Apparatus for collecting surgical fluids

ES 2 230 693 T3

DESCRIPTION

Procedure and apparatus for collecting surgical fluids.

Background of the invention

1. Field of the invention

The present invention relates generically to medical devices, and, in particular, provides devices and systems for collecting surgical fluids during minimally invasive electrosurgery and during other procedures.

Electrocautery has been used for many years as a general surgical tool, particularly for procedures such as transcervical fibroid removal. In a typical fibroid removal, the uterus floods at sufficient fluid pressure to separate the walls of the uterus and make the surgical site suitable for observation. This procedure is generically described as uterine cavity distention. During the flood, a surgical electrocautery tool is placed into the uterus through the cervix. High voltage configured electrical current is transmitted from a cutting surface of the surgical instrument to the surgical site. The electrosurgical device can be both monopolar and bipolar, and the distension fluid can be conductive or not.

Electric current is concentrated on the cutting surface. The heat generated in the tissue resistor by the flow of electrical current is high enough to vaporize cells near the cutting surface. In this way, a cut is made with little physical resistance to the cutting motion, and the heat from the cut cauterizes small blood vessels, helping to maintain visibility and control.

Traditionally, electrosurgical resection of large amounts of tissue has required intermediate water flushing of the internal surgical site to remove severed tissue and electrosurgical debris. Although such intermittent water flushing can restore image quality, it greatly prolongs the time required for a total removal of endometrial tissues targeted during fibroid removal.

More recently, continuous tissue removal procedures and devices have been developed that greatly increase the speed of electrosurgical resection. In particular, resectors have been developed that include morcellators to fragment and remove the severed tissues during resection. Additionally, electrosurgical gross vaporization is now used to remove tissue, while a continuous flow of fluid over the surgical site within the visual range maintains image quality. Each of these new and improved procedures involves a significant increase in total fluid volume when compared to the intermittent water flushing of traditional electrosurgery.

A variety of additional surgical procedures using large volumes of fluid have also been developed, along with laser vaporization, microwave heating (often using a cooled fluid), fluids heated and / or cooled by direct tissue ablation, and the like. Therefore, a wide variety of therapies, both minimally invasive and traditional, now make use of large volumes of surgical fluids. The collection and disposal of these large volumes of surgical fluid are becoming increasingly problematic.

A variety of fluid collection devices are currently available. Unfortunately, existing surgical fluid collection systems were often designed with a small container size, as this was generally sufficient for intermittent flushing with water. In light of the growing awareness of the dangers posed by blood and other surgical waste, these small known devices have been modified to include a disposable liner.

Known coated collection systems primarily have two disadvantages. First, a vacuum within the container often draws fluids into the liner from the surgical site, and known container structures would often have collapsed under pressure loading had they been resized for modern fluid volumes. In other words, simply increasing the size of existing liners to accommodate increased amounts of surgical fluid can cause large pressure loads throughout the liner and / or surrounding vacuum chamber structure, requiring unwieldy and expensive structures.

The second major disadvantage of existing surgical fluid collection systems is that a complex arrangement of tubing is often required to accommodate the many small disposable containers and liners. This complexity increases setup and downtime, increases the likelihood of an error during setup, and greatly increases the likelihood that contaminated surgical fluids will spill during shedding and removal of the liners.

In light of the foregoing, it would be desirable to provide improved surgical fluid collection devices. It would be particularly advantageous if such improved devices could accommodate the large volumes of surgical fluids, which are a by-product of many minimally invasive surgical procedures. It would be especially desirable if such improved devices included a simplified connection arrangement, and facilitated the safe disposal of surgical fluids with minimal risk to the medical personnel in charge.

two. Description of the prior art

US Patent No. 4,516,973 describes a one-piece disposable collection bag having a rigid cover. US Patent No. 4,675,010 describes a chest drain collection system and procedure that makes use of a flexible, disposable collection bag. US Patent No. 5,470,324 describes a non-reflux suction canister system.

US Patent No. 5,279,602 describes an infection control system with aspiration drainage, while US Patent No. 5,437,836 describes a method and container for treating body fluid containing liquid of waste. United States patents n.^you 5,234,419 and 5,185,007 describe aspiration drainage infection control systems.

