US20040078088A1 - Male urethral stent device - Google Patents
Male urethral stent device Download PDFInfo
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- US20040078088A1 US20040078088A1 US10/277,575 US27757502A US2004078088A1 US 20040078088 A1 US20040078088 A1 US 20040078088A1 US 27757502 A US27757502 A US 27757502A US 2004078088 A1 US2004078088 A1 US 2004078088A1
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- Prior art keywords
- coil
- medical device
- patient
- segment
- lumen
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/88—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/0077—Special surfaces of prostheses, e.g. for improving ingrowth
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2002/047—Urethrae
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2002/828—Means for connecting a plurality of stents allowing flexibility of the whole structure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
Definitions
- This invention generally relates to stents and maintaining a body passageway open.
- Bladder outlet obstruction is a urological disorder.
- this urological disorder can be caused by an enlarged prostate that constricts the prostatic urethra.
- Such disorders include, for example, benign prostatic hyperplasia or prostatic carcinoma.
- the prostatic urethra is a section of the urethra that passes through the prostate.
- Bladder outlet obstruction is associated with a plurality of undesirable symptoms such as difficulties in urination, strongly reduced capacity to urinate, an increased desire to urinate, or the complete inability to urinate which may lead to severe renal disorders.
- Foley catheter is a tube that extends from the patient's bladder to a collection bag located outside of the patient's body.
- the Foley catheter provides constant drainage, but it does not allow the patient to control his voiding function.
- U.S. Pat. No. 5,766,209 describes a prosthesis that contains two tubular elements that are intended to be located on either side of the patient's external sphincter, and a connector that is intended to be held in the orifice of the external sphincter.
- the invention generally relates to draining fluid from the bladder of a patient with a stent.
- Devices and methods according to the invention are typically used in the treatment for patients suffering from bladder outlet obstruction to address and relieve urinary retention. It is an object of the invention to maintain the urethra open and able to pass fluids from the bladder while also allowing normal operation of the patient's external sphincter such that the patient has control over the retention and discharge of urine (and/or other fluids) from the bladder. It is another object of the invention to resist migration of a device placed within the patient's urinary system, and also to prevent or reduce the attraction of blood clots (and/or other debris) when the device is placed and used within the patient. It is a further object of the invention to permit ease of removal of the device by the patient when patency of the lumen is restored.
- proximal and distal require a point of reference.
- the point of reference is from the perspective of the body of the patient. Therefore, the term proximal refers to a direction that points into the body of the patient, whereas the term distal refers to a direction that points out of the patient's body.
- the invention features a medical device for use within a body lumen of a patient comprising a first coil, a second coil, and a connecting segment.
- the first coil comprises a plurality of windings defining a first lumen and locatable on the proximal side of the external sphincter and a distal end terminating on the proximal side of the external sphincter.
- the second coil comprises a plurality of windings defining a second lumen and locatable on the distal side of the external sphincter and a proximal end terminating on the distal side of the external sphincter.
- the connecting segment is locatable in the external sphincter when the device is placed within the body of the patient and is disposed between and couples together the first and second coils.
- the medical device can have a removal segment attached to a proximal end of the first coil.
- the removal segment can be disposed within the first lumen and/or the second lumen.
- the first coil, the second coil, and the connecting segment further comprise an inner core and an outer coating covering at least a portion of the inner core.
- the inner core may be formed from a biocompatible material.
- the outer coating is formed from a material that is absorbed into the lumen of a patient at a predetermined degradation rate.
- the outer coating may be formed from polyglycolic acid, polylactic acid, a polymer, or a polymid.
- the outer coating may also comprise a pharmaceutical.
- the windings of the first coil and the second coil are sized and configured to progressively uncoil from the proximal end of the first coil to a distal end of the second coil upon application of a continuous tensile force to the removal segment.
- the proximal end of the first coil may be formed into a variety of shapes to permit atraumatic entry of the medical device into the body of the patient.
- the proximal end of the first coil is a frusto-conical shape.
- the proximal end of the first coil and the distal end of the second coil include one or more hooks to permit connection to a delivery system.
- the windings of the first coil and the second coil are separated from each other by a distance in the range of from about 0.5 millimeters to about 10 millimeters.
- the cross-sectional area of the outer coating is in the range from about 0.0079 millimeters 2 to about 7.1 millimeters 2 .
- the inner core includes a first coil defining a first lumen and having a proximal end and a distal end.
- the inner core also includes a second coil defining a second lumen having a proximal end and a distal end.
- the outer coating provides structural support to the first lumen and the second lumen of the inner core when placed with a body lumen of a patient.
- the inner core further comprises a plurality of spaced coil windings being sized and configured for placement and retention substantially within the urethra of a patient.
- a connecting segment is disposed between and couples together the first coil and the second coil.
- the medical device is of unitary construction.
- the medical device can also have a removal segment attached to the proximal end of the first coil.
- the removal segment can be disposed within the first lumen and/or the second lumen.
- the inner core may be formed from a biocompatible material.
- the outer coating may be formed from a material that loses structural integrity during hydration and may be absorbed into the lumen of a patient at a predetermined degradation rate.
- the outer coating may be formed from polyglycolic acid, polylactic acid, a polymer, or a polymid.
- the outer coating may also comprise a pharmaceutical.
- the windings are sized and configured to progressively uncoil from the proximal end of the first coil to the distal end of the second coil upon application of a continuous tensile force to the removal segment.
- the proximal end of the first coil may be formed into a variety of shapes to permit atraumatic entry of the medical device into the body of the patient.
- the proximal end of the first coil is a frusto-conical shape.
- the proximal end of the first coil and the distal end of the second coil includes one or more hooks to permit connection to a delivery system.
- the windings of the first coil and the second coil are separated by a distance in the range of from about 0.5 millimeters to about 10 millimeters.
- the cross-sectional area of the outer coating is in the range of from about 0.0079 millimeters 2 to about 7.1 millimeters 2 .
- Another aspect of the invention features a method of maintaining the patency of a patient's urethra.
- the method includes supporting the prostatic section of a the urethra with a first coil defining a first lumen and locatable on the proximal side of the external sphincter, supporting the bulbar section of a the urethra with a second coil defining a second lumen and locatable on the distal side of the external sphincter, and permitting substantially normal constriction of the external sphincter with a substantially uncoiled segment coupling the first coil and second coil.
- the method can include providing a delivery system comprising a first element and a second element.
- the first element has an outer diameter smaller than the diameters of the first coil and the second coil and includes a first end, a second end, and a connection member extending out from the first end.
- the second element includes a first end, a second end, and a connection member extending out from the first end with the first and/or the second elements of the delivery system being rotatable.
- the connection member of the first element comprises an arm extending radially outward from the first end and includes an opening sized to receive a hook extending from the proximal portion.
