CA2229555A1 - Bladder control insertion apparatus and method - Google Patents
Bladder control insertion apparatus and method Download PDFInfo
- Publication number
- CA2229555A1 CA2229555A1 CA002229555A CA2229555A CA2229555A1 CA 2229555 A1 CA2229555 A1 CA 2229555A1 CA 002229555 A CA002229555 A CA 002229555A CA 2229555 A CA2229555 A CA 2229555A CA 2229555 A1 CA2229555 A1 CA 2229555A1
- Authority
- CA
- Canada
- Prior art keywords
- tube
- lumen
- urethra
- bladder control
- probe
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3468—Trocars; Puncturing needles for implanting or removing devices, e.g. prostheses, implants, seeds, wires
-
- 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
- A61F2/0004—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
- A61F2/0009—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse placed in or outside the body opening close to the surface of the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B2017/320044—Blunt dissectors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B2017/348—Means for supporting the trocar against the body or retaining the trocar inside the body
- A61B2017/3482—Means for supporting the trocar against the body or retaining the trocar inside the body inside
- A61B2017/3484—Anchoring means, e.g. spreading-out umbrella-like structure
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S128/00—Surgery
- Y10S128/25—Artificial sphincters and devices for controlling urinary incontinence
Abstract
Insertion apparatus for a female bladder control device including an outer tube (12) for insertion into the urethra of a patient, the outer tube (12) having an inner lumen and a retention collar (14) for limiting the depth of insertion of the outer tube (12). A dilator probe (11) with a tapered end, the probe (11) sized for slidable movement into the outer tube (12) and the probe (11) having stop means (17) engageable by the first tube to limit the depth of insertion of the probe tapered end into the urethra. An applicator tube sized for slidable positioning within the outer tube (12) and having an inner lumen for removably carrying a bladder control device (28) for placement within the lumen. Also provided is an insertion device for moving the bladder control device (28) into the second tube. The preferred embodiment described in this disclosure includes a spring-type retaining device mounted on one end of the placed bladder control device (28) and an additional retainer on the other end for retaining the placed bladder control device (28) within the urethra.
Description
CA 02229~ 1998-02-13 W097/06748 PCT~S96/13349 RT-~nn~ CONTROL ~ ON APPARATUS AND l'r~
Cross Reference to Co-Pendinq ApPlications The present invention is related to the following U.S.
Patent Applications which are assigned to the assignee of the pre ent invention and incorporated herein by reference:
07/969,928 SELF-CON~TN~n INTRAu~l~nnAL BLADDER
CONTROL DEVICE
08/l73/636 NONSURGICAL INTRAURETHRAL BLADDER CONTROL
DEVICE
08/298,033 NONSURGICAL INTRAu~l~AL BLADDER CONTROL
DEVICE.
Backqround of the Invention l. Field of the Invention The present invention relates generally to medical devices; more particularly to bladder control devices; and still more particularly to insertion apparatus for placement of bladder control apparatus within the urethra of a patient.
Cross Reference to Co-Pendinq ApPlications The present invention is related to the following U.S.
Patent Applications which are assigned to the assignee of the pre ent invention and incorporated herein by reference:
07/969,928 SELF-CON~TN~n INTRAu~l~nnAL BLADDER
CONTROL DEVICE
08/l73/636 NONSURGICAL INTRAURETHRAL BLADDER CONTROL
DEVICE
08/298,033 NONSURGICAL INTRAu~l~AL BLADDER CONTROL
DEVICE.
Backqround of the Invention l. Field of the Invention The present invention relates generally to medical devices; more particularly to bladder control devices; and still more particularly to insertion apparatus for placement of bladder control apparatus within the urethra of a patient.
2. DescriPtion of the Prior Art The value and advantages of bladder control apparatus, often referred to as artificial sphincters, is well-known to those of skill in the medical art. As can be seen in the prior art, it is desirable to place certain bladder control devices within the urethra of a patient for direct control of the flow of fluid ~orm the bladder through the urethra and thence from the patient. The prior art has recognized various devices for such implantation of bladder control apparatus. Certain of these prior art devices have the disadvantage of being CA 02229~ 1998-02-13 W097/06748 PCT~S96/13349 somewhat difficult or clumsy for the medical personnel to manipulate during insertion, and others carry the disadvantage of potentially damaging the urethra or the bl~er, for example, if an insertion device is placed too far into the bladder from the urethra and damages the bladder wall.
It is to overcome these potential disadvantages and to provide a sure and simple insertion device that the present invention has been made.
Summarv of the Invention The present invention overcomes the disadvantages of the prior art by providing a method and apparatus for atraumatically inserting and removing a bladder control apparatus.
