Background

Insufflation devices are used during surgical procedures to distend cavities within the body. For example, insufflation devices are used in sigmoidoscopy procedures in which a sigmoidoscope is used to examine the large intestine from the rectum. In such a procedure, an insufflation device is connected to the sigmoidoscope and is used to deliver air through a channel of the sigmoidoscope to the large intestine to distend it so that it can be viewed with the sigmoidoscope.

Such insufflation devices typically comprise an inflation bulb similar to those found on blood pressure cuffs and a tube that extends from the bulb and connects to the sigmoidoscope or other endoscope. In some cases, the insufflation device includes an intermediate bladder positioned between the bulb and the tube that is used to control the delivery of air through the tube. In particular, such a bladder acts as a pressure control that enables the operator to provide constant airflow.

In older designs that include an intermediate bladder, the bladder is elastic so that, when it is inflated, it naturally drives air into the tube and to the endoscope. While such a design is useful, the bladder is typically made of a rubber or neoprene material that increases the cost of the insufflation device to the point at which it is too expensive to be used as a disposable device. While newer, disposable designs have been developed that do not use rubber or neoprene to form the bladder, those designs use materials that are inelastic. Therefore, the bladder will not naturally drive air into the tube and the endoscope. Because of this, two persons are required to operate the device: one to squeeze the bulb and hold the tube and another to squeeze bladder. This is undesirable because it is generally preferable to reduce the number of persons in the operating room to as few as possible.

In view of the above discussion, it can be appreciated that it would be desirable to have an inexpensive, disposable insufflation device that includes an elastic intermediate bladder.

Brief Description of the Drawings

The present disclosure may be better understood with reference to the following figures. Matching reference numerals designate corresponding parts throughout the figures, which are not necessarily drawn to scale.

Fig. 1 is a top perspective view of an embodiment of an insufflation device.

Fig. 2 is a side view of an inflation bulb of the device of Fig. 1.

Fig. 3 is a partial cross-sectional side view of an intermediate bladder of the device of Fig. 1.

Fig. 4 is a detail side view illustrating connection between the inflation bulb and the intermediate bladder of the insufflation device of Fig. 1.

Fig. 5 is a detail side view illustrating connection between the intermediate bladder and a delivery tube of the insufflation device of Fig. 1. Fig. 6 is a side view of the insufflation device of Fig. 1 , illustrating the intermediate bladder in a partially-inflated state.

Fig. 7 is a side view of the insufflation device of Fig. 1 , illustrating the intermediate bladder in a more fully-inflated state.

Fig. 8 is a detail side view illustrating connection between an inflation bulb and an intermediate bladder of an alternative insufflation device.

Detailed Description

As described above, it would be desirable to have an inexpensive, disposable insufflation device that includes an elastic intermediate bladder. Disclosed herein are embodiments of such an insufflation device. In some embodiments, the device includes an intermediate bladder constructed of an elastic polymeric material, such as an aromatic polyester polyurethane.

In the following disclosure, various specific embodiments are described. It is to be understood that those embodiments are example implementations of the disclosed inventions and that alternative embodiments are possible. All such embodiments are intended to fall within the scope of this disclosure.

Fig. 1 illustrates an example embodiment of an insufflation device 10. The insufflation device 10 can be used to distend cavities within the body to enable examination of those cavities, for example using an endoscope. In some embodiments, the insufflation device 10 is used in sigmoidoscopy procedures in which the device is connected to a sigmoidoscope and is used to deliver air through a channel of the sigmoidoscope to the large intestine.

As is shown in Fig. 1 , the insufflation device 10 generally includes an inflation bulb 12, a gas (e.g., air) delivery tube 14, and an intermediate bladder 16 that is positioned between the bulb and the tube. The intermediate bladder 16 has a proximal end 18 that is connected to the bulb 12 and a distal end 20 that is connected to the tube 14. Those connections are illustrated in detail in Figs. 4 and 5, which are described below.

Fig. 2 illustrates the inflation bulb 12 in greater detail. As is shown in that figure, the bulb 12 comprises a hollow body 24 having a tapered proximal end 26, a bulbous central portion 28, and a tapered distal end 30. The body 24 is made of a flexible polymeric material that can be either elastic or inelastic. In some embodiments, the body 24 is made of polyvinyl chloride (PVC).

The body 24 forms an internal space 32. Air can enter the internal space 32 through an inlet 34 formed in the proximal end 26, and can leave the internal space through an outlet 36 formed in the distal end 30. Provided within the inlet 34 is a oneway valve 38 that only permits air to pass from outside the bulb 12 and into the internal space 32. Provided within the outlet 36 is a further one-way valve 40 that only permits air to pass from within the internal space 32 to outside of the bulb 12. Because of the presence of the valves 38, 40, air is urged out from the internal space 32 through the outlet 36 when the body 24 is squeezed, and is drawn into the internal space through the inlet 34 after the body is released. Accordingly, the bulb 12 can be operated to pump air through manual, reciprocal squeezing and releasing.

Connected to the distal end 30 of the inflation bulb 12 is a nipple connector 42 that facilitates connection of the bulb to the intermediate bladder 16. The connector 42 is generally cylindrical and can be made of a rigid polymeric material such as polyethylene (PE), polypropylene (PP), or polyoxymethylene (POM). The connector 42 defines an inner passage 44 that extends from the outlet 36 of the bulb 12 to an outlet 46 formed at the distal end of the connector. As is further shown in Fig. 2, the connector 42 includes a collar 48 that, as is described below, facilitates secure attachment of the bladder 16 to the connector and, therefore, the bulb 12.