United States patents n.^you 4,419,093, 4,321,922 and 3,745,999 describe procedures

ES 2 230 693 T3 for receiving and disposing of fluids from the body, and related devices. US Patent No. 5,112,323 describes a wound evacuator. United States patents n.^you 4.930.997, 4.798.578, 4.795.448, 4.775.360, 4.522.623, 4.346.711, 4.060.107, 3.845.765,

3,704,709 and 3,699,815 are also relevant.

German patent application GE 35 00538 describes a discharge receiving bag for suction devices with reduced pressure discharge. The bag can be closed with a lid and liquids sucked from the body or from an operating area can be fed into the bag through a feed line. The bag has an upper clamping element by means of which the bag can be fixed, in the open state, in a vessel opposite the feed line. The bag has openings in the upper region of its wall which allow pressure equalization between the interior of the bag and the interior of the cup, and the bag has a closure means located below the pressure equalization openings.

Summary of the invention

The present invention provides surgical fluid collection devices and systems which are particularly well suited for the collection of large volumes of surgical fluids. A simplified collection system allows individual vessels to be coupled in series using a single flow inlet port and a single flow outlet port in each vessel.

The present invention provides a surgical fluid collector comprising at least one container, each container including: a container having a rigid container body and a container cover, the container body having an open end, the container cover being hermetically closable. receptacle on the open end defining a vacuum chamber; a disposable liner within the vacuum chamber of the canister, the liner defining an interior liner; a vacuum port in hydraulic communication with the liner interior through the rigid receptacle; a fluid flow inlet port in hydraulic communication with the liner interior through the rigid receptacle; characterized by: a one-way valve located between the interior of the liner and the vacuum chamber that surrounds the liner, allowing the valve to flow into the liner and preventing surgical fluid from flowing from the interior of the liner into the surrounding vacuum chamber, in the which the liner comprises a flexible bag and a liner cap, which is more rigid than the liner bag, the one-way valve being mounted on the liner cap, and further comprising an edge extending radially from the liner cap, the edge being locatable between the receptacle body and the receptacle lid to help seal the vacuum chamber, substantially separating the liner cap and the rim. the vacuum chamber in an upper part and a lower part, an opening being provided between the edge and the liner cap to equalize the pressure between the upper part and the lower part of the vacuum chamber.

The one-way valve in the liner prevents fluid from spilling into the surrounding vacuum chamber, and also admits air from the surrounding vacuum chamber into the interior of the liner to equalize pressure throughout the liner when a vacuum is drawn from the inside of the liner. This arrangement allows the use of inexpensive interior volume liners without resorting to complex piping arrangements to equalize pressure.

The valve allows flow into the liner, but prevents surgical fluid from flowing from the interior of the liner into the surrounding vacuum chamber. The valve therefore equalizes pressure through the liner material when a vacuum is drawn through the vacuum port. The valve comprises a simple, reliable and low cost one-way valve.

In another aspect, the present invention provides a surgical fluid collection system further comprising a plurality of containers. A surgical fluid flow inlet tube is coupled to the inlet flow valve of a first container for draining surgical fluids from the body of a patient. An inter-container tube couples the fluid port of a second container with the vacuum port of the first container. Thus, surgical fluids flow through the liner of the first container, and into the liner of the second container when the liner of the first container is full. In most embodiments, each liner contains at least five liters of surgical fluid, and the liners have a combined capacity of at least 20 liters of surgical fluid.

Brief description of the drawings

Figure 1 illustrates a system for collecting surgical fluids in accordance with the principles of the present invention.

Figure 2 illustrates a disposable surgical fluid container liner, for use in the system of Figure 1.

Figure 3 is an exploded view of a rigid polymer canister for use in the system of Figure 1.

Figure 4 is a cross-sectional view of a surgical fluid container in which the liner of Figure 2 is removably disposed within the rigid receptacle of Figure 3, when used in the system of Figure 1.

Figures 5A and 5B are perspective views of an alternative receptacle and liner, in which a gland on the edge of the liner assists in the seal between the lid and the receptacle body, and in which the constriction valves on the pipe flexible tubes can seal the surgical fluid within the liner.

