Minimally invasive suturing device

Abstract

The invention relates to a device for closing a tissue opening in tissue. In particular, the present invention relates to a device for closing an opening in a membrane by suturing in minimally invasive surgery.

Description

Background Art

[0001] The present invention relates to a minimally invasive suturing device for closing a tissue opening in a tissue, and in particular to a minimally invasive suturing device for closing an opening in a membrane by suturing.

[0002] Minimally invasive closure of tissue openings remains a challenge in various medical procedures.

[0003] For example, a kind of such operation is to sew up the fetal membranes during fetoscopy and / or fetal surgery. The fetal membranes are relatively thin tissue layers with a thickness of several hundred microns that surround the fetus during development. It is necessary to prevent iatrogenic premature rupture of the membranes. In open fetal surgery, the fetal membranes are attached to the uterus along the surgical opening to avoid large-scale detachment from the uterus. After the fetus is operated on, the uterus is closed using sutures, typically resorbable sutures. Minimally invasive fetal intervention is considered to be beneficial. For example, it is believed that the limited size of the incision can significantly reduce wound healing time, pain and residual scars. However, there is still a need for suitable surgery to attach the fetal membranes to the uterus and to close the tissue defect produced by the access puncture (accesspuncture) in this minimally invasive method, for example, wherein the operation is performed by a sheath introducer.

[0004] Devices for suturing various other tissue openings in minimally invasive surgery are known. Prior art suturing devices are known, for example, from WO 2012 / 142338 A2, which relates to a suturing device for suturing anatomical valves. EP 2412317 A1 relates to a wound closure device for suturing openings in tissue. US Pat. No. 8,992,549 B2 relates to an intraperitoneal suturing device designed for closing puncture wounds caused by surgical trocars and similar puncture devices. US Pat. No. 10,413,296 B2 relates to devices, systems, and methods for closing wounds or openings in tissue.

[0005] However, it is believed that each of these devices has certain disadvantages in use. Furthermore, it is believed that none of these devices is suitable for suturing tissue openings in minimally invasive fetal surgery. Therefore, there is a need for improved devices for closing access openings in fetal interventions. In addition, improved devices for closing openings in other tissues and / or in minimally invasive procedures in other areas of the body would be desirable.

[0006] It is an object of the present invention to provide an improved device and method for closing a tissue opening in tissue with at least one suture.

[0007] It is another object of the present invention to provide an improved device and method for closing openings created for minimally invasive fetal surgery.

[0008] Another object of the present invention is to provide a device and method that can be easily and safely performed, for example, in utero.

[0009] It is also an object of the present invention to provide an apparatus and method that can be operated by a single user in an intuitive and consistent manner.

[0010] Another object of the present invention is to provide a device that reduces the complexity of the suturing process for the user and provides fail-safe operation.

[0011] Another object of the present invention is to provide a device and method that enables suturing without the need for additional support equipment, such as one or more cameras for visualization (e.g., fetal endoscopy cameras), for example, in fetal surgery. Another object of the present invention is to thereby reduce the overall cost of the corresponding medical procedures.

[0012] At least some of these objectives are achieved by the devices and methods according to the present invention described herein. Summary of the Invention

[0013] According to a first aspect of the present invention, a device for closing a tissue opening in tissue is disclosed. The tissue extends at least partially around a body cavity or lumen.

[0014] The device includes an elongated shaft having a proximal end and a distal end. The elongated shaft extends along a longitudinal axis and is configured to be inserted into a tissue opening within tissue. The device also includes: at least one first needle guide and at least one second needle guide, each needle guide having an outlet at its distal end; at least one first hollow needle and at least one second hollow needle, each first needle and second needle being configured to translate in a distal and radially outward direction along a corresponding needle guide in the needle guides and to push the corresponding needle guide in the needle guides from a retracted position to an extended position; at least one first snare configured to be pushed out of the distal opening of the at least one first hollow needle; and at least one second snare configured to be pushed out of the distal opening of the at least one second hollow needle.

[0015] Preferably, the needle is configured to penetrate tissue from outside the body cavity or lumen to the inside. It is believed that this can allow a simple and safe actuation mechanism to be provided. The handle of the device can include one or more actuators for moving the needle in a distal and / or proximal direction.

[0016] At least one first snare and / or at least one second snare can be constructed and / or preformed to extend in a radially inward direction toward the elongated shaft when pushed out of the distal opening of the at least one first hollow needle. Alternatively or additionally, the device can be configured such that the distal end of the first and / or second snare is disposed distal to the distal end of the elongated shaft when the respective snare is in the fully advanced position. This configuration of the snare can help provide reliable capture of the suture, as explained in more detail below. The handle can include one or more actuators for moving the first snare and / or the second snare in the distal and / or proximal direction.

[0017] The device according to the first aspect of the present invention may further include at least one first snare sleeve configured to be ejected from the distal opening of the first needle and at least one second snare sleeve configured to be ejected from the distal opening of the second needle. Preferably, the at least one first snare is configured to be ejected from the distal opening of the first snare sleeve, and the at least one second snare is configured to be ejected from the distal opening of the second snare sleeve. The first snare sleeve may be configured to advance along the first snare and / or close the first snare, and the second snare sleeve may be configured to advance along the second snare and / or close the second snare, for example, while the first snare and the second snare are respectively held in position. This arrangement may facilitate closing the respective snares and / or prevent the suture from being pulled out of the snares once the suture has been captured therein. The handle may include one or more actuators for moving the first snare sleeve and / or the second snare sleeve in a distal and / or proximal direction.

[0018] The device may include at least one first suture portion. The device may be configured to place the first suture portion within the first snare when the first snare is advanced out of the distal opening of the first needle. Preferably, the device is configured to place the first suture portion within the first snare when the first snare is advanced out of the distal opening of the first snare sleeve. The first suture portion may be a first suture end.

[0019] The device may further comprise at least one second suture portion. The device may be configured to dispose the second suture portion within the second snare when the second snare is advanced out of the distal opening of the second needle. Preferably, the device is configured to dispose the second suture portion within the second snare when the second snare is advanced out of the distal opening of the second snare sleeve. The second suture portion may be a second suture end.

[0020] The first suture portion and the second suture portion can be formed by a common suture. Preferably, the first suture portion and the second suture portion are the first end and the second end of the suture. The common suture can be understood as a suture that includes and connects the first suture portion and the second suture portion.

[0021] The first suture portion and / or the second suture portion can be configured to remain in the tissue after the device is withdrawn from the tissue opening.

[0022] Any suture or suture portion mentioned herein can be made of or comprise a polymeric material as known in the art (including polylactic acid, polyglycolic acid, polydioxanone, polycaprolactone, polyhydroxybutyrate and copolymers and / or blends thereof), silk, gut or other materials. The suture or suture portion can be monofilament or braided. Any suture or suture portion mentioned herein can be made of a resorbable material and / or be provided with a coating. This coating can have antibacterial properties and / or provide easier sliding. The suture mentioned herein can be elastically deformable and / or plastically deformable. The suture mentioned herein can be provided with glue, one or more growth factors and / or gelatin. This glue can help to contain liquid in a body cavity or lumen.

[0023] The ends of the first suture portion and / or the second suture portion can be releasably retained near the distal end of the shaft. The first suture portion and / or the second suture portion can be retained near the longitudinal axis of the shaft in a first configuration. When released, the ends of the first suture portion and / or the second suture portion protrude radially outward from the shaft. When the first snare and the second snare are pushed out of the needle and the first suture portion and / or the second suture portion move from the first configuration to the second configuration, the ends of the first suture portion and / or the second suture portion can be configured to extend into the first snare and the second snare, respectively (e.g., into the open loop formed by the first snare and the second snare, respectively). The device can be configured to allow release of the first suture portion only after the first snare is pushed out of the first needle and preferably out of the first snare sleeve. The device can be configured to allow release of the second suture portion only after the second snare is pushed out of the second needle, preferably out of the second snare sleeve.

[0024] The first suture portion and / or the second suture portion can be retained in a suture retainer disposed at a distal portion of the device to be inserted into a body cavity or lumen. Preferably, the first suture portion and / or the second suture portion are configured to be pulled out of the suture retainer. More preferably, the length of the first suture portion and / or the second suture portion extending into the shaft is configured to be stretched in a proximal direction to release the first suture portion and / or the second suture portion from the suture retainer.

[0025] The suture retainer can be configured to releasably retain a first segment (e.g., an end) of the first suture portion and / or the second suture portion extending outside the lumen of the shaft. The second segment of the first suture portion and / or the second suture portion can at least partially extend through the lumen. The lumen can, for example, extend from an opening at the distal end of the shaft into and / or through the shaft. The first suture portion and the second suture portion can extend into the lumen through a common opening.

[0026] The first suture portion and / or the second suture portion can be configured to be released from the suture retainer by pulling the first suture portion and / or the second suture portion (eg, the second segment) in a proximal direction.

[0027] The distal portion of the device, preferably the distal end of the elongated shaft, can include a plurality of grooves along its outer circumferential surface, and the first segment of the first suture portion and the first segment of the second suture portion can be received in the grooves. The first segment of the first and / or second suture portion can be pre-installed in the grooves so that it does not interfere with other moving parts of the device (e.g., a basket as described below).

