Apparatus and method for implanting prostheses within periurethral tissues

• US 5,637,074 A
• Filed: 09/14/1994
• Issued: 06/10/1997
• Est. Priority Date: 09/14/1993
• Status: Expired due to Term

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Andino, Rafael V., Brooks, Christopher J., Butcher, Ken, Cerny, David E., Genese, Joseph N.
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): Lacyk, John P.
• Application Number:
  US08/305,869
• Time in Patent Office: 1,000 Days
• Field of Search: 128/DIG. 25, 128/DIG. 26, 600/29-32, 604/115-117, 604/174, 604/175
• US Class Current: 600/29
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61F 2/004 inflatable
• CPC Class Codes: A61M 2025/0233 specifically adapted for attaching to a body wall by means which are on both sides of the wall, e.g. for attaching to an abdominal wall
• CPC Class Codes: Y10S 128/25 Artificial sphincters and devices for controlling urinary incontinence

Abstract

An apparatus is disclosed for guiding a medical instrument to a predetermined target location within the periurethral tissues of a patient. The apparatus directs the instrument along a predetermined path with respect to the patient'"'"'s urethra and limits penetration of the instrument to a predetermined depth. The disclosed embodiment comprises an apparatus for implanting inflatable prostheses within the periurethral tissues to coapt the urethra and thereby manage incontinence.

A method for effecting coaptation of a urethra of a patient is also disclosed. According to this method, a pair of working channels are formed within the periurethral tissues, and an inflatable prosthesis is introduced into each working channel. The prostheses are inflated only after both working channels have been formed, and preferably after both prostheses have been positioned within their respective working channels. The inflated prostheses confront the urethra and effect coaptation of the urethra.

Claims

1. An apparatus for guiding a tool along a path in predetermined relation with respect to the urethra of a patient, comprising:

catheter means dimensioned to be inserted into the urethra of a patient for placing said urethra in predetermined alignment;

template means operatively associated with said catheter means;

guide means operatively associated with said template means for directing a tool along a path in predetermined relation to said predetermined alignment; and

standoff means operatively associated with one of said catheter means or said template means for bearing against the abdomen of said patient so as to exert a tension on said catheter means,

whereby said guide means is operative to direct said tool along said path in predetermined relation with respect to said urethra of said patient.

2. The apparatus of claim 1, wherein said standoff means comprises a tensioning collar operatively associated with said catheter means, said tensioning collar being slidable on said catheter means, and said tensioning collar comprising locking means for selectively locking said tensioning collar with respect to said catheter means, said tensioning collar being slidable on said catheter means to a location bearing against the introitus of said patient and then lockable with respect to said catheter means so as to exert a tension on said catheter means.

3. An apparatus for guiding a tool along a path in predetermined relation with respect to the urethra of a patient, comprising:

catheter means dimensioned to be inserted into the urethra of a patient for placing said urethra in predetermined alignment;

template means operatively associated with said catheter means;

guide means operatively associated with said template means for directing a tool along a path in predetermined relation to said predetermined alignment; and

means operatively associated with one of said catheter means or said template means for defining a fixed reference plane exterior of said patient such that a tool directed along said path in predetermined relation with respect to said urethra of said patient can be directed to a predetermined depth within the periurethral tissues of said patient by positioning said tool with respect to said fixed reference plane,

whereby said guide means is operative to direct said tool along said path in predetermined relation with respect to said urethra of said patient.

4. The apparatus of claim 3, wherein said means for defining a fixed reference plane exterior of said patient comprises a surface of said template.

5. The apparatus of claim 3, wherein said means for defining a fixed reference plane exterior of said patient comprises a marking on said catheter means.

6. The apparatus of claim 5, further comprising:

a punch dimensioned to be received through said guide means so as to be directed along said path in predetermined relation to said predetermined alignment such that when said catheter is inserted into the urethra of said patient and said punch is inserted through said guide means, said punch penetrates the periurethral tissues of said patient; and

a punch outer sleeve dimensioned to be received through said guide means along with said punch such that when said catheter is inserted into the urethra of said patient and said punch is inserted into the periurethral tissues of said patient, said punch outer sleeve is also inserted into the periurethral tissues of said patient, and such that said punch can be withdrawn, leaving said punch outer sleeve disposed within said periurethral tissues of said patient so as to define a working channel therethrough, said punch further comprising a marking positioned thereon such that when said marking on said punch outer sleeve is correspondingly aligned with said marking on said catheter means, said punch outer sleeve is inserted into the periurethral tissues of said patient to a predetermined depth.

7. The apparatus of claim 6, further comprising a plurality of markings on said punch outer sleeve, whereby a physician can insert said punch outer sleeve to a depth other than said predetermined depth by aligning one of said plurality of markings on said punch outer sleeve other than said marking corresponding to said marking on said catheter means.

8. An apparatus for guiding a tool along a path in predetermined relation with respect to the urethra of a patient, comprising:

catheter means dimensioned to be inserted into the urethra of a patient for placing said urethra in predetermined alignment;

template means operatively associated with said catheter means; and

guide means operatively associated with said template means for directing a tool along a path in predetermined relation to said predetermined alignment,

whereby said guide means is operative to direct said tool along said path in predetermined relation with respect to said urethra of said patient.