- the connection member of the second element comprises an arm extending radially outward from the first end and includes an opening sized to receive the hooks extending from the proximal portion of the first segment and the distal end of the second segment.
- FIG. 1A is a side view of one embodiment of a prostatic stent according to the invention.
- FIG. 1B shows an enlarged perspective view of a representative section of the coil segment labeled B in FIG. 1A.
- FIG. 1C shows an enlarged cross-sectional view taken along a line C-C in FIG. 1B.
- FIG. 1D shows an enlarged view of the proximal end of the stent in FIG. 1A.
- FIG. 2 is a side view of a prostatic stent including a frusto-conical proximal tip.
- FIG. 3 is a side view of a one embodiment of a delivery system.
- FIG. 4A is a schematic view of the prostatic stent connected to the delivery system depicted in FIG. 3.
- FIG. 4B is a schematic view of the prostatic stent connected to the delivery system depicted in FIG. 3 and in a configuration for insertion into the urethra of the patient.
- FIG. 5A is an expanded schematic view of a prostatic stent being inserted into the male patient's urinary system using the delivery system depicted in FIG. 3.
- FIG. 5B is an expanded schematic view of a clinical application of a prostatic stent properly positioned in a male patient's urinary system.
- FIG. 6A is a view of a male patient's urinary system.
- FIG. 6B is a view of the prostatic stent implanted in a male patient's urinary system.
- FIG. 7A is a side view of a prostatic stent-properly being removed and uncoiled.
- FIG. 7B is a side view of a prostatic stent being further removed and uncoiled.
- FIG. 7C is a schematic view of a prostatic stent being removed from the male patient's urinary system.
- the invention generally relates to relieving urinary retention.
- the invention provides devices and methods for assisting urinary release in a male patient suffering from bladder outlet obstruction while allowing normal functioning of the patient's external sphincter such that the patient has control over bladder voiding.
- the prostate is a chestnut shaped organ that surrounds the urethra in a man's urinary system. When it becomes enlarged due to disease or changes in male hormone production, the prostate can constrict the urethra resulting in bladder outlet obstruction.
- the medical condition described above is generally referred to as benign prostatic hyperplasia (BPH).
- BPH benign prostatic hyperplasia
- blood clots or other debris collecting in the constricted urethra may further obstruct the urethra of a patient suffering from BPH.
- One of the objects of the invention is to maintain an open passageway clear of debris from the patient's bladder through the urethra while preserving the patient's normal control of voiding function by allowing the external sphincter to open and close normally and under patient control.
- a further object of the invention is to permit practical removal of the device by the patient, thereby avoiding the cost and inconvenience of returning to a medical practitioner's office following the conclusion of treatment of the urological disorder.
- the prostatic stent 10 in accordance with an embodiment of the invention, comprises an elongate coil segment 12 extending substantially longitudinally and including two distinct layers.
- the coil segment 12 of prostatic stent 10 comprises an inner core 13 surrounded by an outer coating 14 of thickness W.
- the outer coating 14 may only partially surround the inner core 13 .
- the inner core 13 is made from one or more biocompatible materials such as a polyimid.
- the outer coating 14 is made of a material which can be absorbed into the body and which provides the rigid support for the stent 10 when implanted in the male urinary system.
- the outer coating 14 is preferably a polyglycolic acid, polylactic acid, or a polymer blend, for example.
- any biocompatible and bio-absorbable material(s) capable of providing rigid support for the stent 10 can be used for the outer coating 14 .
- the coil segment 12 is wound to form a plurality of windings 15 spaced from each other along some of the length of the coil segment 12 .
- the plurality of windings 15 form a first coil (or prostatic segment) 18 and a second coil (or bulbar segment) 20 .
- the windings 15 along the prostatic segment 18 defines a first lumen 21 a and the windings 15 along the bulbar segment 20 defines a second lumen 21 b .
- the first lumen 21 a and second lumen 21 b extend longitudinally along the prostatic stent 10 to allow fluid(s), such as urine, to pass therethrough.
- the prostatic segment 18 and the bulbar segment 20 are coupled together by a substantially unwound section along the coil segment 12 that defines a connecting segment 22 .
- the windings 15 of those sections of the stent 10 are sufficiently flexible to conform to the shape of the urethra for ease of insertion while sufficiently rigid to maintain an open passageway through the urethra when placed in the male urinary system.
- the segments 18 , 20 can have cross-sectional shapes that are circular or can have other cross-sectional shapes, such as elliptical or even rectangular, square, or triangular, for example.
- the prostatic stent 10 includes a proximal tip 24 extending proximally from the prostatic segment 18 . An end view of the prostatic stent 10 at the proximal tip 24 is depicted in FIG. 1D.
- the connecting segment 22 connects to the prostatic segment 18 at a distal end 26 .
- the proximal tip 24 can be either of constant diameter as shown in FIG. 1A, or a tapered diameter as shown in FIG. 2, yielding a conical or frusto-conical shape providing an atraumatic tip for ease of insertion into the patient's urethra.
- the first lumen 21 a extends through the prostatic segment 18 to the proximal tip 24 for fluidic communication with the bladder of the patient.
- a removal segment 34 continues from the proximal tip 24 , through the prostatic segment 18 , along the connecting segment 22 , and through the bulbar segment 20 , such that a distal portion 36 of the removal segment 34 may extend outside the penis when the prostatic stent 10 is implanted in the male urinary system.
- the prostatic stent 10 is manufactured by heat setting the inner core 13 comprising the polyimid material in the desired coiled configuration defining the prostatic and bulbar segments 18 , 20 about a mandrel at approximately 240 degrees Celsius for approximately two hours.
- the prostatic and bulbar segments 18 , 20 may also include hooks 38 , 39 .
- the hooks 38 , 39 are positioned such that the prostatic stent 10 may be connected to a delivery device 40 (see FIG. 3) used to wind the prostatic stent 10 to a smaller width for delivery into the body of the patient.
- the hooks 38 , 39 are positioned such that they extend lengthwise beyond the prostatic and bulbar segments 18 , 20 , respectively.
- the hooks 38 , 39 need not be positioned as shown in FIG. 1A to allow the coil segment 12 to connect to the delivery device 40 as other hook positions are possible.
- the proximal tip 24 is located within the bladder near the bladder opening
- the prostatic segment 18 is located substantially within the prostatic urethra (the section of the urethra that is surrounded by the patient's prostate) with the distal end 26 of the prostatic segment 18 terminating just prior to the proximal side of the patient's external sphincter
- the bulbar segment 20 is located on the distal side of the external sphincter.
- the connecting segment 22 is sized to extend through the external sphincter to attach the bulbar segment 20 to the prostatic segment 18 while not interfering with the normal operation of the external sphincter.
- the connecting segment 22 in the embodiment shown in FIG. 1A is substantially an uncoiled portion of coil segment 12 .
