DE102016208047A1 - Cervical cap - Google Patents

Abstract

The subject of the invention is a cervical cap (2) comprising luminescence material, which allows a vaginal-cervical transition region (10) to be illuminated vaginally in such a way that from the abdominal side a precise incision is made to separate the cervix (11) from the vagina is possible.

Description

The present invention relates to a cervical cap and a uterine manipulator comprising a cervical cap, as known from the prior art (see for example US Pat. No. D 749,725 p ) and in the separation of the uterus from the vagina in laparoscopic supracervical hysterectomy (LASH) and total laparoscopic hysterectomy (TLH).

In particular, in TLH, in which, unlike the LASH, the cervix (cervix) of the uterus is removed, a targeted separation of the cervix from the posterior and anterior form of the vagina in the vagina-cervix transition area is required to an otherwise threatening undesirable Shortening of the vagina to avoid. The vagina and cervix can be histologically differentiated in the transitional area. The epithelium of the vagina is undyed squamous epithelium, while the epithelium of the cervix is characterized by highly prismatic columnar epithelium.

Because the vaginal-cervical transition is only possible from the vaginal side, but the incision is made from the abdominal side, the abdominal surgeon usually makes a tactile localization to the upper margin of the cervical cap and inserted into the vaginal canal separates the tissue on this edge area of the cervix cap. An accurate cut is therefore difficult. Basically, a backlighting of the vaginal-cervical transition region from the vaginal side by introduction of an external illumination device, such as a fiber optic cable is possible with abdominalseitiger cut, but this is associated with considerable additional effort in terms of equipment and load on the patient.

Compared to this prior art, the invention has for its object to provide a cervical cap and such a cervical cap comprehensive uterus manipulator avoid the aforementioned disadvantages, in particular allow a precise cut to separate the cervix from the vagina to an undesirable shortening to prevent the vagina.

The solution of this arises from the claims. According to the invention the object is achieved in that the cervical cap has a luminescent material, as disclosed in the independent claims. Advantageous embodiments of the invention can be found in the subclaims.

First, some terms used in the context of the invention will be explained and reference is made to advantageous embodiments of the invention.

"Cervical cap" in the context of the present invention, a hollow member having a cylindrical portion which merges at a distal end in a substantially outwardly widening, conical portion and ends therewith. The cervical cap may also be formed solely from the outwardly flared conical region, i. without the above-described cylinder area, be formed. The conical region has its geometric base at its distal end, which has a larger diameter than the opposite proximal end due to the expansion. This base has a diameter sufficient to encompass the cervix of the uterus, the internal diameter at the base preferably being 35 mm to 55 mm, more preferably 40 mm to 50 mm, more preferably 43 mm to 47 mm, and most preferably 45 mm is. The conical region merges at its distal end in an end region ending with the edge. This edge region is used in the operation of the patient usually as Schnittkantenunterlage for a resting on the cervix-vagina transition region. According to a preferred embodiment of the invention said edge region is formed by one or more (for example 2, 3, 4, 5 or 6) axially or radially superposed rings, wherein at least one of the rings may be interrupted by one or more spaces in the ring structure. At least one of said rings is made of the luminescent material according to the invention and / or coated therewith.

The end portion may be formed as a wood cylinder. The end region which, as described above, may be hollow-cylindrical or conical and may also have the above-described ring structure, is also referred to below as the "collar region". The edge at the end region can be formed as a chamfered edge, so that the chamfer can serve as a cutting guide underlying the vagina-cervix transition surface. Preferably, this collar portion has a height of less than 20 mm, more preferably less than 10 mm, more preferably less than 5 mm. The lateral surface of the collar is preferably less than 50%, more preferably less than 40%, more preferably less than 30%, more preferably less than 20%, more preferably less than 10%, more preferably less than the total envelope area of the cervical cap than 5%. The cervical cap is preferably made of plastic that is compatible with the patient and used in the medical field as a base material, for example polymethyl methacrylate (PMMA).

"Luminescent material" in the sense of the present invention is a material which is excited by externally supplied energy and emits light, including radiation outside the visible range. "Luminescence" includes fluorescence and phosphorescence.

According to a preferred embodiment of the invention, the cervical cap is at least partially made of luminescent material and / or coated therewith. Thus, for example, the lateral surface of the cervical cap may be at least partially coated with luminescent material. Furthermore, the coating with luminescent material can be applied on the outer side of the lateral surface and / or on the opposite inner side of the collar region as well as on the upper surface between them in the collar region described above. It is particularly preferred if only the cutting edge region of the cervical cap, i. the area on which the vaginal-cervical transition area rests during the incision is made of and / or coated with the luminescent material. Since the collar region rests directly against the vagina-cervix transition region during the cutting procedure, sufficient backlighting of this transitional region during the cutting procedure on the abdominal side is ensured. Consciously dispensing with luminescent material below the collar area of the cervical cap also strengthens the contrast at the interface, since no additionally disturbing scattered light is emitted in the direction of the interface from the jacket area below the collar.

