may be at least two different PTFE fibers having differing deniers, density, lengths or dimensional differences. In another aspect of the present invention, a multiple strand yarn which is comprised of at least one PTFE fiber and at least one other type of fiber that is not PTFE may be knitted. In this aspect, the PTFE fiber in the multiple strand yarn self-bonds at the crossover points of PTFE fiber crossed over PTFE fiber. The PTFE fiber may be the same strand or a differing strand in the same multiple strand yarn.
A non-microporous PTFE fiber prevents the penetration and harboring of bacteria. Open knitted structures provide for tissue in-growth and may provide for better infection treatable implants. A PTFE knit is a monofilament structure in its simplest form. The structure may be filled or loaded with therapeutic agents, to facilitate, for example, drug delivery, as desired.
The PTFE fiber is knitted into an article, forming multiple fiber cross-over points formed where the PTFE fiber is in contact with itself. The PTFE yarn is configured into the desired knit pattern and the knit pattern is then heat treated to increase stiffness. The heating bonds the PTFE fiber onto itself in at least one cross-over point.
One way to form the knitted structure 2 of the present invention is by configuring the PTFE fiber 4 into a knit pattern formed onto or attached to a restraining means 12, and exposing the knitted structure 2 to heat while the knitted structure 2 remains fully constrained, thus preventing the knitted structure from contracting or moving. The restraining means 12 may be a pin hoop, clasp, frame, or any suitable mechanism which allows the knit to be firmly affixed and heated. When exposed to heat, the PTFE fiber 4 will shrink in a primarily longitudinal manner. This shrinkage causes the constrained article on the pin hoop to become taut which creates pressure at the cross-over points or the intersections of the fibers within the knitted article.
It was unexpected that PTFE fibers self-bond without externally applied pressure and heat or the use of a bonding agent. This type of bonding is an advantage in producing a fully PTFE or fully ePTFE knit article. The temperature at which the fibrils are able to self-bond ranges from between 327-400° C. A controlled temperature of between 350-370° C. and a controlled exposure time for a period of about 5-10 minutes may be desired in the processing of meshes.
The stiffness of the knit may be increased with longer durations of heating at a controlled temperature setting. The self-bonding of two or more PTFE fibers with oriented fibrils is a result of being contacted under heat and fiber to fiber tension, allowing the fibers to fuse or lock at the interfaces of the fibers without the need of a bonding agent. When the fibrils are fused together, they are prevented from relative movement with regard to each other, referred to as cross-fibril locking. The knitted structure 2 may be cooled prior to removing from the restraining means. The cooled article may then be cut into a finished geometry using various methods known in the art. The bonding at the multitude of fiber intersections within the textile results in a significant increase in the stiffness of the article providing more preferred handling characteristics. For instance, if desired, the resulting stiffness of a knit structure can be increased by at least 50%, over the same knit structure in a non-self-bonded form. Accordingly, various knit patterns and fiber deniers may result in differing stiffness measurements.
The stiffness of PTFE knitted structures may be modulated as desired by choice of material thickness and composition, and measured by standard tests, i.e. INDA Standard Test IST 90.3 (95) Handle-O-Meter of Nonwoven Fabrics. For instance, a PTFE knitted structure in the form of a single thickness mesh may be formed having a mass between 50-70 g/m2, 70-90 g/m2, or 90-165 g/m2 and having a stiffness of greater than 25 g, 35 g, or 50 g, respectively.
A surprising feature of the knitted structure 2 is that the PTFE fiber 4 comprises oriented fibrils 6 which may be self-bonded in a relatively non-parallel configuration which allows the structure to have increased pattern stability and stiffness.
A PTFE knit structure of the present invention is able to be easily handled due to the self-bonded regions, hence providing additional stability and stiffness to prevent twisting and wrinkling associated with traditional PTFE articles. Similarly, articles formed of the present invention may provide a patient with a more comfortable article which provides support to the injured area and also provides the patient with greater flexibility of the in situ article.
As exemplified in
The PTFE knitted structure 2 can further be gravure printed with a discrete pattern of adhesive. The pattern can be designed such that it closely matches that of the knit pattern allowing maximum surface coverage with absorbable adhesive. The knitted structure 2, with adhesive present, can then be laminated to a non-woven self adhering web. Other methods for manufacturing the composite article include but are not limited to thermal bonding, sewing, solvent bonding, using a tie layer of a separate absorbable material to join layers or permanent layer coatings or similar known means for forming composite articles. One skilled in the art could use these processes to achieve a multi-layer composite article of at least one PTFE knitted structure 2 and at least one functional layer.
Other examples of articles of the present invention include PTFE knit structures formed into surgical meshes and incorporated into multi-layer composite constructions having individual absorbable and non-absorbable layers imbibed throughout at least a portion of the PTFE knitted structure 2, as illustrated in
The PTFE surgical mesh may be coated with absorbable or drug-eluting compositions as described in the examples below or coating methods known in the art. Additionally, it is within scope of the present invention that a bioactive agent, antimicrobial agents, and/or antibiotics may be embedded in the drug-eluting compositions prior to coating the PTFE surgical mesh. The bioactive may be an analgesic, non-steroidal-anti-inflammatory drug (NSAID), or an anesthetic.
Table 2 illustrates a typical example of knitted mesh as utilized by this invention. These examples are illustrative only and are not intended to limit the scope of the present invention. Various knit patterns may be used to form the PTFE knits used in the present invention.
The overall hand, or average textile stiffness, was measured for each of the knit examples in Table 1 according to INDA Standard Test IST 90.3 (95) Handle-O-Meter Stiffness of Nonwoven Fabrics. A summary table of original stiffness can be found below in Table 3. As seen by Table 2 and Table 3, various knit patterns and fiber deniers may result in differing stiffness measurements.
The untreated PTFE knits exemplified in Table 2 were treated to increase stiffness by attaching the textile to a pin hoop such that when exposed to heat the material will be fully constrained, thus preventing the article from contracting. The pin hoop is constructed of stainless steel, has a diameter of approximately 24 inches, and has 0.020 inch pin needles approximately 1 inch in length that are spaced evenly every 1-2 inches around the perimeter. The pin hoop, with textile firmly affixed, was then heated to 365° C. for 7 minutes. This treatment results in self-bonding at the fiber cross-over points.
The article described in example 3 was cooled to room temperature, removed from the pin hoop. The cooled article was cut into a finished geometry. The bonding at the multitude of fiber intersections (self-bonds) within the textile results in a significant increase in the stiffness of the article providing more preferred handling characteristics. Table 3 discloses the stiffness measurements of PTFE knits disclosed in Table 2 before and after self-bonding at the fiber cross-over points.
Although several examples are described here, one skilled in the art may easily influence mesh mass by changing stitch pattern, fiber denier, or fiber density to influence final mesh stiffness. One skilled in the art may also use different constraining and thermal treatment methods to obtain similar results.
While particular embodiments of the present invention have been illustrated and described herein, the present invention should not be limited to such illustrations and descriptions. It should be apparent that changes and modifications may be incorporated and embodied as part of the present invention within the scope of the following claims.
