Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1999-11-08
2003-07-08
Casler, Brian L. (Department: 3762)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
Reexamination Certificate
active
06589212
ABSTRACT:
TECHNICAL FIELD OF THE INVENTION
This invention relates to a surgical implement guide and more particularly to a flexible guide used to percutaneously introduce a surgical instrument, including a cannula and a trocar, into or through various tissue.
BACKGROUND OF THE INVENTION
Peritoneal dialysis is a procedure in which a sterile glucose and salt solution is placed into the peritoneal cavity. The solution plus impurities are removed from the blood at some later time and fresh fluid is reinfused or the cycle can repeat itself. Peritoneal dialysis is effective for treatment of kidney failure and has been used for more than 30 years for this purpose.
One of the most successful devices used for peritoneal dialysis is the Tenckhoff catheter developed in the mid 1960's. This catheter is a silicon rubber tube with numerous drainage holes on its inner portion. Generally, the catheter has two polyester (e.g. Dacron
R
) “cuffs” which are respectively placed in the subcutaneous tissue and the muscle layer of the patient. These cuffs serve to limit peritoneal leakage, minimize infection and enclose the catheter in the body. The issue arises in the placement of the catheter.
Likewise, insertion of catheters into blood vessels is frequently accomplished percutaneously, where a needle with a guide wire is used to initially enter the vessel, rather than use a surgical cut-down procedure. Early procedures used the puncture needle itself as the direct conduit into the abdomen or a blood vessel for a catheter of sufficiently small diameter.
Subsequent art first developed metal sheaths and/or trocars that were formed with a slot, or were split into two distinct pieces for subsequent removal. Rapid development in the art substituted thin-walled plastic sheaths, or other suitable material, for the metal sheaths. The most common such prior art sheath is generally known as a “split sheath”. It consists of a cylindrical sheath which, at the distal end is formed to taper to a small diameter opening to permit insertion of a guide wire. The opposing proximal end typically has two handles or finger stops formed on opposing sides of the sheath. Score marks are formed along the full length of the sheath and are designed to cause the guide to split apart when the handles are pulled, facilitating the removal of the guide from the body.
The process of implanting a catheter with this type of split sheath is called the Seldinger Technique. Specifically, in this technique a needle is inserted into a blood vessel. A stainless steel braided wire is then inserted through the needle into the blood vessel, and then the needle is retracted.
The catheter is inserted into the sheath and the opposite or trailing edge of the wire is inserted into the distal opening of the sheath. The wire is pushed through the distal end of the catheter and out the proximal end. Then the sheath with the catheter is pushed into the blood vessel, using the wire as a guide. The cone-shaped end of the guide/sheath enters the vessel wall so that the main body of the sheath can be inserted into the blood vessel. After the majority of the sheath, preferably between about 75% to about 80%, is inserted into the vessel, the wire is removed by pulling it out through the sheath tip.
The physician then grasps the handles and simultaneously pulls them apart one from the other, causing the sheath to split. While the sheath is being split, it is simultaneously retracted from the blood vessel. It should be noted that retracting the sheath may cause the catheter to be inadvertently retracted during this step. If so, then the catheter must be advanced again back to its original position. The same procedure is utilized to gain access to the peritoneal region.
The process of splitting, retracting, and readvancing is repeated as necessary until the sheath is totally removed, and the catheter fully and accurately positioned. If the catheter does inadvertently come out at any point during the process, the entire process must be repeated, beginning with the insertion of the needle.
Generally, during the process, the sheath becomes covered in fluid, making it difficult to grasp. Thus, the above discussed sheaths have a disadvantage in that both hands must be employed to remove the sheath, leaving the catheter unattended, unless an assistant is present. In some instances, it was found that pulling on the sheath caused it to tear prematurely. Another example of a split sheath is disclosed in Y.TEC's Peritoneoscopic Placement of Peritoneal Dialysis Catheters. This sheath attempts to solve some of the disadvantages of the prior art, displaying a guide with a tip and a substantially flat tab. The tab is substantially flat and smooth and can be difficult to grab when it becomes covered in fluid. Again, both hands must be employed, or some other device, such as a hemostat, must be used.
Another disadvantage is that such prior art sheaths tend to be of a predetermined specific diameter which is not adjustable. These sheaths generally don't provide alternatives, nor are they adaptable to accommodate different types of catheters, trocars, or instruments, or even patient situations.
SUMMARY OF THE INVENTION
The present invention provides a device which overcomes the above discussed problems using a surgical implement guide sized for insertion into tissue. The guide includes a shaft formed of a flexible material with memory to return to a predetermined configuration, or with ability to have a new or different memory set into it, an opening and passage way of infinitely adjustable dimensions between a predetermined minimum and maximum dimension extendable through the entire length of the shaft and an elongated tab member having at least one textured surface extending from the shaft that acts as a handle for placing, removing or controlling the guide.
In particular, the present invention comprises a surgical implement guide sized for insertion into tissue and a surgical assembly employing the guide. The guide includes a shaft formed of a flexible material with memory to return to its predetermined configuration. The shaft is adapted to receive a catheter in a chamber defined in the shaft. Moreover, the shaft includes an elongated tab member, preferably a tab integral with the shaft, extending from the shaft that is used as a handle to both place, control and remove the guide.
The guide further includes an opening and passageway of adjustable dimensions as well as a tip portion for the shaft. Preferably the tip is integral with the shaft. The passageway preferably extends axially the entire length of the shaft, although some lesser distance can be utilized depending on the application as long as it allows for removal of the catheter. The tip is situated opposite the elongated tab member. The tip configuration can vary and is selected to assist in the insertion of the guide.
The guide may have many different forms to accommodate different surgical instruments, surgical procedures, patients or surgeons. The tab member can be integral with the shaft or joined thereto, and have a width substantially equal to or less than an outer circumference of the shaft. The tab can be substantially flat, curved or pointed in relation to the shaft and rectangular, angled or curved in shape. Moreover, the guide and the tab can have at least one smooth surface and one textured surface, or portion thereof, or two textured surfaces or portions thereof.
Likewise, the tip and shaft configurations can vary depending on the application. The tip can have an outer diameter substantially equal to or less than the outer diameter of the shaft, so that the tip is pointed, blunted, round, angled or even curved in some fashion. Furthermore, the shaft's outer diameter can be substantially the same over its entire length, so that it is substantially cylindrical in shape, or it can vary over the length of the shaft so that it is substantially conical or truncated in shape.
Numerous other advantages and features of the present invention will become readily apparent from the following detailed des
Casler Brian L.
Janin Group, Inc.
Lam Ann Y.
Olson & Hierl Ltd.
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