WO2004049910A2

WO2004049910A2 - Rectosigmoid and vaginal manipulator apparatus

Info

Publication number: WO2004049910A2
Application number: PCT/US2003/038071
Authority: WO
Inventors: Gerard Cappiello; Mimi Cappiello
Original assignee: Gerard Cappiello; Mimi Cappiello
Priority date: 2002-12-03
Filing date: 2003-12-02
Publication date: 2004-06-17
Also published as: AU2003299573A8; AU2003299573A1; US20040106943A1; WO2004049910A3; US6913611B2

Abstract

An apparatus for manipulating the rectosigmoid during surgery which includes a cannula portion (12), having a rounded and flexible tip (16). An inflatable balloon (21) surrounding at least a portion of the cannula. The balloon inflatable with water, gas, or dye, where at a first first end of the cannula for sealing around an opening. A stylet lock (44) introduces the fluid into the balloon to provide a soft yet somewhat rigid device for allowing gentle manipulation of anatomical structures during surgical procedures. The method performed with the apparatus of the present invention would include the steps of providing a cannula (12) around 20cm-30cm; providing an inflatable balloon (21) around at least a portion of the cannula; providing a cone end (16) to at least a first end of the cannula; inserting a hook stylet (34) into the cannula to provide some rigidity to the cannula; inserting the second end of the cannula which the balloon surrounds into the rectum to a distance of around 10 to 20cm balloon length, where inserting a fluid into the balloon to inflate the balloon to around 3cm-5cm; moving the outer end of the stylet extending from the cannula in a first direction so that the second end of the cannula is moved in the opposite direction and manipulates the anatomical structure in that direction.

Description

PCT PATENT APPLICATION

Attorney Docket No. A02170 O (98632/2 WO) TITLE OF THE INVENTION

"Rectosigmoid and Vaginal Manipulator Apparatus" INVENTOR(S): CAPPIELLO, Gerard, a US citizen, of 1965 Lynwood Ct., Dunedin, Florida 34698-2845; and CAPPIELLO, Mimi, a US citizen, of 1965 Lynwood Ct., Dunedin, Florida 34698-2845. CROSS-REFERENCE TO RELATED APPLICATIONS

Priority is hereby claimed to US application serial number 10/308,679, filed 03 December 2002.

US application serial number 10/308,679, filed 03 December 2002, is incorporated herein by reference.

In the US, this is a continuation in part of US application serial number 10/308,679, filed 03 December 2002. STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not applicable REFERENCE TO A "MICROFICHE APPENDIX" Not applicable BACKGROUND

1. Field

The present invention relates to medical devices. More particularly, the method and apparatus of the present invention relates to an apparatus for insertion into the rectum for manipulating the rectosigmoid to facilitate access to other anatomical structures during surgical procedures. The method and apparatus of the present invention can also be used for manipulation of the vagina during various medical procedures.

2. General Background

During the course of some surgical procedures, more specifically, minimal invasive surgery, it is at times necessary to be able to gently move the rectosigmoid out of position so as to avoid damage to the structure and to facilitate access to other anatomical locations needed during the procedure. Additionally, manipulation of the vagina can be required during various medical procedures. Laparoscopy is commonly used to perform hysterectomies, vaginal vault suspensions using the utero-sacral ligaments, also by attachment of the vagina to the hollow of the sacrum, uterine suspensions utilzing the utero-sacral ligaments and other surgeries in the gynecological and colo-rectal arena. Previously, to manipulate the rectum, the surgeon would utilize a sponge stick, well lubricated, that was placed in the rectum and pushed up, usually to about 10 cm or to the peritoneal reflection. Another instrument which was utilized was an EES sizer, which was very heavy and again difficult to utilize in laparoscopy.

The apparatus can also be used for manipulation of the vagina during various medical procedures .

Other devices which may be related to this procedure are discussed in the patents which are included in the information disclosure statement submitted with the corresponding US application.

