Fabric (woven – knitted – or nonwoven textile or cloth – etc.) – Knit fabric
Reexamination Certificate
2000-11-06
2004-05-18
Juska, Cheryl A. (Department: 1771)
Fabric (woven, knitted, or nonwoven textile or cloth, etc.)
Knit fabric
C428S373000, C428S071000, C428S374000, C428S375000, C428S376000, C428S378000, C442S001000, C442S318000, C442S319000, C442S304000, C442S066000, C623S001210, C623S011110, C623S011110, C623S066100, C623S013190, C623S014110
Reexamination Certificate
active
06737371
ABSTRACT:
The present invention relates to a hernia implant, a method for its manufacture and its use in surgery.
Hernia is a frequently encountered illness. It generally involves a passage of organs or organ parts out of the natural body cavity through a preformed or acquired gap. Inguinal, umbilical and cicatricial hernias are the most frequently encountered external hernias, in which the hernial sac is always surrounded by peritoneum. The reasons for hernias occurring are in particular muscular or connective tissue weaknesses in conjunction with strains, slackening caused by age, congenital weakening of the abdominal wall or inadequate cicatrization following an abdominal incision (cicatricial hernia).
An effective treatment is possible in most cases by a surgical operation, where the content of the hernia is passed back from the hernial sac into the abdomen and the hernial orifice is sealed. The sealing of the hernial orifice generally takes place by means of a suture.
However, this surgical procedure suffers from the disadvantage that in up to 20% of cases a further hernia can occur, which is known as the hernial recidivation or recurrence.
Due to this unsatisfactory recurrence rate following conventional hernia operations, in modern hernia surgery use is being increasingly made of synthetic reinforcing materials for reconstructing the abdominal wall. An important part is played by nets of polyester, polypropylene and polytetrafluoroethylene.
Although the use of such nets has clearly led to a marked reduction in the recurrence rate, these implants give rise to problems as a result of possible infections, the formation of hard scar scales, displacements or fistula formations. Particularly in the hypogastric region, due to leg mobility, a supply with a very elastic implant and elastic scar formation is necessary for rapid healing and freedom from complaints on the part of the patient.
The problem of the invention is to make available a hernia implant for use during surgical operations, which overcomes the difficulties encountered with the prior art implants, which is easy and inexpensive to manufacture and which is easy to handle in standard surgical procedures.
This problem is solved by a hernia implant for use in surgery having a flexible fabric, which is formed from at least two substantially independently constructed textile fabric structures, which are firmly interconnected over the entire surface of the implant so as to form a composite structure. Such a composite structure offers a high initial implant strength.
Preferably, in the hernia implant according to the invention, substantially all the composite components are formed from monofilaments and preferably exclusively from monofilaments. The use of monofilaments in implant structures compared with multifilament yarns is characterized by a reduced infection susceptibility, because germs find no colonization spaces such as are encountered between single fibres.
Advantageously a monofilament can have a thickness of 10 to 500 &mgr;m, particularly 100 to 150 &mgr;m. According to an embodiment of the invention the monofilaments of the independent textile fabric structures essentially have the same thicknesses. According to another embodiment of the invention the monofilaments of the independent textile fabric structures can have different thicknesses.
According to the invention the fabric can be produced by a textile method, particularly knitting, weaving or braiding. Such procedures are known to the expert, so that a detailed description is not provided here. The invention gives preference to knitted fabrics.
Thus, in a preferred embodiment the hernia implant is formed from knitwear, particularly knit goods. This permits a simple, inexpensive manufacture according to known, proven procedures using conventional machines and tools.
Advantageously the individual textile fabric structures can be constructed in the form of net structures, particularly knitted net structures. Knitwear is characterized compared with other textile structures by a higher flexibility of the fabric, which is desirable for uses in medicine. In an embodiment the at least two nets can have substantially the same structure. In another preferred embodiment the at least two nets can have different structures. Differences in the structure can in particular be formed by different binding of the filamentary material in the textile fabric.
The openings or pores of the nets can have random polygonal or oval shapes. For example the net structure can be rhombic, latticed, honeycombed, circular or slot-shaped. Advantageously openings of at least one fabric structure preferably have a substantially hexagonal shape. A knitted net can e.g. have a honeycombed structure and hexagonal pores are surrounded by bridges formed from knitted monofilaments.
According to the invention the individual textile fabric structures can have a pore structure with pore sizes or opening sizes of 0.1 to 10 mm, particularly 0.5 to 5 mm. In an embodiment of the invention the pore sizes of the individual textile fabric structures can be substantially identical. In another preferred embodiment of the invention the pore sizes of the individual textile fabric structures can differ.
According to an embodiment of the invention the individual textile fabric structures can be produced according to the same procedure. According to a further embodiment of the invention the individual textile fabric structures can be produced according to different binding procedures. For example, in a preferred embodiment, one textile fabric is formed by knitting in accordance with the satin or atlas 2-row binding method. In another preferred embodiment one textile fabric can be formed by knitting according to the tulle fillet binding method. The production of the individual fabric structures with different binding methods permits in simple manner the formation of different pore shapes and sizes.
Advantageously the textile fabric structures can be interconnected by textile methods. Particular preference is given according to the invention to the textile fabric structures being interconnected by knitting. In this way fabric structures produced by knitting can be combined to form a composite in simple manner using the same machines and procedures.
According to the invention the textile fabric structures, particularly net structures, can be so mutually arranged that their structure pores, particularly openings do not align and in particular roughly overlap by half. The hernia implant according to the invention can be characterized in that the textile fabric structures, particularly net structures, overlap in both dimensions of the net planes. In this way, for the same weight per unit area, a fabric which is tighter with respect to the passage of substances such as body fluids, cells or microorganisms is obtained than when the net pores are oriented in aligned manner. In addition, a close-mesh textile structure facilitates the growing of the hernia implant into the body and consequently aids rapid healing.
In the case of knitting, such net structures can be produced in that two independent fabrics are constructed on mutually laterally displaced needles. In an embodiment fabrics can be produced with different mesh sizes. In this way e.g. in the internal pore size of a coarser meshed net can be located several meshes of a finer meshed net. With particular advantage such overlapping structures can be produced by the simultaneous knitting with different knitting constructions or bonds.
The hernia implant according to the invention can advantageously be characterized in that it is at least partly absorbable in vivo. The decomposition or degradation of a bioabsorbable polymer takes place by metabolic processes in the body of an animal or human. Body and tissue fluids participate in the reaction. As a result of hydrolysis the polymer chain is split into smaller and more easily soluble fragments. The fragments are further degraded, optionally accompanied by the participation of enzymatic processes. The degradation products are transp
Arnold Anette
Leibl Bernhard
Mueller Erhard
Planck Heinrich
Schmees Hans-Gerd
Deutsche Institute fur Textil-und Faserforschung Stuttgart Stift
Juska Cheryl A.
Meyer Jerald L.
Nath Gary M.
Nath & Associates PLLC
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