Detailed description of the specific realizations

The present invention enables the collection of surgical fluids into large fluid reservoirs which are connected in a simple series arrangement. This simplified arrangement facilitates setup and disruption of the fluid collection system, and also enhances the ease and safety of transporting and disposing of collected surgical fluids. Hence, the present invention will find applications in a wide variety of medical procedures, including both minimally invasive therapies and open surgery, post-3 care.

ES 2 230 693 T3 surgical procedures and the like. The surgical fluid containers and systems of the present invention will find their most immediate application in minimally invasive surgeries of the thorax, pelvic region and joints, particularly when said minimally invasive surgeries are performed in an internal surgical site flooded with saline, sorbitol, mannitol, sorbitol-mannitol, or with any other conductive or non-conductive fluid medium. The present invention is particularly well suited for use in resection and / or ablation of the endometrial lining of the uterus.

Referring now to Figure 1, a surgical fluid collection system 10 includes four surgical fluid containers 12 coupled together in series. Each container 12 has a pair of ports 14. Tubing 16 couples containers 12 to each other, to a source 18 of vacuum, and to a source of surgical fluids from a patient 20. For example, tubing 16 can couple canisters 12 to an endometrial resection probe such as that described in co-pending United States patent application Serial No. 08 / 542,289, filed October 12, 1995. (Agent File # 16944-000130).

The combined volume of containers 12 will generally have a capacity of at least 10 liters, preferably more than about 20 liters to accommodate the large amounts of surgical fluids used in some of the recently developed minimally invasive surgical procedures. To accommodate such large amounts of fluid, each container 12 will preferably have a capacity of greater than about 5 liters, ideally having a capacity of about 8 liters. This gives a fluid collection system 10 with a total capacity of approximately 32 liters with four containers. This total fluid capacity can be easily varied by fitting additional vessels 12 into system 10. Generally, three to seven containers will be included to avoid the complexity of a greater number of containers and inter-container connecting tubes, and also to limit the weight of each filled container for ease of handling and disposal.

In each of the containers 12, one of the ports 14 acts as a fluid flow inlet port 22, through which surgical fluid from the patient 20 enters the container. Similarly, the other port 14 acts as a vacuum port 24 through which the vacuum source 18 causes the internal pressure within the container to drop. Once the container has reached its predetermined capacity, the surgical fluids entering the inflow port 22 will pass through the container 12 and exit the vacuum port 24 to be stored within another of the containers.

The use of a single port to apply a vacuum, and also to transfer overflow surgical fluids to an adjacent container, allows operation of the surgical fluid collection system 10 with only two ports per container. This simple serial connection or "daisy chain" allows surgical personnel to vary the capacity of the fluid collection system 10 by simply increasing or reducing the number of containers 12 that are connected in line between the patient 20 and the vacuum source 18. . Additionally, the lack of branch interconnections along line 16 minimizes debris and simplifies postoperative cleaning. Allowing air to enter the system once the fluid has been collected can help clean any residual surgical fluids from the tubing and distribute them completely within vessels 12, thereby minimizing the likelihood of any significant spillage while separating the elements from the tubing. collection system 10.

Referring now to Figures 2-4, each container 12 generally comprises a disposable liner 26 and a rigid receptacle 28. Liner 26 includes a flexible polymeric bag 30 that is sealed around the lower perimeter of a semi-rigid or rigid lid 32. Cover 32 supports a one-way valve 34, a hermetically closable cap 36, and a pair of removable valves 38. An edge 40 extends radially from the cap 32, and a significant portion of the edge is separated from the cap by a circumferential groove 42.

Surgical fluids 44 (see Figure 4) are confined within a liner interior 46 26. Liner interior 46 is sealed by the surrounding flexible bag 30 and by cap 32, with the exception of removable valves 38, the cap 36 and a one-way valve 34. Flexible bag 30 typically comprises a polymer, such as polyvinyl chloride (PVC), but can be formed from a wide variety of alternative materials. Similarly, cap 32 ideally comprises acrylic styrene butadiene (ABS), but may alternatively be formed from a variety of materials. Cap 32 will generally have sufficient mechanical strength to substantially maintain its shape while supporting the weight of surgical fluid 44, to facilitate removal of disposable liner 26 from receptacle 28.

