Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2001-05-30
2003-07-08
Lazarus, Ira S. (Department: 3749)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S090000, C604S102010, C604S107000, C604S174000, C604S164040, C606S232000
Reexamination Certificate
active
06589208
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to medical and surgical devices, and more specifically to catheter assemblies.
2. Description of Prior Art and Related Information
Catheter assemblies are generally inserted through body conduits to provide access to body cavities so as to enable medical procedures to be performed less invasively. In certain procedures, such as surgery or drainage, it is necessary for the catheter to be temporarily anchored in the body cavity to allow the desired procedure to be completed.
Different mechanisms have been provided for the purpose of deploying a catheter within a body cavity in order to prevent withdrawal during a procedure. One example includes an inflatable balloon disposed on the tip of a catheter. Once the tip is within the body cavity, the balloon is inflated through an inflation lumen running through the shaft of the catheter. The presence of the inflation lumen, however, increases the necessary diameter of the shaft which must also accommodate a second lumen intended for the desired procedure, such as a drainage lumen.
A larger catheter diameter, however, increases discomfort. While decreasing the diameter of the inflation lumen may contribute to a slightly smaller overall diameter of the catheter, an inflation lumen with a small diameter is more likely to develop kinks in the passageway, obstructing the flow of fluid necessary to inflate and deflate the balloon.
Conventional balloons are not liquid permeable. In drainage procedures, therefore, ports must be provided in the shaft at a location outside of the balloon. In typical catheters where ports are disposed on the shaft proximate to the balloon, a greater length of the catheter must be inserted into the body cavity in order to provide fluid communication between the ports and the liquid within the cavity. This greater “stack profile” increases discomfort. Furthermore, particular body cavities can only accommodate a-certain length of catheter. Therefore, limited room is available for the placement of ports on the shaft, which leads to a small overall area for drainage. This smaller area contributes to excessive residual liquid remaining in the body cavity which may lead to infections and other complications.
Conventional catheters, including balloon catheters, must be manually deployed. Thus, an operator must gauge when the tip portion of the catheter, including the balloon, is sufficiently within the target body cavity in order to initiate inflation. Predilation, resulting in severe trauma to the patient, can occur if the deploying device, such as a balloon, is prematurely expanded in the narrow body conduit connected to the cavity.
The removal of conventional catheters is also problematic because manual manipulation is required. A typical anchor, such as a balloon, deployed in the body conduit is configured in its expanded, high-profile state. Before the catheter may be withdrawn, the conventional anchor must be manually returned to its low-profile state so that it may re-enter the narrow body conduit. Various mechanisms are provided in the prior art for manually converting the anchor from its high-profile state to its low-profile state. One existing method includes inserting a stylet through the catheter to push the distal tip out in order to form the low-profile state. The necessity for manual manipulation in conventional assemblies increases time, effort, expense and inconvenience in withdrawing a catheter.
SUMMARY OF THE INVENTION
The present invention provides structures and methods which overcome the deficiencies of the prior art.
In one aspect, a method is provided for inserting a medical instrument through a body conduit and for anchoring the medical instrument in a body cavity. The method comprises the steps of providing an elongate tube having a shaft proximal end and a shaft distal end, affixing a stop along the tube at an anchoring position, forming an anchoring device with an anchor proximal end and an anchor distal end, providing the anchoring device with characteristics including a high-profile state when the anchor proximal end and the anchor distal end are in a generally proximate relationship, and a low-profile state when the anchor proximal end and the anchor distal end are in a generally spaced relationship, and mounting the anchoring device relative to the tube with the anchor distal end movable between a distal end proximal position distal of the stop and a distal end distal position, and with the anchor proximal end movable between a proximal end proximal position and a proximal end distal position proximal of the stop.
The method also comprises the steps of inserting the tube into the body conduit toward the body cavity, and during the inserting step, moving the anchor proximal end to the proximal end proximal position with the anchor distal end at the distal end proximal position to maintain the anchoring device in the low-profile state. The method further comprises the steps of positioning the tube with the stop in the body cavity, and withdrawing the tube sufficiently to move the anchor proximal end to the proximal end distal position and to provide the anchoring device with its high profile characteristics.
The step of withdrawing the tube comprises the step of moving the anchor proximal end to the proximal end distal position within the body cavity. The method further comprises the step of releasably locking the distal end of the anchoring device in the distal end proximal position, retracting the shaft from the body cavity, during the retracting step, releasing the anchor distal end from the distal end proximate position; and, after the releasing step, moving the anchor distal end to the distal end distal position to space the anchor distal end from the anchor proximal end so as to provide the anchoring device with its low-profile characteristics during the retracting step.
The releasably locking step comprises the step of coupling the anchor distal end to a suture engaged in a proximal direction. The releasing step comprises the step of disengaging the suture from the proximal direction. The step of forming an anchoring device comprises the step of forming a bulb, the step of forming a hinged wing structure, or the step of forming a spiral. The method further comprises the step of draining fluid from the body cavity with the anchoring device and the tube.
In another aspect, a method is also provided for inserting a catheter assembly through a body conduit and automatically deploying the assembly into a body cavity. The method comprises the steps of coupling an anchoring device with an anchor proximal end and an anchor distal end to a tube, providing the anchoring device with characteristics ranging between a high-profile state when the anchor proximal end and the anchor distal end are in a generally proximate relationship, and a low-profile state when the anchor proximal end and the anchor distal end are in a generally spaced relationship, disposing a stop on the tube between the anchor proximal end and the anchor distal end, automatically forming the low-profile state upon inserting the anchoring device into the body cavity, and automatically forming the high-profile state upon withdrawing the tube with the anchoring device disposed in the body cavity.
The step of automatically forming the low-profile state comprises the step of forming the low-profile state only by inserting the tube in a distal direction. The step of automatically forming the high-profile state comprises the step of forming the high-profile state only by moving the tube in a proximal direction once the anchoring device is disposed in the body conduit without any manual manipulation of the anchoring device.
Once the anchor distal end is disposed in the body cavity, the method further comprises the step of moving the anchor distal end from a distal end proximal position adjacent to the stop to a distal end distal position further from the stop to facilitate a low-profile state for removal of the anchoring device. The step of
Dulak Gary R.
Ewers Richard C.
Pravong Boun
Applied Medical Resources Corporation
Lazarus Ira S.
Myers Richard L.
Nguyen Tu Cam
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