The luminescent material of the cervical cap of the present invention may be supplied with energy prior to insertion of the cervical cap into the vaginal canal, wherein afterglow of the luminescent material for visualization of the vaginal-cervical junction from the abdominal side is sufficient to allow clean cutting in this area. Alternatively or additionally, energy may be supplied to the luminescent material from the abdominal side and through the vaginal-cervical junction region through a radiation source such that the luminescent material is correspondingly excited and emits radiation, i. the cervix-vagina transition region is backlit on the abdominal side.

• – dem Nah-Infrarot(NRI)-Bereich, wobei der NRI-Bereich vorzugsweise 640 nm bis 1000 nm, weiter vorzugsweise 650 nm bis 1000 nm, weiter vorzugsweise 700 nm bis 900 nm, besonders bevorzugt 780 nm bis 850 nm beträgt,
• – dem Ultraviolett(UV)-Bereich, wobei der UV-Bereich vorzugsweise 50 nm bis 380 nm, besonders bevorzugt 200 nm bis 380 nm beträgt,
• – dem Licht-Bereich, wobei der Lichtbereich vorzugsweise 380 nm bis 640 nm beträgt,

wobei besagter NRI-Bereich besonders bevorzugt ist, wie nachfolgend erläutert wird.The cervical cap is at least partially made of material and / or is at least partially coated with material that can absorb energy and emit light, including radiation outside the visible range. The emitted light is preferably from a range with a wavelength spectrum of 50 nm to 1000 nm. These include:

• The near infrared (NRI) region, wherein the NRI region is preferably 640 nm to 1000 nm, more preferably 650 nm to 1000 nm, further preferably 700 nm to 900 nm, particularly preferably 780 nm to 850 nm,
• The ultraviolet (UV) range, wherein the UV range is preferably 50 nm to 380 nm, particularly preferably 200 nm to 380 nm,
• The light region, wherein the light region is preferably 380 nm to 640 nm,

wherein said NRI region is particularly preferred, as explained below.

The invention has recognized that when using excitation light of short wavelength, in particular below 450 nm, biological material itself generates a strong background signal and therefore the fluorescence detection is considerably impeded by this autofluorescence of the tissue. The invention has further recognized that the use of longer wavelength light and corresponding dyes, especially those which absorb and emit radiation in the near infrared (NIR) region, significantly improves the signal-to-noise ratio, ie, enhances contrast enhancement. Also, greater penetration depths greater than 1 cm tissue depth can be achieved because the tissue absorbs significantly less light from the NIR spectrum. For these reasons, NRI dyes are preferred according to the invention which absorb and / or emit radiation in an NRI range of 650 nm to 1000 nm, preferably 700 nm to 900 nm, particularly preferably 780 nm to 850 nm. A wide range of suitable NIR dyes from the prior art are available to the person skilled in the art, this range being constantly supplemented by dye redevelopments (see, for example, US Pat Fischer Georg M., Pyrrolopyrrole Cyanine: New NIR Dyes, Logos Berlin (15.10.2010), ISBN 10: 3832525823 ).

The advantages of the invention will become apparent from the following description of an embodiment of the invention with reference to the accompanying drawings, in which:

1 a uterine manipulator inserted into the vaginal canal with a cervical cap at the vagina-cervix junction;

2 : a subsection of 1 in which the cervical cap has been further inserted into the vaginal canal so that the upper end of the vaginal canal is stretched over the collar area of the cervical cap; and

3 : An abdominalseitige inside view of the inventive cervical cap on the vaginal side backlit vagina-cervix transition region.

1 shows a prepared for the operation vaginal area of a patient using the cervical cap of the invention.

In detail: Shown is a rod-shaped uterine manipulator 1 with a distal end that mates with the proximal end of a cervical cap formed as a hollow cone 2 connected is. The cervix cap 2 gets into the vaginal entrance along the vaginal canal 7 pushed and at the back of the vaginal canal 7 , immediately at the vagina-cervix junction 10 placed. The cervix cap 2 contacts with its distal end portion into the vaginal canal 7 protruding cervix 11 of the uterus 12 , This is where the anterior formix lie 8th and Posterior Formix 9 the vagina on the lateral surface of the distal end of the cervical cap 2 while the marginal inside of the end of the cervical cap 2 the cervix protruding into the vaginal canal like a peg 11 contacted. These contact surfaces increase with further insertion of the cervical cap 2 in the vaginal canal 7 along the direction of the arrow until reaching an in 2 shown end position. The luminescent material of the cervical cap ( 2 ) was before the introduction of the cervical cap 2 in the vaginal canal 7 stimulates and emits radiation into the vagina-cervix transition area on the vaginal side 10 , Alternatively or additionally, the luminescent material of the cervical cap 2 be excited by a dorsal side introduced into the abdominal pelvic cavity radiation source (not shown). The of the luminescent material of the cervical cap 2 through the vagina-cervix transition 10 emitted radiation is transmitted from a dorsal end into the abdominal pelvic cavity endoscope 6 which is connected to an imaging system (not shown) around the luminescent material of the cervical cap 2 to detect radiation emitted from the vaginal side into the abdominal pelvic area and to image it. This gives the surgeon the opportunity to monitor the dorsal side of manipulations of the vagina-cervix transition 10 and a clean and visually controlled incision using the also introduced dorsal surgical instrument 5 allows.