9. The apparatus of claim 8, wherein said template means comprises first and second channels defined therethrough, said catheter means being received within said first channel to operatively associate said template with said catheter means, and said guide means comprising said second channel defined within said template such that a tool inserted through said second channel will be directed along a path in predetermined relation to said predetermined alignment of said urethra.

10. The apparatus of claim 9, wherein said first and second channels defined in said template comprise parallel channels, whereby said path along which a tool is directed is parallel to said predetermined alignment of said urethra.

11. The apparatus of claim 8, further comprising a punch dimensioned to be received through said guide means so as to be directed along said path in predetermined relation to said predetermined alignment such that when said catheter is inserted into the urethra of said patient and said punch is inserted through said guide means, said punch penetrates the periurethral tissues of said patient.

12. The apparatus of claim 11, further comprising a punch outer sleeve dimensioned to be received through said guide means along with said punch such that when said catheter is inserted into the urethra of said patient and said punch is inserted into the periurethral tissues of said patient, said punch outer sleeve is also inserted into the periurethral tissues of said patient, and such that said punch can be withdrawn, leaving said punch outer sleeve disposed within said periurethral tissues of said patient so as to define a working channel therethrough.

13. The apparatus of claim 8, further comprising an instrument for implanting and inflating an inflatable prosthesis, said instrument being operatively associated with said guide means so as to be directed by said guide means along said path in predetermined relation with respect to said urethra of said patient, whereby said instrument is operative to cause an inflatable prosthesis to be implanted and inflated at a location along said path.

14. The apparatus of claim 13, wherein said instrument comprises a means for selectively engaging said template so as to be retained in engagement therewith.

15. The apparatus of claim 8, wherein said template means further comprises a plurality of legs associated therewith for bearing against the abdomen of said patient so as to exert a tension on said catheter means.

16. The apparatus of claim 15, wherein said plurality of legs are selectively extendible.

17. The apparatus of claim 8, wherein said guide means directs said tool along a path which is parallel to said predetermined alignment, whereby a tool directed by said guide means will not lacerate or puncture said urethra.

18. An apparatus for guiding a tool to a predetermined depth with respect to the bladder neck of a patient, comprising:

a catheter having an elongated shaft and being dimensioned to be inserted into the urethra of a patient, said catheter comprising engagement means disposed thereon operative upon said engagement means being introduced into the bladder of said patient for engaging the bladder neck of said patient;

a template operatively associated with said shaft of said catheter at a location in predetermined spaced apart relation to said engagement means of said catheter, whereby when said engagement means engages said bladder neck of said patient said template is located in predetermined location with respect to said bladder neck;

guide means operatively associated with said template for directing a tool along a predetermined path; and

stop means operatively associated with said guide means for limiting the extent of tool travel along said predetermined path,

whereby when a tool is directed along said predetermined path and advanced until limited by said stop means, said tool is guided to a predetermined depth with respect to said bladder neck of said patient.

19. The apparatus of claim 18, wherein said template comprises first and second channels defined therethrough, wherein said template is operatively associated with said catheter by said catheter being received through said first channel, and wherein said guide means comprises said second channel defined through said template such that a tool inserted through said second channel will be directed along said predetermined path.

20. The apparatus of claim 19, wherein said stop means comprises a collar circumferentially mounted to said catheter at a location on said elongated shaft of said catheter such that when said catheter is inserted through said first channel and advanced until said collar engages said template, said template is located in said predetermined location with respect to said bladder neck.

21. The apparatus of claim 20, wherein said collar defines an annular space between said collar and said shaft of said catheter, wherein said template comprises a sleeve portion, and wherein said collar engages said template by said sleeve portion being snugly received within said annular space so as to form an interference fit with said collar and said catheter shaft.

22. An apparatus for guiding a tool along a predetermined path with respect to the urethra of a patient and to a predetermined depth with respect to the bladder neck of said patient, said apparatus comprising:

catheter means dimensioned to be inserted into the urethra of a patient for placing said urethra in predetermined alignment;

bladder neck engagement means disposed on said catheter means and operative upon said engagement means being introduced into the bladder of said patient for engaging the bladder neck of said patient;

template means operatively associated with said catheter means at a predetermined location with respect to said engagement means of said catheter;

guide means operatively associated with said template means for directing a tool along a path in predetermined relation to said predetermined alignment; and

stop means operatively associated with said guide means for limiting the extent of tool travel along said predetermined path,

whereby said guide means is operative to direct said tool along a path in predetermined relation with respect to said urethra of said patient; and

whereby when said tool is directed along said path and advanced until limited by said stop means, said tool is guided to a predetermined depth with respect to said bladder neck of said patient.

