Arthroscopy pouch - Patent Review 5494050

What is claimed is:

1. An arthroscopic pouch for use with a surgical drape, the pouch comprising:

a single folded sheet of flexible fluid impermeable material having a front portion with a central region and an upper front edge having a length furthest away from a patient when disposed on a patient, the central region of said front portion having a first fenestration for receiving a leg, a back portion with a central portion and an upper back edge having a length nearest the patient when disposed on a patient, the central region of said back portion having a second fenestration for receiving the leg, and only a single seam formed on said back portion by joining edges of said folded sheet to form the pouch wherein the single folded sheet formed with the single seam in a folded shape has a fold and at least a first outer perimeter side defined by the seam, a second outer perimeter side defined by the fold, a third outer perimeter side substantially opposite the first side and a fourth outer perimeter side substantially opposite the second side, wherein the first and second sides join to form an angle less than 90.degree. and the first and fourth sides join to form an angle less than 90.degree. and wherein the fourth side defines the upper back edge, and

a layer of adhesive applied to the back portion of said folded sheet adjacent the upper back edge wherein the length of the upper back edge of said back portion is defined by said layer of adhesive such that the length of the upper front edge is greater in length than the length of the fourth outer perimeter side and greater than the length of the upper back edge.

2. An arthroscopic pouch as recited in claim 1 wherein said sheet of flexible fluid impermeable material is a polyethylene film.

3. An arthroscopic pouch as recited in claim 1 wherein said single seam joining said folded sheet is formed by heat sealing.

4. An arthroscopic pouch as recited in claim 1 wherein said sheet of flexible fluid impermeable material is lined with double-faced adhesive strips of tape surrounding the second fenestration in said back portion of said flexible sheet.

5. An arthroscopic pouch as recited in claim 4 wherein said adhesive strips are covered with removable backings that are removed prior to use.

6. An arthroscopic pouch as recited in claim 1 wherein said sheet of flexible fluid impermeable material is attached to a surgical drape having a fenestration corresponding to said second fenestration of said back portion of said pouch.

7. An arthroscopic pouch as recited in claim 6 wherein said surgical drape is attached to said sheet of flexible fluid impermeable material by a sprayed-on adhesive located on the surfaces of said sheet that contact said surgical drapes.

8. An arthroscopic pouch as recited in claim 7 wherein said single seam is located in between adhesive portions of said back portion of said pouch, said location of adhesive portions thereby reinforcing said back portion to protect said seam.

9. An arthroscopic pouch as recited in claim 1 wherein a fenestration covering for said first fenestration is heat sealed to the peripheral edges of said pouch surrounding said first fenestration of said front portion.

10. An arthroscopic pouch as recited in claim 1 wherein said membrane covering for said first fenestration is Kraton.

11. An arthroscopic pouch as recited in claim 1 wherein said upper front edge of said pouch is held in an open position to control fluids at a surgical site by a contoured wire maintaining said upper front edge of said pouch in an outward position.

12. An arthroscopic pouch as recited in claim 11 wherein said contoured wire is a plastic coated metal wire.

13. An arthroscopic pouch as recited in claim 1 further including a port, wherein said port is heat sealed onto a portion of said pouch.

14. An arthroscopic pouch as recited in claim 13 wherein said port is formed with a one-piece construction.

15. An arthroscopic pouch for use with a surgical drape, the pouch comprising:

a single folded sheet of flexible fluid impermeable material having a fold and having first and second edges joined in a seam,

at least two spaced apart adhesive portions applied to the sheet for attachment to the surgical drape, and a front portion furthest away from a patient and a back portion nearest the patient, said front portion having a front fenestration for receiving an appendage of the patient, said back portion having a back fenestration for receiving the appendage of the patient wherein the back fenestration for receiving an appendage is substantially surrounded by said first adhesive portion and said second adhesive portion is applied spaced apart from said first adhesive portion on said sheet, and wherein the seam joining the edges of said folded sheet to form the pouch is positioned within the second adhesive portion and wherein the single folded sheet formed with the single seam in a folded shape has at least a first outer perimeter side defined by the seam, a second outer perimeter side defined by the fold, a third outer perimeter side substantially opposite the first side and a fourth outer perimeter side substantially opposite the second side, wherein the first and second sides join to form an angle less than 90.degree. and the first and fourth sides join to form an angle less than 90.degree. and wherein the fourth side defines the upper back edge.