In the preferred mode of practicing the present invention, the insertion apparatus consists of an outer tube having a retention collar, a solid urethral dilation probe, a device h~n~ling tube, and a device insertion rod, in addition to the bladder control device. The outer tube has a length greater than that of the urethra and a lumen of sufficient size to slideably accn~o~Ate the solid urethral dilation probe. Using suitable topical lubricants, antiseptics, and pain control, the dilation probe is inserted through the lumen of the outer tube, and the assembly is advanced through the urethra, until the neck of the bladder is located via manual sensation. The dilation probe is removed leaving the outer , -CA 02229~ l998-02-l3 W097/06748 PCT~S96/13349 tube extending the entire length of the urethra and about 1 cm. into the bladder. The distal end of the outer tube is stabilized by sliding the retention collar proxim~lly until it rests against the meatus, where it is removably locked in place by a retention screw.
The device hAn~l;ng tube has an outside diameter sufficiently small to position slideably within the distal end of the outer tube and has an inside diameter sufficiently large to slideably Acc~ te the blA~e~ control device.
The bladder control device is loaded into the device hAn~l;ng tube to restrain the proximal retaining elements of the bladder control device against the inner walls of the device h~n~l;ng tube. The insertion rod is removably attached to the distal end of the bladder control device. The pro~; -l end of the device handling tube is inserted into the distal end of the outer tube and the bladder control device is advanced pro~;m~lly into the outer tube. The device h~n~l;ng tube is removed distally from the insertion rod.
The insertion rod is advanced prox;~-lly until the bladder control device traverses the length of the outer tube permitting the retA;n;ng means to expand within the bladder.
The outer tube and its retention collar are removed from the patient leaving the bladder control device and insertion rod in place. The insertion rod is pulled distally until the distal end of the bladder control device is visually positioned at the distal end of the urethra. This assumes CA 02229~ 1998-02-13 W097/06748 PCT~S96/13349 that the bl~ r control device is of a proper length which may necessitate the use of an extension. The insertion rod is disconnected from the bladder control device and the distal ret~;ning ring is attached. R~ v~l of the bl~e~ control device is accomplished using the reverse of the above explained procedure.
Brief Descri~tion of the Drawinas Other objects of the present invention and many of the attendant advantages of the present invention will be readily appreciated as the same becomes better understood by reference to the following detailed description when considered in connection with the accompanying drawings, in which like reference numerals designate like parts throughout the figures thereof and wherein:
Fig. 1 is a plan view of the outer tube with retention collar;
Fig. 2 is a plan view of the dilation probe;
Fig. 3 is a plan view of the dilation probe of Fig. 2 as it appears when placed within the outer tube of Fig. 1;
Fig. 4 is a plan view showing the outer tube of Fig. 1 and dilation probe of Fig. 2 assembled together and placed within the urethra;
Fig. 5 is a plan view similar to that of Fig. 4 with the dilation probe of Fig. 2 removed from the outer tube of Fig.
CA 02229~ 1998-02-13 W097/06748 PCT~S96/13349 Fig. 6 is a partially sectioned view of the device handler tube contA;n;ng a bladder control device removably coupled to an insertion rod;
Fig. 7 is a partially sectioned view showing the position for loading of the bl~er control device from the device handler tube into the outer tube;
Fig. 8 is a similar view showing the position after completion of the loading with the device handler tube removed;
Fig. 9 shows a bladder control device in place within the urethra;
Fig. lO is a view s;m;lAr to Fig. 9 after removal of the outer tube and retention,collar;
Fig. lla is a partially sectioned view showing the properly positioned bladder control device after removal of the insertion rod; and Fig. llb is a view s;m; 1 Ar to Fig. lla after attachment of the distal ret~;n;ng ring.
Detailed DescriPtion of the Preferred Embodiment Fig. l is a partially sectioned view of outer tube 12.
It is significantly longer than the adult female urethra.
Preferably it is a smooth metallic tube of a biocompatible material such as #304 stainless steel. It has a single central lumen sufficiently large to slidably accommodate each of the bladder control device, the insertion rod, and the CA 02229~ 1998-02-13 W097/06748 PCT~S96/13349 dilation probe. The walls of outer tube 12 are preferably as thin as possible consistent with the strength requirements of the procedure. The inside and outside ~; -nsions of outer tube 12 are constant except for the very distal end. The distal end of outer tube 12 is flared as shown to A~C~ te insertion of the pro~~ end of the device hAn~ling tube as described in more detail below.
Retention collar 14 is slidably positioned over the shaft of outer tube 12 as shown. It has a flat distal surface for engagement of the meatus of the patient as shown in detail below. Thumb screw 16 is utilized to removably hold retention collar 14 at a selected longitu~;nAl position along the shaft of outer tube 12.
Fig. 2 is a plan view of dilation probe 11, which is preferably a solid rod of a biocompatible material, such as #304 stainless steel. It is conically shaped at prs~ l end 13 to provide a smooth point. Distal end 13 is thus shaped for atraumatic dilation of the urethra. Except for smooth point 13, the shaft of dilation probe 11 pro~ l of shoulder 17 has a constant outer diameter sized for convenient slidable insertion within the central lumen of outer tube 12. The length of the shaft from distal point 13 to shoulder 17 is greater that the length of outer tube 12.
