Amniotome comprising a sheath
The amniotome's sheath and retractable hook design addresses the risks of tissue damage and fetal contact by ensuring controlled deployment, enhancing safety and precision during amniotomy.
Patent Information
- Authority / Receiving Office
- FR · FR
- Patent Type
- Applications
- Current Assignee / Owner
- PETIT LAURENT
- Filing Date
- 2024-11-29
- Publication Date
- 2026-06-05
AI Technical Summary
Existing amniotomes risk damaging surrounding tissues and potentially touching the fetus during insertion and amniotomy due to their design, which can cause discomfort and lack of control.
An amniotome with a sheath and retractable hook design, allowing the hook to be deployed only when in position, minimizing tissue damage and providing controlled sac rupture.
Reduces tissue damage and enhances control during amniotomy by ensuring the hook is deployed only when needed, maintaining stability and precision.
Smart Images
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Abstract
Description
Title of the invention: Amniotome comprising a sheath
[0001] The present invention relates to an amniotome.
[0002] During childbirth, it may be useful to break the amniotic sac, i.e. to perform an amniotomy, if it has not already ruptured.
[0003] A person scratches the membranes of the amniotic sac to rupture it, using an amniotome.
[0004] This instrument is generally a simple rod with a hook at one end.
[0005] However, such an instrument is likely to impress the person on whom amniotomy is performed, so there is a risk of fearing this procedure.
[0006] In addition, during the insertion of the amniotome into the vagina up to the amniotic sac, there is a risk of damaging the surrounding tissues, particularly depending on the orientation of the hook.
[0007] Finally, if, during the amniotomy, the amniotome hook is inserted too deeply into the membranes or is misoriented, then there is a risk of touching the fetus.
[0008] The aim of the invention is then to propose an amniotome that avoids damage to surrounding tissues during insertion and has a different appearance.
[0009] To this end, the invention relates to an amniotome, comprising:
[0010] - a distal retaining element intended to surround an end portion of a a user's finger,
[0011] - a second element adapted to hold the amniotome on the hand of the user, the second element comprising a bracelet adapted to encircle the user's wrist and / or one or more additional rings adapted to encircle the user's finger at a distance from the distal support element,
[0012] - a sheath extending at least between the distal retaining element and the second element, the sheath comprising a distal portion, the sheath having an opening into the distal portion via a distal aperture, and
[0013] - a rod extending partially within the sheath, the rod being able to slide in the orifice, the rod being provided with a hook at a distal end, the rod being able to slide between an extended position, in which the hook comes out of the sheath at the distal opening, and at least one retracted position, in which the hook extends into the sheath.
[0014] During insertion, the rod may be placed in the retracted position, so that the hook extends into the sheath. Alternatively, during insertion, the rod may not be inserted into the sheath, and then inserted and slid into the extended position only once in place. Thus, there is no risk to avoid damaging the surrounding tissues. Furthermore, since the hook only protrudes from the sheath when deployed, and for a shorter length than the stalk, its deployment is stable and guided by the opening. In addition, the hook is deployed at its tip, allowing for very good control. Finally, the amniotome's appearance is likely to be less intimidating since the stalk is primarily contained within the sheath.
[0015] According to other advantageous aspects of the invention, the amniotome comprises one or more of the following features, taken individually or in all technically possible combinations:
[0016] - the distal retaining element is a ring or finger cot intended to surround the end portion;
[0017] - the second element comprises at least one additional ring, the element of distal support and at least one additional ring being arranged to be distributed over different phalanges of the user's finger;
[0018] - the sheath extends between a first end and a second end, the portion distal including the first end, the sheath having a length such that, when the distal retaining element surrounds the end portion of the user's finger, then the second end of the sheath extends between the metacarpophalangeal joint and the carpometacarpal joint of the user;
[0019] - the orifice opens opposite the distal opening at the level of an opening proximal, the stem being provided with a stop notch, the stop notch being arranged on the stem so as to extend outside the orifice and such that, in the deployed position, the stop notch forms a stop coming into contact with the proximal opening;
[0020] - the locking notch is arranged on the rod such that, in the deployed position, the hook extends from the distal opening by a given distance, the given distance being between 1 mm and 3 mm;
[0021] - the sheath extends between a first end and a second end, the proximal opening being arranged at the second end;
[0022] - the sheath is adapted to extend against the user's finger, more particularly against the palmar surface of the finger;
[0023] - the sheath has a thickness of less than 10 mm, more particularly less or equal to 5 mm; and / or
[0024] - the sheath is capable of deforming to follow a bending of the finger of the user.
