LU84725A1 - IMPROVEMENTS IN OR WITH REGARD TO SURGICAL INSTRUMENTS - Google Patents

Description

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The present invention relates to improvements in or relating to surgical instruments and, more particularly, to a device for intubating the cervix.

Intubation of the cervix provides access to the uterus and fallopian tubes. It is used, for example, when you want to implant a fertilized egg, or with certain methods that involve the fallopian tubes.

! Until now, intubation of the cervix has been a difficult procedure.

The catheter must be fairly rigid to insert it! to allow in the vagina as well as an exact placement of the catheter tip (under view) in the cervix. The cervix is the gateway to the cervix and uterus. An i catheter must protrude about 6 cm beyond the cervix! be pushed before it reaches the fundus uteri (in a grown woman). So far, catheters have been made from polymers that are stiff enough to allow direct penetration into the cervix through the vagina; however, such material can easily damage the vulnerable mucous membrane of the cervical canal and the! Damage the uterine cavity. If the catheter is flexible enough for a safe introduction into the well-defined cervical canal, it cannot move in the cervix be placed exactly.

; »I ^; It has also been proposed to use a flexible - Create catheter that is distally from a stiffer one! outer vagina, (which is made of splint for the proximal

Area serves) protrudes. However, it still isn't! difficult to push such a flexible end forward through the vagina to achieve an exact placement in the cervix.

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In one aspect, the invention provides an apparatus for intubating the cervix, which has a hub connected to a flexible catheter and a sheath surrounding said catheter, said sheath being more rigid than said catheter and having an enlarged grip area suitable for it proximal end to be gripped by an operator. The aforementioned sheath is also set up in such a way that it moves from a first position, in which the distal end of said catheter ends approximately at the same height as the distal end of said sheath, to I a second position, in which the mentioned grip area strikes the attachment and the er! thought that the catheter protrudes a little over the distal end of said vagina 1, which is not shorter than the intended intubarion depth 3 into the cervical canal, 1.

The invention overcomes the above-described problems of known devices for cervical intubation, since it allows the catheter tip to be placed exactly in the cervix and then advanced through the fixed vagina without damaging the cervical canal. The catheter can therefore be selected from the point of view of the greatest possible flexibility without impairing the ability of the surgeon to place it exactly in the cervix. The vagina itself is only advanced as far as the cervix.

The extension preferably has a conical connector such as a Luen or Luer lock adapter, for connection to other devices, e.g. a syringe. The catheter should be made of a suitable, bio-compatible, highly flexible material, which is preferably elastomeric.

'i. Suitable polyester polymers are able to meet this requirement Ï / \ requirements.

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The sheath can be made from a fluorocarbon polymer such as polytetrafluoroethylene (PTFE) or FEP polymer and made radio opaque.

The vagina will usually have some flexibility, but it will be much stiffer than the catheter.

The widened grip area can have any suitable shape that gives the surgeon good access. E.g. a collar, preferably with raised ribs or wings, can be provided. Preferably, the grip area can snap into place on the extension, e.g. by means of a tapered connection such as a Luer connection, or by mechanical connection with suitable locking devices. The attachment and grip areas can be made of thermoplastic material such as Polyethylene can be manufactured.

Attention should be paid to the shape of the catheter tip, which should depend on which procedure is to be performed. E.g. the catheter tip for embryo transfer can be rounded, sealed and provided with a side eye.

In this case, the tip should be massive at the beginning of the eye, so that the embryo does not sit trapped in a dead space. This massive area can be designed on the inside so that the embryo is directed to the exit eye. A rounded tip also allows non-traumatic manipulation in the cervical canal and prevents blockage due to mucus in the cervical canal.

Alternatively, the catheter can either end flat or obliquely with respect to its length (a so-called whistle or flute tip), the edges being rounded / sufficiently rounded in any case. Furthermore, the extreme end h

Ides catheters preferably beveled or tapered to facilitate their passage through the cervical canal.

