Kit for reversible and modular hemostatic ligation of uterine vessels

Abstract

A hemostatic suture kit (10) for reversibly suturing uterine vessels comprises a straight suture needle (12) having a through opening to couple with a suture thread (18), a suture thread (18) comprising a first portion (20) made of elastic material and a second portion (22) made of absorbable material and configured to be coupled with the suture needle (12). A locking device (24) comprising a tubular element (26) having a first end (28) open and defining an internal cavity to accommodate the suture thread (18), and a closure element (32) joined with the tubular element (26) and configured to removably engage with the first end (28) to lock the suture thread (18). A coupling device (36) configured to pass at least partially through the inner cavity of the tubular element (26) and comprising a coupling portion (40) for engaging the suture thread (18) and guiding it through the inner cavity.

Description

[0001] Kit for reversible and modular hemostatic ligation of uterine vessels

[0002] Technical field

[0003] The present invention relates to the field of surgical suturing of biological tissues and refers, in particular, to a kit for reversible hemostatic suturing of uterine vessels.

[0004] State of the art

[0005] Following childbirth, especially in the case of caesarean section, hemorrhage can occur, which in turn can lead to complications or, in some cases, even the death of the mother. Postpartum hemorrhage is still one of the main causes of maternal mortality and morbidity and affects between 1% and 5% of childbirths. Several causes induce this hemorrhage including, for example, uterine atony, genital tract lacerations or coagulation defects.

[0006] In the case of uterine atony, i.e. in the presence of a uterus with reduced muscle tone, a typical procedure to stop the bleeding is to use compression ligatures, while in the case of lacerations or bleeding of the lower uterine segment, hemostatic surgical ligation of the uterine vessels are generally applied.

[0007] Typically, hemostatic ligation of uterine vessels, for example of the uterine artery, is an irreversible type of ligation, i.e. it involves the permanent closure of the uterine blood vessels. This procedure, although resolving the hemorrhagic emergency in many cases, is however burdened by important complications on the woman's future reproductive life. The resulting uterine devascularization may, in fact, lead to a series of subsequent ureteral and / or reproductive complications, thus increasing the risk of secondary infertility or miscarriage. In the most complicated cases, when even hemostatic ligations are not resolving the problem, it may be necessary to resort to destructive surgery such as hemostatic hysterectomies, which irreversibly affect the woman's reproductive potential. Examples of irreversible ligations are described in the scientific articles O'Leary JL, O'Leary JA, "Uterine artery ligation in the control of intractable postpartum hemorrhage" , Am J Obstet Gynecol, 1966 Apr 94(7):920- 4 and AbdRabbo SA, "Stepwise uterine devascularization: a novel technique for management of uncontrolled postpartum hemorrhage with preservation of the uterus", Am J Obstet Gynecol, 1994 Sep 171(3):694-700.

[0008] Some ligation techniques also include removable ligation devices for blood vessels. See, for example, patent publications CN204765788U and CN214907613U which describe devices characterized by comprising two curved arms elastically connected to each other at a relative first end. At a second end, the two arms also have a hook and a seat for the hook, respectively, so that the closure of the two arms brings the relative inner surfaces of the two arms into contact, clamping a possible blood vessel placed between them.

[0009] In addition, document CN217219112U describes a removable uterine artery clamping device comprising a first arm having two parallel transverse portions and a longitudinal portion, arranged transversely between the two parallel portions, and a second arm having two transverse portions, clampable onto the two transverse portions of the first arm.

[0010] However, blood ligation devices of the prior art have the severe limitation of causing partial devascularization of the uterus with the consequent risk of insufficient hemostasis because the tightening of these devices does not involve the entire uterine side but selectively one vessel. This is even more important considering that uterine blood vessels are not always clearly identifiable, for example in the case of distorted uterine anatomy or in the case of ongoing hemorrhage. Furthermore, a further disadvantage of the above-mentioned devices is that they have a non-negligible spatial requirement when inserted into a woman's pelvis, a space that is in itself already limited, thus being difficult to apply to the vascular anatomy of the uterus.