[0025] The invention will become clearer upon reading the following description, given solely by way of non-limiting example, and made with reference to the drawings in which:
[0026] [Fig.1] [Fig.1] is a view of an example of an amniotome according to an embodiment of the invention, on a hand, from the palmar surface of the hand, in the deployed position of the stalk,
[0027] [Fig.2] [Fig.2] is a side or sagittal view of the amniotome of [Fig.1] on a finger, in the retracted position of the stem, and
[0028] [Fig.3] [Fig.3] is a side or sagittal view of the amniotome of figures 1 and 2 on the finger, in the deployed position of the stalk.
[0029] An example of an amniotome 10 according to an embodiment of the invention is shown in Figures 1 to 3.
[0030] The amniotome 10 comprises a distal support element 12, a second element 14, a sheath 16 and a stem 18.
[0031] The amniotome 10 is intended to be placed on a finger 20, here the middle finger, of a hand of a person who is to perform an amniotomy.
[0032] The distal retaining element 12 is intended to surround a portion of the finger tip, more particularly the distal phalanx of the finger.
[0033] The distal retaining element 12 is designed to surround the end portion without play.
[0034] The distal retaining element 12 includes, for example, a ring, called a distal ring.
[0035] More specifically here, the distal retaining element 12 is the distal ring.
[0036] The distal ring 12 here has an annular band shape.
[0037] Alternatively, the distal retaining element 12 includes a finger cot adapted to surround the distal phalanx of the finger.
[0038] In one embodiment, the distal retaining element 12, more particularly the distal ring, is elastic, so as to allow its insertion around the finger, and then its tight retention in position around the finger.
[0039] The distal retaining element 12 is, for example, made of silicone.
[0040] The second element 14 is adapted to hold the amniotome on the user's hand, more particularly here on the finger.
[0041] The second element 14 includes, for example, a bracelet adapted to encircle the user's wrist and / or one or more additional rings 22, 24 adapted to encircle the user's finger 20 at a distance from the distal retaining element 12.
[0042] Here, the second element 14 includes at least one additional ring, for example in the example shown two additional rings 22, 24.
[0043] Alternatively, the second element 14 comprises a single additional ring.
[0044] The distal retaining element 12 and at least one additional ring 22, 24 are arranged to be distributed over different phalanges of the user's finger, for example on the distal phalanx and on the proximal phalanx.
[0045] More particularly, the second element 14 comprises a proximal ring 24 arranged and adapted to surround the proximal phalanx of the finger and, for example, additionally an intermediate ring 22 arranged and adapted to surround the intermediate phalanx of the finger.
[0046] In the case of a single additional ring, it is, for example, a proximal ring, arranged and adapted to surround the proximal phalanx of the finger.
[0047] In the case of two additional rings, the distal retaining element 12 and the additional rings 22, 24 are arranged to be distributed over the different phalanges of the user's finger
[0048] The sheath 16 extends at least between the distal retaining element 12 and the second element 14, more particularly here at least between the distal retaining element 12 and the proximal ring 24.
[0049] The sheath 16 has a main extension direction X.
[0050] The distal retaining element 12 and the second element 14, here each of the rings, are fixed on the sheath 16, more particularly at a distance from each other along the main extension direction X.
[0051] Their arrangement along the sheath 16 is as described previously.
[0052] Thus, the placement of the amniotome 10 with the distal retaining element 12 and the second element 14 allows the sheath 16 to be held on the user's hand.
[0053] The sheath 16 extends between a first end 26 and a second end 28, more particularly along the main extension direction X.
[0054] The sheath 16 has a length, measured between the first end 26 and the second end 28, such that, when the distal retaining element 12 surrounds the end portion of the user's finger 20, then the second end 28 of the sheath 16 extends between the metacarpophalangeal joint and the carpometacarpal joint.