Fig. 3 is a partial cross-sectional side view of the intermediate bladder 16. As is shown in that figure, the bladder 16 is formed from first and second layers 52 and 54 that are attached along their edges (see below). The layers 52, 54 of material are made from the same inexpensive elastic polymeric material. By "elastic" it is meant that the material exhibits elasticity as opposed to mere flexibility. That is, the material is capable of being easily stretched or expanded and then resumes its former shape after the stretching/expanding forces no longer act on the material. In some embodiments, the material that is used to form layers 52, 54 comprises an aromatic polyester polyurethane produced by Chiorino S.p.A. under the tradename Elastar UE100. The layers 52, 54 can have a nominal thickness of approximately 90 to 110 microns (μιτι), for example approximately 100 μηη. The material can have an ISO 37 elastic modulus at 100% strength of approximately 3.5 to 4.5 Newtons per square millimeter (N/mm ² ), and an ISO 37 elastic modulus at 300% strength of approximately 6.75 to 8.25 N/mm ² . For example, the material can have an ISO 37 elastic modulus at 100% strength of approximately 4 N/mm ² , and an ISO 37 elastic modulus at 300% strength of approximately 7.5 N/mm ² .

The material further can have an ISO 37 load at break of approximately 35 to 45 N/mm ² , for example 40 N/mm ² ; an ISO 37 elongation at break of approximately 370 to 690%, for example approximately 530%; an ISO 6383/1 tear strength of approximately 55 to 105 N, for example approximately 80 N; and an AST D2240 hardness of approximately 80 to 90 Shore A, for example approximately 85 Shore A. Irrespective of its properties, the material used to form the layers 52, 54 is free of formaldehyde, latex, PVC, tributyltin (TBT), mercaptobenzothiozole (MBT), and dibenzothiophene (DBT), and is approved by the Food and Drug Administration (FDA) for medical use.

Fig. 4 illustrates the connection of the intermediate bladder 16 to the inflation bulb 12. As is shown in that figure, the first and second layers 52, 54 of material are attached along their edges to form joints 58 that form an internal space 60 into which air can be delivered by the bulb 12. In some embodiments, the layers 52, 54 are bonded together at the joints 58, for example by welding. As is further shown in Fig. 4, the layers 52, 54 are passed over the distal end of the nipple connector 42 and are secured to the connector with a fastener 62. In some embodiments, the fastener 62 comprises a polymeric cable tie that wraps around the two layers 52, 54 and the connector 42. The fastener 62 is prevented from sliding off of the connector 42 by the collar 48. When the fastener 62 is tightly fastened in place, an air-tight seal is formed between the bladder 16 and the connector 42.

Fig. 5 illustrates the connection of the intermediate bladder 16 to the delivery tube 14, which can be a flexible tube that is made of a suitable polymeric material, such as PVC, polyurethane (PE), or a thermoplastic elastomer. As is shown in Fig. 5, the tube 14 is inserted between the first and second layers 52, 54 of material, which are bonded (e.g., welded) together around the tube. Auxiliary layers of material 66 and 68 overlie the first and second layers 52, 54, respectively, to improve the strength of the connection between the bladder 16 and the tube 14. The auxiliary layers 66, 68 can, in some embodiments, be made from the same elastic polymeric material of the intermediate bladder 16. During manufacturing, the tube 14 can be placed between to the layers 52 and 54, the layers 66 and 68 can be applied to the layers 52 and 54, and then all the layers can be fused to the tube with a welding process that forms multiple transverse welds 70 along the length of the tube. Like the connection between the bladder 16 and the inflation bulb 12, the connection between the bladder and the tube 14 forms an air-tight seal.

Figs. 6 and 7 show the insufflation device 10 in use. Referring first to Fig. 6, the inflation bulb 12 has been squeezed multiple times to inflate the intermediate bladder 16. Because the bladder 16 is elastic, it exerts a squeezing force that pressurizes the air within the bladder so that the air will be driven through the tube 14 and into a patient cavity without requiring the assistance of a second human operator.

Referring next to Fig. 7, the inflation bulb 12 has been squeezed multiple further times to further inflate the intermediate bladder 16 to the point at which the layers 52, 54 have elastically stretched to a significant degree. Because the bladder 16 has been stretched to a larger degree than in Fig. 6, the bladder exerts a greater squeezing force on the air that it contains.

As is apparent from the above discussion, the disclosed insufflation device can be operated by a single individual because of the elasticity of the intermediate bladder. Specifically, an additional human operator is not needed to squeeze the bladder to urge air within the bladder into an endoscope and a body cavity that is to be examined. Unlike previous insufflation devices having elastic bladders, the bladder of the disclosed insufflation device is made of an inexpensive polymeric material. As a result, the insufflation device can therefore be produced and sold for much less cost, and can therefore can be used as a disposable device.

Fig. 8 illustrates the connection of the intermediate bladder 16 to an alternative inflation bulb 80 of an alternative insufflation device. In this embodiment, the bladder 16 is attached to a nipple connector 82 of the bulb 80 without the use of a separate fastener. In some embodiments, the bladder 16 is bonded (e.g., welded) to the connector 82. In such a case, no collar is needed on the connector 82, and the air-tight seal is formed between the bladder 16 and the connector via the bonding.