[0028] The suture retainer can be an annular structure, preferably an elastic ring, preferably wherein the first suture portion and / or the second suture portion is configured to be at least partially disposed between the annular structure and the shaft. Alternatively, the suture retainer can be formed by a plurality of holes or tubes, preferably wherein the first and / or second suture portion is configured to be at least partially inserted into a respective one of the holes or tubes.

[0029] The first suture portion and / or the second suture portion can be configured to protrude radially outward and / or bend when released from the elongated shaft. The stiffness and / or recoil of the suture portion can be selected so that the protrusion and / or bending motion provides for positioning the suture portion into the snare (e.g., into the open loop of the corresponding snare when pushed out of the needle). It is believed that forming the first suture portion and / or the second suture portion from a monofilament may be particularly advantageous for providing the desired stiffness and / or recoil.

[0030] The first suture portion and / or the second suture portion may have a diameter of less than 0.6 mm, preferably less than 0.4 mm, more preferably less than 0.25 mm, even more preferably less than 0.22 mm.

[0031] A segment of the first suture portion and / or the second suture portion (e.g., the second segment described above) can be stored within the lumen of the shaft. The segment of the first suture portion and / or the second suture portion can extend through the lumen along the longitudinal axis. The lumen can extend from the proximal end to the distal end of the elongated shaft. Storing the first and / or second suture portion within the lumen of the elongated shaft is believed to make the operation safer and more orderly because it prevents the suture portion from inadvertently interacting and / or becoming entangled with other components of the device.

[0032] The length of the first suture portion and / or the second suture portion stored in the lumen can be at least 30 mm, preferably at least 200 mm. In the case where the first suture portion and the second suture portion form a common suture, the length of the suture stored in the lumen can be at least 60 mm, more preferably at least 400 mm. This length is considered suitable for fetal applications. When closing other tissue openings, the length can be longer or shorter.

[0033] The length of suture may be stored as at least one loop within the lumen.

[0034] The lumen may have a diameter of less than 5 mm, preferably less than 2 mm, more preferably less than 1 mm. The lumen may have a diameter greater than 0.25 mm, preferably greater than 0.5 mm.

[0035] As an alternative or alternative to the lumen, segments of the first and / or second suture portions can be stored in a cavity and / or cartridge disposed at the distal end of the elongated shaft. The cavity or cartridge can include a spool around which at least a portion of the first and / or second suture portions is wound.

[0036] The first suture portion and / or the second suture portion can be coupled to one or more actuators arranged near the proximal end of the shaft. The one or more actuators can be configured to pull the first suture portion and / or the second suture portion in a proximal direction. The one or more actuators can be arranged at the handle.

[0037] Alternatively, the first suture portion and / or the second suture portion may extend out of the shaft near the proximal end of the shaft to allow a user to grasp the respective portion and manually pull it proximally.

[0038] Device can also comprise one or more washers, and it is connected to the first suture portion and / or the second suture portion and is configured to be kept in tissue together with it.One or more washers can be configured to cover the hole caused by the first needle and the second needle in tissue.One or more washers can have a diameter less than 3mm, preferably less than 2mm and / or a thickness less than 2mm, preferably less than 1mm.In particular, one or more washers can be configured to be positioned at body cavity or lumen against tissue.One or more washers can be resorbable.Alternatively or additionally, device can comprise at least one patch, at least one patch is configured to be kept in body cavity or lumen and overlap with closed tissue opening in cavity, preferably, wherein patch is elastic and / or resorbable.Patch can be connected to the first suture portion and / or the second suture portion.

[0039] Tissue, such as the fetal membrane, can be very fragile, and pulling the suture through the tissue or forming a suture knot with too much force can result in cutting into the tissue. The holes formed by the needle are fragile areas in the tissue. Placing a washer, for example, 1.5 mm in diameter and 0.5 mm thick, under the suture at each hole can help minimize the risk of cutting into the tissue. Such a washer can also help press the fetal membrane toward the uterus, thereby believing (without wishing to be bound by theory) that the resistance of the fetal membrane to cutting can be increased.

[0040] The tissue can include at least one first tissue layer and at least one second tissue layer, the second tissue layer extending between the first tissue layer and the body cavity or lumen. A third tissue layer (e.g., fetal membrane) can be attached to the second tissue layer (e.g., uterus). Instead of or in addition to this third tissue layer, an artificial sheath can be placed in the cavity and attached to the second tissue layer.

[0041] The device may further include a support structure at the distal end of the elongated shaft. The support structure is configured to move between a first contracted configuration and a second expanded configuration. The support structure is configured to expand in a body cavity or lumen. The support structure in the second expanded configuration may be configured to preferably press against the second tissue layer in a proximal direction from within the cavity, more preferably in a proximal direction by pulling the elongated shaft against the second tissue layer. The support structure may provide a more stable positioning of the device and / or may support the second and / or third tissue layers during needle penetration.

[0042] The first needle can be configured to penetrate the second tissue layer along a first trajectory, which extends from the corresponding exit opening in the second tissue layer at an angle relative to the longitudinal axis and radially outward toward the support structure, and / or the second needle can be configured to penetrate the second tissue layer along a second trajectory, which extends from the corresponding exit opening in the second tissue layer at an angle relative to the longitudinal axis and radially outward toward the support structure.

[0043] The support structure may be formed as a support basket, preferably a Nitinol basket.

[0044] The device may also include at least one expandable pushing member configured to push the first tissue layer away from the first trajectory and the second trajectory, the pushing member being configured to move between a radially contracted configuration and a radially expanded configuration, preferably, wherein the device is configured to move the pushing member from the contracted configuration to the expanded configuration by compressing the pushing member in the longitudinal direction of the axis.

[0045] Preferably, the pushing member is configured to push aside the covering first tissue layer (e.g., fascia) to prevent the first tissue layer from being penetrated by the needle. Thus, undesirable suturing connecting the first tissue layer and the second tissue layer can be avoided, which may otherwise lead to medical complications, for example, uneven expansion of the tissue layers surrounding the uterus in the case of a patient during pregnancy.

[0046] In other words, when the push member is in the expanded configuration, at least a portion of the first and second trajectories can extend through the cavity formed between the push member and the elongated shaft. The push member in the expanded configuration can form an enclosure and / or cage, wherein at least a portion of the first and second trajectories extend through the enclosure and / or cage. Thus, each needle can move within the cavity or enclosure and / or cage formed between the elongated shaft and the push member, thereby preventing contact between the needle and the first tissue layer.

[0047] When the push member is expanded, the needle exit opening is located distally of a first position at which the push member is coupled to the elongated shaft, more preferably distally of a proximal-most position at which the push member is coupled to the elongated shaft. Alternatively or additionally, the exit opening may be located proximal of a second position at which the push member is coupled to the elongated shaft, more preferably proximal of a distal-most position at which the push member is coupled to the elongated shaft when the push member is expanded.

[0048] At least one pushing member can be configured to not extend radially beyond the outer diameter of the elongated shaft when in the collapsed configuration. Furthermore, the pushing member, when expanded, can be configured to lift the first tissue layer away from the second tissue layer in a proximal direction. Alternatively or additionally, the pushing member can be configured to push the first tissue layer away from the device in a radially outward direction perpendicular to the longitudinal axis. This movement of the pushing member is believed to facilitate lifting the first tissue layer, such as fascia, in a soft and safe manner without damaging other tissue layers.

[0049] At least one pushing member may be formed as a pushing member basket, preferably a nitinol basket. The pushing member basket may be integrally and / or monolithically formed with the support basket forming the support structure. Alternatively or additionally, the pushing member basket and the support basket forming the support structure may be connected by one or more struts extending along the longitudinal axis.

[0050] The urging member may expand together with the support structure or independently of the support structure.

[0051] The expandable push member and support structure can be combined and / or integrated into a single subcomponent and / or a single expandable subassembly of the device. This can provide a space-saving design, which is particularly advantageous for, for example, fetoscopy, but the devices disclosed herein are not limited in this regard. Depending on the selected application, it is also contemplated that the expandable push member and support structure will be provided as separate subassemblies. For example, the expandable push member and support structure can be arranged at the same or different positions along the longitudinal axis of the elongated shaft.

[0052] The device, preferably the handle, may be configured such that the pushing member can only be moved to its expanded configuration once the support structure has been moved to its expanded configuration.

[0053] In the expanded configuration, the at least one pushing member may be located at least 2 mm, preferably at least 5 mm, and / or at most 100 mm, preferably at most 20 mm, from the distal end of the elongated shaft. These distances are believed to help push relevant tissue, particularly fascia, out of the needle's trajectory.

[0054] The pushing member may comprise a membrane cover, preferably wherein the membrane cover covers at least a proximally facing side of the pushing member.

[0055] At least one pushing member may include a plurality of fins, preferably two or at least four fins. The proximal portion of each fin may be connected to the elongated shaft at a first position, preferably via a first pushing member collar, preferably wherein the first pushing member collar is stationary relative to the elongated shaft. The distal portion of each fin may be connected to the elongated shaft at a second position, preferably via a second pushing member collar, preferably wherein the second position is distal to the first position, more preferably wherein the second pushing member collar is movable relative to the elongated shaft along the longitudinal axis. The proximal and distal portions of each fin may be connected via a hinge portion, preferably wherein the fin bends at the hinge portion when the pushing member is moved to its expanded configuration, more preferably wherein the hinge portion has a lower bending resistance than the proximal and distal portions.