While certain novel features of this invention shown and described below are pointed out in the annexed claims, the invention is not intended to be limited to the details specified, since a person of ordinary skill in the relevant art will understand that various omissions, modifications, substitutions and changes in the forms and details of the device illustrated and in its operation may be made without departing in any way from the spirit of the present invention. No feature of the invention is critical or essential unless it is expressly stated as being "critical" or "essential." BRIEF SUMMARY

The method and apparatus of the present invention solves the problems in the art in a simple and straightforward manner. In a preferred embodiment a method and apparatus is provided for manipulating the rectosigmoid during surgery, to move the rectosigmoid to a pre-determined position, which includes a cannula portion, having a rounded and flexible tip, an inflatable balloon surrounding at least a portion of the cannula; the balloon inflatable with water, gas, or dye; a cone at a first end of the cannula for sealing around the opening of the anus; a stylet insertable in the cannula opening to provide partial rigidity to the cannula; and a syringe lock for introducing the fluid into the balloon, so as to provide a soft yet somewhat rigid device for allowing gentle manipulation of the recto-sigmoid during surgical procedures.

In an alternative embodiment, the method and apparatus of the present invention can also be used for manipulation of the vagina during various medical procedures. Exemplar medical procedures include, but are not limited to, abdominal or laparoscopic sacral culpoplexy.

In an alternative embodiment, the apparatus can be fitted with a light source, such as an fiberoptic light source to trans-illuminate the balloon thereby delineating the boundaries of the rectum or vagina.

The method performed with the apparatus of the present invention would include the steps of providing a cannula of a certain length, around 20cm-30cm; providing an inflatable balloon around at least a portion of the cannula; providing a cone end to at least a first end of the cannula; inserting a hook stylet into the cannula opening to provide some rigidity to the cannula; inserting the second end of the cannula upon which the balloon surrounds into the rectum to a distance of around 10 to 20cm balloon length; sealing the cone end to the outer surface of the anal opening; inserting a fluid into the balloon to inflate the balloon to around 3 cm; moving the outer end of the stylet extending from the cannula in a first direction so that the second end of the cannula is moved in the opposite direction and manipulates the rectosigmoid in that direction.

Therefore, it is a principal object of the present invention to provide a concise method and apparatus for gently manipulating the rectosigmoid during surgery which is easy to manipulate and efficient in its use; It is a further obj ect of the present invention to provide an apparatus which allows a surgeon to gently manipulate the rectosigmoid during surgery as to be able, for example, to attach the vagina to the concave of the sacrum, or to more readily locate lesions such as endometriosis;

It is a further object of the present invention to provide an apparatus which allows a physician to avoid injuring the rectum when doing complicated rectocele repairs. BRIEF DESCRIPTION OF THE DRAWINGS

For a further understanding of the nature, objects, and advantages of the present invention, reference should be had to the following detailed description, read in conjunction with the following drawings, wherein like reference numerals denote like elements and wherein:

Figure 1 illustrates an overall view of the apparatus of the present invention inserted within the rectum with the balloon portion uninflated; Figure 2 Figure 1 illustrates an overall view of the apparatus of the present invention inserted within the rectum with the balloon portion inflated; and

Figure 3 illustrates an overall view of the preferred embodiment of the apparatus of the present invention inserted into the rectum and manipulating the rectosigmoid. DETAILED DESCRIPTION OF THE INVENTION

Detailed descriptions of one or more preferred embodiments are provided herein. It is to be understood, however, that the present invention may be embodied in various forms. Therefore, specific details disclosed herein are not to be interpreted as limiting, but rather as a basis for the claims and as a representative basis for teaching one skilled in the art to employ the present invention in any appropriate system, structure or manner.

Figures 1-3 illustrate the preferred embodiment of the apparatus and method of the present invention with the apparatus being identified by the numeral 10. As illustrated in full view in Figure 1, apparatus 10 includes an elongated cannula portion 12 of a predetermined length in the neighborhood of 20cm-30cm, having a first open end 14, with an opening 15, and a second closed rounded end 16. As illustrated, cannula 10 further comprises a cone member 18 positioned at a first end 14 of cannula 10, which includes a flat shoulder member 20 which will be utilized in a function to be described further. There is also noted an inflatable balloon portion 21, at the second end 16, the function also which will be identified later. As seen in Figure 1, the cannula 10 has been inserted into the rectum 40 of a person, to a point where cannula 10 occupies the entire rectosigmoid portion 19 of the intestine 23. At that point, the shoulder 20 of cone member 18 is making contact with the rectal opening wall 42 and can be sealed against wall 42 via taping or the like. The balloon portion 21 is shown in the deflated state, as illustrated. Further, along the length of cannula 12 there could be a plurality of graduations 25, which represent particular distances along its length in order to provide the depth that the cannula 10 is being inserted into the rectum 40.