[0011] Further examples of suture locking devices are disclosed in the prior art.

[0012] Patent application US 2012 / 065678 describes a suture locking device comprising a tubular element and a closure element configured to lock a suture thread passing through the tubular element.

[0013] Patent application US 2010 / 137679 Al describes a suture comprising a portion of elastic material and a portion of absorbable material, and a suture coupling device having a coupling portion arranged at one end thereof.

[0014] Patent application US 2023 / 021371 Al describes a locking device having a tubular element and a coupling device configured to pass through the tubular element.

[0015] Summary of the invention

[0016] It is an object of the present invention to provide a hemostatic suture kit which enables a transient ligation of uterine vessels, thereby minimizing uterine devascularization.

[0017] Another object of the present invention is to provide a reversible hemostatic suture kit for uterine vessel that is small in size and easy to use.

[0018] A further object is to provide a reversible hemostatic suture kit for uterine vessels that reduces the risk of ureteral injury during its use.

[0019] The aforementioned and other objects and advantages, which will be better understood below, are achieved according to the present invention which has the characteristics set forth in independent claim 1. Preferred embodiments of the invention are set forth in the dependent claims.

[0020] In brief, a hemostatic suture kit according to the invention for reversibly suturing uterine vessels comprises a suture needle, a suture thread, a locking device and a coupling device. The suture needle is straight, elongated in a first axial direction and has a first proximal end provided with a through opening configured to couple with the suture thread. The suture thread includes a first portion made of elastic material and a second portion made of absorbable material, and it is configured to be coupled with the suture needle through the through opening. The locking device comprises a tubular element and a closure element. The tubular element has a first open end and a second open end, and defines an internal cavity configured to accommodate the suture thread. The closure element is joined with the tubular element and configured to removably engage with the first end of the tubular element so as to lock the suture thread passing through the inner cavity of the tubular element. The coupling device includes an elongate portion in a second axial direction and a coupling portion disposed at one end of the coupling device. The coupling device is also configured to pass at least partially through the inner cavity of the tubular element of the locking device, and the coupling portion is configured to engage the suture thread and guide it through the inner cavity.

[0021] Brief description of the drawings

[0022] The features and advantages of the present invention will become more clear from the following detailed description, given purely as a non-limiting example with reference to the accompanying drawings, wherein:

[0023] Figure 1 illustrates a suture needle, a suture thread, a locking device and a coupling device;

[0024] Figure 2 is a perspective view of a suture thread being coupled with the coupling device and passed through the locking device; and

[0025] Figure 3 illustrates a suture thread that passes at least partially through a tubular element of the locking device and is locked in place with a closure element.

[0026] Detailed description

[0027] Figure 1 illustrates a hemostatic suture kit 10 for reversibly suturing uterine vessels comprising a suture needle 12, a suture thread 18, a locking device 24 and a coupling device 36.

[0028] The term "hemostatic suture", as used herein, refers to the application of one or more stitches to close a blood vessel to control hemostasis.

[0029] In this description, the terms "ligation" and "suture" are used interchangeably as synonyms.

[0030] The suture needle 12 is straight or straight-line and is extended in a first axial direction x. Preferably, the suture needle 12 has a length in the range of about 7 cm to about 9 cm. Even more preferably, suture needle 12 has a length of approximately 8 cm.

[0031] A pregnant uterus at the isthmus level generally ranges in size from about 4 cm to about 8 cm, typically about 6 cm. Therefore, the use of a straight-shaped suture needle 12 with a length within the above-mentioned range advantageously allows it to pass through the tissues of the uterus without difficulty.

[0032] The suture needle 12 has a first proximal end 14 provided with an opening or through-hole and configured to couple with the suture thread. The suture needle 12 may also have a second pointed distal end 16 to facilitate entry of the suture needle 12 into the uterine tissue.

