Single-use indicator for a surgical instrument and a surgical instrument incorporating same

A single-use indicator is provided and is particularly well suited for use with a surgical catheter device. The indicator includes an absorbent filament or wick which is placed in a transparent or translucent indicator lumen of a multi-lumen catheter. The lumen is provided with at least one side port. When the catheter is inserted into a blood vessel, blood enters the indicator lumen through the side port and is absorbed by the filament, thus turning the filament red or purple in color. When the instrument is removed from the blood vessel, the stained filament is clearly visible as an indicator that the instrument has been used. Because the filament is trapped inside a lumen of a relatively long catheter, it is difficult or impossible to remove it during a remanufacturing process.

INCORPORATION BY REFERENCE

The following co-owned patents and applications, the complete disclosures of which are incorporated by reference herein, are useful in understanding the applications of the present invention: Ser. Nos. 10/358,523 [SYN-053CIP]; 10/621,943 [SYN-079]; 10/544,082 [SYN-080]; 10/922,221 [VRX-001CIP1]; 10/922,123 [VRX-001CIP2]; 11/624,412 [VRX-006]; 11/624,431 [VRX-007]; and 11/675,919 [VRX-011], U.S. Pat. No. 7,077,836 entitled “Methods and Apparatus for Sclerosing the Wall of a Varicose Vein”, published International Application WO 2006/076699, entitled “Valve System for a Medical Device Having an Inflatable Member”, published International Application WO 2006/023203, entitled “An Occludable Intravascular Catheter for Drug Delivery and Method of Using the Same”, and published International Application WO 2004/071612, entitled “Methods and Apparatus for Treating the Interior of a Blood Vessel”.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates broadly to surgical instruments. More particularly, this invention relates to single-use surgical instruments. Most particularly this invention relates to an indicator which indicates whether a surgical instrument has been used.

2. State of the Art

The manufacture of surgical instruments comprises a very large industry. Some surgical instruments are designed for multiple use. That is, they are cleaned and sterilized after use for use again. Single-use surgical instruments have been available for more than twenty years. These surgical instruments are used only once and then discarded as medical waste.

There is a great desire to reduce the per procedure cost of surgery. This has given rise to a substantial secondary market for companies engaged in salvaging, cleaning, and sterilizing used single-use surgical instruments.

SUMMARY OF THE INVENTION

The invention provides a single-use indicator for a single-use surgical instrument.

The invention provides an indicator that clearly indicates that a surgical instrument has been used.

The invention provides a relatively tamper proof single-use indicator for a surgical instrument.

The invention provides a single-use indicator which is easy to incorporate into a single-use surgical instrument.

The invention provides a single-use indicator which is inexpensive.

The invention provides a single-use indicator which is reliable.

The invention also provides a single-use surgical instrument which incorporates a single-use indicator.

The invention provides a single-use indicator which is particularly well suited for use with a surgical catheter device such as the devices disclosed in the previously incorporated co-owned applications and patent. The indicator includes an absorbent filament or wick which is placed in a transparent or translucent indicator lumen of a multi-lumen catheter. The lumen is provided with at least one side port. When the catheter is inserted into a blood vessel, blood enters the indicator lumen through the side port and is absorbed by the filament, thus turning the filament red or purple in color. When the instrument is removed from the blood vessel, the stained filament is clearly visible as an indicator that the instrument has been used. Because the filament is trapped inside a lumen of a relatively long catheter, it is difficult or impossible to remove it during a remanufacturing process.