[0056] At least one urging member, preferably at least one fin, may include at least one marking for determining the configuration of the urging member during medical imaging, preferably wherein the marking is an ultrasonic marker and / or a radiopaque material. Preferably, at least one urging member, preferably at least one fin, is made of an ultrasonically visible material and / or a radiopaque material.

[0057] Ultrasound visibility can be achieved, for example, by using a porous polymer (e.g., foam), providing bubbles on the inner or outer surface of the fin (as discussed, for example, in WO 2012 / 148265 A1, which is incorporated herein by reference in its entirety), surface roughening (e.g., by polishing, sandblasting, or electro-discharge machining), or by introducing contrast-enhancing particles into the material (as discussed, for example, in EP 1 155 418 B1, which is incorporated herein by reference in its entirety). It should be noted that any intervention according to the method of the present invention can be performed under ultrasound guidance. In particular, such ultrasound guidance can be provided during expansion and / or retraction of the support structure, during expansion of at least one pushing member, and / or when the needle is advanced toward the expanded support structure. Preferably, fetal intervention (e.g., fetoscopy) can be performed using ultrasound guidance throughout the operation or at least during expansion of at least one pushing member and when the needle is advanced toward the expanded support structure. The use of an ultrasound-visible material can provide additional visibility and certainty as to whether the first tissue layer has been sufficiently pushed aside before the needle is advanced.

[0058] As an alternative or supplement to the above-mentioned wings, at least one pushing member can be configured as or can include an expandable structure, such as an expandable balloon. Such an expandable structure can, for example, be used to expand the wings (by, for example, expanding the expandable structure with gas or liquid).

[0059] The elongated shaft may have a length between 10 mm and 2000 mm, preferably between 50 mm and 500 mm, more preferably between 100 mm and 200 mm. The elongated shaft may be rigid and / or straight along the longitudinal axis. In addition, the elongated shaft may have a diameter of less than 15 mm, preferably less than 7 mm, more preferably less than 4 mm. Preferably, the elongated shaft is made of a metallic material (e.g., stainless steel), a fiber-reinforced polymer, or is provided by a polymer tube, preferably an extruded polymer tube.

[0060] A handle may be provided at the proximal end of the elongated shaft. The handle may be adapted to allow a user to hold the device in a manner convenient for the respective application. The handle may include measurement indicator lines to provide the user with visual information regarding the positioning of the device within the cavity or lumen.

[0061] The device may further comprise at least one actuator, preferably a plurality of actuators, at the proximal end of the elongated shaft, preferably at the handle. The actuators may be used to operate the expandable push member and / or the support structure, to advance and / or retract the needle, to advance and / or retract the suture, and / or to inject at least one fluid through the needle.

[0062] The device includes a distal end. The distal end is preferably atraumatic. The distal end can be formed by the distal end of an elongated shaft, which can be atraumatic (e.g., hemispherical or circular). The atraumatic end of the elongated shaft reduces the risk of potential damage that may be caused by, for example, unintentional contact with a fetus.

[0063] The distal portion of the device, preferably the distal end of the elongated shaft, may include a plurality of recesses or openings, wherein each recess or opening may be configured to at least partially receive a respective one of the snares when the snare is pushed out of the respective snare sleeve. This configuration is believed to allow for more precise positioning of the snare at the distal end of the elongated shaft.

[0064] The distal portion of the device, preferably the distal end of the elongated shaft, may include a stop feature for limiting distal movement of the support structure, preferably wherein the stop feature is a protrusion extending radially outward from the shaft. The stop feature may prevent the support structure from being accidentally released from the elongated shaft.

[0065] The longitudinal axis of the elongated shaft can be configured to be oriented substantially perpendicular to the tissue when closing the tissue opening.

[0066] The needle guide may have a diameter of less than 2 mm, preferably less than 1 mm and / or a diameter of more than 0.5 mm, preferably more than 0.7 mm.

[0067] When the support structure is in the second, expanded configuration, the outlet opening can be spaced at least 3 mm, preferably at least 8 mm, in a proximal direction from a proximally facing side of the support structure that is pressed against the second tissue. The outlet opening can be located proximal to a location where the support structure is coupled to the elongated shaft, preferably proximal to a proximal-most location where the support structure is coupled to the elongated shaft.

[0068] The dimensions of the needle guide as described above are considered most suitable and effective for closing tissue openings, particularly in fetoscopy.

[0069] Each needle guide may have a first portion and a second portion, the second portion being inclined to the longitudinal axis and / or extending radially outwards, preferably wherein the first portion is substantially parallel to the longitudinal axis. In addition, the second portion may form a distal portion of the respective needle guide. Preferably, each needle guide comprises a curved section, preferably wherein the curved section is located between the first portion and the second portion, and / or the second portion is curved. Each needle guide may be configured such that the trajectory along which the respective needle extends from the outlet opening extends at an angle to the longitudinal axis, preferably wherein the angle is at most 50°, more preferably at most 30°, and / or wherein the angle is at least 5°, more preferably at least 10°.

[0070] The inclined extension of the needle guide can determine the trajectory of the needle from the exit opening toward the support structure. When the needles reach their expected position at the support structure, the inclined design can also determine the distance between the two opposing needles, which in turn defines the size of the suture pattern and / or the tissue opening that can be closed.

[0071] Preferably, the needle guides and / or outlet openings are spaced around the circumference of the elongate shaft, and more preferably, the outlet openings are spaced at regular intervals around the circumference of the elongate shaft.

[0072] The outlet opening may be provided along a peripheral side surface of the elongated shaft. Alternatively, the outlet opening may be located at a distally facing surface of the elongated shaft, for example, at a distally facing surface of the shaft provided by a reduction in diameter of the shaft. The needles may be pre-installed in their respective needle guides.

[0073] Each needle guide may have an access opening at its proximal end. Preferably, the elongated shaft includes two or more access openings, preferably four access openings. The access openings may be positioned along the outer surface of the elongated shaft. The needles may be pre-installed in their respective needle guides. The access openings make it easier to install and adjust the needles within the needle guides of the elongated shaft.

[0074] The elongated shaft may comprise at least three needle guides, preferably at least four needle guides.The elongated shaft may comprise at least three outlet openings, preferably at least four outlet openings.

[0075] The support structure in the first collapsed configuration can be configured to be inserted through a tissue opening into a body cavity or lumen. To this end, the support structure in the first collapsed configuration can be configured to not radially extend beyond the outer diameter of the elongated shaft, and / or the support structure in the first collapsed configuration can have a diameter of 10 mm or less, preferably 5 mm or less.

[0076] The support structure in the second expanded configuration can be configured to preferably press against the second tissue layer in a proximal direction from within the cavity, more preferably by pulling the slender shaft in the proximal direction. To this end, the support structure in the second expanded configuration can extend beyond the outer diameter of the slender shaft and / or the support structure in the second expanded configuration can have a diameter of at least 5 mm, preferably at least 8 mm. Preferably, the support structure is configured to switch between the first contracted configuration and the second expanded configuration by pushing and pulling the slender shaft along the longitudinal axis, respectively. In this way, the device can be easily inserted through a tissue opening and deployed within a body cavity or lumen of tissue to stably press against tissue, for example, against the second tissue layer within the cavity. Alternatively, the support structure can be configured to switch between the first contracted configuration and the second expanded configuration by moving the proximal end of the support structure in the proximal direction along the slender shaft and / or by pushing and pulling a wire extending through the lumen in the slender shaft. In other words, the support structure can be configured to expand by squeezing the support structure along the longitudinal axis.

[0077] The support structure can include a membrane cover and / or one or more expandable components. When expandable components are used, the support structure can be moved from a collapsed configuration to an expanded configuration by inflating the one or more expandable components. The membrane cover can prevent portions of tissue from being captured by the support structure, for example, when the support structure is moved from an expanded configuration back to a collapsed configuration.

[0078] The support structure may comprise a plurality of support arms, for example at least two, at least four or at least six support arms.Each support arm in the first collapsed configuration may be substantially parallel to the longitudinal axis.

[0079] The proximal portion of each support arm can be connected to the elongated shaft at a first location, more preferably via a proximal collar of the support structure (e.g., a proximal collar of the support basket). The proximal portion of the support arm in the second expanded configuration can be substantially perpendicular to the longitudinal axis.

[0080] The distal portion of each support arm can be connected to the elongated shaft at a second location, preferably via a distal collar of the support structure (e.g., a distal collar of the support basket). The device can be configured to be actuated to move the distal portion and / or distal collar in a proximal direction along the elongated shaft to move the support structure from a first, collapsed configuration to a second, expanded configuration.

[0081] The proximal and distal portions of the support arm may be connected via a hinge portion, preferably wherein the support arm bends at the hinge portion when the support structure moves to its expanded configuration, more preferably wherein the hinge portion has a lower bending resistance than the proximal and distal portions. Such a configuration may provide a stable design that is cost-effective to manufacture at a desired size.

[0082] Preferably, the proximal and distal portions of the support arm are integrally formed and / or formed as a single-piece component. In particular, the support structure can be formed as a support basket, preferably wherein the support basket is made of Nitinol. This provides a reliable and space-saving arrangement. The support arm can be formed from a plurality of struts of the support basket, preferably wherein the struts are provided with curved and / or articulated portions having reduced thickness and / or width.