16. An arthroscopic pouch as recited in claim 15 further comprising a drape, wherein the at least two spaced apart adhesive portions joins the pouch to the drape and wherein the seam is adjacent the drape.

17. An arthroscopic pouch as recited in claim 15 wherein the pouch further includes an adhesive portion extending transversely of the seam for joining a portion of the pouch to the drape.

18. An arthroscopic pouch as recited in claim 15 wherein the back fenestration includes walls defining the fenestration and wherein the walls include adhesive portions for joining the walls to the drape.

19. A method of manufacturing an arthroscopic pouch for use with a surgical drape comprising the steps of:

selecting a single flexible sheet of fluid impermeable material with a top edge, a bottom edge and two opposite edges with respect to a center line of said sheet,

folding said top edge creating a channel defined by the sheet and the folded portion of said top edge for receiving a draw wire,

joining said folded portion of said top edge to said sheet enclosing a portion of said channel,

forming a first fenestration along said center line for receiving a limb,

applying a fenestration covering over said first fenestration,

folding said sheet along said center line,

removing a portion of said folded sheet along at least one of said overlapping bottom edge, top edge, and two opposite edges,

joining the overlapping bottom edges of said sheet to form the only seam in said fluid collection pouch,

forming a second fenestration along said bottom edge for receiving a limb,

inserting a draw wire into said channel along the length of said top edge,

and applying adhesive along both sides of said only seam of said pouch for attachment to the surgical drape.

20. A method of manufacturing an arthroscopic pouch to be used for collecting fluids at a surgical site, the method comprising the steps of:

selecting a sheet of flexible fluid impermeable material with a top portion and top edge, a bottom portion and a bottom edge and first and second substantially opposite side portions and side edges,

folding said sheet substantially along an approximate center line of said sheet forming a fold having a given length and bringing said side edges together in overlapping position,

removing at least a first angled portion from one of said top, bottom and side portions of said sheet, said first removed angled portion of said sheet consisting of an area along a separated edge leaving one of said other edges adjacent the separated edge shorter in length than the separated edge while leaving the fold length substantially unchanged, and

sealing one of said folded top and bottom edges of said folded sheet to form a fluid collection pouch.

21. The method as recited in claim 20 wherein said sheet is folded along said center line to form a polygon having at least four sides.

22. The method as recited in claim 21 wherein the step of removing a first angled portion includes the step of removing an angled portion from the bottom portion, and further comprising the step of removing a second angled portion from the side portion.

23. The method as recited in claim 22 wherein the step of removing first and second angled portions includes the steps of removing the first angled portion larger than the second angled portion such that four edges of the folded sheet are of different lengths.

24. The method as recited in claim 20 further comprising the step of applying adhesive to an area of said pouch on both sides of said seam for attachment to the surgical drape.

25. The method as recited in claim 20 further comprising the step of forming an opening in at least one of the edge portions for forming a fenestration.

26. The method as recited in claim 25 wherein the step of forming an opening includes the step of forming an opening in the bottom side portion, wherein the folded sheet includes a folded side and further comprising the step of forming a second opening in the folded side for forming a fenestration, and wherein the step of sealing includes the step of sealing the edge of the bottom portion.

27. The method as recited in claim 20 further comprising the step of applying an adhesive layer along an edge defined by the edge of the opposite side portions for attaching the pouch to a drape.