[0033] In a preferred embodiment, hemostatic suture kit 10 comes with suture thread 18 already inserted and passing through the through opening of suture needle 12 so that the application of hemostatic suture kit 10 can be speeded up in emergencies.

[0034] The suture needle 12 can be made of metal material, for example, it can be made of steel or other metal alloys.

[0035] The suture thread 18 comprises a first portion 20 made of elastic material and a second portion 22 made of absorbable material, and the suture thread 18 is configured to be coupled to the suture needle 12 through the corresponding through opening present in the first proximal end 14 of the suture needle 12.

[0036] Advantageously, the first portion 20 of the suture thread 18 made of elastic material allows to generate a greater tension of said suture thread than a conventional suture thread, thus allowing to operate an adjustment of the occlusion or tightening pressure on the flaps of uterine tissue to be sutured according to the elastic properties of said thread. According to the present invention, a suture thread 18 with an elastic portion 20 also advantageously allows the tensioning of the suture thread 18 to be adapted to the sudden changes in tension of the myometrial muscle that occur during childbirth, i.e. it allows for modulable tensioning. A further advantage of the presence of an elastic portion 20 in the suture thread 18 is that it significantly reduces the damaging effect on the surrounding biological tissues during its insertion and / or removal.

[0037] According to the present invention, the suture thread 18 may also be referred to as hybrid suture thread 18 since it comprises a first elastic portion 20 and a second absorbable portion 22.

[0038] In an embodiment of the invention, the first elastic portion 20 of the suture thread 18 may be made of silicone and the second absorbable portion 22 of the suture thread 18 may be made of polyglycolic acid. In this embodiment, the second portion 22 may comprise a plurality of polyglycolic acid filaments intertwined with each other, i.e. it may be a polyglycolic acid multifilament.

[0039] According to the invention, the second absorbable portion 22 can also be made using another material characterized by a resorption profile corresponding to that of a suture thread made of multifilament polyglycolic acid.

[0040] The selection of the material of the absorbable portion of the suture thread most suitable for use in the kit of the present invention is largely within the abilities of the skilled person in the art.

[0041] The multifilament structure of the second portion 22 allows for easier use of the same, advantageously reducing or preventing what is known in the art as the "memory effect" of a monofilament thread, i.e. the natural tendency of a monofilament suture thread to return to its original position inducing difficulties in handling the thread during suturing.

[0042] Preferably, the first portion 20 of the silicone suture thread 18 may be platinum vulcanised to improve its biocompatibility and / or the second portion 22 of the polyglycolic acid multifilament suture thread 18 may be coated with polycaprolactone and calcium stearate to minimize the undesirable shear injury effect during passage through biological tissues.

[0043] According to the invention, the first elastic portion 20 of the suture thread 18 may have an elliptical or ovoid shape in cross-section and may have a major diameter between about 1 mm and about 3 mm and a minor diameter between about 0.5 mm and about 1.5 mm. Preferably, the first portion 20 of the suture thread 18 has a major diameter of about 2 mm and a minor diameter of about 1 mm.

[0044] Still according to the invention, the second multifilament portion 22 of the suture thread 18 may have a circular shape in cross-section and may have a diameter between about 5 mm and about 6 mm. As is well known, with regard to gauge, sutures are defined according to the metric system of the European Pharmacopoeia (-E.P.-), in which the thickness of the thread is expressed in a tenth of a millimeter, or according to the American one (United States Pharmacopoeia -U.S.P.-), which is not directly dependent on the gauge of the thread. In other words, the multifilament portion of the suture thread 18 preferably has a gauge of 2 on the U.S.P. scale or a gauge of 5 on the E.P. scale.

[0045] In an alternative embodiment, the second portion 22 of the suture thread 18 may have a gauge of 1 on the U.S.P. scale or a gauge of 4 on the E.P. scale, corresponding to a diameter of approximately 4 mm to ensure a fit between the first portion 20 and the second portion 22 of suture thread 18.

