Device for Clean Catheterization

Abstract

A device for catheterization is disclosed. Such a device includes a hollow catheter, a cylindrical sheath, and a flange through which the catheter passes. Before insertion, the sheath begins at a first opening near the catheter tip and extends into the catheter to a first circumferential fold, then back towards the catheter tip to a second circumferential fold about the tip to the exterior surface, and ends at a second opening attached to the flange. As the device is inserted up to a length, the flange abuts the cavity opening, and a corresponding length of the sheath deploys from the catheter interior, around the first and second circumferential folds, to the catheter outer surface. Once fully inserted, all, or a substantial portion, of the sheath initially positioned within the catheter has been deployed to the outer surface, thereby forming a protective barrier between the catheter and the surrounding tissues.

Claims

1. A device for catheterization, comprising: a hollow catheter member having a tip, a base opposite said tip in the axial direction, an outer surface, and an inner surface defining a cavity, a cylindrical sheath member having a first portion, a second portion, a third portion, a first opening, and a second opening, and a flange member having an opening; wherein said flange member is configured such that said catheter member passes through the opening in said flange member; wherein said second opening is attached to said flange member; wherein said first opening is circumferentially attached to surface of said catheter member near the opening of said tip; wherein, prior to insertion of said device into a body cavity, said first portion of said sheath member begins at said first opening and extends axially within said cavity in the direction of the base to a first circumferential fold; said second portion of the sheath member begins at said first circumferential fold and extends axially within said cavity back towards the catheter tip to a second circumferential fold about said tip; and said third portion of the sheath member begins at the second circumferential fold as said sheath member folds around the tip to the outer surface of the catheter member, and extends to said first opening; wherein, as the device is inserted into said body cavity up to a length, said flange abuts the opening of said body cavity, a corresponding length of said first portion is deployed into said second portion, then from said second portion into said third portion encompassing a corresponding length of the outer surface of said catheter; and wherein, upon complete insertion of said device into said body cavity, all of said first portion and said second portion have fed into said third portion along the outer surface of said catheter.

2. The device of claim 1, wherein said sheath member and said catheter member are manufactured as a single, continuous member.

3. The device of claim 2, wherein said first opening is circumferentially attached to the inner surface of said catheter member.

4. The device of claim 3, wherein said first opening is circumferentially attached to the outer surface of said catheter member.

5. The device of claim 1, wherein said sheath member is configured to be removable and disposable such that said sheath member is removed and replaced after each use.

6. The device of claim 5, wherein said first opening is circumferentially attached to the inner surface of said catheter member.

7. The device of claim 6, wherein said first opening is circumferentially attached to the outer surface of said catheter member.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0015] FIG. 1 is an isometric exterior view of a device for clean catheterization, according to an exemplary embodiment of the present invention.

[0016] FIG. 2 is a front view exterior of a device for clean catheterization, according to an exemplary embodiment of the present invention.

[0017] FIG. 3 is a side exterior view of a device for clean catheterization, according to an exemplary embodiment of the present invention.

[0018] FIG. 4 is a side cross-section view of a device for clean catheterization, according to an exemplary embodiment of the present invention.

[0019] FIG. 5 is an isometric cross-section view of a device for clean catheterization, according to an exemplary embodiment of the present invention.

[0020] FIG. 6 is a side view of a device for clean catheterization, according to an exemplary embodiment of the present invention, being deployed through a urethra into a bladder.

DETAILED DESCRIPTION

[0021] FIGS. 1, 2, and 3 are isometric, front, and side external views, respectively, of a device 100 for clean catheterization according to an exemplary embodiment of the present invention. Said device 100 may comprise a catheter member 105 having a base 110 and a tip 115, a sheath member 120, a flange member 125, and a handle member 130. Sheath member 120 may be comprised of any flexible material such that a first portion of said sheath member 120 is positioned inside of catheter member 105, with a second portion of said sheath member 120 extending out of tip 115 and back around catheter member 105 such that it makes contact with flange member 125, which is configured such that said catheter member 105 passes through an opening in flange member 125. In preferred embodiments, sheath member 120 may be attached to flange member 125, but in others, sheath member 120 merely makes contact with flange member 125. Base 110 may be configured to receive handle member 130, which may be configured to be gripped by a user. In certain embodiments, handle member 130 may be further configured to prevent the flow of liquid out of catheter member 105 through base 110 until handle member 130 is opened or removed.

