Controlled vacuum cassette in ophthalmic retinal surgery

United States Patent im

Gillette et al.

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US005584824A [11] Patent Number: [45] Date of Patent:

5,584,824 Dec. 17, 1996

[54] CONTROLLED VACUUM CASSETTE IN OPHTHALMIC RETINAL SURGERY

[75] Inventors: Richard J. Gillette, County of Lincoln; James C. Easley, County of St. Charles, both of Mo.

[73] Assignee: Syntec, Inc., Winfield, Mo.

[21] Appl. No.: 255,659
[22] Filed: Jun. 8,1994

[51] Int. CI.6 A61M 1/00

[52] U.S. CI 604/319; 604/320; 604/119

[58] Field of Search 604/30, 34, 317-320,

604/118, 119, 133, 141, 149, 321, 323;

137/192-194

[56] References Cited

U.S. PATENT DOCUMENTS 3,768,478 10/1973 Fertik 604/320

4,475,904 10/1984 Wang 604/119

4,626,248 12/1986 Scheller 604/319

4,650,477 3/1987 Johnson 604/321

4,706,687 11/1987 Rogers et al 128/752

4,758,238 7/1988 Sundblom et al 604/319

4,773,897 9/1988 Scheller et al 604/34

4,838,281 6/1989 Rogers et al 128/752

Primary Examiner—Debra S. Brittingham

Assistant Examiner—Mark O. Polutta

Attorney, Agent, or Firm—Polster, Lieder, Woodruff & Luc

chesi

[57] ABSTRACT

The invention relates to a cassette and vacuum aspiration collection system for ophthalmic surgery. The cassette comprises two parts under vacuum where the smaller part discharges into the larger part and the vacuum provided to both parts is provided by a single unit. The vacuum control system has improved response to the user's demand.

11 Claims, 2 Drawing Sheets

CONTROLLED VACUUM CASSETTE IN
OPHTHALMIC RETINAL SURGERY

FIELD OF THE INVENTION

5

The present invention relates to an apparatus for controlling vacuum in ophthalmic surgery. More particularly, the invention relates to a cassette and to a vacuum aspiration collection system containing the cassette. The cassette provides rapid response to the vacuum requirements. 10

BACKGROUND OF THE INVENTION

In ophthalmic retinal surgery there exists a need for controlled vacuum. This vacuum can be used to remove debris, fluids or gases from the eye. It may also be used to 15 manipulate membranes or other structures. When a vacuum is used to perform various tasks during surgery, different vacuum levels are required. Ideally, a surgeon is allowed to choose the appropriate vacuum level as the requirements change. This is normally accomplished through the use of a 20 foot pedal. As the foot pedal is depressed, the vacuum level is increased proportionally. Most desirably, the vacuum level should track very closely to commands from the foot pedal or other control device.

Another requirement of the vacuum control system is to quickly and easily dispose of the aspirant (fluid or material suctioned or removed from the surgical process). Usually this is accomplished by flowing the aspirant into a bottle, bag or other container which generally has a volume of about 250 cc or more. The container is desirably transparent in order to aid in observation of the contents. These containers are commonly referred to as aspiration cassettes or aspiration bags. The aspiration cassette (cassette) should have enough capacity to capture the entire aspirant generated during a surgical procedure without overflowing or releasing fluids into the rest of the vacuum system.

Desirably, the cassette is simple to operate and inexpensive to manufacture as well as reliable during use. Since the vacuum control system is used for surgery, the system 4Q should operate quietly so as not to be a distraction.

In the past, various systems have been used to provide the vacuum control. One method uses a peristaltic pump. The aspiration line is connected to the surgical instrument at one end, runs through the pump and then empties into a bag or 45 container at the other end. The vacuum is pulsed because of the roller action. It is difficult to measure and control the actual vacuum in the aspiration line without invading the line. The traditional method for changing the vacuum is to change the speed that the roller turns. It is difficult to control 50 the pump speed rapidly enough to vary the vacuum synchronous with the changing requirements.

Most methods utilize a vacuum pump for a vacuum source. The vacuum is modulated by changing the pump speed or by using a variable orifice control for the vacuum. 55 The vacuum is usually applied to a container to capture the aspirant. An aspiration line is connected to the container at one end and the surgical instrument at the other. In order for the vacuum to be responsive to the surgical requirements, the vacuum pump must evacuate the container volume. If the 60 vacuum pump is sized so as to evacuate the volume quickly, the pump is prohibitively large. The most popular current method applies a Venturi as the vacuum source. This method requires a separate air source generally supplied by a tank of compressed nitrogen. In order to change the vacuum being 65 generated, either the pressure to the Venturi can be modulated or the vacuum generated can be changed. As is the case

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with the vacuum pump, the vacuum is routed to a container. Since the system uses a separate pressure source, a change in vacuum is effected more quickly than with a vacuum pump, but the response time is still less than ideal. A higher flow Venturi could be used, but the increased input flow is objectionable. An internal air compressor could be included in the system, but like the vacuum pump, the compressor would be prohibitively large.

In order to increase vacuum responsiveness without increasing input air flow requirements, one system uses a cassette that is comprised of two containers. A smaller container has aspirant and controlled vacuum by a Venturi routed to it. When the system senses that the smaller container is almost full, it temporarily interrupts the vacuum. It then applies vacuum from a second Venturi to the larger container. This causes the aspirant to transfer from the smaller container into the larger one. Although this method works better than its forerunners, the vacuum response is still slower than desired, a separate pressure source is required, and the cassette mechanism is complex.

Objects to be met in the development of a new system would include: deposit of aspirant with no interruption of vacuum level; quick response of vacuum level when needed; sufficient containment space for aspirant; simple and inexpensive parts; and, requirement of only one vacuum source.

SUMMARY OF THE INVENTION

The present invention provides a surgical cassette which has two interconnected chambers. The first chamber is the smaller and has a volume of at least about 25 cc. The second chamber has a volume at least about four times that of the first chamber. The chambers are interconnected by a controlled orifice. When the chambers are under vacuum, the level of vacuum in the first chamber is at least about 40 mm Hg absolute less than in the second chamber thereby assisting the passage of aspirant through the controlled orifice from the first chamber to the second larger chamber. The vacuum level in the first chamber is substantially uninterrupted when the aspirant is passed from the first chamber to the second chamber.

The present invention further provides a surgical suction control system for aspirating and cutting tissue comprising:

(a) a cassette having two interconnected chambers, a first chamber having a volume of at least about 25 cc and a second chamber having a volume at least about four times that of the first chamber, the chambers being interconnected by a controlled orifice whereby aspirant is passed from the first chamber to the second chamber;

(b) a vacuum pump connected to the second chamber to provide a vacuum of at least about 400 mm Hg absolute, the vacuum being maintained at a predetermined level;

(c) a vacuum conduit interconnecting the second chamber to the first chamber to provide a vacuum means for the first chamber;

(d) a vacuum regulator to regulate the vacuum in the first chamber to a level selected by an external control means, the level being at least about 40 mm Hg absolute less than the vacuum level of the second chamber; and

(e) an aspiration line connected from the first chamber to a surgical device.

More specifically, the present invention provides a cassette with two chambers which require only a small vacuum