- the connecting segment 22 may be a helical coil with a diameter smaller than that of prostatic and bulbar segments 18 , 20 .
- Each of the ends of the connecting segment 22 smoothly transitions to the respective prostatic and bulbar segments 18 , 20 , so as to form no rough discontinuities or edges that would promote the formation of blood clots or collection of other bodily material.
- the prostatic and bulbar segments 18 , 20 have a greater diameter than connecting segment 22 .
- the prostatic stent 10 is located substantially within the patient's prostatic urethra with the prostatic segment 18 located within the bladder opening and the bulbar segment 20 located on the proximal side of the patient's external sphincter, so as not to interfere with the normal operation of the external sphincter.
- the greater diameter of the prostatic and bulbar segments 18 , 20 is sized such that prostatic and bulbar segments 18 , 20 are in contact with and exert a compressive force on the patient's urethral wall, thereby anchoring the prostatic stent 10 within the patient's urinary system and preventing the migration of the prostatic stent 10 .
- the greater diameter of the prostatic segment 18 prevents the distal migration of the prostatic stent 10 (down and out of the bladder opening).
- the greater diameter of the bulbar segment 20 prevents the proximal migration of the prostatic stent 10 (up into the bladder of the patient).
- the diameter of the prostatic and bulbar segments 18 , 20 is about 40 French.
- FIG. 1C shows an enlarged cross-sectional view of the coil segment 12 taken along a line C-C in FIG. 1B.
- a dimension labeled W defines the wall thickness of the segment. Thickness W may be varied to effect the rate of absorption of the outer coating 14 .
- the material composition and heat treatment of the outer coating 14 may also be selected to vary the rate of absorption or degradation.
- the prostatic stent 10 may also include the removal segment 34 .
- the removal segment 34 continues from the proximal tip 24 and is threaded back through the prostatic segment 18 , the connecting segment 22 , and the bulbar segment 20 .
- the distal portion of the removal segment terminates outside of the patient's body when the prostatic stent 10 is placed within the urinary system of the patient for removal from the patient's body by a medical professional or patient.
- the stent 10 comprising now substantially the inner core 13 , is sufficiently compliant to permit easy removal.
- the patient or medical professional pulls on the distal portion of the removal segment 36 along a longitudinal axis of the stent 10 to progressively unwind the windings 15 of the coil segment 12 , enabling the stent 10 to assume a substantially linear configuration for complete withdraw from the patient's body.
- the spaced windings 15 provide radial strength to the prostatic stent 10 , while permitting the degree of flexibility necessary to conform to the patient's anatomy.
- the windings 15 are spaced such that a distance of about 1 millimeter exists between each adjacent winding. In other embodiments, where a greater amount of flexibility is desired, the windings 15 may be spaced at a greater distance, such as, for example, up to about 10 millimeters.
- a medical professional may insert a prostatic stent 10 having windings 15 closely spaced, at a smaller distance.
- the windings 15 may be spaced at a distance no less than about 0.5 millimeters.
- a medical professional such as, for example, a physician uses the delivery system 40 as shown in FIG. 3.
- the delivery system 40 can be made from a biocompatible material that is flexible enough to conform to the patient's body, but also rigid enough to advance the prostatic stent 10 through the patient's urinary system.
- the delivery system 40 includes a rotatable element 42 and has an outer diameter less than the smaller diameter of the prostatic and bulbar segments 18 , 20 of the prostatic stent 10 so as to be insertable into the second lumen 21 b of the prostatic stent 10 .
- the rotatable element 42 includes a first end 44 having a connection arm 46 that extends radially outward from the first end 44 , and a second end 48 that is accessible to the medical professional for positioning the prostatic stent 10 within the urinary system of the patient.
- the connection arm 46 may pivot about a hinge 50 , which attaches the connection arm 46 to the rotatable element 42 .
- connection arm 46 includes an opening 52 that permits connection between the bulbar segment 20 of the prostatic stent 10 and the rotatable element 42 .
- a stationary element 54 of the delivery system 40 includes a first end 56 having a connection arm 58 and a second end 60 .
- the connection arm 58 extends radially outward from the first end 56 and includes an opening 62 , which permits connection between the bulbar segment 18 of the prostatic stent 10 and the stationary element 54 .
- the stationary element 54 has an outer diameter larger than the diameter of prostatic and bulbar segments 18 , 20 and includes a lumen sized to receive the rotatable element 42 .
- FIGS. 4A, 4B show one embodiment of the prostatic stent 10 having windings 15 of the coil segment 12 spaced apart at a large distance, L.
- the width of the winding of the coil segment 12 is reduced to allow the prostatic stent 10 to easily pass through the patient's urethra.
- the width of the prostatic stent 10 may be temporarily reduced by twisting or winding the proximal segment 18 about a longitudinal axis while restraining movement of the bulbar segment 20 . Alternatively, twisting the bulbar segment 20 about the longitudinal axis while restraining the prostatic segment 18 may also reduce the width of the prostatic stent 10 .
- the stationary element 54 may have an outer diameter less than or equal to the diameter of the rotatable element 42 such that the rotatable and stationary elements 42 , 54 extend substantially parallel to each other when attached to the prostatic stent 10 .
- the stationary element 54 may be replaced with another rotatable element.
- the two rotatable elements rotate in opposing directions.
- the delivery system 40 may also include a lumen extending through the rotatable element 42 from the first end 44 to the second end 48 to assist a medical professional with placing the prostatic stent 10 with the patient's urinary system.
- either a manufacturer or a medical professional uses the stationary and rotatable elements to reduce the outer diameter or width of the prostatic stent 10 .
- a manufacturer or a medical professional uses the stationary and rotatable elements to reduce the outer diameter or width of the prostatic stent 10 .
- connection arms 46 , 58 have openings 52 , 62 to permit connection to hooks 38 , 39 extending from the prostatic and bulbar segments 18 , 20 of the prostatic stent 10 .
- the connection arms 46 , 58 may be bent into hooks to permit connection with hooks 38 , 39 .
- the manufacturer or the medical professional temporarily reduces the diamater of the prostatic stent 10 by twisting or ratcheting the rotatable element 42 that is attached to the prostatic segment 18 of the prostatic stent 10 while simultaneously holding the stationary element 54 that is connected to the bulbar segment 20 of the prostatic stent 10 .
- the width of the prostatic stent 10 has decreased sufficiently to allow passage through the patient's urethra without significantly irritating or bruising the walls of the patient's urethra.
- the length of the coil segment 12 consequently extends in longitudinal length.
- the coil segment 12 expands and the length of the coil segment 12 contracts until the prostatic stent 10 has returned to substantially its original dimensions.
- a medical professional inserts the prostatic stent 10 with attached delivery system into the meatus urinarius 62 of the patient, as shown in FIG. 5A.