[0046] The above-mentioned diameters of the first portion 20 and the second portion 22 are advantageously used to provide the suture thread 18 with sufficient strength and robustness to tensile stress to pass through, without breaking, the tissue of the uterine wall, which includes not only blood vessels, but also muscle tissue subject to variations in tension and volume during childbirth, thus also inducing variations in tension on the suture thread.

[0047] Preferably, one end of the first portion 20 of the suture thread 18 and one end of the second portion 22 of the suture thread 18 are fixed together by alternative techniques selected from fusing, splicing, and braiding.

[0048] Within the scope of the present invention, the fusing technique provides for joining relative end edges of the ends of the first portion 20 of suture thread 18 and the second portion 22 of suture thread 18 by, for example, but not limited to, changes in temperature or affixing an intermediate material.

[0049] In the splicing technique as understood according to the present invention, the first portion 20 of suture thread 18 and the filaments of the second portion 22 of suture thread 18 are twisted together in such a way as to obtain a fixation between the ends of the two portions 20, 22 of suture thread 18.

[0050] According to the braiding technique, in the present invention the first portion 20 of suture thread 18 and the filaments of the second portion 22 of suture thread 18 are overlapped following a predefined pattern.

[0051] Preferably, the suture thread 18 may have a length in the range of 70 cm to 90 cm, and the first 20 and the second 22 portions of suture thread 18 may preferably have substantially corresponding lengths, i.e. each of the first 20 and the second 22 portions of suture thread 18 may have a length in the range of about 35 cm to about 45 cm.

[0052] A suture thread 18 with a length in the range of 70 cm to 90 cm is particularly preferred because it advantageously allows the suture thread 18 to be passed one or more times through the uterine wall and to be passed, at least partially, through the locking device 24, ensuring ease of use and workability during use.

[0053] In addition to the suture needle 12 and suture thread 18, the hemostatic suture kit 10 of the invention also includes a locking device 24 comprising a tubular element 26 and a closure element 32 or cap.

[0054] According to the invention, the tubular element 26 has a first open end 28 and a second open end 30 and defines an internal cavity configured to accommodate the suture thread 18. The closure element 32, joined or connected with the tubular element 26, is configured to engage removably, i.e. to couple and uncouple, with the first open end 28 of the tubular element 26 so as to block the suture thread 18 passing through the inner cavity of the tubular element 26. In other words, the closure element 32 is releasable from the first end 28 of the tubular element 26. By the terms joined or connected, it is meant that the closure element 32 can be made separately from the tubular element 26 and connected to it directly, for example by means of a shape fit, or indirectly, for example by means of a hook or pin element, or it is meant that the closure element 32 can be made as a single piece or integrally to the tubular element 26.

[0055] The tubular element 26 and / or the closure element 32 are made of a material suitable to provide the advantageous mechanical properties of being flexible and / or reducing possible injury to surrounding biological tissues during use.

[0056] According to a preferred embodiment, the tubular element 26 and / or the closure element 32 are made of a material selected from polyvinyl chloride, silicone and combinations thereof.

[0057] In a preferred embodiment, tubular element 26 has a length of between about 5 cm and about 7 cm. The working space in the pelvic area during surgery operations on the uterus is limited, which is why having a compact tubular element 26, i.e. with a shorter length of the tubular element 26 than typical tubular element lengths normally used in surgery, advantageously allows the space occupied by the locking device 24 during use to be limited, ensuring a limited overall dimension of the same.

[0058] Preferably, the inner cavity of the tubular element 26 is cylindrical with a diameter preferably between about 6 mm and about 8 mm. This diameter of the inner cavity allows for accommodating a single suture thread 18 or a double suture thread 18, i.e. a folded suture thread 18.

[0059] The outer diameter of the tubular element 26 of the locking device 24 can be in the range of about 7 mm to about 8 mm in order to have a small, i.e. compact, tubular element 26, limiting the space occupied during its use.

[0060] According to an embodiment, the closure element 32 may have a protrusion 34 of a truncated cone shape configured to be removably inserted into the inner cavity of the tubular element 26 so as to close the first open end 28 and block or clamp the suture thread 18 therein.

