PROCEDURES

BACKGROUND OF THE INVENTION

During arthroscopic surgery the flow of fluids and suction to the site must be controlled based on the surgeon's needs. Normally, fluid control is achieved with the use of a mechanical pump. Mechanical pumps have high initial costs plus maintenance costs and there is always the possibility that, during surgery, a pump will fail. There is always a risk of electric conduction injury and a risk of compartment syndrome where fluid pressure in a compartment exceeds venous pressure causing a loss of circulation to a limb or muscle group. This risk can be even greater with some of the current mechanical fluid systems when fluid leaks into spaces outside the joint as occurs in acute trauma when there is communication between the joint and local soft tissue. The invention gravity controlled positive pressure, in combination with the various modes of flow, reduces this risk and can eliminate the need for a tourniquet, thereby also reducing tourniquet related injuries due to vascular compromise and postoperative lactic acid accumulation in a limb.

There is a need in the art for a fluid control device not relying on a mechanical pump that provides adequate flow, control of direction of the flow and control of the flow rate.

Existing electromechanical systems are based on constant pressure or constant flow. The invention has distinct advantages over such a system because it only replenishes fluid that flows out of the joint, decreasing the amount of soft tissue swelling during the course of the procedure. Also, the gravity based system creates positive pressure environment in the joint to decrease intraarticular bleeding. Also, the system has multiple modes of flow allowing for more ways to clear intraarticular debris in the joint. SUMMARY OF THE INVENTION

The fluid control device is attached to tubes carrying irrigation solution to form the system. The control device splits the flow through a fiber optic scope and a fluid control unit. The fluid control unit controls rate of flow and direction. The flow of fluid into the joint, out of the joint, or no flow is easily controlled by the operator. The device also allows more than one inflow, useful when using suction or suction shaving devices. The increased flow prevents collapse of a joint space and maintains clear visualization. The fluid flow relies on gravity by having a fluid reservoir positioned at a high point in the system.

BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 shows the fluid control device in each of three positions.

Figure 2 shows views of the fluid control device.

Figures 3-8 show the system in various modes used during surgery.

Figure 9 is an alternate embodiment of the fluid flow control system and device.

Figure 10 is an alternate embodiment of the fluid flow control system and device.

Figure 11 is an alternate embodiment of the fluid flow control system and device.

Figure 12 is an alternate embodiment of the fluid flow control system and device.

Figure 13 is an alternate embodiment of the fluid flow control system and device.

Figure 14 is an alternate embodiment of the fluid flow control system and device.

Figure 15 is an alternate embodiment of the fluid flow control system and device.

Figure 16 is an alternate embodiment of the fluid flow control system and device.

Figure 17 is an alternate embodiment of the fluid flow control system and device.

Figure 18a, 18b, 18c shows variations of the control device.

Figure 19a and 19b show views of the slider device of the control device; Figure 20 shows the control device with flow markings thereon.

Figure 21a, 21b, 21c, and 2 Id depict variations of the slider device of the control device.

Figure 22, displays a variation of the control device. Figures 23a, 23b, 23c, 23d, 23e and 23f display a side view of variations of the slider device.

Figures 24a and 24b display variations of the control device.

Figure 25a, 25b, 25c and 25d display variations of the control device.

DETAILED DESCRIPTION OF THE INVENTION

Figure 1 shows a fluid control device 10 having three ports 12, 14, 16. A slider is positioned between the two ports 12, 14. In Figure 1A, the slider 18 is in the central position and there is no fluid communication between any ports. In Figure IB, the slider is moved to the right position and fluid flows between port 12 through port 16. In Figure 1C, a slider is moved to the left position and there is fluid communication between the port 16 and port 14.

Figure 2 shows the front rear end perspective view of the fluid control device. In the front view, the slider and port 16 are seen. In the rear view, the ports 12 and 14 are seen, as well as the slider. This perspective view shows all three ports 12, 14, 16 and the slider 18.

Figure 3 shows the complete fluid control system, with fluid reservoirs 20 each having an outlet line 22 connected to a fluid divider, such as a Y junction 24, with line 26 leading from the Y junction 24 to a second Y junction 28. A single reservoir may be used which would be connected to the line 26. A first line 30 leads from the Y junction 28 to an arthroscope 32. A second line 34 extends from the Y junction 28 to the port 12 on the fluid control device 10. Leading from the port 16 is a line 36 terminating in a flow port cannula 38. A drain line 40 is connected to port 14 and leads to a gravity drainage 42.