[0022] Sheath member 120 may be further configured to be biocompatible, clean, and/or sterile. In further embodiments of the present invention, sheath member 120 may be a urethane, a silicone, a polyvinyl, or any other similar material. Sheath member 120 may be further configured to have a Young's modulus of elasticity from about 1.32 to about 2.97 MPa. Sheath member 120 may be further configured to minimize friction to the interior of a body cavity into which the device is inserted in order to prevent injury to surrounding tissues.

[0023] As it is moved into position for insertion into a body cavity, such as a urethra, device 100 may be configured such that flange member 125 abuts the cavity opening, and further configured such that a user handles device 100 on the base-facing side of flange member 125, thereby preventing contact with, and contamination of, sheath member 120. According to an exemplary embodiment of the present invention, as device 100 is inserted into said cavity up to a given length, a corresponding length of sheath member 120 is deployed from inside of catheter member 105 such that it wraps around tip 115 to the outer surface of catheter member 105 extending in the direction opposite the direction of insertion, towards base 110.

[0024] FIGS. 4 and 5 are side and isometric cross-section views, respectively, of a device 200 for clean catheterization according to an exemplary embodiment of the present invention. Said device may further comprise a hollow catheter member 205 having a base 210, a tip 215, an outer surface 220, and an inner surface 225; a sheath member 230 having a first opening 235, a second opening 240, a first circumferential fold 245, and a second circumferential fold 250; a flange member 255; and a handle member 260. Said flange member 255 may be configured such that said catheter member 205 passes through an opening in flange member 255. Device 200 may be further configured such that sheath member 205 comprises three portions: a first portion extending from first opening 235 to first circumferential fold 245, a second portion extending from first circumferential fold 245 to second circumferential fold 250, and a third portion extending from second fold 250 to second opening 240. Thus, in certain embodiments, device 200 may be configured such that: said first portion of sheath member 230 extends along inner surface 225 of catheter member 205 from tip 215 to first circumferential fold 245 such that the outer surface of sheath member 230 faces or contacts inner surface 225 of catheter member 205 along the length of said first portion. At first circumferential fold 245, sheath member 230 may double back in the direction of tip 215, thereby defining said second portion of sheath member 230 extending from first circumferential fold 245 back towards second circumferential fold 250 at tip 215. At second circumferential fold 250, sheath member 230 may fold from the inner surface 225 of catheter member 205 to outer surface 220, thereby defining said third portion of sheath member 230 extending along the outer surface 225 from tip 215 toward flange 255, wherein second opening 240 of sheath member 230 terminates at flange member 255.

[0025] As it is moved into position for insertion into a body cavity, such as a urethra, device 200 may be configured such that flange member 255 abuts the cavity opening, and further configured such that a user handles device 200 on the base-facing side of flange member 255, thereby preventing contact with, and contamination of, sheath member 230. According to an exemplary embodiment of the present invention, as device 200 is inserted into said cavity up to a given length, a corresponding length of said first portion of sheath member 230 feeds into said second portion of sheath member 230, then from said second portion of sheath member 230 into said third portion of said sheath member 230, such that a corresponding length of sheath member 230 is deployed from inside of catheter member 205 such that it wraps around tip 215 to outer surface 220 of catheter member 205 extending in the direction opposite the direction of insertion, towards base 210.

[0026] According to an exemplary embodiment of the present invention, sheath member 230 may have a second opening 240 terminating at flange member 255, and a first opening 235 which may terminate either on the interior surface 225 or exterior surface 220 of catheter 205. Thus, in certain embodiments, first opening 235 may terminate at a location on the interior surface 225 of catheter 205 just within the opening of tip 215 as illustrated in FIG. 5, or, in other embodiments, first opening 235 may terminate on the outer surface 220 of catheter 205 at a location towards flange 255. In further embodiments of the present invention, said first opening 235 of sheath member 230 may be fused with or otherwise attached to catheter 205 at said locations either on the inner surface 225 or on the outer surface 230 of catheter 205. In a preferred embodiment of the present invention, catheter member 205 and sheath member 230 are manufactured as a single, continuous piece consisting of both lumen (catheter member 205) and protective sheath member 230. Therefore, according to said preferred embodiment of the present invention, once device 200 has been fully inserted into a body cavity such that substantially all of sheath member 230 has been deployed from the interior of catheter 205 to the exterior surface 220 of catheter 205 such that said first portion and said second portion and circumferential fold 245 have been eliminated, the joining of sheath member 230 to catheter member 205 at first opening 235 prevents exposure—accidental or otherwise—of outer surface 220 to surrounding tissues of said body cavity. Thus, sheath member 230 remains in place, completely encompassing the length of outer surface 220 that has been inserted into said body cavity. Moreover, said joining of sheath member 230 to catheter member 205 at first opening 235 further prevents leakage from tip 215 of any liquid—such as urine—flowing through inner surface 225 after device 200 is in place, as said liquid will be prevented from exiting tip 215 due to the fusion and/or connection of sheath member 230 to catheter 205 at first opening 235.