[0061] Such a truncated protrusion 34 may have a length between about 1.5 cm and about 2 cm and may have a base diameter of about 7 mm and an apical diameter of about 4 mm.

[0062] According to an alternative embodiment not illustrated in the figures, the closure element may comprise a cage-like portion or a crown portion in such a way as to engage with a relative outer surface of the tubular element end by closing it and blocking the suture thread passing through the inner cavity.

[0063] In a further alternative embodiment, not illustrated in the figures, the closure element can be comb slits in such a way that the suture thread can be passed one or more times through the slits and then blocked.

[0064] According to the present invention, the hemostatic suture kit 10 further comprises a coupling device 36 comprising an elongated portion 38 in a second axial direction y and a coupling portion 40 disposed at a distal end 42 of the coupling device 36. The coupling device 36 is configured to pass at least partially through the inner cavity of the tubular element 26 of the locking device 24 and the coupling portion 40 is configured to engage the suture thread 18 and guide it through the inner cavity.

[0065] In other words, the coupling device 36 is configured to be at least partially inserted through the first end 28 of the tubular element, into the inner cavity of the tubular element 26 and out of the second end 30 of the tubular element 26 in such a way as to engage the suture thread 18 and, with a reverse movement of the coupling device, guide it through the inner cavity to out of the first end 28.

[0066] The coupling device 36 may have a length between about 12 cm and about 20 cm. Preferably, the coupling device 36 measures 15 cm in length in the y-direction.

[0067] Preferably, the elongated portion 38 of the coupling device 36 has a length greater than the length of the tubular portion 26 of the locking device 24 such that it passes at least partially through the tubular element 26 of the locking device 24, i.e. at least partially through the inner cavity of the tubular element 26, entering from the first open end 28 and exiting from the second open end 30 to engage the suture thread 18 and guide it within the inner cavity of the tubular element 26.

[0068] The coupling portion 40 of the coupling device 36 may have a hooked folded portion 44 for coupling the suture thread 18 and wherein said coupling portion 40 may have a dimension in the radial direction substantially corresponding to the dimension in the radial direction of the elongated portion 38 such that they can be passed at least partially through the internal cavity of the tubular element. Preferably, the dimension in radial direction of the elongate portion 38 and the coupling portion 40 is about 5 mm.

[0069] Preferably, coupling device 36 is made of polyamide.

[0070] Figure 2 illustrates how the coupling device 36 can be inserted through or be passed at least partially through the tubular element 26 of the locking device 24, i.e. how the coupling device 36 can be threaded through or be inserted into or be passed at least partially through the inner cavity of the tubular element 26, entering from a first end 28 and exiting from a second end 30 of the tubular portion 26. When exiting from the second end 30 of the tubular element (Figure 2), the coupling portion 40 of the coupling device 36 is configured to couple the suture thread 18 and, by a reverse movement of the coupling device 36, is configured to guide it through the inner cavity of the tubular element 26 in order to out of the first end 28.

[0071] Figure 3 illustrates a portion of uterine biological tissue sutured with suture thread 18 that is locked in a removable, i.e. reversible or releasable, manner by means of the coupling device 36. When hemostasis is achieved, i.e. bleeding ceases, the suture can be advantageously removed, avoiding devascularization of the uterine tissue and its dangerous complications. The suture kit of the present invention enables a removable suture to be obtained by at least partially passing the suture thread 18 through the tubular element 26 of the locking device 24, as described above and as illustrated in figure 2, and locking it in place by means of the closure element 32 which engages with the first end 28 of the tubular element 26 of the locking device 24 (figure 3). Removal of the suture is achieved by simply releasing the closure element 32, i.e. disengaging it from the tubular element 26, removing or disengaging the locking device 24 from the suture thread 18 and removing the suture thread 18 from the biological tissue. Without prejudice to the principle of the invention, the details of implementation and embodiments may be widely varied from what is described and illustrated, without departing from the scope of the present invention as identified by the following claims.