2 shows an extension of the upper end of the vaginal canal with further advancement of the cervical cap 2 in the vaginal canal 7 along the arrow lines in 1 , The vagina-cervix transition 10 lies on the edge of the cervical cap 2 in the collar area 4 wherein the edge may have a groove (not shown) suitable as a cutting guide.

3 shows a dorsal-sided view of the vagina-cervix transition area with a clear vaginal-sided backlighting on the collar area 4 the cervix cap 2 Overlying vagina-cervix transition 10 ,

LIST OF REFERENCE NUMBERS

1

 Uterine manipulator

2

 Cervical cap

3

 Outside of the cervix cap

4

 Collar area of the cervix cap

5

 Surgical instrument

6

 endoscope

7

 vaginal canal

8th

 Anterior Formix

9

 Posterior Formix

10

 Vagina cervical transition

11

 Cervix (cervix)

12

 Uterus (uterus)

13

 Rectum (rectum)

14

 bladder

QUOTES INCLUDE IN THE DESCRIPTION

This list of the documents listed by the applicant has been generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Cited patent literature

• US 749725 S [0001]

Cited non-patent literature

• Fischer Georg M., Pyrrolopyrrole Cyanine: New NIR Dyes, Logos Berlin (Oct. 15, 2010), ISBN 10: 3832525823 [0013]

Claims (11)

Cervical Cap ( 2 ), characterized the cervical cap ( 2 ) Has luminescent material. Cervical Cap ( 2 ) according to claim 1, characterized in that the cervical cap ( 2 ) is at least partially made of luminescent material and / or coated therewith. Cervical Cap ( 2 ) according to one of the preceding claims, characterized in that the cervical cap ( 2 ) is formed as a hollow member comprising a conical portion, the conical portion having a proximal and opposite distal end with a larger diameter than the proximal end. Cervical Cap ( 2 ) according to claim 3, characterized in that the inner diameter of the distal end corresponds to the outer diameter of the cervix of the uterus of a human, said inner diameter preferably 35 mm to 55 mm, more preferably 40 mm to 50 mm, further preferably 43 mm to 47 mm and more preferably 45 mm. Cervical Cap ( 2 ) according to claim 3, characterized in that the cervical cap ( 2 ) ends at its distal end with an edge region, the edge region serving as a cutting edge support for a cervix-vagina transition region ( 10 ) is arranged and said edge region is preferably formed by one, more preferably a plurality of superimposed rings, and at least one ring made of said luminescent material and / or is coated therewith. Cervical Cap ( 2 ) according to claim 4, characterized in that at least one ring is interrupted by gaps in the ring structure. Cervical cap according to claim 3, characterized in that the coating is preferably applied to the distal end region, wherein the end portion may be formed as a hollow cylinder and said end portion, starting from the distal end in the direction of the proximal end, a height of preferably at most 20 mm, farther preferably at most 10 mm, more preferably at most 5 mm. Cervical Cap ( 2 ) according to one of the preceding claims, characterized in that the luminescent material is fluorescent material and / or phosphorescent material. Cervical Cap ( 2 ) according to claim 8, characterized in that the luminescent material is a dye and said dye preferably has a wavelength spectrum from a range of 50 nm to 1000 nm. Cervical Cap ( 2 ) according to claim 9, characterized in that the wavelength spectrum range is selected from the group consisting of: - the near infrared (NRI) region, wherein the NRI region is preferably 640 nm to 1000 nm, more preferably 650 nm to 1000 nm, more preferably 700 nm to 900 nm, particularly preferably 780 nm to 850 nm, the ultraviolet (UV) range, wherein the UV range is preferably 50 nm to 380 nm, particularly preferably 200 nm to 380 nm, the light Range, wherein the light range is preferably 380 nm to 640 nm, with said NRI range being particularly preferred. Uterine manipulator ( 1 ) comprising a cervical cap ( 2 ) according to one of the preceding claims.

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