Description Submit all comments and votes

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to fluid collection pouches or bags for use in surgical procedures to collect, channel and contain fluids from a surgical site during an operation, and more specifically to pouches such as arthroscopic fluid collection pouches and to pouch and drape assemblies. The invention also relates to methods of making such pouches and such pouch and drape assemblies.

2. Related Art

During many surgical procedures, it is frequently desirable to create a sterile field around a surgical site to reduce the possibility of infection of a patient. Typically, a sterile field is created by draping a sterile material over a patient in such a manner as to leave an opening only at the actual site of an incision. Such surgical drapes have been used for many years. Originally, the focus of draping was to protect the patient from infection. Recently, that focus has expanded to include protection of the surgical staff from infection. Examples of the types of infection that a staff member may be exposed to from fluids include the hepatitis B virus and the AIDS virus. Thus, another function of surgical drapes used today is to provide a barrier to the exposure of liquids or bacteria which may result in contamination of the patient or the staff performing the surgical procedure.

In some surgical procedures very large volumes of fluid may be present either from irrigation sources or from the patient's body fluids. It is desirable in most instances to control and contain such fluids. Some drapes have been used in the past which contain a pouch to collect fluids present during surgery. Collection of the fluids in the pouch also facilitates disposal of the fluids after the surgery.

Fluid collection pouches are commonly used in a number of surgical procedures. Cranial procedures, endourological operations, ophthalmic procedures and arthroscopic surgery use fluid collection pouches to collect, contain and facilitate disposal of fluids produced during the procedure. In arthroscopic surgery, patient blood, other body fluids, as well as irrigation fluid used to flush material from the joint, is collected in the fluid collection pouch.

Fluid collection during arthroscopic procedures is different in some respects from fluid collection during other surgical procedures. For example, using a collection pouch to collect and contain fluid during abdominal surgery has the fluid collection pouch placed adjacent one side of the surgical site and extending down the side of the patient. Arthroscopy procedures typically place a patient's leg through a collection pouch mounted to a drape with one sheet of the collection pouch in front of the surgical site on the limb and another sheet of the collection pouch in back of the surgical site. Therefore, the fluid collection pouch is supported in part by the limb itself, as well as by the surgical drape to which the fluid collection pouch is attached.

One disadvantage of the currently available disposable collection pouches is that they are formed of separate sheets sealed together, and may leak. Leaks may form at any number of seals in the pouch when the pouch is pulled outward or is opened before the procedure for collecting fluids. As many as five seals may be used in the construction of a single bag, each of which may present a risk of leakage in the pouch.

A relatively large number of seals used in assembling a fluid collection pouch uses significant labor and assembly time. Depending on the complexity of a collection pouch design, the location and the positioning of the seal lines may substantially add to handling time. This additional time and labor represents a significant increase in the cost of production for disposable fluid collection bags.

Another disadvantage of prior fluid collection pouches is that they are relatively complicated to manufacture in that they require the joining of multiple sheets to form a pouch that is conformable to the body of a patient to control fluids. For certain applications, the collection pouch pattern may be more complicated in order to control fluids released at a particular surgical site, such as the arm or leg of a patient. Substantial labor steps may be necessary for forming odd-shaped patterns, or for joining multiple sheets of material into a pattern for a pouch specifically constructed for controlling fluids during surgery, such as an arthroscopic procedure.

Another disadvantage of some fluid collection bags, particularly for use during surgical procedures on a patient's leg, is that the collection pouch may not extend forward and away from the patient far enough to adequately expose a surgical site, and it may not provide an opening large enough for capturing fluids. The opening in a conventional fluid pouch, for example, may be symmetrical and relatively simple to manufacture and pack. However, a symmetrical opening in a fluid pouch may not adequately control fluid at an irregularly-shaped area of a body, such as the leg of a patient.

Some conventional collection pouches having extended portions to control fluids during a surgical procedure formed of multiple sheets of flexible plastic that require multiple seals and multiple sealing steps. One disadvantage of these pouches is that they require separate sheets of plastic and a significant number of seals. The increased number of seals in a collection bag generally increases the risk of fluid leakage and the spread of infection, in addition to an added cost of assembly.