A one-way valve 34 is arranged to allow flow from the outer side of the liner 26 to the interior 46 of the liner, but to block flow from the interior of the liner to the surrounding environment. Thus, a one-way valve 34 prevents release of surgical fluids from the liner interior 46 once the liner is full. A one-way valve 34 preferably comprises a simple flapper diaphragm valve such as that commercially available from Qosina of Edgewood, New York, model # 51465. The hermetically sealable cap 36 allows access to the collected surgical fluid 44 for disposal. inspection and / or testing before discarding the filled liner 26. The removable valves 38 are mounted in the cap 32 so that they can rotate, and seal the ports 14 from the liner interior 46 when the tubular bodies 48 are oriented horizontally. To open the removable valves 38 and allow access through ports 14, the tubular bodies 48 are simply oriented upward.

As can be more clearly understood by referring to Figures 3 and 4, rigid receptacle 28 generally comprises a receptacle body 50 and a receptacle lid 52. The receptacle body 50 and the receptacle lid 52 define a vacuum chamber 53, and, ideally, will have a resistance.

ES 2 230 693 T3 sufficient mechanical strength and structural rigidity to withstand an external load of 1 atmosphere. To facilitate sterilization, minimize weight, and withstand the substantial pressure loads associated with the large volumes of surgical fluid in newer minimally invasive surgical procedures, the receptacle body 50 and the receptacle lid 52 are preferably formed of a polymer. high mechanical strength and high temperature, such as General Electric's Ultem®. A handle 54 allows the receptacle 28 to hang from a pedestal

IV or similar. O-rings 56 are inserted into grooves of the receptacle body 50 and the receptacle cover 52, and the cover is fastened onto the body using clamps 58. Alternatively, a gland attached to the liner edge 40 may allow sealing without gaskets. toric.

The receptacle cover 52 includes two through holes 60 through which the removable valves 38 protrude when the tubular bodies 48 are oriented vertically. The pipe bodies 48 have accommodative rings 49 which seal against the cap material that confines the holes 60. The projections 62 along the edge 40 mate with latching elements in the socket cover to help align the removable valves 38 with the inserted elements 60.

Disposable liner 26 edge 40 helps seal receptacle 28, and also provides a handle that facilitates removal and disposal of surgical fluids. Edge 40 may be disposed between O-rings 56 of receptacle lid 52 and receptacle body 50. As mentioned above, a gland on edge 40 can provide a seal without O-rings. Once the disposable liner is full, the edge portion 40 that is separated from the cap 32 by the slot 42 can be flexed upwardly away from the receptacle body. By flexing the two opposing portions of edge 40 upward and toward each other, they define a carrying handle 63 suitable for removing and transporting the filled disposable bag. As the lid 32 substantially separates the vacuum chamber 53 into an upper chamber 64 and a lower chamber 66, the grooves 42 also allow the pressure between these volumes to be equalized, thus avoiding the imposition of large pressure forces against disposable liner cap.

During use, a member of the surgical team will determine the required surgical fluid capacity for a particular procedure, and will provide at least enough containers 12 to accommodate this predetermined volume of fluid. A disposable liner 26 is placed on any receptacle body 50 with the rim 40 engaging the associated O-ring 56. Optionally, the projections on the bottom of the rim 40 (similar to the projections 62 on the upper part of the rim) engage the associated latching elements on the receptacle body (not shown). The removable tubular valve bodies 48 38 are oriented upward to open the valves, and to provide access to the interior of the liner through ports 14. The socket cover 52 is positioned on the socket body by sliding the tubular bodies 48 through the holes 60, and also aligning the projections 62 with associated latching elements on the bottom of the socket cover (not shown). The O-ring 56 associated with the socket cap 52 engages the top of the disposable liner edge 40 26 such that the edge is sandwiched between the two O-rings. Since the tubular bodies 48 seal the holes 60, the only openings through the receptacle 28 are the ports 14, which are in communication with the liner interior.