[0055] The sheath 16 is such that, when the amniotome is held in position on the hand, here the finger, by the distal retaining element 12 and the second element 14, the main direction of extension X corresponds to a direction of extension of the finger.
[0056] The sheath 16 is adapted to extend against the finger 20, more particularly against the palmar face 30 of the finger 20.
[0057] The sheath 16 is such that, when the amniotome is arranged on the hand, the sheath 16 does not extend over the dorsal face and / or the sides of the finger 20.
[0058] The sheath 16 has an inner face 32 intended to extend against the hand, here the finger 20, more particularly the palmar face 30, and an outer face 34 opposite the inner face 32.
[0059] The inner face 32 is, for example, flat, in the absence of constraints.
[0060] The inner face 32 is adapted to follow the flexion of the user's finger.
[0061] Alternatively, the inner face 32 is, for example, curved, more particularly so as to present a complementary shape to the finger 20.
[0062] The sheath 16 has a thickness, measured between the inner face 32 and the outer face 34, of less than 10mm, preferably less than or equal to 5mm.
[0063] The sheath 16 includes a distal portion 36.
[0064] The distal portion 36 includes the first end 26.
[0065] More particularly, the distal portion 36 corresponds to an end portion of the sheath 16, including the first end 26, along the main extension direction X.
[0066] The distal retaining element 12 is fixed to the distal portion 36 of the sheath 16.
[0067] The sheath 16 has an orifice 38 opening into the distal portion 36 through a distal opening 40.
[0068] The distal opening 40 is, more particularly, arranged here on the external face 34 of the distal portion 36.
[0069] The orifice 38 opens opposite the distal opening 40 at the level of a proximal opening 42.
[0070] The proximal opening 42 is here arranged at the second end 28.
[0071] The orifice 38 is closed between the distal opening 40 and the proximal opening 42.
[0072] More specifically, the orifice 38 only opens outside the sheath 16 at the level of the distal opening 40 and the proximal opening 42.
[0073] The orifice 38 extends here along the main extension direction X.
[0074] The sheath 16 has a given shape, in the absence of constraints.
[0075] The sheath 16 is here, for example, capable of deforming to follow a bending of the user's finger.
[0076] Then, when the user stops flexing the finger, the sheath 16 returns to its initial shape.
[0077] The sheath 16 allows contact to be made with the patient's membrane.
[0078] The sheath 16 is, for example, made of silicone.
[0079] The stem 18 extends between a distal end 44 and a proximal end 46.
[0080] The stem 18 is provided with a hook 48 at the distal end 44.
[0081] The stem 18 is, for example, straight outside the hook 48.
[0082] The rod 18 is, for example, rigid.
[0083] The rod 18 here has a complementary section to the orifice 38, so that the rod 18 is able to slide in the orifice 38 as described below, without play perpendicular to the direction of sliding.
[0084] The rod 18 is, for example, made of silicone or stainless steel.
[0085] The rod 18 is, in addition, here provided with a stop notch 50.
[0086] The stop notch 50 is arranged in an external portion 52 of the stem 18, the external portion 52 comprising the proximal end 46.
[0087] The external portion 52 here corresponds to the portion of the stem 18 between the stop notch 50 and the proximal end 46.
[0088] The stop notch 50 forms a local protrusion of the rod 18.
[0089] The stop notch 50 extends here perpendicularly to the rest of the rod.
[0090] The rod 18 extends partially into the sheath 16, more particularly into the orifice 38.
[0091] The external portion 52 always extends outside the orifice 38.
[0092] The rod 18 is able to slide in the orifice 38 between a deployed position ([Fig.3]) and at least one retracted position ([Fig. 1]).
[0093] The orifice 38 thus guides the translation of the rod 18.
[0094] In the deployed position, the hook 48 emerges from the sheath at the opening distal 40.
[0095] The stop notch 50 is arranged on the rod 18, such that, in the deployed position, the stop notch 50 forms a stop coming into contact with the edges of the proximal opening 42.
[0096] Thus, the stop notch 50 prevents the insertion of the external portion 52 into the orifice 38.
[0097] In the deployed position, the hook 48 protrudes from the distal opening 40 by a given distance, the given distance being between 1 and 3 mm.