Therefore, there is a need for a fluid collection pouch and for a pouch and surgical drape assembly which minimizes the possibility of leaks developing during use, such as at seal points, and which is easier to assemble and use.

SUMMARY OF THE INVENTION

In view of the foregoing, it is an object of the present invention to provide a more reliable fluid collection pouch that can be economically formed from one sheet of flexible fluid impermeable material for channeling, collection and control of fluid during surgical procedures.

Another object of the invention is to provide a pouch that can be formed using a single seal joining edges of a sheet of flexible fluid impermeable material cut and folded to provide the pouch with an opening that extends forward and away from a patient.

It is also another object of the invention to provide a fluid collection pouch that has an exit port with a reliable seal to minimize the possibility of leaking around the port.

Another object of the invention is to provide a method of manufacturing an economical fluid collection pouch formed with a single seal that is resistant to tearing.

Further object of the invention is to provide a method of manufacturing a fluid collection pouch that is joined with a surgical drape where the pouch has a single seam positioned adjacent the drape and between spaced apart points where the pouch is joined to the drape so that the drape serves to reinforce the pouch.

These as well as other objects are achieved through the present invention which provides a fluid collection pouch, such as for a pouch and surgical drape assembly, which minimizes the possibility of leaks developing during use and which is easier to use and assemble. In one preferred form of the invention, a pouch is preferably formed with a single seal, preferably at a rear portion of the pouch, joining edges of the sheet to form the pouch. In one preferred embodiment, the pouch is formed from a single sheet of flexible, fluid impermeable material folded in such a way as to form the pouch once the single seal is formed.

In another preferred form of the invention, the pouch is formed from a sheet of flexible fluid impermeable material initially rectangular, and which has the edges of preferably a long side cut, from a center line parallel to the short sides, downward in a direction toward the opposite long side. The resulting cut long side will thereafter form an upper back edge spaced from an upper front edge, and the cutting of the long side gives a final pouch which has an effectively wider opening as defined by the upper back and front edges.

In a further preferred form of the invention, a single seam fluid collection pouch is attached to a surgical drape having an opening therethrough so the seam is in the back of the pouch positioned between the junction points between the pouch and the drape so that the drape reinforces the pouch material around the seam and isolates the seam from stress which may be created elsewhere in the pouch.

These and other aspects of the invention will become apparent from a consideration of the drawings, a brief description of which follows, along with a consideration of the preferred embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of one embodiment of the invention when the pouch is in the open position, showing a patient's leg for environment but omitting the conventional accompanying surgical drape for clarity.

FIG. 2 is a side elevation view of the pouch of FIG. 1 in a partially open position on a patient's leg, omitting the conventional surgical drape, and showing the pouch as it would appear if the left side of the pouch were partially folded toward the right side.

FIG. 3 is a partially exploded and perspective view of a sheet of material and components used to form the pouch of the present invention showing cuts made in the sheet and adhesive tape and release paper, a fenestration and contour wire.

FIG. 4 is a perspective view of the pouch of FIG. 1 in a folded, flat configuration prior to application of adhesive and attachment to a conventional surgical drape.

FIG. 5 is a partial cross-sectional view of the front fenestration and the folded pouch taken along a line 5--5 in FIG. 4.

FIG. 6 is a partial cross-sectional view of the single seal joining a common edge of the flexible sheet of plastic material to itself, taken along the line 6--6 in FIG. 4, along with a schematic representation of sealing rollers for forming the seal.

FIG. 7 is a detailed top plan view of a complete pouch in accordance with the embodiment of FIGS. 1 and 4 in a folded configuration and showing release paper covering adhesive for use in attaching the pouch to a conventional drape.

FIG. 8 is a cross-sectional view of the pouch and double-faced adhesive tape with release paper taken along line 8--8