Surgery – Devices transferring fluids from within one area of body to...
Reexamination Certificate
1999-02-25
2001-07-24
Seidel, Richard K. (Department: 3763)
Surgery
Devices transferring fluids from within one area of body to...
C604S523000
Reexamination Certificate
active
06264624
ABSTRACT:
BACKGROUND OF THE INVENTION
The present invention relates to a system for use in delivering a drainage catheter within a body cavity. More particularly, it is directed toward a preassembled device configured to provide single-step deployment and repositioning of a drainage catheter within the body cavity.
A drainage catheter or stent is widely recognized as an efficient and effective device for treating an obstructed body cavity, such as the ducts of the biliary tree or a ureter. These stents are used to bypass and drain an obstructed lumen and can be configured for long-term positioning within the lumen. It should be understood that the terms “drainage catheter” and “stent” can be used interchangeable with reference to these applications.
While drainage catheters are highly useful, proper placement of the drainage catheter often is a difficult and time-consuming procedure. Typically, an endoscope is first placed into the body cavity and positioned at the proper anatomical area. In this regard, a distal end of the endoscope is placed in close proximity to the desired area of drainage catheter placement. If necessary, a pre-dilating device is directed through the distal end of the endoscope to dilate the stricture. The dilating device is removed from the endoscope and replaced by a guide wire. Then, a guide catheter is placed over the guide wire and positioned near the stricture. The drainage catheter or stent is placed over the guide catheter until a proximal end of the drainage catheter is beyond a proximal end of the guide catheter. A push catheter is then placed over the guide catheter until a distal end of the push catheter abuts the proximal end of the drainage catheter. The drainage catheter is then pushed via the push catheter down the length of the guide catheter until the drainage catheter reaches the desired body cavity location. At this point, the drainage catheter is manipulated via the push catheter to secure the drainage catheter within the ureter.
Once properly positioned, the guide catheter and guide wire are removed from inside of the push catheter and the drainage catheter. The push catheter remains in place to prevent movement of the drainage catheter during removal of the guide catheter and guide wire.
Every effort is made to secure the drainage catheter at the proper location within the body cavity. However, there are times when the drainage catheter is placed too far into the body or migrates to a less desirable location in which case there are several time-consuming secondary procedures available. These may include placing the endoscope back into the body and directing a tool into the endoscope to grasp the drainage catheter and pull it back into position. It is impossible to retract the drainage catheter relative to the body cavity with the push catheter because there is only one point of interaction between the two components. Thus, retraction of the push catheter simply pulls the push catheter away from the drainage catheter. Positioning of the drainage catheter is unaffected by the push catheter retraction.
Drainage catheters or stents are highly useful devices. However, the procedures involved in positioning a drainage catheter or stent are highly time-consuming and leave little room for error. In fact, it is impossible to retract a drainage catheter with present push catheters without the use of additional tools. Therefore, a substantial need exists for a drainage catheter delivery system configured to allow one-step placement and simple repositioning of the drainage catheter.
SUMMARY OF THE INVENTION
The present invention provides a drainage catheter or stent delivery system for deploying a drainage catheter or stent within a body cavity. The delivery system includes a guide or guide catheter, a push catheter or placement catheter, a drainage catheter and a retention device. For purposes of this specification, it is understood that the term “drainage catheter” includes a stent.
The guide catheter is defined by a proximal end, an intermediate portion and a distal end. The push catheter includes a proximal end, a distal end and a central lumen running from the proximal end to the distal end. The central lumen of the push catheter is preferably sized to slidably engage an outer circumference of the guide catheter. Similarly, the drainage catheter includes a proximal end, a distal end and a central lumen sized to slidably engage an outer circumference of the guide catheter. Finally, the retention device is configured to selectively secure the drainage catheter to the push catheter. In one preferred embodiment, the retention device is a suture secured to the distal end of the push catheter.
The delivery system of the present invention is assembled by first sliding the push catheter over the intermediate portion of the guide catheter such that the proximal end of the push catheter is near the proximal end of the guide catheter. Similarly, the drainage catheter is slidably placed over the intermediate portion of the guide catheter, distal the previously-positioned push catheter. The retention device selectively secures the push catheter to the drainage catheter. In one preferred embodiment, the drainage catheter includes a passage from an outer circumference to the central lumen of the drainage catheter, defining a barb. The retention device, which preferably includes a suture extending from the distal end of the push catheter, is passed through the passage in the drainage catheter and around the guide catheter otherwise positioned within the central lumen of the drainage catheter.
During use, the delivery system of the present invention is pre-assembled as previously described. The delivery system is positioned with a body cavity such that the drainage catheter is proximate a desired location in the body cavity. The guide catheter is held stationary while the push catheter is slid over the guide catheter toward the distal end of the guide catheter. The distal end of the push catheter is sized to interact with the proximal end of the drainage catheter. Thus, distal movement of the push catheter imparts a distal movement onto the stent. Distal movement of the push catheter and reciprocal distal movement of the drainage catheter along the guide catheter is continued until the drainage catheter is positioned at the desired body cavity location.
Proximal movement or retraction of the drainage catheter is also available via movement of the push catheter. In this regard, the retention device transfers a retraction movement of the push catheter to the drainage catheter.
Once the drainage catheter is properly positioned within the body cavity, the drainage catheter is released from the guide catheter and push catheter. In one preferred embodiment, the push catheter is maintained in a stationary position while the guide catheter is retracted relative to the drainage catheter. As the distal end of the guide catheter nears the proximal end of the drainage catheter, the retention device is released from the drainage catheter.
In an alternative embodiment, the guide catheter includes a tapered tip at the distal end thereof. The guide catheter is configured such that upon final assembly, the tapered tip extends from the distal end of the drainage catheter. During use, the delivery system is directed into the body cavity such that the tapered tip of the guide catheter dilates a stricture in the body cavity.
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Desmond, III Joseph P.
Perkins D. H.
Sherwood Leslie P.
Boston Scientific Coporation
Crompton Seager & Tufte LLC
Rodriguez Cris
Seidel Richard K.
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