The distal end of shoulder 17 is greater than the diameter of the central lumen of outer tube 12 to prevent over insertion. The distal end of dilation probe 11 has a CA 02229~ 1998-02-13 W097/06748 PCT~S96/13349 convenient textured handle 15 to enhAnce the grip during the procedure.
Fig. 3 is a partially sectioned view of outer tube 12 with dilation probe 11 inserted to the ~-~; . As can be seen, shoulder 17 acts as a stop against the distal tip of outer tube 12. The r~ ;n;ng elements are as previously discussed.
Fig. 4 is a partially sectioned view of outer tube 12 and dilation probe 11 after insertion into the partially sectioned urethra of a female patient. During the procedure, the assembly of Fig. 3 is inserted into the urethra using localized antiseptic, lubrication, and pain control. Smooth point 13 atraumatically dilates the urethra for entry of outer tube 12. Upon proper insertion, the prox; ~1 end of outer tube 12 extends about 1 cm. into the bladder. Note that smooth point of dilation probe 11 extends even further pro~i m~ 1 ly .
After the proper position of outer tube 12 has been established, retention collar 14 is moved prox;~lly along outer tube 12 until it impinges upon the meatus of the patient. Retention collar 14 is held in place by tightening thumb screw 16 against outer tube 12.
Fig. 5 is a sectioned view of the assembly of Fig. 4 with dilation probe 11 completely removed distally. At this place in the procedure, outer tube 12 provides a stable conduit CA 02229~ 1998-02-13 W097/06748 PCT~S96/13349 along the entire length of the urethra. The r~ oi n; ng elements are as previously described.
Fig. 6 is a partially sectioned view of bl~e~ control device 28 as loaded into device handler tube 20 and removably attached to insertion rod 24. Device handler tube 20 is preferably a stainless steel tube which is shorter than outer tube 12 but has s;m;l~ inside and outside ~;~-nsions.
B1A~e~ control device 28 has pro~i~ol ret~o;n;ng springs 30 which are compressed as shown upon being loaded into the pro~;~-l end of device handler tube 20.
Insertion rod 24 is preferably a solid stainless steel rod which readily slides within the lumen of device handler tube 20 (and hence outer,tube 12 as shown below). The distal end of bl~e~ control device 28 is compatibly tapped to engage the threaded pro~; ol end of insertion rod 24. This creates a readily removable coupling between the distal end of bladder control device 28 and the proximal end of insertion rod 24. Handle 26 of insertion rod 24 is textured to ~nh~nce the grip during the procedure.
Fig. 7 is a partially sectioned view of the insertion assembly of Fig. 6 engaged in the distal flare of outer tube 12 as positioned in Fig. 5. ~ote that device handler tube 20 and the main shaft of outer tube 12 have the same radial ~;m~sions which prevents advancement of device handler tube 20 prn~;m~lly of the distal flare of outer tube 12. From this view it can be seen that bladder control device 28 may be CA 02229~ 1998-02-13 W097/06748 PCT~S96/13349 advanced pro~im-lly from device handler tube 20 into outer tube 12 while continning to restrain retention springs 30 using a small force on handle 26. Other elements are as previously explained.
Fig. 8 is a partially sectioned view of the apparatus of Fig. 7 with device handler tube 20 removed. After bladder control device 28 has been advanced pro~i~lly into outer tube 12, device handler tube 20 is removed by sliding over handle 26 distally. The r~m~ining elements are as previously described.
Fig. 9 is a partially sectioned view similar to Fig. 8 wherein bladder control device 28 is advanced pro~i -lly through outer tube 12. Ret~ining springs 30 spread open within the bladder of the patient as shown upon being advanced pro~im~l to the pro~;m-l tip of outer tube 12. Other elements are as previously described.
Fig. lO is a view similar to Fig. 9 following removal of outer tube 12. Outer tube 12 is removed by sliding distally over handle 26. After removal of outer tube 12, insertion rod 24 is pulled distally until retention springs 30 engage the wall of the bladder as shown. Other elements are as previously described.
F~g~ lla is a ~i~ simila~ to that Qf Fig~ lQ ~f~er removal of insertion rod 24. Bladder control device 28 and insertion rod 24 are decoupled by unscrewing insertion rod 24 via handle 26. At this point bladder control device 28 _g_ CA 02229~ 1998-02-13 W097/06748 PCT~S96/13349 occupies the entire length of the urethra. To acc -'Ate varying lengths between patients, a bladder control device extension may be required as is explained in the above referenced c: -n~ y assigned application which was incorporated herein by reference. Other elements are as previously described.
Fig. llb is a view si i-~r to Fig lla wherein distal ret~;ning ring 32 is 1~ --v~bly attached to the distal end of bladder control device 28. In the preferred mode, distal ret~;ning ring 32 has threads compatible with those tapped into the distal end of bladder control device 28. After insertion rod 28 has been removed, distal retention ring 32 i8 readily screwed into b~ er control device 28 in its place.
The resulting assembly is 1- vdbly secured from distal ,--~v~ -nt by ret~ining springs 30 and from pro~i~l ~.o-vel..=nt by distal retention ring 32.