As further seen in Figures 1 and 2, there is illustrated a stylet member 34, preferably a hook stylet, which has been positioned within the interior space 35 of cannula 10. The hook stylet 34 would be inserted into the cannula 10 in order to provide some rigidity to the cannula 10 during use, although the cannula must remain somewhat flexible to undertake its gentle manipulation task. There would be further provided, as seen in the figures, a syringe 44 which may be integral or secured to the cannula at fixture 45, so that air or a fluid such as water, gel, or other non-toxic, benign fluid 46 within syringe barrel 48 could be inserted to inflate the balloon via line 29 through cannula 12. Preferably the balloon would be inserted to around 3cm in diameter. As seen in Figure 2, the balloon is being inflated (arrows 22)by introducing the fluid (arrow 27) from the syringe 44. The cannula 10, housing the stylet 34 would be ready for use. As seen in Figure 3, the second end of the stylet 34 would be extending from the opening in the cannula 10 and would be the means by which the cannula 10 would be manipulated within the rectum to manipulate the rectosigmoid 19. Movement of the end of the stylet 34 in a certain direction (arrow 50) would impart movement of the second end of the cannula 10 with the balloon 21 in the opposite direction, (arrow 52). This movement of the rectosigmoid 19 in this manner would define a gentle means for moving the rectosigmoid so the surgeon would have greater access to other anatomical structures and be able to perform difficult surgeries without the rectosigmoid being in harms way.

In construction, the cannula 10 would be preferably constructed of a rubber or latex free material. The length of the cannula would be around 20cm-30cm, but the cannula balloon length could vary between 5cm and 20cm, depending on its particular use. In an alternative embodiment, apparatus 10 can be fitted with a light source 60, such as an fiberoptic light source to trans-illuminate balloon 21 thereby delineating the boundaries of the rectum 40 or vagina 70. Light source 60 can be attached to stylet member 34 and source 60 along with stylet member 34 can both be inserted into cannular portion 12. Apparatus 10 can be used for various medical procedures. The following is a non-exclusive list of rectal uses: (a) to manipulate rectum 40 and especially useful in laparoscopic procedures for endometriosis, abdominal and laparoscopic sacroculpoplexy adenexal surgery and lysis of adhesions and other procedures where manipulation of rectum 40 may be necessary; (b) repairs of fourth degree lacerations at child birth and rectal trauma; (c) identification of rectal boundaries during sacrospineous vault suspension either bilaterally or unilateral; and (d) identification of rectal boundaries during rectocele repairs either with or without a mesh. The following is a non-exclusive list of vaginal uses: (a) manipulation of vagina 70 during abdominal or laparoscopic sacral culpoplexy; (b) obstructing the loss of gas during laparoscopic hysterectomy by inflating balloon 21; and (c) inflating balloon 21 with any dye.

LIST OF REFERENCE NUMERALS The following is a list of reference numerals used.

10 apparatus

12 cannula portion

14 first open end

15 opening 16 second closed end

18 cone member

19 rectosigmoid

20 shoulder member

21 balloon portion 22 arrows

23 intestine

25 graduations

27 arrow

29 line 34 stylet member

35 interior space

40 rectum

42 rectal opening wall

44 syringe 45 fixture

46 fluid

48 syringe barrel

50 arrow

52 arrow 60 light source

70 vagina It will be understood that each of the elements described above, or two or more together may also find a useful application in other types of methods differing from the type described above. Without further analysis, the foregoing will so fully reveal the gist of the present invention that others can, by applying current knowledge, readily adapt it for various applications without omitting features that, from the standpoint of prior art, fairly constitute essential characteristics of the generic or specific aspects of this invention set forth in the appended claims. The foregoing embodiments are presented by way of example only; the scope of the present invention is to be limited only by the following claims.

Claims

1. An apparatus for manipulating anatomical structures comprising: a. a cannula of a predetermined length, having a hollow interior, an open first and a closed second end, the second end insertable a distance into an opening in an anatomical structure; b. a seal, the seal located on the first end and sealing the first end of the cannula against the opening; c. a stylet insertable into the hollow interior of the cannula; d. a balloon surrounding at least a portion of the exterior of the cannula; and e. a fluid injectable into the balloon for inflating the balloon so that the apparatus can be gently manipulated against the anatomical structure to move the structure during surgery or examinations.