- the medical professional may insert a sheath (not shown) into the patient's urethra 60 prior to inserting the prostatic stent 10 attached to the delivery system 40 .
- the sheath is a smooth tubular member sized to receive the prostatic stent 10 and the delivery system 40 .
- the prostatic stent 10 attached to the delivery system 40 may be inserted into the sheath prior to the medical professional inserting the sheath including the prostatic stent 10 and delivery system 40 into the patient's body.
- the medical professional advances the prostatic stent 10 and the delivery system 40 through the patient's urinary system until the prostatic stent 10 is located substantially within the prostatic urethra with the prostatic segment 18 located near the opening of the patient's bladder 66 and the bulbar segment terminating prior to the proximal side of the patient's external sphincter 68 so as not to interfere with the normal operation of the external sphincter 68 .
- the medical professional After confirming proper placement of the prostatic stent 10 using, for example, radiographic techniques, the medical professional returns the prostatic stent 10 to its original or first width by rotating the rotatable element 42 in a second direction while restraining the stationary element 54 from moving.
- the prostatic and bulbar segments 18 , 20 now with the restored, larger diameters on either side of the external sphincter 68 , anchor the prostatic stent 10 within the proper position within the patient's urinary system as shown in FIG. 5B.
- the medical professional is then able to detach the rotatable element 42 from the prostatic segment 18 and the stationary element 54 from the bulbar segment 20 of the prostatic stent 10 .
- connection arm 46 With the connection arm 46 no longer attached to the prostatic stent 10 , the connection arm 46 is able to pivot about hinge 50 , thereby allowing the medical professional to remove the rotatable element 42 and the connection arm 46 from the prostatic stent 10 without dislodging the positioning of the prostatic stent 10 after placement.
- the detached rotatable element 42 and stationary element 54 are then removed from the patient's urinary system.
- the urethra extends upward from the meatus urinanus 62 as far as the neck 64 of the bladder 66 .
- the urethra comprises a super-collicular prostatic segment 70 and a sub-collicular prostatic segment 72 of the prostate 74 .
- the urethra comprises, toward the meatus urinarius 62 , the membranous segments 76 , the bulbar segment 78 , the perineal segment 80 , and the penile segment 82 .
- the medical professional uses the delivery system 40 to advance the proximal tip 24 of the prostatic stent 10 along the urethra 60 , past the external sphincter 68 , and into the bladder 66 .
- the medical professional inserts the prostatic stent 10 connected with the delivery system 40 into the patient's urethra at the meatus urinarius 62 .
- the medical professional then further advances the prostatic stent 10 such that the prostatic segment 18 is in the super-collicular prostatic section 70 of the urethra 60 surrounded by the prostate 74 with the bulbar segment 20 located on the distal side of the patient's external sphincter 68 along the bulbar segment 78 of the urethra 60 .
- the prostatic stent 10 is properly positioned in the detailed depiction of the male urinary system as shown in FIG. 6B.
- the delivery system 40 extends from the bladder 66 through the urethra 60 and terminates at a location external to the patient's body.
- the medical professional looks for urine flowing from the second end of the rotatable element 48 of the delivery system 40 located external to the patient's body to confirm correct placement of the prostatic stent 10 .
- the positioned prostatic stent 10 maintains the patency of the patient's prostatic urethra, while simultaneously allowing the patient to control the opening and closing of the external sphincter 68 .
- the positioned prostatic stent 10 has no parts or elements that communicate external to the patient's body during use, thereby reducing the high risk of infection associated with catheters.
- the radial strength provided by the coil segment 12 prevents the patient's prostatic urethra from collapsing due to the pressure created by the patient's enlarged prostate 68 .
- the prostatic stent 10 is anchored in position by the prostatic and bulbar segments 18 , 20 that inhibit migration of the prostatic stent 10 .
- the prostatic stent may be removed as follows. As all of the segments 18 , 20 , 22 and windings 15 of the prostatic stent 10 are formed from the single coil segment 12 , the prostatic stent 10 may be removed by applying a tensile force along the removal segment 34 , thereby unwinding the coil segment 12 and removing the prostatic stent 10 . At the end of a prescribed time period, the patient can remove the prostatic stent 10 by pulling on the distal portion of the removal segment 36 extending back from the proximal tip 24 , threaded through the prostatic and bulbar segments 18 , 20 and extending through the penile segment 82 and through the meatus urinarius 62 .
- the structurally integrity of the prostatic stent 10 is sufficiently attenuated to permit removal of the prostatic stent 10 transurethrally by the patient.
- the proximal tip 24 of the prostatic segment 18 first unwinds and the remainder of the stent 10 progressively unwinds until uncoiling and removal of the prostatic stent 10 is achieved.
- this invention is designed for indwelling within a lumen for a prescribed time period of minimal duration, incorporation of the stent within the urethra due to tissue ingrowth is not a concern.
Abstract
Description
- This invention generally relates to stents and maintaining a body passageway open.
- Bladder outlet obstruction is a urological disorder. In males, this urological disorder can be caused by an enlarged prostate that constricts the prostatic urethra. Such disorders include, for example, benign prostatic hyperplasia or prostatic carcinoma. The prostatic urethra is a section of the urethra that passes through the prostate. Bladder outlet obstruction is associated with a plurality of undesirable symptoms such as difficulties in urination, strongly reduced capacity to urinate, an increased desire to urinate, or the complete inability to urinate which may lead to severe renal disorders.
- To eliminate these symptoms, medical devices that attempt to maintain an open passageway through the prostatic urethra have been developed. One of the medical devices developed for this purpose is a Foley catheter. The Foley catheter is a tube that extends from the patient's bladder to a collection bag located outside of the patient's body. The Foley catheter provides constant drainage, but it does not allow the patient to control his voiding function.
- Some indwelling prostatic stents seek to allow the patient to control their voiding function while also retaining the prostatic urethra open. For example, U.S. Pat. No. 5,766,209 describes a prosthesis that contains two tubular elements that are intended to be located on either side of the patient's external sphincter, and a connector that is intended to be held in the orifice of the external sphincter.
- Following conclusion of the treatment of the urological disorder (for example, when patency of the urethra is restored), a medical professional is generally required to remove an indwelling prostatic stent either transurethreally or endoscopically. A partially absorbable stent which can be implanted following a surgical procedure and be easily removed by the patient would obviate the need for a patient to return to the doctor for removal of the stent.
- The invention generally relates to draining fluid from the bladder of a patient with a stent. Devices and methods according to the invention are typically used in the treatment for patients suffering from bladder outlet obstruction to address and relieve urinary retention. It is an object of the invention to maintain the urethra open and able to pass fluids from the bladder while also allowing normal operation of the patient's external sphincter such that the patient has control over the retention and discharge of urine (and/or other fluids) from the bladder. It is another object of the invention to resist migration of a device placed within the patient's urinary system, and also to prevent or reduce the attraction of blood clots (and/or other debris) when the device is placed and used within the patient. It is a further object of the invention to permit ease of removal of the device by the patient when patency of the lumen is restored.
