URETHRAL DEVICE

Abstract

An indwelling urethral device is described that includes an elongated tubular member extending along a longitudinal axis (L) from a distal inlet end portion, via an intermediate portion, to a proximal outlet end portion, the tubular member defining a lumen extending along the longitudinal axis between the distal inlet end portion and the proximal outlet end portion, the distal end portion of the elongated tubular member comprising a plurality of urine inlet openings, at least a part of the distal end portion being preconfigured to be reversibly transformable between a linear state for passage through the urethra when inserted there through and a preconfigured coiled state for anchored receipt within the bladder in the use position. The plurality of urine inlet openings is provided on the interior spiral section and urine inlet openings are absent on the exterior spiral section.

Claims

1. An indwelling urethral device for use in drainage of urine from a bladder when the urethral device in a use position is indwelling in a patient, the urethral device comprising an elongated tubular member extending along a longitudinal axis (L) from a distal inlet end portion, via an intermediate portion, to a proximal outlet end portion, the tubular member defining a lumen extending along the longitudinal axis between the distal inlet end portion and the proximal outlet end portion, the distal end portion of the elongated tubular member comprising a plurality of urine inlet openings, the proximal end portion of the elongated tubular member having a drainage outlet, the lumen of the elongated tubular member providing fluid communication between the plurality of urine inlet openings and the drainage outlet, at least a part of the distal end portion being preconfigured to be reversibly transformable between a linear state for passage through the urethra when inserted there through and a preconfigured coiled state for anchored receipt within the bladder in the use position, the preconfigured coiled state of the distal end portion forming a spiral emanating from a point (P) on the longitudinal axis (L) of the elongated tubular member and the spiral extending in at least a first (x) and a second direction (y), the second direction being orthogonal to the first direction and each of the first and second direction (x, y) being axially transverse to the longitudinal axis (L) of the elongated tubular member, the spiral comprising an interior spiral section facing inwards the spiral and an exterior spiral section facing outwards away from the spiral, characterized in that the plurality of urine inlet openings are provided on the interior spiral section and urine inlet openings are absent on the exterior spiral section.

2. An indwelling urethral device according to claim 1, wherein the spiral revolves around said point (P) on the longitudinal axis (L) of the elongated tubular member.

3. An indwelling urethral device according to claim 1, wherein the urethral device is an urethral catheter.

4. An indwelling urethral device according to claim 3, wherein the urethral catheter comprises a drainage port at the proximal outlet end portion and the drainage port is provided with means for connecting the drainage port to a urine collection bag or to a sampling device.

5. An indwelling urethral device according to claim 1, wherein the urethral device is an urethral stent.

6. An indwelling urethral device according to claim 5, further comprising a retention member for retaining the urethral stent within the urethra, to be disposed externally of the bladder and in the urethra, when the urethral stent in the use position is indwelling, the retention member being provided at or in proximity to said proximal outlet end portion.

7. An indwelling urethral device according to claim 6, wherein the retention member is provided by a part of the proximal end portion preconfigured to be transformable between a linear state for passage through the urethra when inserted there through and a twisted preconfigured state for retention thereof within the urethra when the urethral stent in the use position is indwelling.

8. An indwelling urethral device according to claim 6, wherein the retention member is provided by a part of the proximal end portion preconfigured to be transformable between a linear state for passage through the urethra and a compressed preconfigured state forming a bump on the elongated tubular member for retention thereof within the urethra when the urethral stent in the use position is indwelling.

9. An indwelling urethral device according to claim 1, wherein the indwelling urethral device is a single lumen urethral device.

10. An indwelling urethral device according claim 1, wherein the distal inlet end portion, the intermediate portion and the proximal outlet end portion of the indwelling urethral device is an integral unit.

11. An indwelling urethral device according to claim 1, wherein the elongated tubular member has a varying wall thickness (T) along the longitudinal axis (L) such that a section of the intermediate portion of the elongated tubular member has a wall thickness (T.sub.a) which is less than the wall thickness (T.sub.b) of any adjacent section of the elongated tubular member, said section of the intermediate portion of the elongated tubular member being configured to be positioned in proximity to urethral sphincter (S) when the device in the use position is indwelling.