[0083] One or more pairs of support arms can be configured to expand on diametrically opposite sides of the elongated shaft.When the support structure is in the second expanded configuration, a support extension can extend radially outward from each support arm.

[0084] When the first needle and the second needle are in the extended position and the support structure is in the second expanded configuration, the distal opening of the first needle and the distal opening of the second needle can be arranged distal to the first position where the proximal portion of the support arm is connected to the slender shaft, preferably distal to the proximal collar, and proximal to the second position where the distal portion of the support arm is connected to the slender shaft, preferably proximal to the distal collar.

[0085] Additionally or alternatively, when the first needle and the second needle are in the extended position and the support structure is in the second expanded configuration, the distal opening of the first needle and the distal opening of the second needle can be arranged to be closer to the longitudinal axis than the radially outermost portion of the support arm (for example, closer to the longitudinal axis than the hinge portion).

[0086] In other words, when the first and second needles are in the extended position and the support structure is in the second expanded configuration, the distal opening of the first needle and the distal opening of the second needle can be arranged within an enclosure and / or cage formed by the support structure and / or support arm.

[0087] The support structure, preferably the support arm, may be made of an ultrasound visible material and / or a radiopaque material.

[0088] The first needle and the second needle may be configured to move individually or in conjunction upon actuation of an actuator of the device.

[0089] The first needle and / or the second needle may have a sharpened distal end, preferably wherein the distal end has a blunt portion and a sharp portion, more preferably wherein the blunt portion is provided by a chamfered or rounded edge portion. Preferably, the blunt portion is positioned closer to the elongated shaft or more inwardly than the sharp portion. Such a blunt portion may prevent the snare from being cut by the corresponding needle during retraction of the snare into the needle.

[0090] At least one first needle and / or at least one second needle may comprise a proximal portion and a distal portion, wherein the distal portion is more flexible than the proximal portion. To this end, at least one first needle and / or at least one second needle may comprise a distal portion made of Nitinol and / or a proximal portion made of stainless steel, Nitinol or titanium. Alternatively or additionally, at least one first needle and / or at least one second needle may comprise a curved portion, preferably wherein the sidewall of the first needle and / or the second needle is provided with a plurality of slots and / or struts along the curved portion, more preferably wherein the slots are formed by laser cutting.

[0091] The first needle and / or the second needle may have an outer diameter of 0.65 mm to 0.8 mm and / or an inner diameter of 0.5 mm to 0.65 mm. Such size is considered to be most suitable for suturing the fetal membrane.

[0092] The device can be configured to inject a fluid through the at least one first needle and / or the at least one second needle, preferably, wherein the fluid comprises a growth factor, an anesthetic and / or a glue. Since the suture hole can be a vulnerable area that may tear during closure of the tissue opening, the additional injection of a fluid, such as a glue or a growth factor, can stabilize the tissue.

[0093] Preferably, the device comprises at least two first needles and at least two second needles. Four needles may be advantageous for providing cross stitching utilizing two sutures. In view of the small size of the opening, cross stitching is considered to be useful in ensuring sufficient closure of the tissue opening, such as in fetoscopy.

[0094] The distal ends of the first and second snare sleeves may be provided with one or more notches.

[0095] The first snare sleeve and / or the second snare sleeve may be a polymer tube. The first snare may be configured to be closed by advancing the first snare sleeve distally toward the elongated axial direction out of the first needle, and / or the second snare may be configured to be closed by advancing the second snare sleeve distally toward the elongated axial direction out of the second needle.

[0096] According to another aspect, the present invention relates to a method for suturing tissue, particularly a tissue opening. The method comprises suturing the opening using any of the devices described herein. In particular, the method may comprise inserting an elongated shaft through the tissue opening into a body cavity or lumen. Optionally, the support structure may be open in the body cavity or lumen. A first hollow needle and a second hollow needle may be advanced distally and / or radially outwardly from a retracted position to an advanced position outside of respective needle guides. A first snare and a second snare may be advanced out of the distal openings of the first hollow needle and the second hollow needle, respectively, wherein the snares may bend radially inwardly toward the elongated shafts upon advancement. The first and second suture portions retained in the elongated shafts may be released to bend radially outwardly into the advancing snares (e.g., by pulling the suture portions out of the suture holders). The snares may then be closed, retaining the respective suture portions therein, for example, by retracting the snares into the respective needles and / or by advancing the snare sleeves onto the respective snares. The closed snares may then be retracted proximally into the needles and passed through the needles, retaining the suture portions therein. The needle can then be retracted, the support structure can be closed, and the elongated shaft can be withdrawn from the tissue opening. BRIEF DESCRIPTION OF THE DRAWINGS

[0097] The present invention will be described in more detail below with reference to the accompanying drawings. These drawings disclose embodiments of the present invention for illustrative purposes only. In particular, the disclosure provided by the drawings is not intended to limit the scope of protection granted by the present invention.

[0098] Figure 1 is a schematic front view of a device for closing a tissue opening according to an embodiment of the present invention.

[0099] Figures 2A-2F is a schematic perspective view showing the various steps of a procedure performed to close a tissue opening. Figure 1 The distal end of the device.

[0100] Figure 3A It shows Figure 1 Schematic front view of the distal end of the device when inserted into a tissue opening and displaced to an expanded configuration. The first and second needles, the first and second snare sleeves, and the first and second snares are each shown in a distally advanced configuration.

[0101] Figure 3B It shows Figure 3A Schematic bottom view of the device.

[0102] Figure 4A It shows Figure 1 Schematic cross-sectional perspective view of the proximal portion of the device.

[0103] Figure 4BIt shows Figure 1 Schematic cross-sectional perspective view of the distal portion of the device.

[0104] Figure 5 is a schematic perspective view of a second tissue layer of tissue with a suture and a gasket according to the present invention as seen from within a body cavity or lumen. DETAILED DESCRIPTION

[0105] As used herein, "proximal" means closer / closest to the surgeon, while "distal" means farther / farthest from the surgeon. In other words, "proximal" means farther / farthest from a tissue opening, while "distal" means closer / closest to a tissue opening, and / or furthest within a body cavity or lumen (i.e., for those portions of a device that are inserted into a cavity or lumen).

[0106] Figure 1 The device 1 according to the present invention is schematically shown. The device 1 comprises an elongated shaft 10 having a proximal end 11, a distal end 12 and extending along a longitudinal axis A. L The proximal end 11 may include a handle (not shown) that is operated by a user. The distal end 12 is configured to be inserted into a body cavity or lumen 105 of the tissue 100 through a tissue opening 101 in the tissue 100 (see Figure 3A ).

[0107] picture Figures 2A-2F 3A and 3B show detailed views of the distal end 12 of the device 1, as shown in FIG. Figure 1 As shown in the circled area in FIG. As shown, the device 1 may include an atraumatic distal tip 111 to avoid damaging the body cavity or lumen (or the fetus in the body cavity).

[0108] Figures 2A-2F The device 1 is schematically shown for closing a tissue opening 101 in tissue 100 .

[0109] After completion of the desired surgical and / or endoscopic procedure, the associated instruments are removed. A catheter (not shown) providing access to the tissue opening 101 may remain inserted into the tissue opening 101 .

[0110] Figure 2A The device 1 is shown in a configuration in which it may be inserted through a catheter such that the distal end 12 of the device 1 protrudes into a body cavity or lumen.

[0111] like Figure 2AAs shown, grooves or channels 25 can be formed at the distal end 12, particularly at the distal tip 111. As shown, a plurality of grooves 25 can extend along the outer circumferential surface of the distal end 12 of the device 1. The grooves 25 are configured to receive segments of the first and second suture portions 51, 52 in a first, contracted configuration. When the device 10 is in a second, expanded configuration, the segments of the first and second suture portions 51, 52 are released from the grooves 25, as described in more detail below. The first and second suture portions 51, 52 can be the first and second ends of the suture 50.

[0112] In the next step, if Figure 2B As shown, the support structure 20 at the distal end 12 is displaced from a first contracted configuration to a second expanded configuration, for example, along the longitudinal axis A. L By pulling the actuator or by compressing the support structure 20. Once expanded, the support structure 20 can be pulled proximally against the tissue 100, for example, against the second tissue layer 104 (see Figure 3A ), the second tissue layer 104 may be the uterus. The second tissue layer 104 extends between the first tissue layer 103 and the body cavity or lumen 105. The first tissue layer 103 may be the fascia. Figure 3A As shown, the first tissue layer 103 can be lifted and / or pushed away from the second tissue layer 104. A person skilled in the art will appreciate that the first and second tissue layers 103, 104 are Figure 3A However, it will be appreciated that the shape of the tissue layer will actually be more natural and rounded.

[0113] Return to Figure 2B , the support structure 20 includes a plurality of support arms 21. The proximal portion 22 of each support arm 21 is connected to the elongated shaft 10 via a proximal collar 28 of the support structure 20. The distal portion 23 of each support arm 21 is connected to the elongated shaft 10 via a distal collar 29 of the support structure 20. The support structure 20 is formed as a support basket 24, wherein the support arms 21 are formed by a plurality of struts.