- It is noted initially that the directional terms proximal and distal require a point of reference. As used herein, the point of reference is from the perspective of the body of the patient. Therefore, the term proximal refers to a direction that points into the body of the patient, whereas the term distal refers to a direction that points out of the patient's body.
- In one aspect, the invention features a medical device for use within a body lumen of a patient comprising a first coil, a second coil, and a connecting segment. When placed within the body of the patient the first coil comprises a plurality of windings defining a first lumen and locatable on the proximal side of the external sphincter and a distal end terminating on the proximal side of the external sphincter. The second coil comprises a plurality of windings defining a second lumen and locatable on the distal side of the external sphincter and a proximal end terminating on the distal side of the external sphincter. The connecting segment is locatable in the external sphincter when the device is placed within the body of the patient and is disposed between and couples together the first and second coils. The medical device can have a removal segment attached to a proximal end of the first coil. The removal segment can be disposed within the first lumen and/or the second lumen.
- In one embodiment, the first coil, the second coil, and the connecting segment further comprise an inner core and an outer coating covering at least a portion of the inner core. The inner core may be formed from a biocompatible material. In one embodiment, the outer coating is formed from a material that is absorbed into the lumen of a patient at a predetermined degradation rate. The outer coating may be formed from polyglycolic acid, polylactic acid, a polymer, or a polymid. The outer coating may also comprise a pharmaceutical.
- In another embodiment, the windings of the first coil and the second coil are sized and configured to progressively uncoil from the proximal end of the first coil to a distal end of the second coil upon application of a continuous tensile force to the removal segment. The proximal end of the first coil may be formed into a variety of shapes to permit atraumatic entry of the medical device into the body of the patient. In one embodiment, the proximal end of the first coil is a frusto-conical shape. In another embodiment, the proximal end of the first coil and the distal end of the second coil include one or more hooks to permit connection to a delivery system.
- In one embodiment, the windings of the first coil and the second coil are separated from each other by a distance in the range of from about 0.5 millimeters to about 10 millimeters. In one embodiment, the cross-sectional area of the outer coating is in the range from about 0.0079 millimeters2 to about 7.1 millimeters2.
- Another aspect of the invention features a medical device for use within a body lumen of a patient comprising an inner core and an outer coating layered upon a portion of the inner core. The inner core includes a first coil defining a first lumen and having a proximal end and a distal end. The inner core also includes a second coil defining a second lumen having a proximal end and a distal end. The outer coating provides structural support to the first lumen and the second lumen of the inner core when placed with a body lumen of a patient. The inner core further comprises a plurality of spaced coil windings being sized and configured for placement and retention substantially within the urethra of a patient. A connecting segment is disposed between and couples together the first coil and the second coil. In one embodiment, the medical device is of unitary construction. The medical device can also have a removal segment attached to the proximal end of the first coil. The removal segment can be disposed within the first lumen and/or the second lumen.
- The inner core may be formed from a biocompatible material. The outer coating may be formed from a material that loses structural integrity during hydration and may be absorbed into the lumen of a patient at a predetermined degradation rate. The outer coating may be formed from polyglycolic acid, polylactic acid, a polymer, or a polymid. The outer coating may also comprise a pharmaceutical.
- In another embodiment, the windings are sized and configured to progressively uncoil from the proximal end of the first coil to the distal end of the second coil upon application of a continuous tensile force to the removal segment. The proximal end of the first coil may be formed into a variety of shapes to permit atraumatic entry of the medical device into the body of the patient. In one embodiment, the proximal end of the first coil is a frusto-conical shape. In another embodiment, the proximal end of the first coil and the distal end of the second coil includes one or more hooks to permit connection to a delivery system. In one embodiment, the windings of the first coil and the second coil are separated by a distance in the range of from about 0.5 millimeters to about 10 millimeters. In one embodiment, the cross-sectional area of the outer coating is in the range of from about 0.0079 millimeters2 to about 7.1 millimeters2.
- Another aspect of the invention features a method of maintaining the patency of a patient's urethra. The method includes supporting the prostatic section of a the urethra with a first coil defining a first lumen and locatable on the proximal side of the external sphincter, supporting the bulbar section of a the urethra with a second coil defining a second lumen and locatable on the distal side of the external sphincter, and permitting substantially normal constriction of the external sphincter with a substantially uncoiled segment coupling the first coil and second coil.
- The method can include providing a delivery system comprising a first element and a second element. The first element has an outer diameter smaller than the diameters of the first coil and the second coil and includes a first end, a second end, and a connection member extending out from the first end. The second element includes a first end, a second end, and a connection member extending out from the first end with the first and/or the second elements of the delivery system being rotatable. In one embodiment, the connection member of the first element comprises an arm extending radially outward from the first end and includes an opening sized to receive a hook extending from the proximal portion. In another embodiment, the connection member of the second element comprises an arm extending radially outward from the first end and includes an opening sized to receive the hooks extending from the proximal portion of the first segment and the distal end of the second segment.
- The foregoing and other objects, aspects, features and advantages of the present invention will be more fully understood from the following description and embodiments when read together with the accompanying drawings.
- In the drawings, like reference characters generally refer to the same parts throughout the different views. Also, the drawings are not necessarily to scale, emphasis instead generally being placed upon illustrating the principles of the invention.
- FIG. 1A is a side view of one embodiment of a prostatic stent according to the invention.
- FIG. 1B shows an enlarged perspective view of a representative section of the coil segment labeled B in FIG. 1A.
- FIG. 1C shows an enlarged cross-sectional view taken along a line C-C in FIG. 1B.
- FIG. 1D shows an enlarged view of the proximal end of the stent in FIG. 1A.
- FIG. 2 is a side view of a prostatic stent including a frusto-conical proximal tip.
- FIG. 3 is a side view of a one embodiment of a delivery system.
- FIG. 4A is a schematic view of the prostatic stent connected to the delivery system depicted in FIG. 3.
- FIG. 4B is a schematic view of the prostatic stent connected to the delivery system depicted in FIG. 3 and in a configuration for insertion into the urethra of the patient.
- FIG. 5A is an expanded schematic view of a prostatic stent being inserted into the male patient's urinary system using the delivery system depicted in FIG. 3.
- FIG. 5B is an expanded schematic view of a clinical application of a prostatic stent properly positioned in a male patient's urinary system.
- FIG. 6A is a view of a male patient's urinary system.
- FIG. 6B is a view of the prostatic stent implanted in a male patient's urinary system.
- FIG. 7A is a side view of a prostatic stent-properly being removed and uncoiled.