An exemplary single-use surgical instrument according to the invention includes an elongate body having a proximal end, a distal end, and a plurality of lumens extending there-through. The lumens include an infusion lumen, an occlusion balloon inflation lumen, a guide wire lumen and an indicator lumen according to the invention. Along a length of the elongate body are a plurality of infusion holes in valved communication with the infusion lumen, and a valve member is movable inside the infusion lumen from a first position in which some of the infusion holes are blocked to a second position where fewer of the infusion holes are blocked. An inflatable occlusion balloon is provided at the distal end of the elongate body and is in fluid communication with the inflation lumen. The guide wire lumen has openings at both its proximal and distal ends. The indicator lumen is filled, at least partially, with an absorbent filament or wick and at least one, preferably a plurality of side ports providing fluid communication between the environment and the indicator lumen. The presently preferred material for the filament is 100% fine silk. The elongate body is preferably a single extruded piece of polymeric material (preferably nylon) and is either transparent or translucent to the extent that the filament inside the indicator lumen can be clearly seen. The ends of the indicator lumen are closed by sonic welding or other means so that the filament cannot be removed. The side ports and the filament have relative dimensions such that the filament cannot be removed from the indicator lumen by pulling it through a side port. Preferably. The ends of the silk thread are anchored with glue before the ends of the indicator lumen are closed.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Turning now toFIGS. 1-3, an exemplary single-use surgical instrument10incorporating the invention is of the type described in the previously incorporated applications and patent. The instrument10, which is for treating the interior of a blood vessel, includes an elongate body12having a proximal end14, a distal end16. and an infusion lumen18extending there-through (FIGS. 2 and 3). A plurality of infusion holes20(FIG. 3) are in valved communication with the infusion lumen18. An elongate valve member22(FIG. 2) having a distal sealing element (not shown) is movable inside said infusion lumen18. The elongate valve member is a non-perforate cylinder having a lumen (not shown). By moving the valve member proximally or distally more or fewer elution holes are unblocked.

As seen best inFIG. 1, the proximal end of the elongate valve member22is provided with an infusion port24(a luer lock). The proximal end14of the elongate body12is provided with a hub15. As seen best inFIG. 2, the elongate body12is provided with a second lumen28. The distal end of the second lumen28terminates inside an inflatable balloon30(FIG. 3). An atraumatic tip32is coupled to the distal end of the balloon30. The proximal end of the second lumen28is coupled to the side port36of the hub15shown inFIG. 1. The side port36includes a luer with a luer activated valve for connecting a balloon inflation syringe (not shown). The elongate body12is also provided with a guide wire lumen38(FIG. 2) for a guide wire40. The guide wire lumen38extends from a hole in the tip32to the side port33of the hub15. The side port33is provided with a plug cap to close off the guide wire lumen when not in use.

According to the invention, the elongate body12is provided with a fourth lumen50for an absorbent filament52. The presently preferred filament is an eighteen inch long bundle of six strands of 100% silk each having a diameter of 0.006 inch. The lumen50is provided with at least one, and preferably a plurality of side ports54(FIG. 3). The lumen50and the filament52preferably extend the entire length of the elongate body12. However, the invention will still function correctly provided that the lumen50, the filament52, and at least one of the side ports54are located somewhere along the length of the elongate body which is known to enter a blood vessel during surgery. For example, the distal end16of the elongate body12is certain to be introduced into a blood vessel. However, depending on the patient, a proximal length, e.g.17inFIG. 1, may never enter a blood vessel. Therefore, it is preferred that, if the filament52does not extend the entire length of the elongate body, it should extend proximally from the distal end16of the elongate body12for a visible length. The lumen50containing the filament is preferably sealed at its ends by sonic welding or other means so that the filament cannot be removed. According to the presently preferred embodiment, the ends of the filament are anchored with glue before the lumen is sealed. The side ports54and the filament52have relative dimensions such that the filament cannot be removed from the indicator lumen by pulling it through a side port.

The method of utilizing the apparatus10generally includes introducing the elongate body12over guide wire40into a blood vessel and locating the distal end16at a predetermined location in the blood vessel and the guide wire40is removed. The balloon30is then inflated to occlude the blood vessel. At some point before the next step, the elongate valve member22is adjusted (i.e. the distal sealing element is located to select a treatment length). Then, a treating agent is injected into the infusion port24, through the elongate valve member22and into the lumen18whereupon the agent exits the elution holes20distal of the sealing element. While the elongate body12is present in the blood vessel, blood enters the side ports54of the lumen50and is absorbed by the filament52. When the desired quantity of treating agent has been infused into the blood vessel, the balloon30is deflated and the elongate body12is removed. Once removed from the blood vessel, the instrument10will contain clearly visible evidence that it has been used, i.e. a red or purplish stripe extending the length of the filament52, preferably the entire length of the elongate body12.

There have been described and illustrated herein a single use indicator for a surgical instrument and a single-use surgical instrument incorporating same. While particular embodiments of the invention have been described, it is not intended that the invention be limited thereto, as it is intended that the invention be as broad in scope as the art will allow and that the specification be read likewise. It will therefore be appreciated by those skilled in the art that yet other modifications could be made to the provided invention without deviating from its spirit and scope as claimed.