12. An indwelling urethral device according to claim 1, wherein the elongated tubular member is formed at least partially from a shape memory material.

13. A device assembly comprising an indwelling urethral device according to claim 1 and a guide wire adapted to be inserted coaxially into the lumen of the tubular member of the urethral device during insertion of the urethral device through the urethra.

14. An intermittent urethral catheter for use in drainage of urine from a bladder when the urethral catheter in a use position is intermittently inserted in a patient, the urethral device comprising an elongated tubular member extending along a longitudinal axis (L) from a distal inlet end portion, via an intermediate portion, to a proximal outlet end portion, the tubular member defining a lumen extending along the longitudinal axis between the distal inlet end portion and the proximal outlet end portion, the distal end portion of the elongated tubular member comprising a plurality of urine inlet openings, the proximal end portion of the elongated tubular member having a drainage outlet, the lumen of the elongated tubular member providing fluid communication between the plurality of urine inlet openings and the drainage outlet, at least a part of the distal end portion being preconfigured to be reversibly transformable between a linear state for passage through the urethra when inserted there through and a preconfigured coiled state for anchored receipt within the bladder in the use position, the preconfigured coiled state of the distal end portion forming a spiral emanating from a point (P) on the longitudinal axis (L) of the elongated tubular member and the spiral extending in at least a first (x) and a second direction (y), the second direction being orthogonal to the first direction and each of the first and second direction (x, y) being axially transverse to the longitudinal axis (L) of the elongated tubular member, the spiral comprising an interior spiral section facing inwards the spiral and an exterior spiral section facing outwards away from the spiral, characterized in that the plurality of urine inlet openings are provided on the interior spiral section and urine inlet openings are absent on the exterior spiral section.

Description

BRIEF DESCRIPTION OF DRAWINGS

[0060] FIG. 1 illustrates an embodiment of an indwelling urethral device according to the present disclosure. The urethral device is shown in the linear state as well as in the preconfigured coiled state.

[0061] FIG. 2 illustrates the coiled distal end portion of the indwelling urethral device of FIG. 1.

[0062] FIG. 3 is a cross-section taken along the longitudinal axis of the elongated tubular member of the urethral device of FIG. 2.

[0063] FIG. 4 illustrates the indwelling urethral device of FIG. 1 in use position when the urethral device is indwelling.

[0064] FIG. 5 illustrates a first type of retention member which is part of the indwelling urethral device of FIG. 1. This figure also illustrates the function of a thin-walled intermediate section.

[0065] FIG. 6 illustrates a second type of retention member of an indwelling urethral device as disclosed herein as well as the function of a thin-walled intermediate section.

[0066] FIG. 7 illustrates an indwelling urethral device as disclosed herein having a so-called Tiemann tip.

[0067] FIG. 8 illustrates the urethral device, in the preconfigured coiled state, according to the present disclosure provided with a drainage port.

[0068] FIG. 9 illustrates the urethral device in FIG. 8 in the linear state.

DETAILED DESCRIPTION

[0069] It is to be understood that the drawings of the urethral devices shown are schematic and that individual components are not necessarily drawn to scale.

[0070] As used herein, distal portion refers to the portion of the urethral device furthest away from the medical operator inserting the urethral device in the urethra of a patient. Thus, the distal portion of the urethral device is the portion which is configured to be positioned in the bladder of the patient when in use.

[0071] As used herein, proximal portion refers to the portion of the urethral device closest to the medical operator inserting the urethral device in the urethra of a patient. Thus, the proximal portion of the urethral device is the portion which is configured to be positioned externally of the bladder of the patient when the urethral device is in use (indwelling). The proximal portion of the urethral device may be positioned in the urethra or outside the patient when the urethral device is in use (indwelling).

[0072] As used herein, the term urinary catheter refers to a device including a thin tube which is adapted to be inserted into the urethra and the urinary bladder to void the bladder of urine that has been collected in the urinary bladder. The term urinary catheter includes both urinary catheters partly extending externally from the user's body and urinary catheters which are adapted to be completely internally housed within the user body during use. The latter type of urinary catheters may also be referred to as urinary stents or prostatic stents.