Bladder control device 28 may be readily removed from the urethra using the opposite of the above described procedure.
Having thus described the preferred embodiments of the present invention, those of skill in the art will be readily able to practice yet other embodiments within the te~chings found herein and within the scope of the following claims.
It is to overcome these potential disadvantages and to provide a sure and simple insertion device that the present invention has been made.
Summarv of the Invention The present invention overcomes the disadvantages of the prior art by providing a method and apparatus for atraumatically inserting and removing a bladder control apparatus.
In the preferred mode of practicing the present invention, the insertion apparatus consists of an outer tube having a retention collar, a solid urethral dilation probe, a device h~n~ling tube, and a device insertion rod, in addition to the bladder control device. The outer tube has a length greater than that of the urethra and a lumen of sufficient size to slideably accn~o~Ate the solid urethral dilation probe. Using suitable topical lubricants, antiseptics, and pain control, the dilation probe is inserted through the lumen of the outer tube, and the assembly is advanced through the urethra, until the neck of the bladder is located via manual sensation. The dilation probe is removed leaving the outer , -CA 02229~ l998-02-l3 W097/06748 PCT~S96/13349 tube extending the entire length of the urethra and about 1 cm. into the bladder. The distal end of the outer tube is stabilized by sliding the retention collar proxim~lly until it rests against the meatus, where it is removably locked in place by a retention screw.
The device hAn~l;ng tube has an outside diameter sufficiently small to position slideably within the distal end of the outer tube and has an inside diameter sufficiently large to slideably Acc~ te the blA~e~ control device.
The bladder control device is loaded into the device hAn~l;ng tube to restrain the proximal retaining elements of the bladder control device against the inner walls of the device h~n~l;ng tube. The insertion rod is removably attached to the distal end of the bladder control device. The pro~; -l end of the device handling tube is inserted into the distal end of the outer tube and the bladder control device is advanced pro~;m~lly into the outer tube. The device h~n~l;ng tube is removed distally from the insertion rod.
The insertion rod is advanced prox;~-lly until the bladder control device traverses the length of the outer tube permitting the retA;n;ng means to expand within the bladder.
The outer tube and its retention collar are removed from the patient leaving the bladder control device and insertion rod in place. The insertion rod is pulled distally until the distal end of the bladder control device is visually positioned at the distal end of the urethra. This assumes CA 02229~ 1998-02-13 W097/06748 PCT~S96/13349 that the bl~ r control device is of a proper length which may necessitate the use of an extension. The insertion rod is disconnected from the bladder control device and the distal ret~;ning ring is attached. R~ v~l of the bl~e~ control device is accomplished using the reverse of the above explained procedure.
Brief Descri~tion of the Drawinas Other objects of the present invention and many of the attendant advantages of the present invention will be readily appreciated as the same becomes better understood by reference to the following detailed description when considered in connection with the accompanying drawings, in which like reference numerals designate like parts throughout the figures thereof and wherein:
Fig. 1 is a plan view of the outer tube with retention collar;
Fig. 2 is a plan view of the dilation probe;
Fig. 3 is a plan view of the dilation probe of Fig. 2 as it appears when placed within the outer tube of Fig. 1;
Fig. 4 is a plan view showing the outer tube of Fig. 1 and dilation probe of Fig. 2 assembled together and placed within the urethra;
Fig. 5 is a plan view similar to that of Fig. 4 with the dilation probe of Fig. 2 removed from the outer tube of Fig.
CA 02229~ 1998-02-13 W097/06748 PCT~S96/13349 Fig. 6 is a partially sectioned view of the device handler tube contA;n;ng a bladder control device removably coupled to an insertion rod;
Fig. 7 is a partially sectioned view showing the position for loading of the bl~er control device from the device handler tube into the outer tube;
Fig. 8 is a similar view showing the position after completion of the loading with the device handler tube removed;
Fig. 9 shows a bladder control device in place within the urethra;
Fig. lO is a view s;m;lAr to Fig. 9 after removal of the outer tube and retention,collar;
Fig. lla is a partially sectioned view showing the properly positioned bladder control device after removal of the insertion rod; and Fig. llb is a view s;m; 1 Ar to Fig. lla after attachment of the distal ret~;n;ng ring.
Detailed DescriPtion of the Preferred Embodiment Fig. l is a partially sectioned view of outer tube 12.
It is significantly longer than the adult female urethra.
Preferably it is a smooth metallic tube of a biocompatible material such as #304 stainless steel. It has a single central lumen sufficiently large to slidably accommodate each of the bladder control device, the insertion rod, and the CA 02229~ 1998-02-13 W097/06748 PCT~S96/13349 dilation probe. The walls of outer tube 12 are preferably as thin as possible consistent with the strength requirements of the procedure. The inside and outside ~; -nsions of outer tube 12 are constant except for the very distal end. The distal end of outer tube 12 is flared as shown to A~C~ te insertion of the pro~~ end of the device hAn~ling tube as described in more detail below.