The device according to the invention is useful for artificial insemination and especially for the introduction of fertilized ice. The latter procedure is extremely difficult to perform successfully. The success rate has been very low with known devices, while a much higher success rate has been achieved with a suitable device according to the invention. At the same time, other aspects of the method have been refined, but it can be said that the present invention contributes significantly to a higher success rate (which has now become possible).

The device can of course be used both in the human and in the veterinary field by adapting the size and proportions of the components accordingly in order to do justice to the species in question.

An embodiment of the invention will now be described by way of example with reference to the accompanying drawings, in which

1 is an enlarged cross-sectional view of a catheter with a sheath (shown side by side)

Fig. 2 is a plan view of said vagina, attached to the aforementioned catheter and Figures 3t ^ and 5

Cross-sectional views (very enlarged) of three catheter tips are.

In Figure 1, the catheter 1 (made of an elastomeric polyester polymer, with an outer diameter of about 1 mm) with the adapter 2 made of high pressure polyethylene. connected. The extension piece 2 has a female Luer! [^ __ lock connection 3 with locking forwards! I, 6 jumps ("ears") 4. The distal end of the extension tapers to a male Luer lock cone 5

The sheath 6 is a tube made of PTFE (Teflon®), which contains a radio-opaque filler. The sheath 6 bears | , at its proximal end a Luer connector 7 which serves as a grip area for the surgeon. The internal taper 8 is dimensioned so that it cooperates with the taper 5 on the previously described extension.

| The distal end of the vagina is rounded (at 9) to prevent any risk of injury. Sublime

Ribs 17, 18, each in the grip area 7 and on the extension piece Î 2, facilitate handling by the surgeon.

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r! In Figure 2, the catheter 1 is pushed through the vagina 6 ge, and the area 10 projects distally when the Luei ^ Koni 5 and 8 are engaged.

If one now turns to FIG. 4, there is a | Catheter tip shown with a solid rounded portion 11 and an eye 12. In Figure 5 the catheter end is flat.

[The edge is rounded off at 14 and the end is chamfered at 15 ″ to enable a gentler passage through the cervical canal »i.

i. 5 j In FIG. 6 the catheter is cut off obliquely (like a j pipe tip) and the leading edge is rounded and | tapered inside (at 16).

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Claims (8)

1. A device for intubation of the cervix, characterized in that it has an attachment piece connected to a flexible catheter and a sheath which surrounds said catheter, said sheath being more rigid than said catheter and having an enlarged grip area at the proximal end for gripping by an operator, and said sheath is displaceable from a first position, in which the distal end of said catheter ends approximately at the same level as the distal end of said sheath, to a second position, in which said grip area on said attachment piece stops and said catheter protrudes a little beyond the distal end of said vagina, which is not shorter than the intended depth of penetration into the cervical canal * 2. Apparatus according to claim 1, characterized in that said attachment has a conical connector for attachment to a syringe. 3 * Device according to claim 2, characterized in that said conical connector is a Luer or Luer lock connector. 4. Device according to one of claims 1 to 3, characterized in that said grip area has raised ribs or wings. 5. Device according to one of claims 1 to 4, characterized in that said grip area by means of a tapered connection with the end piece tightly ver. can be bound. h w I * i ί * 6. Device according to one of claims 1 to 5, characterized in that the catheter tip is rounded and sealed and is provided with a side eye. 7. Device according to one of claims 1 to 6, characterized- j indicates that said catheter made of elastomeric - polyester material and said sheath made of a fluorocarbon resin, which is radio-opaque. 8. Method for introducing a fertilized egg, characterized in that a) a device according to one of claims 1 to 6 in the <Introduces vagina with said vagina in said j first position until the catheter tip reaches the cervix and b) said catheter is advanced into the cervical canal; is pushed while said vagina is held stationary until the tip of said catheter abuts the fundus uteri,! and ! c) a fertilized egg is ejected from said catheter tip J. I VAÄAjvM ί *! t, i t, \ \ i - |