Surgery – Diagnostic testing – Detecting nuclear – electromagnetic – or ultrasonic radiation
Reexamination Certificate
2001-04-24
2003-04-08
Hindenburg, Max F. (Department: 3736)
Surgery
Diagnostic testing
Detecting nuclear, electromagnetic, or ultrasonic radiation
C604S523000
Reexamination Certificate
active
06546280
ABSTRACT:
TECHNICAL FIELD OF THE INVENTION
The present invention generally relates to medical device and, more specifically, to an indwelling catheter.
BACKGROUND OF THE INVENTION
The following specification, in both the background and in the detailed description, describes the use of the catheter of the present invention in the areas of gastsrostomy and gastrojejunostomy and cecostomy. While the present invention finds particular use in these fields, those skilled in the art will recognize that the catheter of the present invention may be used in any application where connection from the outside of the patients' body to an internal cavity within the body is desired, such as in the biliary tree, the liver, the kidney, etc.
With reference to gastrostomy and gastrojejunostomy procedures as a particular example, catheters for use in these procedures are inserted directly through the abdominal wall of the patient and into the stomach. Gastrostomy catheters can then be used for feeding the patient directly into the stomach, wherein nourishing substances are inserted into an external opening in the catheter and are transported by the catheter to the interior of the patient's stomach. With the gastrojejunostomy catheter, the distal portion of the catheter inside the patient is long enough to be positioned in the jejunum, such that feeding can bypass the stomach entirely.
FIG. 1
illustrates a prior art design for such catheters, indicated generally at
10
. Because these catheters are left in place for extended periods of time, and because they extend externally from the patient, it is necessary that these catheters have some retention means for preventing the catheter from being accidentally removed from the patient. The catheter
10
of
FIG. 1
uses a single, pull string-locked loop inside the stomach for catheter retention. As can be seen by the drawings, the proximal end
12
of the catheter
10
, the fitting
14
, the pull string
16
and the cuff
18
all protrude out of the patient's abdominal wall for a distance of several centimeters. This protruding proximal catheter section can be a source of great distress for many patients. In addition to the emotional stress of having a catheter tube protruding from the stomach, nearly all patients find that lying on the catheter or covering the catheter is uncomfortable. Such prior art catheters are particularly problematic with pediatric patients, who cannot leave the catheter alone and will usually end up pulling the catheter out.
There is therefore a need for a catheter which is designed to extend from an interior cavity of the patient to a point external of the patient, wherein the portion of the catheter which lies external to the patient is minimized. In addition, the catheter must provide means for securely anchoring the catheter in place, such that it is difficult for the catheter to be accidentally removed. The present invention is directed toward meeting these needs.
SUMMARY OF THE INVENTION
The present invention relates to a low profile indwelling catheter having proximal section which is situated external to the patient's body when the catheter is in place. In order to retain the catheter and prevent it from being accidentally dislodged, the catheter includes a series of helical coils which are unformed during catheter insertion and then automatically reform in order to hold the catheter in place internally. The catheter is self-adjusting in that fewer or greater loops will automatically reform depending upon the thickness of the patient's abdominal wall. A flexible connector, such as a suture, is anchored within the catheter near the proximal end and extends through the loops of the catheter. The flexible connector exits through the catheter wall and extends exterior to the catheter back toward the proximal end. The catheter of the present invention is therefore self-adjusting in order to accommodate the distance between the abdominal wall and the stomach, and may be locked into shape by securing the flexible connector to the exterior of the proximal end of the catheter or to some other fixed reference point relative the catheter.
In one form of the invention an indwelling catheter is disclosed, comprising an elongate body having a proximal end, a distal end and an interior lumen therethrough; an exterior flange coupled to the proximal end; a plurality of helical coils formed in the body between the proximal and distal ends and having a central axis passing therethrough; and a flexible connector extending at least partially through the elongate body from substantially adjacent the proximal end; wherein the helical coils may be straightened out by placing a stiffener into the interior lumen in order to facilitate placement of the catheter between an external surface of a patient and an interior cavity thereof; wherein the flexible connector penetrates the plurality of helical coils substantially along a line extending substantially parallel to the central axis; wherein at least one of the helical coils automatically reforms to define a deployed configuration when the stiffener is removed from the interior lumen after placement of the catheter, such that the flange is held against the external surface of the patient and the at least one helical coil is held against an interior surface of the cavity; and wherein the flexible connector may be secured to reinforce the deployed configuration.
In another form of the invention a method of placing an indwelling catheter is disclosed, comprising the steps of: (a) providing an indwelling catheter, comprising an elongate body having a proximal end, a distal end and an interior lumen therethrough; a plurality of helical coils formed in the body between the proximal and distal ends and having a central axis passing therethrough; and a flexible connector extending at least partially through the elongate body from substantially adjacent the proximal end and penetratingly exiting through the elongate body; (b) inserting a stiffener into the interior lumen such that the helical coils are straightened out; (c) inserting the catheter through an external surface of a patient such that the distal end of the elongate body lies within an internal cavity of the patient; (d) holding the elongate body in place while withdrawing the stiffener from the interior lumen, such that at least one of the helical coils reforms within the internal cavity; (e) pulling the flexible connector tight to substantially eliminate flexible connector slack from within the catheter; and (f) securing the flexible connector relative the catheter.
In another form of the invention an indwelling catheter is disclosed, comprising an elongated hollow tube having a proximal end, a first portion, a second portion, and a distal end; a substantially flat cover attached to the proximal end; and a flexible connector anchored near the proximal end extending through the first portion and exiting through the second portion; wherein the first portion is deformable; wherein the first portion is urged to wind into a plurality of helical coils; wherein the first portion may be deformed by the passage of a rigid member therethrough; wherein the flexible connector penetratingly extends substantially linearly through the plurality of helical coils; and wherein the flexible connector is adapted to be secured to prevent deformation of the first portion.
REFERENCES:
patent: 3680562 (1972-08-01), Wittes et al.
patent: 4381765 (1983-05-01), Burton
patent: 5702371 (1997-12-01), Bierman
patent: 5713877 (1998-02-01), Davis
patent: 5718686 (1998-02-01), Davis
patent: 5718691 (1998-02-01), Russo
Cook Incorporated
Hindenburg Max F.
Wingood Pamela L
Woodard, Emhardt, Naughton Moriarty & McNett LLP
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