Retention collar 14 is slidably positioned over the shaft of outer tube 12 as shown. It has a flat distal surface for engagement of the meatus of the patient as shown in detail below. Thumb screw 16 is utilized to removably hold retention collar 14 at a selected longitu~;nAl position along the shaft of outer tube 12.
Fig. 2 is a plan view of dilation probe 11, which is preferably a solid rod of a biocompatible material, such as #304 stainless steel. It is conically shaped at prs~ l end 13 to provide a smooth point. Distal end 13 is thus shaped for atraumatic dilation of the urethra. Except for smooth point 13, the shaft of dilation probe 11 pro~ l of shoulder 17 has a constant outer diameter sized for convenient slidable insertion within the central lumen of outer tube 12. The length of the shaft from distal point 13 to shoulder 17 is greater that the length of outer tube 12.
The distal end of shoulder 17 is greater than the diameter of the central lumen of outer tube 12 to prevent over insertion. The distal end of dilation probe 11 has a CA 02229~ 1998-02-13 W097/06748 PCT~S96/13349 convenient textured handle 15 to enhAnce the grip during the procedure.
Fig. 3 is a partially sectioned view of outer tube 12 with dilation probe 11 inserted to the ~-~; . As can be seen, shoulder 17 acts as a stop against the distal tip of outer tube 12. The r~ ;n;ng elements are as previously discussed.
Fig. 4 is a partially sectioned view of outer tube 12 and dilation probe 11 after insertion into the partially sectioned urethra of a female patient. During the procedure, the assembly of Fig. 3 is inserted into the urethra using localized antiseptic, lubrication, and pain control. Smooth point 13 atraumatically dilates the urethra for entry of outer tube 12. Upon proper insertion, the prox; ~1 end of outer tube 12 extends about 1 cm. into the bladder. Note that smooth point of dilation probe 11 extends even further pro~i m~ 1 ly .
After the proper position of outer tube 12 has been established, retention collar 14 is moved prox;~lly along outer tube 12 until it impinges upon the meatus of the patient. Retention collar 14 is held in place by tightening thumb screw 16 against outer tube 12.
Fig. 5 is a sectioned view of the assembly of Fig. 4 with dilation probe 11 completely removed distally. At this place in the procedure, outer tube 12 provides a stable conduit CA 02229~ 1998-02-13 W097/06748 PCT~S96/13349 along the entire length of the urethra. The r~ oi n; ng elements are as previously described.
Fig. 6 is a partially sectioned view of bl~e~ control device 28 as loaded into device handler tube 20 and removably attached to insertion rod 24. Device handler tube 20 is preferably a stainless steel tube which is shorter than outer tube 12 but has s;m;l~ inside and outside ~;~-nsions.
B1A~e~ control device 28 has pro~i~ol ret~o;n;ng springs 30 which are compressed as shown upon being loaded into the pro~;~-l end of device handler tube 20.
Insertion rod 24 is preferably a solid stainless steel rod which readily slides within the lumen of device handler tube 20 (and hence outer,tube 12 as shown below). The distal end of bl~e~ control device 28 is compatibly tapped to engage the threaded pro~; ol end of insertion rod 24. This creates a readily removable coupling between the distal end of bladder control device 28 and the proximal end of insertion rod 24. Handle 26 of insertion rod 24 is textured to ~nh~nce the grip during the procedure.
Fig. 7 is a partially sectioned view of the insertion assembly of Fig. 6 engaged in the distal flare of outer tube 12 as positioned in Fig. 5. ~ote that device handler tube 20 and the main shaft of outer tube 12 have the same radial ~;m~sions which prevents advancement of device handler tube 20 prn~;m~lly of the distal flare of outer tube 12. From this view it can be seen that bladder control device 28 may be CA 02229~ 1998-02-13 W097/06748 PCT~S96/13349 advanced pro~im-lly from device handler tube 20 into outer tube 12 while continning to restrain retention springs 30 using a small force on handle 26. Other elements are as previously explained.
Fig. 8 is a partially sectioned view of the apparatus of Fig. 7 with device handler tube 20 removed. After bladder control device 28 has been advanced pro~i~lly into outer tube 12, device handler tube 20 is removed by sliding over handle 26 distally. The r~m~ining elements are as previously described.
Fig. 9 is a partially sectioned view similar to Fig. 8 wherein bladder control device 28 is advanced pro~i -lly through outer tube 12. Ret~ining springs 30 spread open within the bladder of the patient as shown upon being advanced pro~im~l to the pro~;m-l tip of outer tube 12. Other elements are as previously described.
Fig. lO is a view similar to Fig. 9 following removal of outer tube 12. Outer tube 12 is removed by sliding distally over handle 26. After removal of outer tube 12, insertion rod 24 is pulled distally until retention springs 30 engage the wall of the bladder as shown. Other elements are as previously described.