- FIG. 7B is a side view of a prostatic stent being further removed and uncoiled.
- FIG. 7C is a schematic view of a prostatic stent being removed from the male patient's urinary system.
- The invention generally relates to relieving urinary retention. The invention provides devices and methods for assisting urinary release in a male patient suffering from bladder outlet obstruction while allowing normal functioning of the patient's external sphincter such that the patient has control over bladder voiding.
- Some men, especially men over fifty years of age, experience urinary retention caused by an enlarged prostate. The prostate is a chestnut shaped organ that surrounds the urethra in a man's urinary system. When it becomes enlarged due to disease or changes in male hormone production, the prostate can constrict the urethra resulting in bladder outlet obstruction. The medical condition described above is generally referred to as benign prostatic hyperplasia (BPH). In addition to the obstruction caused by the enlarged prostate, blood clots or other debris collecting in the constricted urethra may further obstruct the urethra of a patient suffering from BPH. One of the objects of the invention is to maintain an open passageway clear of debris from the patient's bladder through the urethra while preserving the patient's normal control of voiding function by allowing the external sphincter to open and close normally and under patient control. A further object of the invention is to permit practical removal of the device by the patient, thereby avoiding the cost and inconvenience of returning to a medical practitioner's office following the conclusion of treatment of the urological disorder.
- Referring to FIG. 1A, the
prostatic stent 10, in accordance with an embodiment of the invention, comprises anelongate coil segment 12 extending substantially longitudinally and including two distinct layers. As depicted in FIGS. 1B and 1C, thecoil segment 12 ofprostatic stent 10 comprises aninner core 13 surrounded by anouter coating 14 of thickness W. In other embodiments (not shown), theouter coating 14 may only partially surround theinner core 13. Theinner core 13 is made from one or more biocompatible materials such as a polyimid. Theouter coating 14 is made of a material which can be absorbed into the body and which provides the rigid support for thestent 10 when implanted in the male urinary system. Theouter coating 14 is preferably a polyglycolic acid, polylactic acid, or a polymer blend, for example. In general, any biocompatible and bio-absorbable material(s) capable of providing rigid support for thestent 10 can be used for theouter coating 14. - The
coil segment 12 is wound to form a plurality ofwindings 15 spaced from each other along some of the length of thecoil segment 12. The plurality ofwindings 15 form a first coil (or prostatic segment) 18 and a second coil (or bulbar segment) 20. Thewindings 15 along theprostatic segment 18 defines afirst lumen 21 a and thewindings 15 along thebulbar segment 20 defines asecond lumen 21 b. Thefirst lumen 21 a andsecond lumen 21 b extend longitudinally along theprostatic stent 10 to allow fluid(s), such as urine, to pass therethrough. Theprostatic segment 18 and thebulbar segment 20 are coupled together by a substantially unwound section along thecoil segment 12 that defines a connectingsegment 22. - The
windings 15 of those sections of thestent 10 are sufficiently flexible to conform to the shape of the urethra for ease of insertion while sufficiently rigid to maintain an open passageway through the urethra when placed in the male urinary system. Thesegments prostatic stent 10 includes aproximal tip 24 extending proximally from theprostatic segment 18. An end view of theprostatic stent 10 at theproximal tip 24 is depicted in FIG. 1D. The connectingsegment 22 connects to theprostatic segment 18 at adistal end 26. Theproximal tip 24 can be either of constant diameter as shown in FIG. 1A, or a tapered diameter as shown in FIG. 2, yielding a conical or frusto-conical shape providing an atraumatic tip for ease of insertion into the patient's urethra. Thefirst lumen 21 a extends through theprostatic segment 18 to theproximal tip 24 for fluidic communication with the bladder of the patient. - A
removal segment 34 continues from theproximal tip 24, through theprostatic segment 18, along the connectingsegment 22, and through thebulbar segment 20, such that adistal portion 36 of theremoval segment 34 may extend outside the penis when theprostatic stent 10 is implanted in the male urinary system. In one embodiment, theprostatic stent 10 is manufactured by heat setting theinner core 13 comprising the polyimid material in the desired coiled configuration defining the prostatic andbulbar segments - The prostatic and
bulbar segments hooks hooks prostatic stent 10 may be connected to a delivery device 40 (see FIG. 3) used to wind theprostatic stent 10 to a smaller width for delivery into the body of the patient. In the embodiment shown in FIG. 1A, thehooks bulbar segments hooks coil segment 12 to connect to thedelivery device 40 as other hook positions are possible. - When the
prostatic stent 10 is properly positioned within a male patient's urinary system, theproximal tip 24 is located within the bladder near the bladder opening, theprostatic segment 18 is located substantially within the prostatic urethra (the section of the urethra that is surrounded by the patient's prostate) with thedistal end 26 of theprostatic segment 18 terminating just prior to the proximal side of the patient's external sphincter, and thebulbar segment 20 is located on the distal side of the external sphincter. The connectingsegment 22 is sized to extend through the external sphincter to attach thebulbar segment 20 to theprostatic segment 18 while not interfering with the normal operation of the external sphincter. The connectingsegment 22 in the embodiment shown in FIG. 1A is substantially an uncoiled portion ofcoil segment 12. In alternative embodiments, the connectingsegment 22 may be a helical coil with a diameter smaller than that of prostatic andbulbar segments segment 22 smoothly transitions to the respective prostatic andbulbar segments - To retain proper positioning of the
prostatic stent 10 when positioned within the patient's body and to inhibit movement, the prostatic andbulbar segments segment 22. When properly positioned within the patient's body, theprostatic stent 10 is located substantially within the patient's prostatic urethra with theprostatic segment 18 located within the bladder opening and thebulbar segment 20 located on the proximal side of the patient's external sphincter, so as not to interfere with the normal operation of the external sphincter. The greater diameter of the prostatic andbulbar segments bulbar segments prostatic stent 10 within the patient's urinary system and preventing the migration of theprostatic stent 10. The greater diameter of theprostatic segment 18 prevents the distal migration of the prostatic stent 10 (down and out of the bladder opening). Similarly, the greater diameter of thebulbar segment 20 prevents the proximal migration of the prostatic stent 10 (up into the bladder of the patient). In one disclosed embodiment, the diameter of the prostatic andbulbar segments - FIG. 1C shows an enlarged cross-sectional view of the
coil segment 12 taken along a line C-C in FIG. 1B. A dimension labeled W defines the wall thickness of the segment. Thickness W may be varied to effect the rate of absorption of theouter coating 14. The material composition and heat treatment of theouter coating 14 may also be selected to vary the rate of absorption or degradation. - The
