Claims for Patent: 4,634,422

Summary for Patent: 4,634,422

Title:	Percutaneous access device and method for implanting same
Abstract:	A percutaneous access device (PAD) is provided with a sleeve or separable member which may be detached from the device to enable the culturing of a multilayer fibroblast coating on the member in a stable and undisturbed environment. The member is constructed so that when it is assembled into the device and the device is implanted in a patient, the cultured coating of the member is exposed to the patient\'s dermis whose fibroblasts will, after a relatively short healing period, merge with the fibroblasts of the coating to form a barrier layer interlocked with the member to prevent epidermal ingrowth or marsupialization of the implanted device. Implantation techniques for further facilitating the formation of the dermal barrier are also disclosed.
Inventor(s):	Kantrowitz; Adrian (Pontiac, MI), Freed; Paul S. (Bloomfield Hills, MI), Vaughan; Frizell L. (Ann Arbor, MI), Bernstein; Isadore A. (Ann Arbor, MI), Gray; Robert H. (Ann Arbor, MI)
Assignee:
Application Number:	06/615,883
Patent Claims:	1. In a percutaneous device adapted to be implanted beneath the skin of a patient and to project outwardly through the skin; the improvement comprising a detachable member adapted to be assembled to said device at a location such that the external surface of said member constitutes the surface of said device which passes through and is exposed to the dermis of the patient when the device is implanted, means defining a multiplicity of pores or cavities in said external surface of diameters and distribution such that a dermal cell placed at random on said external surface will overlie at least two of said pores or cavities, said pores or cavities having diameters between about 0.5 and about 1.0 microns and depths of at least three times their respective diameters. 2. The invention as defined in claim 1 wherein said external surface is covered with a cultured autologous miltilayer fibroblast coating prior to being assembled upon said device. 3. The method of implanting a percutaneous device beneath the skin of a patient with a portion of the device projecting outwardly through the skin wherein that portion of the surface of the device which, when implanted, is exposed to the dermis is constituted by a nanoporous surface on a member detachable from the device, said method comprising the steps of: A. surgically forming a pocket beneath the dermis of a patient, B. inserting into said pocket a dummy device having a shape substantially similar to that of that portion of the percutaneous device which, when the percutaneous device is implanted, will lie beneath the epidermis of the patient, C. allowing said dummy device to remain undisturbed in said pocket for a period of time sufficient to allow resorption of surgical debris resulting from the formation of the pocket, D. removing the dummy device from said pocket and inserting the percutaneous device with the detachable member assembled thereto into said pocket after the detachable member has been cultured with a multilayer fibroblast coating on the nanoporous surface and attached to the access device prior to insertion into the pocket. 4. The method defined in claim 3 comprising the further steps of allowing said percutaneous device to remain undisturbed in said pocket for a period of time sufficient to permit integration of the fibroblast coating on said member with the dermis of the patient before excising the epidermis to provide extracorporeal access to said device. 5. The method of applying a multilayer fibroblast coating upon a nanoporous surface comprising the steps of: A. placing a quantity of finely minced dermal tissue in a tripsin or collagenase solution and refrigerating said solution for about 18 hours, B. removing the enzyme solution and resuspending the minced tissue in a complete medium comprising Eagle's minimum essential medium supplemented with fetal bovine serum plus growth additives, C. stirring the mixture at room temperature for one hour and removing the resulting cell suspension from the tissue and sedimenting said suspension, D. resuspending the sediment in the aforementioned complete medium and seeding the resulting suspension in the cultured flask, E. adding more complete medium to the remaining tissue and stirring the mixture for three or more hours, F. removing the resulting cell suspension from the tissue and sedimenting said suspension, G. resuspending the sediment in the aforementioned complete medium and seeding the resulting suspension in a cultured flask, H. repeating steps F and G to obtain the cell suspension for seeding a third cultured flask, I. incubating the seeded flask at 35.degree. C. in a humidified atmosphere of 5 percent carbon dioxide and 95 percent air for 10 days, J. harvesting the resulting fibroblasts by suspending them in fresh complete medium with ascorbic acid added, and K. immersing the nanoporous surface to be coated in the suspension described in Step J contained in a culture well and incubating said culture with daily addition of fresh ascorbic acid for a period sufficient to bond a multilayer coating to the said surface.

Details for Patent 4,634,422

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Smith & Nephew, Inc.	SANTYL	collagenase	Ointment	101995	06/04/1965		2039-03-29