The various modes of operation of the system, including the control device 10, are seen in Figures 4-8. Figure 4 shows a dual inflow operation with flow extending through ports 12 and out port 16 to the flow port cannula 38 and also having fluid flow through the arthroscope 32. The slider is moved to the right. In Figure 5, the slide 18 is moved to the right allowing fluid flow into port 12 and out port 16 but fluid flow through the arthroscope exits out the side ports of the scope sheath. In Figure 6 the slide 18 is moved to the left and fluid flows from the reservoir to the arthroscope 32 and drainage fluid flows up through port 16 and out port 14 to the drainage 42. In Figure 7, the slide is moved to the left and fluid flow through the arthroscope exits the side port of the scope sheath, but fluid extends up through the flow port cannula into port 16 and out port 14, eventually to the suction drainage 42. Lastly, in Figure 8, the slide 18 is in the middle position and fluid from the reservoir extends only through the arthroscope with no flow of fluid through the device 10.

The device allows fluid flow to be easily altered to meet the current demand, using no other driving force than gravity, although a pump could be used in conjunction with the system.

While the invention has been described with reference to a preferred embodiment, variations and modifications would be apparent to one of ordinary skill in the art. The invention encompasses such variations and modifications.

In Figure 9, the valve device 10 can be used in alternative configurations namely, its use or uses in multiple surgical situations or to meet the needs or preferences of a given surgeon. In this way the device could be configured with the scope 32 attached to the valve control device 10 instead of the independent cannula 38, as shown in Figure 1.

Referring to Figures 10, 11 and 12, the device can be used to only control fluid into one cannula 38 or arthroscopic instrument 32. In this arrangement, the flow into and out of the scope 32 or cannula 38 (Figure 12), the flow rate and direction, can be controlled with one device.

Figure 13 illustrates the ability to attach the fluid source 58 to one larger bag or other fluid containing device or surgeon preference. The device 10 and its configuration can be set up with one or more bags (Figure 9) of fluid and or a single large bag for extended use.

There are also preferred configurations with more than one controller 10 (Figures 7, 8, 9 and 10). This allows for independent control of each port. The system can now control the rate and direction of flow into two cannulas. This allows for four different flow states along with control of fluid flow rate in each of the four flow states. They are

Figure 14 - Inflow to the accessory portal 38 and out the scope 32.

Figure 15 - Inflow to the scope 32 and out the accessory portal 38.

Figure 16 - Inflow into both the scope 32 and the accessory portal 38. Figure 17 - Outflow into both the scope 32 and the accessory portal 38.

An alternative embodiment for the flow device controller 10 is shown (Figure 18a in the off position, Figure 18b in the inflow position, and Figure 18c in the outflow position) along with a new control slider (Fig 19a and 19b). The internal structure of the fluid controller device allows for a simpler central sliding control piece 54. As a result, this would decrease the cost of manufacture and make the device more accessible. Furthermore, the central sliding control piece 54 has an opening with an elongated shape 56 that tapers at each end 56. This is to allow for better control of fluid rate in lower fluid flow states of operation. In Figures 19a and 19b, the thumb control 52 has a pointer or marker on it so the control box 10 can be marked with calibration lines 44, (markings) adjoining the slider, to make the fluid control flow rates quantifiable by the user or surgeon (Fig. 20). The holes or openings in the slider device can be made of any shape, size or number (Figures 21a- d) to best effect fluid control of any given configuration or flow rate or direction desired.

In another alternative embodiment, the control device can have various configurations. One configuration is seen in Figure 22, which illustrates a thumb or finger wheel controller 62 instead of a thumb or figure slider device 62. This design allows for even more complexity or options on the design of the fluid control holes and modes of operation as shown in Figures 23a-f.

Further embodiments of the control device (Figures 24a, 24b, and 25a-d) are depicted that can be used with any of the prior configurations. The concept is a cylindrical controller 66 and simple rotation of a "t" handle 62 that can change direction or flow rate. In this way a simple rotation can change the direction and because a single flow control hole or opening 68 can be drilled, molded or manufactured (Figure 25a) into the control cylinder 66 at an angle such that a 180 degree rotation of the "t" handle changes direction and rate of the fluid flow. The invention avoids the need for complex electronics, a vacuum or a pump, however this embodiment allows for a simple one way or two way variable speed servo motor 64 attached to the control shaft 70 to control the rotation and creating a new method of operation of the flow system and the possibility of truly remote control of the fluid rate and direction.

A multiple hole cylindrical controller 66 (Figures 18c and 18d), in this way, differing holes or openings can set up a great variety of fluid control states and settings on the device to maximize the function and the fluid control.

Various modifications or changes to the spirit of the invention are also contemplated and part of the unique fluid flow controller and method of operation.