prostatic stent 10 may also include theremoval segment 34. Theremoval segment 34 continues from theproximal tip 24 and is threaded back through theprostatic segment 18, the connectingsegment 22, and thebulbar segment 20. The distal portion of the removal segment terminates outside of the patient's body when theprostatic stent 10 is placed within the urinary system of the patient for removal from the patient's body by a medical professional or patient. After theouter coating 14 is substantially absorbed into the patient's body, thestent 10, comprising now substantially theinner core 13, is sufficiently compliant to permit easy removal. For removal, the patient or medical professional pulls on the distal portion of theremoval segment 36 along a longitudinal axis of thestent 10 to progressively unwind thewindings 15 of thecoil segment 12, enabling thestent 10 to assume a substantially linear configuration for complete withdraw from the patient's body. - One of the advantageous features of the
prostatic stent 10 is its combination of radial strength and flexibility. The spacedwindings 15 provide radial strength to theprostatic stent 10, while permitting the degree of flexibility necessary to conform to the patient's anatomy. In one embodiment thewindings 15 are spaced such that a distance of about 1 millimeter exists between each adjacent winding. In other embodiments, where a greater amount of flexibility is desired, thewindings 15 may be spaced at a greater distance, such as, for example, up to about 10 millimeters. Alternatively, if a greater amount of strength is required to maintain an open passageway through the patient's prostatic urethra, a medical professional may insert aprostatic stent 10 havingwindings 15 closely spaced, at a smaller distance. To maintain a desirable amount of flexibility to be able to conform to the patient's anatomy, thewindings 15 may be spaced at a distance no less than about 0.5 millimeters. - To wind, insert, position, and deploy the
prostatic stent 10, a medical professional, such as, for example, a physician uses thedelivery system 40 as shown in FIG. 3. Thedelivery system 40 can be made from a biocompatible material that is flexible enough to conform to the patient's body, but also rigid enough to advance theprostatic stent 10 through the patient's urinary system. - In the disclosed embodiment, the
delivery system 40 includes arotatable element 42 and has an outer diameter less than the smaller diameter of the prostatic andbulbar segments prostatic stent 10 so as to be insertable into thesecond lumen 21 b of theprostatic stent 10. Therotatable element 42 includes afirst end 44 having aconnection arm 46 that extends radially outward from thefirst end 44, and asecond end 48 that is accessible to the medical professional for positioning theprostatic stent 10 within the urinary system of the patient. Theconnection arm 46 may pivot about ahinge 50, which attaches theconnection arm 46 to therotatable element 42. Theconnection arm 46 includes anopening 52 that permits connection between thebulbar segment 20 of theprostatic stent 10 and therotatable element 42. Astationary element 54 of thedelivery system 40 includes afirst end 56 having aconnection arm 58 and asecond end 60. Theconnection arm 58 extends radially outward from thefirst end 56 and includes anopening 62, which permits connection between thebulbar segment 18 of theprostatic stent 10 and thestationary element 54. In the disclosed embodiment, thestationary element 54 has an outer diameter larger than the diameter of prostatic andbulbar segments rotatable element 42. - FIGS. 4A, 4B show one embodiment of the
prostatic stent 10 havingwindings 15 of thecoil segment 12 spaced apart at a large distance, L. Before theprostatic stent 10 is inserted into the patient's urinary system, the width of the winding of thecoil segment 12 is reduced to allow theprostatic stent 10 to easily pass through the patient's urethra. One may reduce the width of theprostatic stent 10 to have a largest outer diameter that is in a range between about 16 French to about 18 French. The width of theprostatic stent 10 may be temporarily reduced by twisting or winding theproximal segment 18 about a longitudinal axis while restraining movement of thebulbar segment 20. Alternatively, twisting thebulbar segment 20 about the longitudinal axis while restraining theprostatic segment 18 may also reduce the width of theprostatic stent 10. - Alternatively, in another embodiment of a
delivery system 40, thestationary element 54 may have an outer diameter less than or equal to the diameter of therotatable element 42 such that the rotatable andstationary elements prostatic stent 10. In another embodiment, thestationary element 54 may be replaced with another rotatable element. In this embodiment, the two rotatable elements rotate in opposing directions. In a further embodiment, thedelivery system 40 may also include a lumen extending through therotatable element 42 from thefirst end 44 to thesecond end 48 to assist a medical professional with placing theprostatic stent 10 with the patient's urinary system. - Before inserting the
prostatic stent 10 in the proper position within the patient's body, either a manufacturer or a medical professional (typically, the manufacturer) uses the stationary and rotatable elements to reduce the outer diameter or width of theprostatic stent 10. By reducing the diameter of theprostatic stent 10, possible injury or bruising to the urethra is substantially prevented during insertion and/or advancement of theprostatic stent 10 through the patient's urinary system. To connect theprostatic stent 10 with thedelivery system 40, the manufacturer or medical professional attaches thebulbar segment 20 of theprostatic stent 10 to thefirst end 44 via theconnection arm 46 of therotatable element 42 and theprostatic segment 18 to thefirst end 56 via theconnection arm 58 of thestationary element 54, as shown in FIG. 4A. In the disclosed embodiment, theconnection arms openings hooks bulbar segments prostatic stent 10. Alternatively, theconnection arms hooks prostatic stent 10 by twisting or ratcheting therotatable element 42 that is attached to theprostatic segment 18 of theprostatic stent 10 while simultaneously holding thestationary element 54 that is connected to thebulbar segment 20 of theprostatic stent 10. By twisting therotatable element 42 in a first direction as shown in FIG. 4B, the width of theprostatic stent 10 has decreased sufficiently to allow passage through the patient's urethra without significantly irritating or bruising the walls of the patient's urethra. As the width of thecoil segment 12 is reduced, the length of thecoil segment 12 consequently extends in longitudinal length. Upon being released from the delivery system, thecoil segment 12 expands and the length of thecoil segment 12 contracts until theprostatic stent 10 has returned to substantially its original dimensions. - With the width of the
prostatic stent 10 temporarily reduced, a medical professional inserts theprostatic stent 10 with attached delivery system into themeatus urinarius 62 of the patient, as shown in FIG. 5A. To further protect the patient's urethra from irritation, the medical professional may insert a sheath (not shown) into the patient'surethra 60 prior to inserting theprostatic stent 10 attached to thedelivery system 40. The sheath is a smooth tubular member sized to receive theprostatic stent 10 and thedelivery system 40. Alternatively, theprostatic stent 10 attached to thedelivery system 40 may be inserted into the sheath prior to the medical professional inserting the sheath including theprostatic stent 10 anddelivery system 40 into the patient's body. - With continued reference to FIG. 5A, the medical professional advances the