[0114] The support structure 20 is expanded by bringing the distal collar 28 and the proximal collar 29 closer to each other, for example, by moving the distal collar 29 in a proximal direction along the elongated shaft 10. This causes the hinge portion 27 connecting the proximal and distal portions 22, 23 to bend and preferably has a lower resistance to bending than the two portions 22, 23. Thus, the support structure 20 moves between a first, collapsed configuration to a second, expanded configuration.

[0115] In the first retracted configuration, each support arm 21 is arranged substantially parallel to the longitudinal axis A. L , while in the second expanded configuration, the proximal portion 22 of the support arm 21 is configured to be substantially perpendicular to the longitudinal axis (A L ).

[0116] After or during expansion of the support structure 20, the expandable push member 80 is deployed from a first, contracted configuration to a second, expanded configuration using an actuator (see FIG. Figure 2C ). The expandable pushing member 80 lifts and / or pushes the first tissue layer 103 located proximal to the second tissue layer 104 away from the trajectory of the first and second needles 30, 40 (see again Figure 3A ).

[0117] The expandable push member 80 includes a plurality of wings or push arms 81. Proximal portions 84 of the arms 81 are connected to the elongated shaft 10 via a first push member collar 85. Distal portions 86 of the arms 81 are each connected to the elongated shaft 10 via a second push member collar 87. The push member 80 is expanded by approximating the distal and proximal collars 85, 87 to one another, for example, by moving the distal collar 87 in a proximal direction along the elongated shaft 10. The first push member collar 85 can be stationary relative to the elongated shaft 10.

[0118] When the expandable pushing member 80 moves from the first, collapsed configuration to the second, expanded configuration, a hinge portion 88 connecting the proximal portion 84 and the distal portion 86 and preferably having a lower resistance to bending than both portions 84, 86 bends.

[0119] As shown in the figure, the pushing member 80 and the support structure 20 can be provided as an integral expandable structure. L The extending one or more struts are connected to each other. The unitary expandable structure is preferably a basket made of metal or polymeric material (eg Nitinol). Preferably, the support arm 21 and the push arm 81 are formed by laser cutting a thin tubular body.

[0120] Figure 2D 1 and 2. It shows how the first and second needles 30, 40 are directed from the exit opening 14 of the elongated shaft 10 (eg, through the second tissue layer 104; see FIG. 1 ). Figure 3A ) is pushed out. The four needles 30 and 40 can be used to provide a cross stitch.

[0121] The exit opening 14 is located at the distal end of the needle guide 13 extending along the elongated shaft 10. The exit opening 14 is preferably located in a space that is enclosed and / or surrounded by the push member 80 when the push member 80 is expanded. This is believed to ensure that the trajectory of the needles 30, 40 is not affected by the first tissue layer 103.

[0122] The needle guide 13 has a first portion 16 and a second portion 17. The second portion 17 forms the distal end of the respective needle guide 13 and is oriented relative to the longitudinal axis A of the elongated shaft 10. LAs a result, the trajectory of the needles 30, 40 is inclined relative to the longitudinal axis A of the elongated shaft 10. L The outer surface of the housing extends obliquely, and preferably extends obliquely in a radially outward direction.

[0123] The needles 30, 40 are pushed out of the needle guide 13 in a distal and radially outward direction within the first enclosure formed by the expanded push member 80. Preferably, the first and second needles 30, 40 pierce only the second tissue layer 104 and reach or near the distal-most position within the second enclosure and / or cage formed by the support structure 20 (see also FIG. Figure 3A ). Preferably, the distal ends of the needles 30, 40 do not protrude outside the space enclosed by the expanded support structure 20. In other words, the distal ends of the needles 30, 40 at their most distal positions are preferably disposed within the space enclosed by the support structure 20. This is believed to help prevent undesired contact between the needles 30, 40 and another tissue within the body cavity or lumen 105 (e.g., a fetus).

[0124] The first and / or second needles 30, 40 are hollow. They may include a needle lumen extending therethrough. The needle lumen may be configured to allow a corresponding snare and / or a corresponding snare sleeve to be advanced and / or retracted therethrough. The needle lumen may also be configured to inject a fluid (such as a fluid with a growth factor or a glue) into the tissue 100.

[0125] When the device 1 is in Figure 2D , at least one first snare 71 and at least one second snare 72 are respectively pushed out of the hollow needles 30, 40 toward the distal end of the elongated shaft 10. As shown, the snares 71, 72 can be pre-shaped (e.g., by heat treatment) to bend toward the elongated shaft when extended from the needles 30, 40. It is believed that such pre-shaped snares help ensure that the first and second suture portions 51, 52 are captured in the snares 71, 72 when released from the elongated shaft 10. However, other configurations that may be suitable are also contemplated, depending on the size of the device, the type of tissue opening, and the mechanical properties of the suture.

[0126] Once the preformed snares 71, 72 are positioned near the distal end of the elongated shaft 10, as shown Figure 2E As shown, the first and second suture portions 51, 52 that were pre-installed and releasably held near the distal end 111 of the elongated shaft 10 are released (not shown). Upon release, the first and second suture portions 51, 52 rebound into the open loops of the respective snares 71, 72. To this end, various different release mechanisms may be implemented.

[0127] Then, if Figure 2FAs shown, at least one first snare sleeve 61 and at least one second snare sleeve 62 are advanced from the first needle 30 and the second needle 40, respectively. By advancing the snare sleeves distally, the loops of the snares 71, 72 can be narrowed and closed (not shown), thereby capturing the first and second suture portions 51, 52 with the first and second snares 71, 72, respectively.

[0128] The suture portions 51, 52 and the first and second snares 71, 72 are then retracted proximally into the first and second needles 30, 40 and pulled in a proximal direction through the first and second needles 30, 40. The needles 30, 40 are then retracted into the shaft 10, and the support structure 20 is moved back to its collapsed configuration. The device 10 is then retracted proximally from the tissue opening 101. When or after the device 10 is removed from the opening 101, the suture portions 51, 52 can be released so that the suture portions 51, 52 pass through the second tissue layer 104 but are accessible from outside the body cavity or lumen 105. The tissue opening 101 can then be closed by pulling the edges of the opening 101 toward each other, for example, by knotting the suture portions 51, 52 together. In the case of using four needles 30, 40, the suture can be formed into two half loops, each half loop passing through the tissue opening 101 (e.g., forming a cross suture).

[0129] Figure 3A The device 1 is schematically shown in its fully expanded configuration, also shown in FIG. Figure 2F shown. Figure 3B Schematically shown from below Figure 3A Device 1 in the configuration of . Figure 3A and 3B Both the support structure 20 and the expandable pushing member 80 are shown in their expanded configurations. The first and second needles 30, 40 are fully advanced to their distalmost positions, penetrating only the second tissue layer 104. After the first and second snares 71, 72 are advanced to positions near the distal end of the elongated shaft 10, the first and second suture portions 51, 52 are released (not shown) into the loops of the first and second snares 71, 72, respectively. The loops of the snares 71, 72 are closed by advancing the first and second snare sleeves 61, 62.

[0130] The support structure 20 and / or the pushing member 80 can be made of or include a material with high ultrasonic visibility and / or radiopaqueness. This can help the user determine whether the support structure 20 has been fully expanded distal to the tissue opening 101. In addition, this allows the user to see whether the second tissue layer 103 has been fully moved. For example, ultrasonic and / or radiopaque markings can be provided on the support arm 21 and / or the pushing arm 81. Alternatively, as described above, the pushing arm 81 can be made of or coated with an ultrasonically visible and / or radiopaque material.

[0131] like Figure 3A As shown, the needle 30, 40 can be provided with a sharper portion 31, 41 and a chamfered and / or blunter portion 32, 42 around its distal end. The sharper portion 31, 41 can be optimized for piercing tissue 100. The blunter portion 32, 42 can be provided to avoid damaging the sleeve 61, 62 and / or the first and second suture portions 51, 52 during retraction of the sleeve 61, 62 and / or the first and second suture portions 51, 52 into the needle 30, 40.

[0132] Further Figure 3A and 3B As shown, each sleeve 61, 62 can be provided with one or more notches 63 at its distal end. In this way, the sleeves 61, 62 can be configured to better protect the first and second suture portions 51, 52 during retraction into the needles 30, 40.

[0133] Figure 4A A cross-section of the elongated shaft 10 along a section thereof is shown. As shown, a suture 50 connecting first and second suture portions 51, 52 can be stored within the lumen 15 of the elongated shaft 10 (e.g., as a loop). The first and second suture portions 51, 52 can be the first and second ends of such a common suture 50. One or more such sutures 50 can be stored in the lumen 15 (e.g., two sutures when four needles are used).

[0134] The lumen 15 may be along the longitudinal axis A of the elongated shaft 10. L The elongated shaft 10 includes at least one distal opening 112 through which the suture 50 can pass into the lumen 15 (see Figure 4B ).

[0135] Figure 4B A cross-section of the elongated shaft 10 at its distal end 12 is shown with two pre-installed sutures 50 .

[0136] like Figure 4BAs further shown in FIG, the stop feature 19 can be formed as a protrusion at the distal end 12 of the elongated shaft 10. The stop feature 19 can be configured to limit distal movement of the support structure 20.