F~g~ lla is a ~i~ simila~ to that Qf Fig~ lQ ~f~er removal of insertion rod 24. Bladder control device 28 and insertion rod 24 are decoupled by unscrewing insertion rod 24 via handle 26. At this point bladder control device 28 _g_ CA 02229~ 1998-02-13 W097/06748 PCT~S96/13349 occupies the entire length of the urethra. To acc -'Ate varying lengths between patients, a bladder control device extension may be required as is explained in the above referenced c: -n~ y assigned application which was incorporated herein by reference. Other elements are as previously described.
Fig. llb is a view si i-~r to Fig lla wherein distal ret~;ning ring 32 is 1~ --v~bly attached to the distal end of bladder control device 28. In the preferred mode, distal ret~;ning ring 32 has threads compatible with those tapped into the distal end of bladder control device 28. After insertion rod 28 has been removed, distal retention ring 32 i8 readily screwed into b~ er control device 28 in its place.
The resulting assembly is 1- vdbly secured from distal ,--~v~ -nt by ret~ining springs 30 and from pro~i~l ~.o-vel..=nt by distal retention ring 32.
Bladder control device 28 may be readily removed from the urethra using the opposite of the above described procedure.
Having thus described the preferred embodiments of the present invention, those of skill in the art will be readily able to practice yet other embodiments within the te~chings found herein and within the scope of the following claims.
Claims (10)
1. Insertion apparatus for urethral placement of bladder control apparatus comprising:
a. first tube means having a first interior lumen and including distal and proximal ends;
b. adjustable retention means connected to the exterior of said first tube means for setting the depth of insertion of the distal end of said first tube means, said calibration means including stop means for contacting the body of a patient adjacent to the urethral entrance;
c. probe means for slidable mounting within said first lumen, said probe means having a tapered distal end and including further stop means mounted to the exterior thereof for limiting extension of said probe means distal end beyond said first tube means distal end;
d. applicator means for slidable insertion into said first lumen, including means for removably carrying a bladder control apparatus for slidable positioning within said first lumen; and e. retention means for mounting on the bladder control apparatus for retaining the apparatus within the urethra after removal of the first tube means.
a. first tube means having a first interior lumen and including distal and proximal ends;
b. adjustable retention means connected to the exterior of said first tube means for setting the depth of insertion of the distal end of said first tube means, said calibration means including stop means for contacting the body of a patient adjacent to the urethral entrance;
c. probe means for slidable mounting within said first lumen, said probe means having a tapered distal end and including further stop means mounted to the exterior thereof for limiting extension of said probe means distal end beyond said first tube means distal end;
d. applicator means for slidable insertion into said first lumen, including means for removably carrying a bladder control apparatus for slidable positioning within said first lumen; and e. retention means for mounting on the bladder control apparatus for retaining the apparatus within the urethra after removal of the first tube means.
2. The apparatus of claim 1 in which said applicator means includes: second tube means defining a second interior lumen of sufficient dimension to slidably receive a bladder control apparatus, said second tube means having an exterior dimension sized for slidable movement into at least a portion of said first lumen.
3. The apparatus of claim 2 in which said applicator means further includes: an insertion rod having distal and proximal ends, and having an external dimension sized for slidable movement within said second lumen, said rod distal end including means for removable connection to the distal end of a bladder control apparatus.
4. The apparatus of claim 2 or 3 including: applicator stop means mounted on the exterior of said second tube for limiting the slidable movement of said second tube means within said first lumen.
5. The apparatus of claims 1, 2, or 3 in which said retention means includes at least a portion automatically operable when the bladder control apparatus distal end is positioned adjacent said proximal ends of said first and second lumens.
6. The apparatus of claim 4 in which said retention means includes at least a portion automatically operable when the bladder control apparatus proximal end is positioned adjacent said proximal ends of said first and second lumens.
7. The method of placing a medical apparatus within the urethra of a patient comprising the steps of:
a. providing a first tube having a first lumen;
b. dilating the urethra with an insertion probe slidably mounted within the first lumen;
c. sliding the first tube into the dilated urethra;
d. removing the probe;
e. providing a second tube having a second lumen, and an insertion rod for slidable movement through the second lumen;
f. attaching the insertion rod to a medical apparatus;
g. sliding the medical apparatus into the second lumen with the insertion rod;
h. sliding the second tube into the first lumen;
i. removing the first tube and second tubes from the urethra by sliding them over the insertion rod;
j. disconnecting the rod from the medical apparatus; and k. retaining the medical apparatus within the urethra during steps i, j, and k, and thereafter.
a. providing a first tube having a first lumen;
b. dilating the urethra with an insertion probe slidably mounted within the first lumen;
c. sliding the first tube into the dilated urethra;
d. removing the probe;
e. providing a second tube having a second lumen, and an insertion rod for slidable movement through the second lumen;
f. attaching the insertion rod to a medical apparatus;
g. sliding the medical apparatus into the second lumen with the insertion rod;
h. sliding the second tube into the first lumen;
i. removing the first tube and second tubes from the urethra by sliding them over the insertion rod;
j. disconnecting the rod from the medical apparatus; and k. retaining the medical apparatus within the urethra during steps i, j, and k, and thereafter.