prostatic stent 10 and thedelivery system 40 through the patient's urinary system until theprostatic stent 10 is located substantially within the prostatic urethra with theprostatic segment 18 located near the opening of the patient'sbladder 66 and the bulbar segment terminating prior to the proximal side of the patient'sexternal sphincter 68 so as not to interfere with the normal operation of theexternal sphincter 68. After confirming proper placement of theprostatic stent 10 using, for example, radiographic techniques, the medical professional returns theprostatic stent 10 to its original or first width by rotating therotatable element 42 in a second direction while restraining thestationary element 54 from moving. Once theprostatic stent 10 is returned to its original width, the prostatic andbulbar segments external sphincter 68, anchor theprostatic stent 10 within the proper position within the patient's urinary system as shown in FIG. 5B. The medical professional is then able to detach therotatable element 42 from theprostatic segment 18 and thestationary element 54 from thebulbar segment 20 of theprostatic stent 10. With theconnection arm 46 no longer attached to theprostatic stent 10, theconnection arm 46 is able to pivot abouthinge 50, thereby allowing the medical professional to remove therotatable element 42 and theconnection arm 46 from theprostatic stent 10 without dislodging the positioning of theprostatic stent 10 after placement. The detachedrotatable element 42 andstationary element 54 are then removed from the patient's urinary system. - Refer to FIG. 6A for a more detailed depiction of the male urinary system. The urethra extends upward from the
meatus urinanus 62 as far as theneck 64 of thebladder 66. Above theexternal sphinder 68, the urethra comprises a super-collicularprostatic segment 70 and a sub-collicularprostatic segment 72 of theprostate 74. Below theexternal sphincter 68, the urethra comprises, toward themeatus urinarius 62, themembranous segments 76, thebulbar segment 78, theperineal segment 80, and thepenile segment 82. The medical professional uses thedelivery system 40 to advance theproximal tip 24 of theprostatic stent 10 along theurethra 60, past theexternal sphincter 68, and into thebladder 66. The medical professional inserts theprostatic stent 10 connected with thedelivery system 40 into the patient's urethra at themeatus urinarius 62. The medical professional then further advances theprostatic stent 10 such that theprostatic segment 18 is in the super-collicularprostatic section 70 of the urethra 60 surrounded by theprostate 74 with thebulbar segment 20 located on the distal side of the patient'sexternal sphincter 68 along thebulbar segment 78 of theurethra 60. Theprostatic stent 10 is properly positioned in the detailed depiction of the male urinary system as shown in FIG. 6B. At this point, thedelivery system 40 extends from thebladder 66 through theurethra 60 and terminates at a location external to the patient's body. In another embodiment, (where thedelivery system 40 includes a lumen extending through therotatable element 42 from thefirst end 44 of the rotatable element to the second end 48), the medical professional looks for urine flowing from the second end of therotatable element 48 of thedelivery system 40 located external to the patient's body to confirm correct placement of theprostatic stent 10. - The positioned
prostatic stent 10 maintains the patency of the patient's prostatic urethra, while simultaneously allowing the patient to control the opening and closing of theexternal sphincter 68. The positionedprostatic stent 10 has no parts or elements that communicate external to the patient's body during use, thereby reducing the high risk of infection associated with catheters. The radial strength provided by thecoil segment 12 prevents the patient's prostatic urethra from collapsing due to the pressure created by the patient'senlarged prostate 68. Theprostatic stent 10 is anchored in position by the prostatic andbulbar segments prostatic stent 10. - Referring to FIGS.7A-7C the prostatic stent may be removed as follows. As all of the
segments windings 15 of theprostatic stent 10 are formed from thesingle coil segment 12, theprostatic stent 10 may be removed by applying a tensile force along theremoval segment 34, thereby unwinding thecoil segment 12 and removing theprostatic stent 10. At the end of a prescribed time period, the patient can remove theprostatic stent 10 by pulling on the distal portion of theremoval segment 36 extending back from theproximal tip 24, threaded through the prostatic andbulbar segments penile segment 82 and through themeatus urinarius 62. When theouter coating 14 of thecoil segment 12 is substantially absorbed, the structurally integrity of theprostatic stent 10 is sufficiently attenuated to permit removal of theprostatic stent 10 transurethrally by the patient. As the distal portion of theremoval segment 36 is continuously pulled, theproximal tip 24 of theprostatic segment 18 first unwinds and the remainder of thestent 10 progressively unwinds until uncoiling and removal of theprostatic stent 10 is achieved. As this invention is designed for indwelling within a lumen for a prescribed time period of minimal duration, incorporation of the stent within the urethra due to tissue ingrowth is not a concern. - Variations, modifications, and other implementations of what is described herein will occur to those of ordinary skill in the art without departing from the spirit and the scope of the invention. Accordingly, the invention is not to be limited to only the preceding illustrative description.
Claims (34)
Priority Applications (7)
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US10/277,575 US6733536B1 (en) | 2002-10-22 | 2002-10-22 | Male urethral stent device |
AU2003277357A AU2003277357A1 (en) | 2002-10-22 | 2003-10-10 | Male urethal stent device |
PCT/US2003/032286 WO2004037125A1 (en) | 2002-10-22 | 2003-10-10 | Male urethal stent device |
CA002502891A CA2502891A1 (en) | 2002-10-22 | 2003-10-10 | Male urethal stent device |
EP03809554A EP1553894A1 (en) | 2002-10-22 | 2003-10-10 | Male urethal stent device |
US10/811,196 US7112226B2 (en) | 2002-10-22 | 2004-03-26 | Male urethral stent device |
US11/504,884 US7527651B2 (en) | 2002-10-22 | 2006-08-15 | Male urethral stent device |
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US10/277,575 US6733536B1 (en) | 2002-10-22 | 2002-10-22 | Male urethral stent device |
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US10/811,196 Continuation US7112226B2 (en) | 2002-10-22 | 2004-03-26 | Male urethral stent device |
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US10/811,196 Expired - Lifetime US7112226B2 (en) | 2002-10-22 | 2004-03-26 | Male urethral stent device |
US11/504,884 Expired - Fee Related US7527651B2 (en) | 2002-10-22 | 2006-08-15 | Male urethral stent device |
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US11/504,884 Expired - Fee Related US7527651B2 (en) | 2002-10-22 | 2006-08-15 | Male urethral stent device |
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EP (1) | EP1553894A1 (en) |
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Cited By (11)
Publication number | Priority date | Publication date | Assignee | Title |
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US20070050006A1 (en) * | 2005-08-31 | 2007-03-01 | Cook Ireland Limited | Coaxial dilatation method for stent implantation |
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Also Published As
Publication number | Publication date |
---|---|
US7527651B2 (en) | 2009-05-05 |
US20040181287A1 (en) | 2004-09-16 |
US20060276909A1 (en) | 2006-12-07 |
AU2003277357A1 (en) | 2004-05-13 |
EP1553894A1 (en) | 2005-07-20 |
CA2502891A1 (en) | 2004-05-06 |
US7112226B2 (en) | 2006-09-26 |
WO2004037125A1 (en) | 2004-05-06 |
US6733536B1 (en) | 2004-05-11 |
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