Surgical kit for implantation of an injection site

Details Surgical kit for implantation of an injection site Surgical kit for implantation of an injection site

1999-01-05

2001-03-27

Maynard, Jennifer (Department: 3763)

Surgery

Controlled release therapeutic device or system

Implanted dynamic device or system

C604S131000

Reexamination Certificate

active

06206871

ABSTRACT:

TECHNICAL FIELD
The present invention is generally related to locoregional chemotherapy treatments through percutaneous arterial approach at several body districts, with particular (but not exclusive) reference to hepatic metastases of colon-rectal tumors.
State of the Prior Art
Locoregional chemotherapy of the hepatic metastases (Hepatic Artery Infusion—HAI) of the colon-rectal carcinoma started at the beginning of the 50's, with surprising results in terms of response to systemic chemotherapy. Case survey in this connection however did not reveal a sure gain in terms of patient surviving. On the other hand, recent clinical studies with new therapeutical protocols and novel proposals to employ HAI as adjuvant or neo-adjuvant both in surgical and in cryosurgical treatments, set again interests and hopes towards this kind of neoplasm treatment, and particularly of the hepatic metastases of the colon tumor.
One of the most relevant obstacles in connection with employing HAI is due to the fact that in the case of metachronous metastases (which are predominant), locoregional chemotherapy can be solely carried out by performing a further surgical operation, consisting of isolating the gastro-duodenal artery and joining up the port catheter into the hepatic artery, and subsequently creating a subcutaneous pocket housing the port itself. This surgical operation is not well accepted by the patients and additionally, in case of thrombosis or catheter displacement or infection, etc. the catheter itself can no longer be used and generally cannot be replaced.
More recent methodologies provide, instead of the above surgical operation, a day-hospital implantation method involving access through the left axillary artery and use of a subcutaneous port, under local anaesthesia. In case of occlusion, failure, displacement or infection, the catheter can be readily replaced so as to prosecute the HAI treatment.
Statement of the Invention
The present invention is related to a kit for performing the above disclosed methodology, i.e. implantation of a percutaneous arterial system for locoregional chemotherapy treatments of hepatic metastases, and more generally of tumors at several body districts such as vesica, pancreas, kidney, etc.
The kit according to the invention is essentially characterized in that it comprises:
an arterial catheter made of a non-thrombogenic material and having a substantial length, to be inserted along an artery leading to the region to be treated, through an introduction opening,
an infusion port to be implanted in correspondence of a subcutaneous pocket like cut formed at a short distance from said introduction opening of the catheter,
a tunnelling assembly to perform percutaneous connection between said arterial catheter and said infusion port, including a cannula needle formed by a metal tubular inner stylet having a tapered and bevelled tip and by an outer jacket made of plastic material and adapted to be axially withdrawn from the inner stylet; a metal guide member to be inserted through said outer jacket of the cannula needle; and a tunneler device formed by an inner tubular dilator made of plastic material and by an outer tubular introduction element made of plastic material, having a slightly tapered distal end and a slightly countersunk proximal end, and relatively to which said inner dilator can be axially withdrawn.


REFERENCES:
patent: 4345606 (1982-08-01), Littleford
patent: 4685905 (1987-08-01), Hedwig
patent: 5078702 (1992-01-01), Poneranz
patent: 5158543 (1992-10-01), Lazarus
patent: 5211644 (1993-05-01), Vanbeek et al.
patent: 5476452 (1995-12-01), Thompson
patent: 5476460 (1995-12-01), Montalvo
patent: 5620419 (1997-04-01), Lui et al.

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