[0027] Sheath member 230 may be further configured to be biocompatible and clean/sterile. In further embodiments of the present invention, sheath member 230 may be a urethane, a silicone, a polyvinyl, or any other similar material. Sheath member 230 may be further configured to have a Young's modulus of elasticity from about 1.32 to about 2.97 MPa. Sheath member 230 may be further configured to minimize friction to the interior of a body cavity into which the device is inserted in order to prevent injury to surrounding tissues. In further embodiments, handle member 260 may be further configured to be gripped by as to support device 200 during insertion. Handle member 260 may be further configured to stop the flow of liquid out of catheter member 205 out of base 210 until handle member 260 is removed or opened. Moreover, in some embodiments of the present invention, inner surface 225 may be configured such that said first portion of sheath member 230 (i.e., the portion beginning at first opening 235 and extending to first circumferential fold 245) is loosely adhered to inner surface 225 in order to accomplish a controlled deployment of sheath member 230 from within catheter 205 as the device is inserted into a body cavity in order to prevent the folded sheath member 230 from sliding out of tip 215 before or during insertion. Thus, inner surface 225 may be configured such that said first portion of sheath member 230 adheres to inner surface 225 enough to prevent inadvertent slippage of said first portion out of catheter 205, but not so strongly as to prevent deployment of said first portion as the device is inserted during catheterization. Such adherence may be accomplished by a static electric charge between inner surface 225 and said first portion, texturing inner surface 225 in a manner configured to increase friction between inner surface 225 and said first portion, an adhesive applied to inner surface 225, or other similar means known in the art.

[0028] FIG. 6 is a side view of a device 300 for clean catheterization according to an exemplary embodiment of the present invention. Said device 300 may comprise a catheter member 305 having a base 310 and a tip 315, a sheath member 320, a flange member 325, and a handle member 330. Sheath member 320 may be comprised of any clean, biocompatible, flexible material and configured such that a first portion of said sheath member 320 is positioned inside of catheter member 305, with a second portion of said sheath member 320 extending out of tip 315 and back around catheter member 305 such that it makes contact with flange member 325. In certain embodiments, sheath member 320 may be attached to flange member 325. Base 310 may be configured to receive handle member 330, which may be configured to be gripped by a user.

[0029] As it is moved into position for insertion into a body cavity, such as urethra 335, device 300 may be configured such that flange member 325 abuts the exterior opening of urethra 335, and further configured such that a user handles device 300 on the base-facing side of flange member 325, thereby preventing contact with, and contamination of, sheath member 320. According to an exemplary embodiment of the present invention, as device 300 is inserted into urethra 335 up to length 340, a corresponding length of sheath member 320 is deployed from inside of catheter member 305 such that it wraps around tip 315 to the outer surface of catheter member 305 extending in the direction opposite the direction of insertion, towards base 310.

[0030] While the embodiments of the present invention are described herein with reference to various implementations and exploitations, it will be understood that these embodiments are illustrative and that the scope of the invention(s) is not limited to them. In general, embodiments of a device for separating tissue during dissection as described herein may be implemented using methods, facilities, devices, and materials consistent with any appropriate structure as described or illustrated herein. Many variations, modifications, additions, and improvements are possible.

[0031] For example, plural instances may be provided for components, operations, or structures described herein as a single instance. Boundaries between various components, operations, and functionality are depicted somewhat arbitrarily, and particular operations are illustrated within the context of specific illustrative configurations. In general, structures and actions presented as separate components or steps in the exemplary configurations may be implemented as a combined structure or step. Similarly, structures and actions presented as a single component or step may be implemented as separate components or steps. These and other variations, modifications, additions, and improvements may fall within the scope of the inventive subject matter.