[0137] like Figure 4B As further shown in FIG, the first and second suture portions 51, 52 of the suture 50 are releasably retained in one or more suture retainers 55. Any suitable structure can be used. For example, such a suture retainer 55 can be provided by an opening or tube into which the first segment of each of the first and second suture portions 51, 52 is inserted, or by a structure (e.g., a ring) under which the first and second suture portions 51, 52 are clamped to the shaft 10.

[0138] The first and second suture portions 51, 52 can be released from the suture holder 55 in any suitable manner. For example, the first and second suture portions 51, 52 can be released from the suture holder 55, for example, by pulling the second segments of the first and second suture portions 51, 52 disposed in the lumen 15 in a proximal direction (see Figure 4A ) (manually or via an actuator, such as an actuator at the handle) and pulled out of the suture holder 55.

[0139] Alternatively or additionally, the support structure 55 can be moved (e.g., via an actuator, such as an actuator at the handle). For example, the support structure 55 can be moved in a proximal or distal direction via such an actuator to release the first section of the suture portions 51, 52.

[0140] Once released from the elongated shaft 10 , the first and second suture portions 51 , 52 bend radially outward and / or rebound into the open loops of the snares 71 , 72 .

[0141] Figure 5 Two sutures 50 are schematically shown with washers 54 covering suture holes in the second tissue layer 104 penetrated by the first and second needles 30, 40. The washers 54 are arranged on the sutures 50 in such a manner that they lie within the body cavity 105 against the second tissue layer 104 after closure of the tissue opening 101. Alternatively or additionally, at least one patch (not shown) configured to remain in the body cavity 105 and overlap the closed tissue opening 101 from within the cavity 105 may be used.

[0142] For example, the present invention may be defined by:

[0143] 1. A device (1) for closing a tissue opening (101) in a tissue (100) extending at least partially around a body cavity or lumen (105), the device (1) comprising:

[0144] An elongated shaft (10) having a proximal end (11), a distal end (12) and extending along a longitudinal axis (A L ), the elongated shaft (10) being configured to be inserted into a tissue opening (101) in a tissue (100), the elongated shaft (10) comprising at least one first needle guide (13) and at least one second needle guide (13), each needle guide (13) having an exit opening (14) at a distal end thereof;

[0145] at least one first hollow needle (30) and at least one second hollow needle (40), each first and second needle (30, 40) being configured to translate in a distal and radially outward direction along a corresponding one of the needle guides (13) and to push the corresponding one of the needle guides (13) from a retracted position to an extended position; and

[0146] At least one first snare (71) is configured to be ejected from the distal opening of at least one first hollow needle (30), and at least one second snare (72) is configured to be ejected from the distal opening of at least one second hollow needle (40).

[0147] 2. A device according to the preceding aspects, wherein the at least one first snare (71) is configured to extend in a radially inward direction toward the slender shaft (10) when pushed out of the distal opening of the at least one first hollow needle (30), and / or wherein the at least one second snare (72) is configured to extend in a radially inward direction toward the slender shaft (10) when pushed out of the distal opening of the at least one second hollow needle (40).

[0148] 3. The device according to any one of the above two aspects, wherein the device further comprises:

[0149] at least one first snare sleeve (61) configured to be ejected from a distal opening of the first needle (30); and

[0150] At least one second snare sleeve (62) is configured to be ejected from the distal opening of the second needle (40).

[0151] 4. A device according to any one of the preceding three aspects, wherein the device (1) further comprises at least one first suture portion (51) and is configured to arrange the first suture portion (51) within the first snare (71) when the first snare (71) is pushed out of the distal opening of the first needle (30), preferably, wherein the first suture portion (51) is a first suture end, and

[0152] At least one second suture portion (52) and configured to arrange the second suture portion (52) within the second snare (72) when the second snare (72) is pushed out of the distal opening of the second needle (40), preferably, wherein the second suture portion (52) is a second suture end.

[0153] 5. A device according to the preceding aspect, wherein the first and second suture portions (51, 52) form a common suture (50), preferably wherein the first and second suture portions (51, 52) are the first and second ends of the suture (50).

[0154] 6. The device according to any one of the two preceding aspects, wherein the first and / or second suture portions (51, 52) are releasably retained near the distal end of the shaft (10).

[0155] 7. The device according to the preceding aspect, wherein the first and / or second suture portion (51, 52) is releasably retained in at least one suture holder (55), preferably:

[0156] wherein the first and / or second suture portions (51, 52) are configured to be pulled out from a suture retainer (55), and even more preferably, wherein the length of the first and / or second suture portions (51, 52) extending into the shaft (10) is configured to be pulled in a proximal direction to release the first and / or second suture portions (51, 52) from the suture retainer (55); and / or

[0157] Wherein, the device (1) is configured to allow the first suture portion (51) to be released only after the first snare (71) is pushed out of the first needle (30) and / or the second suture portion (52) to be released only after the second snare (72) is pushed out of the second needle (40).

[0158] 8. A device (1) according to any one of the four aforementioned aspects, wherein the distal portion of the device (1) to be inserted into the body cavity or lumen (105) includes at least one suture retainer (55), wherein the suture retainer (55) is configured to releasably retain the first and / or second suture portions (51, 52), preferably, the first section of the first and / or second suture portions (51, 52) extending outside the lumen (15) of the shaft (10).

[0159] 9. A device (1) according to the preceding aspect, wherein a segment of the first and / or second suture portion (51, 52), preferably the second segment, extends at least partially through the lumen (15), and wherein the first and / or second suture portion (51, 52) is configured to be released from the suture retainer (55) by pulling the segment in a proximal direction.

[0160] 10. A device (1) according to any one of the preceding two aspects, wherein the distal portion of the device (1), preferably the distal end (12) of the elongated shaft (10), comprises a plurality of grooves (25) along its outer circumferential surface, and wherein the first sections of the first and second suture portions (51, 52) are accommodated in the grooves (25).

[0161] 11. The device (1) according to any one of the above three aspects,

[0162] wherein the suture retainer (55) is an annular structure, preferably an elastic ring, preferably wherein the first and / or second suture portions (51, 52) are configured to be at least partially disposed between the annular structure and the shaft (10), or

[0163] wherein the suture retainer (55) is formed by a plurality of openings or tubes (55b), preferably wherein the first and / or second suture portions (51, 52) are configured to be at least partially inserted into a respective one of the openings or tubes (55b).

[0164] 12. The device according to any one of aspects 6 to 11, wherein the first and / or second suture portions (51, 52) are configured to protrude radially outward and / or bend when released from the elongated shaft (10).

[0165] 13. The device (1) according to any one of aspects 4 to 12, wherein the first and / or the second suture portion (51, 52) is a monofilament.

[0166] 14. A device (1) according to any one of aspects 4 to 13, wherein the first and / or second suture portion (51, 52) has a diameter of less than 0.6 mm, preferably a diameter of less than 0.4 mm, more preferably a diameter of less than 0.25 mm, even more preferably a diameter of less than 0.22 mm.

[0167] 15. The device (1) according to any one of aspects 4 to 14, wherein segments of the first and / or second suture portions (51, 52) are stored within the lumen (15) of the shaft.

[0168] 16. The device (1) according to the preceding aspect,

[0169] wherein the length of each of the first and / or second suture portions (51, 52) stored in the lumen (15) is at least 30 mm, preferably at least 200 mm,

[0170] Preferably, the first and second suture portions (51, 52) form a common suture (50), and the length of the suture (50) stored in the lumen (15) is at least 60 mm, more preferably at least 400 mm.

[0171] 17. The device (1) according to any one of the two preceding aspects, wherein the segments of the first and / or second suture portions (51, 52) are arranged along the longitudinal axis (A L ) extends through the lumen (15).

[0172] 18. The device (1) according to any one of aspects 4 to 17, wherein the elongated shaft (10) comprises at least one distal opening, and the first and / or second suture portion (51, 52) enters the lumen (15) of the shaft through the at least one distal opening.

[0173] 19. The device (1) according to any one of the preceding four aspects, wherein the lumen (15) has a diameter of less than 5 mm, preferably less than 2 mm, more preferably less than 1 mm.

[0174] 20. The device (1) according to any one of the five aspects above, wherein the lumen (15) has a diameter greater than 0.25 mm, preferably greater than 0.5 mm.

[0175] 21. The device (1) according to any one of the six aspects above, wherein the lumen (15) extends from the proximal end (11) to the distal end (12) of the elongated shaft (10).

[0176] 22. A device (1) according to any one of aspects 4 to 21, wherein segments of the first and / or second suture portions (51, 52) are stored in a cavity and / or box arranged at the distal end of the slender shaft (10), preferably, wherein the cavity or box includes a spool, and at least a portion of the first and / or second suture portions (51, 52) is wound on the spool.

[0177] 23. The device (1) according to any one of aspects 4 to 22,

[0178] wherein the first and / or second suture portion (51, 52) is coupled to an actuator arranged near the proximal end (11) of the shaft (10), preferably wherein the actuator is configured to pull the first and / or second suture portion (51, 52) in the proximal direction; or

[0179] The first and / or second suture portions (51, 52) extend out of the shaft (10) near a proximal end (11) of the shaft (10).

[0180] 24. A device (1) according to any one of aspects 4 to 23, wherein the device (1) further comprises one or more washers (54), which are connected to the first and / or second suture portions (51, 52) and are configured to be retained together with the first and / or second suture portions in the tissue (100), preferably, wherein the one or more washers (54) are configured to cover the holes formed in the tissue (100) by the first and second needles (30, 40).