2. The apparatus in claim 1 , wherein the inflatable balloon is inflated with air, water, or other benign fluid.

3. The apparatus in claim 1, wherein the seal comprises a cone member sealable against the exterior opening of the rectum.

4. The apparatus in claim 2, wherein the sylet insertable within the hollow of the cannula comprises a hook stylet with its second end extending from the first opening of the cannula.

5. The apparatus in claim 1, wherein the first end of the cannula is closed and rounded for ease of insertion into the rectum.

6. The apparatus in claim 1 , wherein the cannula is graduated at 20cm- 15 cm;

10 cm; 7.5 cm; 5 cm and 2.5 cm along its wall between the cone portion and the balloon portion.

7. The apparatus in claim 1 , wherein the first end of the cannula is adapted with a syringe for injecting the fluid into the balloon.

8. The apparatus in claim 1 , wherein the balloon terminates at the second end of the cannula.

9. The apparatus in claim 1, further comprising a light source, the light source trans-illuminating the balloon.

10. The apparatus in claim 9, wherein the light source is a fiber optic light source.

11. An apparatus for manipulating a rectosigmoid during surgery, comprising: a. a cannula of a predetermined length, having a hollow interior, a first open and a closed second end, the second end insertable a distance into a rectum having a rectal opening; b. a balloon surrounding at least a portion of the exterior of the cannula; c. a sealfor sealing the first end of the cannula against the rectal opening; d. a stylet insertable into the hollow interior of the cannula, the stylet having a second end extending from the first end of the cannula; d. a fluid injectable into the balloon for inflating the balloon so that the stylet can be used to move the second end of the cannula supporting the inflated balloon to gently manipulate the rectosigmoid, without causing injury to the rectosigmoid.

12. The apparatus in claim 11 , wherein the inflatable balloon is inflated with air, water, or other benign fluid.

13. The apparatus in claim 11, wherein the seal comprises a cone member sealable against the exterior opening of the rectum.

14. The apparatus in claim 12, wherein the sylet insertable within the hollow of the cannula comprises a hook stylet with its second end extending from the first opening of the cannula.

15. The apparatus in claim 11, wherein the first end of the cannula is closed and rounded for ease of insertion into the rectum.

16. The apparatus in claim 11, wherein the cannula is graduated at 20cm-

15cm; 10 cm; 7.5 cm; 5 cm and 2.5 cm along its wall between the cone portion and the balloon portion.

17. The apparatus in claim 11 , wherein the first end of the cannula is adapted with a syringe for injecting the fluid into the balloon.

18. The apparatus in claim 11, wherein the balloon terminates at the second end of the cannula.

19. The apparatus in claim 11, further comprising a light source, the light source trans-illuminating the balloon.

20. The apparatus in claim 19, wherein the light source is a fiber optic light source.

21. A method of manipulating a rectosigmoid during surgical procedures, comprising the following steps: a. providing a cannula of a certain length and having first and second ends and a cannula opening located at the first end; b. providing an inflatable balloon around at least a portion of the cannula; c. providing a cone attached to the first end of the cannula; d. inserting a hook stylet into the cannula opening to provide some rigidity to the cannula; e. inserting the second end of the cannula and the balloon into a rectum having an anal opening, the insertion being a distance of around 10 to 20cm balloon length; f. sealing the first end to the outer surface of the anal opening with the cone; g. inserting a fluid into the balloon to inflate the balloon to around 3 cm - 5 cm; moving the outer end of the stylet extending from the cannula in a first direction so that the second end of the cannula is moved in the opposite direction and manipulates the rectosigmoid in that direction.

22. The method of claim 21, wherein in step "g" the fluid is air, water, or other benign fluid.

23. The method of claim 21 , wherein in step "e" the second end of the cannula is closed and rounded for ease of insertion.

24. The method of claim 21 , wherein in step "e" the cannula is graduated at

20cm-15cm; 10 cm; 7.5 cm; 5 cm and 2.5 cm along its wall between the first end and the second end.

25. The method of claim 21 , wherein in step "e" the first end of the cannula is adapted with a syringe for injecting the fluid into the balloon.

26. The method of claim 21 , wherein the balloon terminates at the second end of the cannula.

27. The method of claim 21 , further comprising the step of providing a light source, the light source trans-illuminating the balloon.

28. The method of claim 27, wherein the light source is a fiber optic light source.