8. The method of claim 7 including the step of:
limiting the distance the probe extends beyond the urethra.
limiting the distance the probe extends beyond the urethra.
9. The method of claim 7 including the step of:
limiting the depth of insertion of the first tube into the urethra.
limiting the depth of insertion of the first tube into the urethra.
10. The method of claim 7 or 8 including the step of:
limiting the length of insertion of the second tube into the first lumen.
limiting the length of insertion of the second tube into the first lumen.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US515,564 | 1995-08-16 | ||
| US08/515,564 US5618257A (en) | 1995-08-16 | 1995-08-16 | Bladder control insertion apparatus and method |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2229555A1 true CA2229555A1 (en) | 1997-02-27 |
Family
ID=24051857
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002229555A Abandoned CA2229555A1 (en) | 1995-08-16 | 1996-08-15 | Bladder control insertion apparatus and method |
Country Status (10)
| Country | Link |
|---|---|
| US (3) | US5618257A (en) |
| EP (1) | EP0850028B1 (en) |
| JP (1) | JPH11511990A (en) |
| AT (1) | ATE246474T1 (en) |
| AU (1) | AU701629B2 (en) |
| CA (1) | CA2229555A1 (en) |
| DE (1) | DE69629380T2 (en) |
| ES (1) | ES2205055T3 (en) |
| NO (1) | NO980636D0 (en) |
| WO (1) | WO1997006748A1 (en) |
Families Citing this family (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5618257A (en) * | 1995-08-16 | 1997-04-08 | Hk Medical Technologies Incorporated | Bladder control insertion apparatus and method |
| US5782916A (en) * | 1996-08-13 | 1998-07-21 | Galt Laboratories, Inc. | Device for maintaining urinary continence |
| US5964732A (en) | 1997-02-07 | 1999-10-12 | Abbeymoor Medical, Inc. | Urethral apparatus with position indicator and methods of use thereof |
| FR2762985B1 (en) * | 1997-05-06 | 1999-08-20 | Visco | MODULAR SURGERY DEVICE FOR ENDOSCOPIC SURGERY AND CLASSICAL SURGERY |
| US5971967A (en) | 1997-08-19 | 1999-10-26 | Abbeymoor Medical, Inc. | Urethral device with anchoring system |
| US5996585A (en) | 1997-08-21 | 1999-12-07 | Hk Medical Technologies Incorporated | Nonsurgical intraurethral bladder control device retainer |
| US5871016A (en) * | 1997-10-08 | 1999-02-16 | Hk Medical Technologies Incorporated | Bladder control device retainer and method |
| EP1191902B1 (en) * | 1999-04-30 | 2005-03-09 | HK Medical Technologies Incorporated | Intraurethral device |
| US10327880B2 (en) | 2000-04-14 | 2019-06-25 | Attenuex Technologies, Inc. | Attenuation device for use in an anatomical structure |
| US6830052B2 (en) | 2001-10-03 | 2004-12-14 | Solarant Medical, Inc. | Urethral support for incontinence |
| US7655021B2 (en) * | 2003-03-10 | 2010-02-02 | Boston Scientific Scimed, Inc. | Dilator with expandable member |
| GB2425929A (en) | 2005-05-09 | 2006-11-15 | Cnh Uk Ltd | Hydraulic stabiliser for lower hitch arm |
| WO2010068467A1 (en) | 2008-11-25 | 2010-06-17 | Attenuex Technologies, Inc. | Implant with high vapor pressure medium |
| US8894563B2 (en) | 2012-08-10 | 2014-11-25 | Attenuex Technologies, Inc. | Methods and systems for performing a medical procedure |
| US11419610B2 (en) * | 2018-08-17 | 2022-08-23 | Empress Medical, Inc. | Device and method for passing tension member around tissue mass |
| AU2019320769A1 (en) | 2018-08-17 | 2021-03-11 | Empress Medical, Inc. | Devices and methods for compressing tumors |
| EP3920771A4 (en) | 2019-02-07 | 2022-11-02 | Solace Therapeutics, Inc. | Pressure attenuation device |
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|---|---|---|---|---|
| US3731670A (en) * | 1971-05-03 | 1973-05-08 | David Roy Pressman | Corporeal fluid control using bistable magnetic duct valve |
| US3812841A (en) * | 1972-08-21 | 1974-05-28 | L Isaacson | Urethra magnetic valve structure |
| US4553533A (en) * | 1983-11-08 | 1985-11-19 | Leighton Stephen B | Intra-urethral prosthetic sphincter valve |
| NL8403174A (en) * | 1984-10-17 | 1986-05-16 | Franciscus Jacobus Maria De Vr | IMPLANTABLE SEALING DEVICE. |
| US5112306A (en) * | 1986-03-25 | 1992-05-12 | American Medical Systems, Inc. | Method and apparatus for valving body fluids |