[0181] 25. The device (1) according to the preceding aspect, wherein the one or more washers (54) have a diameter of less than 3 mm, preferably less than 2 mm, and / or wherein the one or more washers (54) have a thickness of less than 2 mm, preferably less than 1 mm.

[0182] 26. The device (1) according to any one of aspects 4 to 25, wherein the device (1) further comprises at least one patch configured to be retained in the body cavity or lumen (105) and to overlap the closed tissue opening (101) from within the cavity (105), preferably

[0183] wherein the patch is elastic and / or resorbable; and / or

[0184] wherein the patch is coupled to the first and / or second suture portions (51, 52).

[0185] 27. The device (1) according to any one of the preceding aspects, wherein the tissue comprises at least a first and a second tissue layer (103, 104), the second tissue layer (104) extending between the first tissue layer (103) and the body cavity or lumen (105).

[0186] 28. A device according to any of the preceding aspects, wherein the device (1) further comprises a support structure (20) at the distal end (12) of the elongated shaft (10), which is configured to move between a first contracted configuration and a second expanded configuration, and the support structure (20) is configured to expand in the body cavity or lumen (105).

[0187] 29. The device (1) according to the preceding aspect, wherein the support structure (20) in the second expanded configuration is configured to preferably be pressed against the second tissue layer (104) in a proximal direction from within the cavity (105), more preferably by pulling the elongated shaft (10) in the proximal direction.

[0188] 30. The device (1) according to any one of the two preceding aspects, wherein the first needle (30) is configured to penetrate the second tissue layer (104) along a first trajectory, the first trajectory being perpendicular to the longitudinal axis (A) L ) extends obliquely and radially outwardly from the corresponding exit opening (14) toward the support structure (20) through the second tissue layer (104), and the second needle (40) is configured to penetrate the second tissue layer (104) along a second trajectory that is perpendicular to the longitudinal axis (A) L ) extend obliquely and radially outwardly toward the support structure (20) from the corresponding exit opening (14) through the second tissue layer (104).

[0189] 31. The device (1) according to the preceding aspects, wherein the device (1) further comprises at least one expandable pushing member (80), the at least one expandable pushing member (80) being configured to push the first tissue layer (103) out of the first trajectory and the second trajectory, the pushing member (80) being configured to move between a radially contracted configuration and a radially expanded configuration, preferably, wherein the device (1) is configured to move the pushing member (80) from the contracted configuration to the expanded configuration by squeezing the pushing member in the longitudinal direction of the shaft (10).

[0190] 32. The device (1) according to the preceding aspect, wherein, when the pushing member (80) is in the expanded configuration, at least a portion of the first trajectory and the second trajectory extend through a cavity formed between the pushing member (80) and the elongated shaft (10).

[0191] 33. The device (1) according to any one of the two preceding aspects, wherein the pushing member (80) in the expanded configuration forms an enclosure and / or cage, wherein at least a portion of the first trajectory and the second trajectory extends through the enclosure and / or cage.

[0192] 34. The device (1) according to any one of the above three aspects,

[0193] wherein, when the push member (80) is expanded, the needle exit opening (14) is located distally of a first position at which the push member (80) is coupled to the elongated shaft (10), more preferably distally of a proximal-most position at which the push member (80) is coupled to the elongated shaft (10); and / or

[0194] Wherein, when the pushing member (80) expands, the outlet opening (14) is located proximal to the second position where the pushing member (80) is connected to the slender shaft (10), and more preferably proximal to the distalmost position where the pushing member (80) is connected to the slender shaft (10).

[0195] 35. The device (1) according to any one of the above four aspects,

[0196] wherein the at least one pushing member (80) does not extend radially beyond the outer diameter of the elongated shaft (10) in the collapsed configuration.

[0197] 36. The device (1) according to any one of the above five aspects,

[0198] wherein the pushing member (80) is configured to lift the first tissue layer (103) away from the second tissue layer (104) in a proximal direction when expanded; and / or

[0199] The pushing member (80) is configured to move perpendicularly to the longitudinal axis (A) in a radially outward direction. L ) pushes the first tissue layer (103) away from the device (1).

[0200] 37. The device (1) according to any one of the six aspects above,

[0201] wherein said at least one pushing member (80) is formed as a pushing member basket (83), preferably wherein said pushing member basket (83) is a Nitinol basket.

[0202] 38. The device (1) according to the preceding aspect,

[0203] wherein the pushing member basket (83) is integrally and / or monolithically formed with the support basket (24) forming the support structure (20); and / or

[0204] wherein the pushing member basket (83) and the support basket (24) forming the support structure (24) are connected along the longitudinal axis (A L ) is connected to one or more pillars (91) extending therefrom.

[0205] 39. The device (1) according to any one of the preceding eight aspects,

[0206] wherein the pushing member (80) can expand together with the supporting structure (20); or

[0207] Wherein, the pushing member (80) can expand independently of the supporting structure (20).

[0208] 40. A device (1) according to any one of the preceding nine aspects, wherein the device (1), preferably its handle, is configured such that the pushing member (80) can only be moved to its expanded configuration once the support structure (20) is moved to its expanded configuration.

[0209] 41. The device (1) according to any one of the preceding ten aspects, wherein, in the expanded configuration,

[0210] The at least one pushing member (80) is positioned at least 2 mm, preferably at least 5 mm, from the distal end (12) of the elongated shaft (10); and / or

[0211] The at least one pushing member (80) is positioned at most 100 mm, preferably at most 20 mm, from the distal end (12) of the elongated shaft (10).

[0212] 42. The device (1) according to any one of the preceding eleven aspects, wherein the pushing member (80) comprises a membrane cover, preferably wherein the membrane cover at least covers a proximal-facing side of the pushing member (80).

[0213] 43. The device (1) according to any one of the twelve preceding aspects, wherein the at least one pushing member (80) comprises a plurality of wings (81), preferably two or at least four wings (81).

[0214] 44. A device (1) according to the preceding aspect, wherein the proximal portion (84) of each of the winglets (81) is connected to the elongated shaft (10) at a first position, preferably via a first pushing member collar (85), preferably wherein the first pushing member collar (85) is stationary relative to the elongated shaft (10).

[0215] 45. The device (1) according to any one of the preceding aspects, wherein the distal portion (86) of each wing (81) is connected to the elongated shaft (10) at a second position, preferably via a second urging member collar (87), preferably wherein the second position is distal to the first position, more preferably wherein the second urging member collar (87) is movable relative to the elongated shaft (10) along the longitudinal axis (A) L )move.

[0216] 46. A device (1) according to the preceding aspect, wherein the proximal and distal portions (84, 86) of each wing (81) are connected via a hinge portion (88), preferably, when the pushing member (80) moves to its expanded configuration, the wing (81) bends at the hinge portion (88), and more preferably, the hinge portion (88) has a lower bending resistance than the proximal and distal portions (84, 86).

[0217] 47. The device (1) according to any one of the preceding sixteen aspects, wherein the at least one pushing member (80), preferably the at least one wing (81), comprises at least one marker for determining the configuration of the pushing member during medical imaging, preferably, wherein the marker is an ultrasonic marker and / or a radiopaque material.

[0218] 48. The device (1) according to any one of the preceding seventeen aspects, wherein the at least one pushing member (80), preferably the at least one wing (81) is made of an ultrasound visible material and / or a radiopaque material.

[0219] 49. The device (1) according to any one of the preceding eighteen aspects, wherein the at least one pushing member (80) is configured as or comprises an expandable structure, such as an expandable balloon.

[0220] 50. The device (1) according to the preceding aspect, wherein the flaps (81) are expanded by inflating the inflatable structure, for example with a gas or a liquid.

[0221] 51. The device (1) according to any one of the preceding aspects, wherein the length of the elongated shaft (10) is between 10 mm and 2000 mm, preferably between 50 mm and 500 mm, more preferably between 100 mm and 200 mm.

[0222] 52. The device (1) according to any one of the preceding aspects, wherein the elongated shaft (10) is rigid and / or wherein the elongated shaft (10) is arranged along the longitudinal axis (A L ) is straight.

[0223] 53. The device (1) according to any one of the preceding aspects, wherein the elongated shaft (10) has a diameter of less than 15 mm, preferably less than 7 mm, more preferably less than 4 mm.

[0224] 54. The device (1) according to any of the preceding aspects, wherein the elongated shaft (10) is made of a metallic material or a fiber-reinforced polymer or of a polymer tube, preferably an extruded polymer tube.

[0225] 55. The device (1) according to any one of the preceding aspects, wherein the device (1) further comprises a handle at the proximal end (11) of the elongated shaft (10).

[0226] 56. The device (1) according to any one of the preceding aspects, wherein the device (1) further comprises at least one actuator, preferably a plurality of actuators, at the proximal end (11) of the elongated shaft (10), preferably at the handle.

[0227] 57. The device (1) according to any of the preceding aspects, wherein the distal end of the device (1), preferably the distal end (12) of the elongated shaft (10), is atraumatic.

[0228] 58. A device (1) according to any one of the preceding aspects, wherein the distal portion of the device (1), preferably the distal end (12) of the slender shaft (10), comprises a plurality of recesses or openings (18), wherein each of the recesses or openings (18) is configured to at least partially receive the corresponding snare (71, 72) when the snare (71, 72) is pushed out of the corresponding snare sleeve (61, 62).