[0073] FIG. 1 illustrates an embodiment of an indwelling urethral device 1, in this case an indwelling urethral stent, for use in drainage of urine from a bladder when the urethral device in a use position is indwelling in a patient. The urethral device is a single lumen urethral device, which comprises an elongated tubular member 2 extending along a longitudinal axis L from a distal inlet end portion 2a via an intermediate portion 2b to a proximal outlet end portion 2c. In the illustrated embodiment, the distal inlet end portion, the intermediate portion and the proximal outlet end portion of the indwelling urethral device is formed as an integral unit.

[0074] As shown in FIG. 3, the tubular member 2 defines a lumen 3 extending along the longitudinal axis L between the distal inlet end portion 2a and the proximal outlet end portion 2c.

[0075] The distal end portion 2a of the elongated tubular member 2 comprises a plurality of urine inlet openings 4.

[0076] The proximal end portion 2c of the elongated tubular member 2 comprises a drainage outlet 5.

[0077] The lumen 3 of the elongated tubular member 2 provides fluid communication between the plurality of urine inlet openings 4 and the drainage outlet 5.

[0078] At least a part of the distal end portion 2a is preconfigured to be reversibly transformable between a linear state (the upper figure of FIG. 1) for passage through the urethra when inserted there through and a preconfigured coiled state (the lower figure of FIG. 1) for anchored receipt within the bladder in the use position as shown in FIG. 4.

[0079] As illustrated in more detail in FIG. 2, the preconfigured coiled state of the distal end portion 2a forms a spiral emanating from a central point P on the longitudinal axis L of the elongated tubular member 2 and the spiral extends in at least a first direction x and a second direction y, the second direction y being orthogonal to the first direction x and each of the first and second direction x, y being axially transverse to the longitudinal axis L of the elongated tubular member 2.

[0080] The spiral comprises an interior spiral section 2a facing inwards the spiral and an exterior spiral section 2a facing outwards away from the spiral. The plurality of urine inlet openings 4 is provided on the interior spiral section 2a and urine inlet openings are absent on the exterior spiral section 2a.

[0081] As seen in FIG. 3, the preconfigured coiled state of the distal end portion 2a provides a disc-like bladder anchor having a lateral extent substantially perpendicular to the longitudinal axis L of the elongated tubular member 2. As further seen, the urine inlet openings 4 of the indwelling urethral device 1 are located in close proximity to the urine bladder neck N.

[0082] In the illustrated embodiment, there are about 8 urine inlet openings 4, each oval-shaped opening 4 having a maximum length within the range of from 2 to 7 mm. The urine inlet openings 4 are spaced such that there is a distance within the range of from about 2 to 20 mm, such as from about 5 to 18 mm, between neighboring urine inlet openings 4.

[0083] As shown in FIG. 3, the elongated tubular member 2 has a varying wall thickness T along the longitudinal axis L such that a section 2b of the intermediate portion 2b of the elongated tubular member 2 has a wall thickness T.sub.a which is less than the wall thickness T.sub.b of any adjacent section of the elongated tubular member 2. The thin-walled section 2b of the intermediate portion 2b of the elongated tubular member 2 is configured to be positioned in proximity to urethral sphincter S (also referred to as external sphincter) when the urethral device in the use position is indwelling.

[0084] As shown in FIG. 3, the thin-walled section 2b of the intermediate portion 2b of the elongated tubular member 2 allows for substantially complete closure of the lumen 3 of the urethral device 1 by the urethral sphincter S.

[0085] The first wall thickness T.sub.a may be within the range of from 0.2 to 1.5 mm.

[0086] The second wall thickness T.sub.b may be within the range of from 0.5 to 2.5 mm.

[0087] The length l of the elongated tubular member of the illustrated urethral device in the linear state may be within the range of from about 6 to 22 cm, such as about 15 to 20 cm.

[0088] The outer diameter d of elongated tubular member is about 5-10 mm.

[0089] FIG. 5 illustrates a first type of a retention member 6 for retaining the urethral device 1 within the urethra. The retention member 6 is to be disposed externally of the bladder and in the urethra, when the urethral device 1 in the use position is indwelling. The retention member 6 enables proximal anchoring in the urethra and prohibits movement of the indwelling urethral device 1 distally when the urethral device 1 is in the use position. The retention member 6 is provided by a part of the proximal end portion 2c which has been preconfigured to be transformable between a linear state for passage through the urethra and a compressed preconfigured state forming a outwardly bulging bump on the elongated tubular member 2 for retention thereof within the urethra when the urethral device 1 in the use position is indwelling.