[0098] More particularly, the stop notch 50 is arranged on the stem 18 so as to come into contact with the edges of the proximal opening 42 when the hook 48 protrudes from the distal opening 40 by the given distance.
[0099] The distance between the end of the hook 48 and the stop notch 50 is thus equal to the sum of the distance between the distal opening 40 and the proximal opening 42 and the given distance.
[0100] Thus, in the deployed position, the rod 18 extends into the orifice 38 with the exception of the hook 48 and the external portion 52.
[0101] In the retracted position, the hook 48 extends into the sheath 16, more particularly within the orifice 38.
[0102] In the retracted position, a portion of the stem 18 comprising the external portion 52 and an additional portion adjacent to the external portion 52 extends outside the orifice 38, at the level of the proximal opening 42.
[0103] In the retracted position, the rod 18 extends into the orifice 38 with the exception of said portion of the rod 18.
[0104] The sheath 16 thus forms a sleeve, here substantially flat, for the rod 18.
[0105] A method of using an amniotome according to the invention will now be described.
[0106] The method of use comprises the following steps: - Placement of the amniotome 10 onto the finger 20, with the stalk 18 in the retracted position, - Insertion of the amniotome 10 into the vagina until the amniotic sac is reached, and - Movement of rod 18 into the deployed position, so as to rupture the amniotic sac.
[0107] The practitioner places the amniotome 10 on his finger 20, here the middle finger.
[0108] More specifically, he inserts his finger and / or his hand through the second element 14 and the distal retaining element 12, up to their respective intended position.
[0109] More specifically, the practitioner inserts his finger through the proximal ring 24, where appropriate the intermediate ring 22, then the distal retaining element 12, here the distal ring, until each ring or retaining element surrounds a corresponding phalanx.
[0110] The practitioner places the amniotome 10, so that the sheath 16 extends against the palmar face 30 of the finger 20, following the placement.
[0111] The amniotome is held securely in position on the hand, here the finger, by means of the distal retaining element 12 and the second element 14, here by at least two, or even three, successive rings.
[0112] Before inserting the amniotome 10 into the vagina, the practitioner tests, for example, the sliding of the rod 18 in the sheath 16, more particularly its deployment until the stop notch 50 blocks the translation of the rod 18. If necessary, the practitioner returns the rod to the folded position before inserting the amniotome into the vagina.
[0113] Then, the practitioner inserts his finger 20 equipped with the amniotome 10 into the vagina.
[0114] The rod 18 is then in the retracted position.
[0115] During insertion, the practitioner maintains, for example, the external portion 52 of the stem 18, to prevent any translation of the stem that could cause the hook 48 to deploy
[0116] Hook 48 therefore does not protrude.
[0117] There is therefore no risk that the practitioner will accidentally injure the patient with the hook during the movement.
[0118] In a particular embodiment, the practitioner simultaneously inserts a second finger, corresponding to a finger adjacent to finger 20, here the index finger, into the vagina.
[0119] Alternatively, when inserting finger 20 into the vagina, the shaft 18 is not arranged in the sheath 16, but is at a distance from the rest of the amniotome.
[0120] When the practitioner feels that the distal phalanx of his finger 20, more particularly at the level of the distal opening 40, is extending in relation to the amniotic sac, either with the finger equipped with the amniotome, or with the adjacent finger, he moves the rod 18 towards the deployed position.
[0121] In addition, the practitioner is likely to feel the opening of the cervix, so as to decide whether or not to use the amniotome.
[0122] The material and thickness of the sheath 16 are, for example, particularly advantageous in allowing the practitioner to feel what he is touching at the level of the pulp of his distal phalanx despite the presence of the sheath.
[0123] Here, the practitioner pushes the rod 18 in the opposite direction of the hook 48 towards the orifice 38, for example with the rest of his hand or his other hand.
[0124] This results in a translation of the rod 18 in the orifice 38 from the proximal opening 42 to the distal opening 40.
[0125] According to the above alternative, in which the rod 18 is not arranged in the sheath at the time of insertion, when the practitioner feels that the distal phalanx of his finger 20 is extending opposite the amniotic sac, as described previously, he inserts the rod 18 into the sheath 16, more particularly into the orifice 38, by first inserting the distal end 44 through the proximal opening 42, until the rod 18 is in the deployed position.
