Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Patent
1996-12-03
1998-09-15
Bockelman, Mark
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
604174, 604282, A61M 2500
Patent
active
058073540
DESCRIPTION:
BRIEF SUMMARY
The invention concerns a permanently implanted peritoneal-dialysis catheter consisting of a flexible catheter tube.
In EP 0 436 154 A1 (Verreet et al.), a Trascutaner Implantatkatheter (Ger.), i.e. a transcutaneous implanting catheter is disclosed, which comprises a first section functioning as a manifold conduit, a second section made of a polyurethane fibre fleece, both of them being incorporated subcutaneously, and a third, extracorporal section. The solution of the said reference is intended to strenghten the said third, extracorporal section in comparison to the said second section. Evidently, no constructional measure is foreseen to protect the patients from inflammations caused by irritating the entry/exit site of the catheter, which occurs when dislocating the extracorporal section of the catheter.
The peritoneal dialysis, the approach thereto, the surgical implantation of a peritoneal catheter as well as catheter-related complications such as infections of the catheter exit site and of the subcutaneous tunnel are clearly and systematically analyzed in Peritoneal Dialysis, ed. Karl D. Nolph, Kluwer Academic Publishers (1989), Dordrecht, The Netherlands.
Of decisive importance for the beginning of inventive activity was the authors'statement in the above reference that the use of a catheter, which in the case of peritoneal dialysis is practically permanently implanted into the patient, is accompanied i.a. by frequent inflammations of the subcutaneous tunnel, particularly the sinus tract thereof i.e. the section of the subcutaneous tunnel between the catheter entry/exit site and the nearest subcutaneous cuff, and of the entry/exit site itself, by the leaking of the dialysis fluid from the abdominal cavity along the outer mantle surface of the catheter, which particularly occurs with single-cuff catheters, and even by peritonitis.
A basic object of the invention was, therefore, to provide measures for protecting the patients from the said inflammations. One line of investigating the causes of inflammations was based on the supposition that the apparatus involved in the dialysis system was faultless. However, in spite of eliminating the possible subjective causes of infections one after the other, inflammations occurred. It turned out that the infections were mainly caused by the catheter entry/exit site on the patient's abdominal wall being continually irritated due to practically continuous changing of the position of the outer section of the catheter. Due to the movements of the free end of the catheter, the neighbouring patient's tissue is subjected to stretching in all directions with respect to the surface area of the abdomen and, additionally, deformations of the skin in the inward and outward directions as well as spiral windings of the skin and of the subcutaneous layer occur.
It has been established that in spite of using double-cuff catheters (two cuffs mean two retaining/anchoring locations of the catheter in the patient) and in spite of penetrating the patient's skin by the catheter tube normally, or essentially normally, to its surface (normal positioning is less stressful for the skin than angular implantation) and in spite of the catheter tube being made of a biocompatible material, which as such is flexible and (from the point of view of the material) not aggressive to the tissue, which all should have been sufficient for eliminating the foreseeable problems, the catheter in use, when its outer free segment is freely moved, evidently behaves substantially as a rigid body in the region of the sinus section of the tunnel; therefore a local irritation of the mouth of the sinus section cannot be excluded.
A solution of the above problem based on moving one of the cuffs to the surface of the patient's abdominal wall and arranging it there in a suitable manner in order to secure the entry/exit site of the catheter would generate several new problems. Hence the said solution has not been elaborated on.
Finally, the object of the invention crystallized as the question how the catheter tube its
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Bockelman Mark
Sadula Jennifer R.
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