Claims

CLAIMS1. A hemostatic suture kit (10) for reversible suturing of uterine vessels, comprising:- a straight suture needle (12), elongated in a first axial direction (x), wherein said suture needle (12) has a first proximal end (14) provided with a through opening configured to couple with a suture thread (18);- a suture thread (18) comprising a first portion (20) made of elastic material and a second portion (22) made of absorbable material, wherein said suture thread (18) is configured to be coupled with said suture needle (12) through the through opening;- a locking device (24) comprising a tubular element (26) having a first open end (28) and a second open end (30) and defining an internal cavity configured to accommodate the suture thread (18), and a closure element (32) joined with the tubular element (26) and configured to removably engage the first end (28) of the tubular element (26) so as to lock the suture thread (18) passing through the inner cavity of the tubular element (26); and- a coupling device (36) comprising an elongated portion (38) in a second axial direction (y) and a coupling portion (40) disposed at a distal end (42) of the coupling device (36), wherein said coupling device (36) is configured to pass at least partially through said internal cavity of the tubular element (26) of the locking device (24), and said coupling portion (40) is configured to engage said suture thread (18) and guide it through said internal cavity.

2. The hemostatic suture kit (10) according to claim 1, wherein the suture needle (12) has a length in the range from about 7 cm to about 9 cm.

3. The hemostatic suture kit (10) according to claim 1 or 2, wherein the first portion (20) of the suture thread (18) is made of silicone and the second portion (22) of the suture thread (18) is made of polyglycolic acid, said second portion (22) of the suture thread (18) comprising a plurality of polyglycolic acid filaments intertwined with each other.

4. The hemostatic suture kit (10) according to claim 3, wherein the first portion (20) of the suture thread (18) is platinum vulcanised and / or the second portion (22) of the suture thread (18) is coated with polycaprolactone and calcium stearate.

5. The hemostatic suture kit (10) according to any one of the preceding claims, wherein the first portion (20) of suture thread (18) has an elliptical shape in cross-section with a major diameter between about 1 mm and about 3 mm and a minor diameter between about 0.5 mm and about 1.5 mm and the second portion (22) of suture thread (18) has a circular shape in cross-section with a diameter between about 5 mm and about 6 mm.

6. The hemostatic suture kit (10) according to any one of the preceding claims, wherein one end of the first portion (20) and one end of the second portion (22) of suture thread (18) are secured together by means of a technique selected from the group consisting of fusing, splicing, and braiding.

7. The hemostatic suture kit (10) according to any one of the preceding claims, wherein the suture thread (18) has a length in the range of 70 cm to 90 cm and the first portion (20) of suture thread (18) and the second portion (22) of suture thread (18) have substantially corresponding lengths.

8. The hemostatic suture kit (10) according to any one of the preceding claims, wherein the tubular element (26) and / or the closure element (32) of the locking device (24) are made of a material selected from polyvinyl chloride, silicone and any combination thereof.

9. The hemostatic suture kit (10) according to any one of the preceding claims, wherein the tubular element (26) has a length between about 5 cm and about 7 cm.

10. The hemostatic suture kit (10) according to any one of the preceding claims, wherein the closure element (32) has a protrusion (34) of a truncated cone shape configured to be removably inserted into the inner cavity of the tubular element (26) to close the first open end (28) and lock the thread therein.

11. The hemostatic suture kit (10) according to any one of the preceding claims, wherein the elongated portion (38) of the coupling device (36) has a length greater than the length of the tubular portion (26) of the locking device (24).

12. The hemostatic suture kit (10) according to any one of the preceding claims, wherein the coupling portion (40) of the coupling device (36) has a portion (44) folded into a hook so as to engage a suture thread (18), wherein said coupling portion (40) has a dimension in the radial direction substantially corresponding to the dimension in the radial direction of the elongated portion (38) so as to be able to be passed at least partially through the inner cavity of the tubular element (26).

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