As can be understood by referring to Figure 1, tubing 16 engages a first container with the source of surgical fluids within patient 20. This leaves only one passage open through the receptacle of the first container. In the exemplary embodiment, the two ports are identical, such that either of the two ports 14 can be used as the fluid inlet port 22. The remaining port is then coupled to either of the two ports of an adjoining container 12, and through this container, under vacuum. Since each container 12 has only two ports, and since they are interchangeable, there is little likelihood that the fluid containment system 10 will be improperly coupled to each other.

The remaining canisters are coupled to the vacuum ports of a preceding canister until sufficient canisters are coupled together to accommodate the predetermined volume of surgical fluid. The final container is then coupled via line 16 to a source 18 of vacuum. It should be understood that there may be valves, filters, pressure regulators and the like disposed between the vessels 12 and the vacuum source 18, and optionally between the patient 20 and the vessels 12.

As may be understood by referring to Figures 1 and 4, the vacuum source 18 reduces the pressure within each container 12 by removing air and / or fluids through the vacuum port 24. The pressure inside 46 of liner 26 is equalized to the surrounding vacuum chamber 53 by air flowing through a one-way valve 34 from around the liner, as shown in FIG. 4. Grooves or ridges within the canister body 50 can help prevent the flexible liner bag 30 from sealing against the surrounding canister body, enhancing pressure distribution and equalization throughout the vacuum chamber (not shown). . Air also flows from under cap 32 into upper chamber 64 through slots 42, which are shown more clearly in Figure 2. In this way, pressure loads on both the flexible liner bag and the liner cap are substantially avoided.

Fluid initially flows from patient 20 to first container 12, where it is confined within the interior of the liner. As fluid 44 fills interior 46 of liner 26, a one-way valve 34 equalizes the pressure within liner interior 46 and the pressure surrounding liner within vacuum chamber 53. However, once fluid 44 substantially fills liner interior 46, one-way valve 34 prevents fluid from spilling out of liner into the surrounding vacuum chamber. Additional fluid then begins to flow out through the vacuum port 24.

Any additional fluid will then flow through

ES 2 230 693 T3 from inside the liner of the first container, and then over the through-line 16 to the inflow port 22 of the adjoining container 12. This adjoining container will then begin to fill, and if enough fluid is introduced from patient 20 to fill the second container, the overflow will continue back to the next container, and so on. The introduction of fluid will preferably cease before the final container is completely filled.

Once the fluid collection system 10 is full, or after the surgical procedure is complete, the tubing 16 is detached from the containers 12, and the clamps 58 are opened to allow the receptacle cover 52 to be removed. Removable tubular valve bodies 48 38 are positioned in a horizontal position, sealing fluid 44 within interior 46 of liner 26.

By grasping the edge 40 along the slot 42, the edge can be flexed upward away from the receptacle body 50. In this way, the rim forms a suitable handle to lift the disposable liner 26 from the receptacle body, and to transport the surgical fluid 44 to a disposal site. One-way valve 34, sealing cap 36, and removable valves 38 prevent leakage of surgical fluid 44, even if the liner inadvertently drips during shipping. Access to surgical fluid 44 may be provided by acting on one of the removable valves, or through the hermetically closable cap 36.

An alternative receptacle 70 and a corresponding liner 72 are illustrated in Figures 5A and 5B, respectively. Here the edge 40 is provided with a bush 74 to seal between the body 76 and the lid 78. The bush 74 extends over the lower and upper surfaces of the edge 40 to seal directly against the material of the lid. 78 and body 76 so that no O-ring is required. The ridges 80 reinforce the body 76, and also distribute and equalize the pressure around the liner.

Liner 72 includes flexible tubing 82 between angled fittings 84 and fixed tubular bodies 86. Constricting fasteners 88 on tubing 82 seal collected surgical fluids within the liner.

Although exemplary preferred embodiments have been described in some detail, by way of example and for clarity of understanding, a variety of changes, modifications, and adaptations of the present invention will be apparent to those skilled in the art. For example, the flexible tubes can couple the interior of the liner to the inflow of fluid, and vacuum ports can be attached to the receptacle. Thus, the scope of the present invention is limited only by the appended claims.