| US5007898A (en) * | 1988-06-02 | 1991-04-16 | Advanced Surgical Intervention, Inc. | Balloon dilatation catheter |
| DE3821631A1 (en) * | 1987-07-28 | 1989-02-09 | Bader Paul | CLOSURE FOR A MALE UTILITY |
| US5123428A (en) * | 1988-10-11 | 1992-06-23 | Schwarz Gerald R | Laparoscopically implanting bladder control apparatus |
| US5097848A (en) * | 1988-10-11 | 1992-03-24 | Schwarz Gerald R | Incontinence bladder control method and apparatus |
| US5012822A (en) * | 1988-10-11 | 1991-05-07 | Schwarz Gerald R | Method for controlling urinary incontinence |
| US4969474A (en) * | 1988-10-11 | 1990-11-13 | Schwarz Gerald R | Incontinence bladder control method and apparatus |
| DE3837196C1 (en) * | 1988-11-02 | 1989-08-03 | Uromed Kurt Drews Gmbh, 2000 Oststeinbek, De | |
| US4968294A (en) * | 1989-02-09 | 1990-11-06 | Salama Fouad A | Urinary control valve and method of using same |
| US5007894A (en) * | 1989-02-10 | 1991-04-16 | Goran Enhorning | Female incontinence device |
| US5041092A (en) * | 1989-08-29 | 1991-08-20 | Medical Engineering Corporation | Urethral indwelling catheter with magnetically controlled drainage valve and method |
| FR2653993B1 (en) * | 1989-11-03 | 1992-01-10 | Synthelabo | HYDRAULIC PRESSURE INVERTER FOR THE CONTROL OF AN ARTIFICIAL SPHINCTER, AND IMPLANTABLE PROSTHESIS COMPRISING SAID INVERTER. |
| US5114398A (en) * | 1990-02-27 | 1992-05-19 | Medical Engineering Corporation | Female incontinence control device with mechanically operable valve |
| US5088980A (en) * | 1990-05-31 | 1992-02-18 | The United States Of America As Represented By The Department Of Health And Human Services | Intra-urethral valve with integral spring |
| US5090424A (en) * | 1990-12-31 | 1992-02-25 | Uromed Corporation | Conformable urethral plug |
| US5479945A (en) * | 1990-12-31 | 1996-01-02 | Uromed Corporation | Method and a removable device which can be used for the self-administered treatment of urinary tract infections or other disorders |
| US5140999A (en) * | 1991-09-30 | 1992-08-25 | Primed International Corp. | Urinary incontinence valve device |
| DE9213656U1 (en) * | 1992-10-09 | 1992-12-03 | Angiomed Ag, 7500 Karlsruhe, De | |
| IL111953A (en) * | 1994-12-12 | 2012-04-30 | Medical Influence Technologies Ltd | Device for catheter fixation |
| US5618257A (en) * | 1995-08-16 | 1997-04-08 | Hk Medical Technologies Incorporated | Bladder control insertion apparatus and method |
-
1995
- 1995-08-16 US US08/515,564 patent/US5618257A/en not_active Expired - Fee Related
-
1996
- 1996-08-15 CA CA002229555A patent/CA2229555A1/en not_active Abandoned
- 1996-08-15 AU AU67780/96A patent/AU701629B2/en not_active Ceased
- 1996-08-15 AT AT96928225T patent/ATE246474T1/en not_active IP Right Cessation
- 1996-08-15 JP JP9509526A patent/JPH11511990A/en not_active Ceased
- 1996-08-15 EP EP96928225A patent/EP0850028B1/en not_active Expired - Lifetime
- 1996-08-15 ES ES96928225T patent/ES2205055T3/en not_active Expired - Lifetime
- 1996-08-15 WO PCT/US1996/013349 patent/WO1997006748A1/en active IP Right Grant
- 1996-08-15 DE DE69629380T patent/DE69629380T2/en not_active Expired - Fee Related
-
1997
- 1997-04-08 US US08/835,495 patent/US5846180A/en not_active Expired - Fee Related
-
1998
- 1998-02-16 NO NO980636A patent/NO980636D0/en not_active Application Discontinuation
- 1998-11-06 US US09/188,398 patent/US6203488B1/en not_active Expired - Fee Related
Also Published As
| Publication number | Publication date |
|---|---|
| EP0850028A4 (en) | 1999-08-04 |
| ES2205055T3 (en) | 2004-05-01 |
| US5618257A (en) | 1997-04-08 |
| US5846180A (en) | 1998-12-08 |
| AU701629B2 (en) | 1999-02-04 |
| NO980636L (en) | 1998-02-16 |
| US6203488B1 (en) | 2001-03-20 |
| EP0850028B1 (en) | 2003-08-06 |
| EP0850028A1 (en) | 1998-07-01 |
| WO1997006748A1 (en) | 1997-02-27 |
| DE69629380T2 (en) | 2004-06-24 |
| NO980636D0 (en) | 1998-02-16 |
| ATE246474T1 (en) | 2003-08-15 |
| JPH11511990A (en) | 1999-10-19 |
| DE69629380D1 (en) | 2003-09-11 |
| AU6778096A (en) | 1997-03-12 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request | ||
| FZDE | Discontinued |