Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2001-07-12
2003-05-13
Douglas, Steven O. (Department: 3751)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S179000, C604S164040, C604S523000, C604S533000, C604S539000
Reexamination Certificate
active
06562005
ABSTRACT:
Priority benefit under 35 U. S. C. § 119 is claimed to Canadian Patent Application No. 2,346,192 filed May 2, 2001.
FIELD OF THE INVENTION
The present invention relates to catheter buttons for anchoring a catheter to tissue. The invention also relates to a method for anchoring a catheter to a patient's body, by fastening a catheter button to a patient's skin or other body tissue.
BACKGROUND OF THE INVENTION
Catheter buttons consist of small button-shaped devices, typically having a central aperture for receiving a catheter and anchoring means to anchor the button to body tissue. Typically, the anchoring means consist of a pair of apertures on either side of the button, through which a surgeon may suture the button directly onto the patient's skin or other tissue. A catheter is threaded through the central aperture for anchoring the catheter to the patient's body.
Typically, the button is in two parts, namely a disc-like member and a hemispherical member. The hemispherical member has a flat base and in use the disc portion abuts the flat base of the domed portion. The disc may comprise a radio opaque component, for use in radiological procedures. In use, the disc may abut the patient's body tissue with the domed portion projecting outwardly, or the structure may be inverted such that the domed portion abuts the patient's skin or other body tissue. For convenience, the disc portion will be referred to as the “lower” portion and the hemispherical member as the “upper” portion. An aligned central catheter-receiving aperture passes through both upper and lower portions, as do one, two or more aligned smaller apertures to the side of the button for receiving suture thread.
In use, both upper and lower components are joined to the catheter tube by sliding the catheter through the central aperture either before or after the catheter tube has been implanted within the patient's body. After the button has been snugged against the patient's body, the surgeon carefully loops a suture thread through the aligned side apertures and the patient's body, forming a thread loop which is then knotted to anchor the button and catheter in place. The process is relatively time consuming and painstaking, since several steps are required, each of which requires particular care.
Catheter buttons having this two part structure are disclosed in U.S. Pat. No. 4,834,713 (Suthanthiran). As well, such buttons are available commercially.
The primary disadvantages of the prior art system described above are the requirements that the surgeon must separately handle two small button components and that he must carefully direct a suture through the side apertures of the button, as well as the patient's body in order to anchor the button. Typically, the side apertures are relatively long and narrow, and passing a suture through these apertures is a painstaking, time consuming and finicky task which must of necessity occur in the surgical theatre where speed and accuracy are both important. There is also the necessity of separately supplying the two button components, adding to the cost and manpower requirements of performing a medical procedure.
SUMMARY AND OBJECTS OF THE INVENTION
It is an object of the present invention to provide an improved catheter button system which permits a surgeon to rapidly anchor a catheter to a patient's body. It is a further object to provide a method for surgically anchoring a catheter to a patient with a catheter button in a quick and convenient manner.
In one aspect, the invention comprises a catheter button system comprising a catheter button having a primary aperture for receiving a catheter tube and at least one and preferably at least two secondary apertures for receiving suture thread, with a pre-formed loop of cord or thread extending through the secondary apertures. The loop includes sufficient slack to permit a surgeon to catch the loop with a suture needle for stitching through a patient's skin or other tissue. The catheter button may comprise two separate components, the first component being disc-shaped and the second component, abutted against the first component, being generally hemispherical. The primary and secondary apertures extend through both components in an aligned fashion. In this embodiment, the cord loops extend through both components of the catheter button to retain them together. Conveniently, the cord loops comprise suture thread. Preferably, the primary aperture is centrally disposed and the secondary apertures comprise two apertures on opposing sides of the button, equispaced on either side of the primary aperture.
Catheter button systems of the present invention may encompass a variety of sizes and configurations for use with a range of catheter types and sizes and for use with a variety of surgical procedures or interventional radiologic procedures. The catheter button systems of the invention may comprise or consist of radio opaque or radiolucent components, depending on the intended use.
In a further aspect, the invention is a method for anchoring a suture to a patient's body, consisting of the steps of:
providing a suture button, consisting of a primary aperture and at least one and preferably two or more secondary apertures, with a pre-formed cord loop extending through each of the secondary apertures;
joining the button with a catheter by sliding the button onto the catheter through the primary aperture, either before or after an end of the catheter has been implanted within a patient's body;
drawing the catheter button snugly against the patient's skin or tissue;
anchoring the catheter button to the patient, by passing a suture thread through body tissue of a patient and catching the cord loop with the suture thread; and
tying off the suture thread or otherwise fastening the cord loop to the suture thread in a snug fashion.
Preferably, two cord loops are provided on opposing sides of the button and the step of fastening the button to the patient's body tissue comprises separately suturing the two cord loops to the patient.
The invention also comprises a method for providing pre-made catheter button systems on-site at a medical facility. In this aspect, catheter button systems as characterized above are assembled on-site at a medical facility in advance of a surgical or other medical procedure. The button systems are then used in a procedure carried out at a subsequent time at the facility.
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Douglas Steven O.
Ramana Anuradha
Spencer Fane Britt & Browne LLP
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