23. An apparatus for placing inflatable prostheses within the periurethral tissues of a patient, comprising:

a template including first, second, and third guide sleeves, said first, second, and third guide sleeves defining first, second, and third axes, said first and second axes being disposed in predetermined relation to said third axis, and said template including first and second stop means operatively associated with said first and second guide sleeves, respectively;

a catheter for inserting through said third guide sleeve of said template and into the urethra of said patient, said catheter having a forward end and comprising a balloon adjacent said forward end and selectively inflatable when said catheter is inserted into the urethra of said patient for engaging the bladder neck of said patient, and said catheter having catheter stop means operatively associated therewith for engaging said template to locate said template at a location along said catheter in predetermined spaced relation to said balloon, whereby said template is placed in predetermined axial alignment with said urethra of said patient, and whereby said template is placed in predetermined spaced relation from the bladder neck of said patient;

first working channel means for insertion through said first guide sleeve of said template for forming a first working channel within said periurethral tissues of said template, said first stop means being operative to limit the extent of travel of said first working channel means such that said first working channel is formed to a predetermined depth with respect to said template;

second working channel means for insertion through said second guide sleeve of said template for forming a second working channel within said periurethral tissues of said template, said second stop means being operative to limit the extent of travel of said second working channel means such that said second working channel is formed to a predetermined depth with respect to said template;

first cannula means for insertion through said first guide sleeve of said template for introducing a first inflatable prosthesis through said first working channel and selectively operable to inflate said first inflatable prosthesis with a suitable medium, said first cannula means including engagement means for engaging said template so as to limit the depth to which said first inflatable prosthesis is introduced through said first working channel and for selectively releasably attaching said first cannula means to said template; and

second cannula means for insertion through said second guide sleeve of said template for introducing a second inflatable prosthesis through said second working channel and selectively operable to inflate said second inflatable prosthesis with a suitable medium, said second cannula means including engagement means for engaging said template so as to limit the depth to which said second inflatable prosthesis is introduced through said second working channel and for selectively releasably attaching said second cannula means to said template.

24. The apparatus of claim 23, wherein said first, second, and third axes defined by said first, second, and third guide sleeves are parallel, whereby when said catheter is placed within the urethra of said patient, said template is engaged with said catheter, and said first and second working channel means are inserted through said first and second guide channel means, said first and second working channels formed by said first and second working channel means are parallel to said urethra of said patient.

25. The apparatus of claim 23, wherein said third guide sleeve comprises a rearward end, and wherein said catheter stop means comprises a collar formed on said catheter which engages said rear guide sleeve end to limit the extent to which said catheter can advance through said third guide sleeve.

26. The apparatus of claim 25, wherein said collar defines an annular recess therewithin, said annular recess being configured to snugly receive said rearward end of said third guide sleeve therewithin to couple said catheter to said template.

27. The apparatus of claim 23, wherein said each of said first and second working channel means comprises a trocar outer sleeve and a trocar punch selectively received within said trocar outer sleeve, whereby said trocar punch and said trocar outer sleeve together can be inserted through the respective guide sleeve to penetrate said periurethral tissues of said patient, and said trocar punch thereafter can be removed from said trocar outer sleeve so as to leave said trocar outer sleeve within said periurethral tissues of said patient to form a working channel.

28. The apparatus of claim 27, wherein said trocar outer sleeve further comprises coupling means for selectively coupling said trocar outer sleeve to said template.

29. The apparatus of claim 23, wherein each of said first and second cannula means comprises means for selectively coupling said first and second cannula means to said template.

30. The apparatus of claim 29, wherein said template comprises at least one tab operatively associated with each of said first and second guide sleeves, and wherein said means for selectively coupling each of said first and second cannula means to said template comprises a laterally extending wing formed on each of said first and second cannula means and operative to engage the corresponding tab on the corresponding guide sleeve.

31. The apparatus of claim 30, wherein each of said wings is comprised of a flexible, resilient material and is angled rearwardly such that each of said wings impinges upon a corresponding tab as its corresponding catheter means is inserted into its respective guide sleeve, flexes as said catheter means is advanced further, and then snaps outwardly as said wing clears said tab, whereby withdrawal of said corresponding catheter means is obstructed by said wing confronting said tab.

32. The apparatus of claim 23, wherein said catheter further comprises a rigid sleeve disposed on a portion of said catheter which resides within the urethra of a patient when said catheter is inserted into said patient, whereby said urethra conforms to the shape of said rigid sleeve.

33. The apparatus of claim 23, wherein said first and second guide sleeves define upwardly opening U-shaped channels, whereby when said first and second working channel means have been withdrawn from said template, said first and second cannula means can be disengaged from said template without removing said first and second cannula means from the periurethral tissues of said patient by displacing said template downward, said first and second cannula means thereby passing through the opening of said U-shaped channels and becoming disengaged from said template.

34. The apparatus of claim 23, further comprising a plurality of legs extensibly mounted to said template and extending forward therefrom, whereby when said template is placed in predetermined spaced relation from the bladder neck of said patient, said legs can be extended forward from said template to bear against the abdominal region of said patient to exert a tension against said catheter and thereby stabilize said template in said predetermined spaced relation from the bladder neck of said patient.