[0090] FIG. 6 illustrates another type of a retention member 7 for retaining the urethral device 1 within the urethra. In this embodiment, the retention member 7 is provided by a part of the proximal end portion 2c preconfigured to be transformable between a linear state for passage through the urethra when inserted there through and a twisted preconfigured state for retention thereof within the urethra when the urethral device 1 in the use position is indwelling.

[0091] The herein disclosed urethral device may be inserted in the urethra using a reinforcing guide wire. The guide wire is inserted coaxially into the lumen 3 of the tubular member 2 of the urethral device 1 during insertion of the urethral device 1 through the urethra.

[0092] By applying a pushing force to the reinforcing guide wire, the preconfigured part of the distal end portion 2a is forced to a temporarily linear state to enable passage of the urethral device 1 through the urethra. When the reinforcing guide wire is removed, the preconfigured part of the distal end portion 2a reverts to its preconfigured coiled state to enable anchored receipt within the bladder in the use position.

[0093] Moreover, as illustrated in FIG. 7, the distal inlet end portion 2a may comprise a so-called angular Tiemann tip (also called ball tip) in order enable the prostate gland to be easier circumnavigated and thereby facilitate insertion of the urethral device 1 into the urethra.

[0094] FIGS. 8 and 9 illustrate an embodiment of an urethral device 10 for use in drainage of urine from a bladder when the urethral device in a use position is in a patient. The urethral device 10 may be either an indwelling or an intermittent catheter. The urethral device is a single lumen urethral device, which comprises an elongated tubular member 20 extending along a longitudinal axis L from a distal inlet end portion 20a via an intermediate portion 20b to a proximal outlet end portion 20c. In the illustrated embodiment, the distal inlet end portion, the intermediate portion and the proximal outlet end portion of the urethral device is formed as an integral unit. The proximal outlet end portion 20c includes a drainage outlet 50 and a drainage port 8. The drainage port 8 may be provided with means for connecting the drainage port 8 to a urine collection bag or to a sampling device.

[0095] The distal inlet end portion 20a is provided with an end opening 9. As illustrated in FIG. 9, the urethral device 10 may be inserted in the urethra using a reinforcing guide wire 11. The guide wire 11 is inserted coaxially into the lumen 30 of the tubular member 20 of the urethral device 10 during insertion of the urethral device 1 through the urethra. FIG. 9 thus illustrates the urethral device 10 provided in a linear state for passage through the urethra. The end opening 9 provided in the distal inlet end portion 20a may be provided to allow easy insertion of the urethral device 10 by means of a guide wire 11. The guide wire 11 may be provided with a more flexible material in the end tip 11a of the guide wire 11 intended to protrude out from the end opening 9 during insertion through the urethra. The urethral device 10, the guide wire 11 or the end tip 11a may be manufactured using a synthetic material such as biologically compatible silicone. Additionally, at manufacturing of urethral devices 1,10 these may be moulded as an integral unit and there after sequentially cut to have a desired length, such manufacturing method provides the urethral devices 1,10 with an end opening 9 at the distal inlet end portion 2a,20a of the elongated tubular member 2,20 and a drainage outlet 5,50 in a proximal outlet end portion 2c,20c.

[0096] FIG. 8 illustrates the urethral device 10 in a preconfigured coiled state for anchored receipt within the bladder in the use position. The preconfigured coiled state of the distal end portion 20a forms a spiral emanating from a point P on the longitudinal axis L of the elongated tubular member 20 and the spiral extending in at least a first x and a second direction y. The second direction is orthogonal to the first direction and each of the first and second direction x, y are axially transverse to the longitudinal axis L of the elongated tubular member 20. The spiral comprises an interior spiral section 20a facing inwards the spiral and an exterior spiral section 20a facing outwards away from the spiral. The plurality of urine inlet openings 40 is provided on the interior spiral section 20a and urine inlet openings are absent on the exterior spiral section 20a