[0126] The rod 18 then temporarily passes through the retracted position, in which the hook 48 extends in the sheath 16, as it slides to reach the deployed position.
[0127] The orifice 38 guides the deployment of the rod 18, so that the hook 48 is stable.
[0128] The translation of the rod 18 is advantageously stopped by the stop 50.
[0129] The hook 48 then protrudes by the given distance.
[0130] The given distance is chosen to allow the rupture of the amniotic sac, while limiting the risk of touching the fetus through the amniotic sac.
[0131] The practitioner is then likely to move his finger equipped with the amniotome laterally, to make a lateral incision in the amniotic sac.
[0132] When the amniotic sac is ruptured, the practitioner then moves, for example, the rod 18 back into the retracted position and extracts his or her fingers from the patient's vagina.
[0133] The fact that the rod is retracted into the amniotome according to the invention, in which the hook does not protrude from the sheath, avoids any risk of damaging the patient's tissues. Deploying the hook only when the amniotome is in position allows for a controlled and precise movement to rupture the amniotic sac. Finally, an amniotome according to the invention has a less intimidating appearance than a conventional amniotome, since the rod only protrudes a portion of the sheath.
Claims
Demands
1. Amniotome (10) comprising: - a distal retaining element (12) designed to encircle a portion of the tip of a user's finger (20), - a second element (14) adapted to retain the amniotome (10) on the user's hand, the second element (14) comprising a band adapted to encircle the user's wrist and / or one or more additional rings (22, 24) adapted to encircle the user's finger at a distance from the distal retaining element (12), - a sheath (16) extending at least between the distal retaining element (12) and the second element (14), the sheath (16) comprising a distal portion (36), the sheath (16) having an opening (38) opening into the distal portion (36) through a distal opening (40), and - a stem (18) extending partially into the sheath (16), the rod (18) being able to slide in the orifice (38), the rod (18) being provided with a hook (48) at a distal end (44),the rod (18) being able to slide between an extended position, in which the hook (48) emerges from the sheath (16) at the distal opening (40), and at least one retracted position, in which the hook (48) extends into the sheath (16).
2. Amniotome according to claim 1, wherein the distal retaining element (12) is a ring or finger cot provided to surround the end portion.
3. Amniotome according to claim 1 or 2, wherein the second element (14) comprises at least one additional ring (22, 24), the distal retaining element (12) and at least one additional ring (22, 24) being arranged to be distributed over different phalanges of the finger (20) of the user.
4. Amniotome according to any one of claims 1 to 3, wherein the sheath (16) extends between a first end (26) and a second end (28), the distal portion (36) comprising the first end (26), the sheath (16) having a length such that, when the distal retaining element (12) surrounds the end portion of the user's finger (20), then the second end (28) of the sheath (16) extends between the user's metacarpophalangeal and carpometacarpal joints.
5. Amniotome according to any one of claims 1 to 4, wherein the orifice (38) opens opposite the distal opening (40) at the level of a proximal opening (42), the rod (18) being provided with a stop (50), the stop (50) being arranged on the rod (18) so as to extend outside the orifice (38) and such that, in the deployed position, the stop (50) forms a stop coming into contact with the proximal opening (42).
6. Amniotome according to claim 5, wherein the stop notch (50) is arranged on the rod (18) such that, in the deployed position, the hook (48) protrudes from the distal opening (40) by a given distance, the given distance being between 1 mm and 3 mm.
7. Amniotome according to claim 5 or 6, wherein the sheath (16) extends between a first end (26) and a second end (28), the proximal opening (42) being arranged at the second end (28).
8. Amniotome according to any one of claims 1 to 7, wherein the sheath (16) is adapted to extend against the finger (20) of the user, more particularly against the palmar face (30) of the finger (20).
9. Amniotome according to any one of claims 1 to 8, wherein the sheath (16) has a thickness of less than 10 mm, more particularly less than or equal to 5 mm.
10. Amniotome according to any one of claims 1 to 9, wherein the sheath (16) is capable of deforming to follow a bending of the user's finger.