[0229] 59. A device (1) according to any one of the preceding aspects, wherein the distal portion of the device (1), preferably the distal end (12) of the elongated shaft (10), includes a stop feature (19) for limiting distal movement of the support structure (20), preferably, wherein the stop feature (19) is a protrusion extending radially outward from the shaft (10).

[0230] 60. The device (1) according to any one of the preceding aspects, wherein the longitudinal axis (A L ) is configured to be oriented substantially perpendicular to the tissue (100) when closing the tissue opening (101).

[0231] 61. The device (1) according to any of the preceding aspects, wherein the elongated shaft (10) comprises at least three needle guides (13), preferably at least four needle guides (13).

[0232] 62. The device (1) according to any of the preceding aspects, wherein the needle guide (13) has a diameter of less than 2 mm, preferably less than 1 mm.

[0233] 63. The device (1) according to any of the preceding aspects, wherein the needle guide (13) has a diameter greater than 0.5 mm, preferably greater than 0.7 mm.

[0234] 64. A device (1) according to any one of the preceding aspects, wherein the outlet opening (14) is spaced at least 3 mm, preferably at least 8 mm, from the proximal side of the support structure (20) in the proximal direction, and when the support structure (20) is in the second expanded configuration, the proximal side of the support structure (20) is pressed against the second tissue (100).

[0235] 65. A device (1) according to any one of the preceding aspects, wherein the outlet opening (14) is located proximal to the position where the support structure (20) is connected to the slender shaft (10), preferably proximal to the most proximal position where the support structure (20) is connected to the slender shaft (10).

[0236] 66. The device (1) according to any one of the preceding aspects, wherein each of the needle guides (13) comprises a first portion (16) and a second portion (17), the second portion (17) being oriented relative to the longitudinal axis (A L ) extends obliquely and / or radially outwardly, preferably wherein the first portion (16) is substantially parallel to the longitudinal axis (A L ).

[0237] 67. Device (1) according to the preceding aspect, wherein the second portion (17) forms the distal portion of the respective needle guide (13).

[0238] 68. The device (1) according to any one of the two preceding aspects,

[0239] wherein each of the needle guides (13) comprises a curved section, preferably wherein the curved section is located between the first portion (16) and the second portion (17); and / or

[0240] The second portion (17) is curved.

[0241] 69. The device (1) according to any one of the preceding aspects,

[0242] wherein each of the needle guides (13) is configured such that the trajectory along which the corresponding needle (30, 40) extends from the outlet opening (14) is substantially parallel to the longitudinal axis (A) L ) extends at an angle (α), preferably:

[0243] wherein the angle (α) is at most 50°, preferably at most 30°; and / or

[0244] The angle (α) is at least 5°, preferably at least 10°.

[0245] 70. A device (1) according to any one of the preceding aspects, wherein the slender shaft (10) comprises at least three outlet openings (14), preferably at least four outlet openings (14), preferably wherein the outlet openings (14) are spaced around the periphery of the slender shaft (10), more preferably wherein the outlet openings (14) are spaced at regular intervals around the periphery of the slender shaft (10).

[0246] 71. The device (1) according to any one of the preceding aspects, wherein the outlet opening (14) is located along a circumferential side surface of the elongated shaft (10).

[0247] 72. The device (1) according to any one of the preceding aspects, wherein the needles (30, 40) are pre-installed in their respective needle guides (13).

[0248] 73. The device (1) according to any of the preceding aspects, wherein the support structure (20) in the first collapsed configuration is configured to be inserted into the body cavity or lumen (105) through the tissue opening (101).

[0249] 74. The device (1) according to any one of the preceding aspects,

[0250] wherein the support structure (20) in the first collapsed configuration does not extend radially beyond the outer diameter of the elongated shaft (10); and / or

[0251] Wherein, the support structure (20) in the first collapsed configuration has a diameter of 10 mm or less, preferably 5 mm or less.

[0252] 75. The device (1) according to any one of the preceding aspects,

[0253] wherein the support structure (20) in the second expanded configuration extends beyond the outer diameter of the elongated shaft (10); and / or

[0254] Therein, the support structure (20) in the second expanded configuration has a diameter of at least 5 mm, preferably at least 8 mm.

[0255] 76. The device (1) according to any one of the preceding aspects,

[0256] wherein the support structure (20) is configured to be L ) pushing and pulling the elongated shaft (10) and / or switching between the first contracted configuration and the second expanded configuration by pulling and / or pushing one or more wires passing through or extending along the elongated shaft (10); or

[0257] wherein the support structure (20) is configured to switch between the first contracted configuration and the second expanded configuration by moving the proximal end of the support structure (20) along the elongated shaft (10) in the proximal direction; and / or

[0258] Wherein, the support structure (20) is configured to switch between the first contracted configuration and the second expanded configuration by pushing and pulling a wire extending through a lumen (15) in the elongated shaft (10).

[0259] 77. The device (1) according to any one of the preceding aspects, wherein the support structure (20) is configured to extend along the longitudinal axis (A L ) squeezes the support structure (20) to expand.

[0260] 78. The device (1) according to any of the preceding aspects, wherein the support structure (20) comprises a membrane cover and / or one or more expandable components.

[0261] 79. The device (1) according to any of the preceding aspects, wherein the support structure (20) comprises a plurality of support arms (21), such as at least two, at least four or at least six support arms (21).

[0262] 80. The device (1) according to the preceding aspect, wherein the proximal portion (22) of each support arm (21) is connected to the elongated shaft (10) at a first location, more preferably via a proximal collar (28) of the support structure.

[0263] 81. The device (1) according to the preceding aspect, wherein the proximal portion (22) of the support arm (21) in the second expanded configuration is substantially perpendicular to the longitudinal axis (A L ).

[0264] 82. A device (1) according to any one of the three aforementioned aspects, wherein the distal portion (23) of each support arm (21) is preferably connected to the slender shaft (10) at a second position via a distal neck ring (29) of the support structure, and more preferably, wherein the device (1) is configured to be actuated to move the distal portion (23) and / or the distal neck ring (29) in a proximal direction along the slender shaft (10) to move the support structure (20) from a first contracted configuration to a second expanded configuration.

[0265] 83. A device (1) according to any one of the preceding four aspects, wherein the proximal portion (22) and the distal portion (23) of the support arm (21) are connected via a hinge portion (27), preferably, wherein when the support structure (20) moves to its expanded configuration, the support arm (21) bends at the hinge portion (27), more preferably, wherein the hinge portion (27) has a lower bending resistance than the proximal portion (22) and the distal portion (23).

[0266] 84. The device (1) according to any one of the five preceding aspects, wherein the proximal portion (22) and the distal portion (23) of the support arm (21) are integrally formed and / or formed as a unitary component.

[0267] 85. The device (1) according to any one of the six aspects above, wherein the support structure (20) is formed as a support basket (24), preferably, wherein the support basket (24) is made of Nitinol.

[0268] 86. Device (1) according to the preceding aspect, wherein the support arm (21) is formed by a plurality of struts of the support basket (24), preferably wherein the struts are provided with curved and / or articulated portions (27) having reduced thickness and / or width.

[0269] 87. The device (1) according to any one of the preceding eight aspects, wherein one or more pairs of support arms (21) are configured to expand on diametrically opposite sides of the elongated shaft (10).

[0270] 88. The device (1) of any one of the preceding nine aspects, wherein, when the support structure (20) is in the second expanded configuration, an extension (61) extends radially outward from each support arm (21).

[0271] 89. The device (1) according to any one of the preceding ten aspects, wherein each of the support arms (21) in the first retracted configuration is substantially parallel to the longitudinal axis (A L ).

[0272] 90. A device (1) according to any one of the aforementioned eleven aspects, wherein, when the first and second needles (30, 40) are in the extended position and the support structure (20) is in the second expanded configuration, the distal opening of the first needle (30) and the distal opening of the second needle (40) are arranged distal to a first position where the proximal portion (22) of the support arm (21) is connected to the slender shaft (10), preferably distal to the proximal neck ring (28), and proximal to a second position where the distal portion (23) of the support arm (21) is connected to the slender shaft (10), preferably proximal to the distal neck ring (29).

[0273] 91. The device (1) according to any one of the twelve aspects, wherein when the first and second needles (30, 40) are in the extended position and the support structure (20) is in the second expanded configuration, the distal opening of the first needle (30) and the distal opening of the second needle (40) are arranged closer to the longitudinal axis (A) than the radially outermost portion of the support arm (21). L ).

[0274] 92. A device (1) according to any one of the preceding aspects, wherein, when the first and second needles (30, 40) are in the extended position and the support structure (20) is in the second expanded configuration, the distal opening of the first needle (30) and the distal opening of the second needle (40) are arranged in an enclosure and / or cage formed by the support structure (20) and / or the support arm (21).

[0275] 93. The device (1) according to any of the preceding aspects, wherein the support structure (20), preferably the support arm (21), is made of an ultrasound visible material and / or a radiopaque material.

[0276] 94. The device (1) according to any one of the preceding aspects,

[0277] wherein the first needle (30) and the second needle (40) are configured to move independently; or

[0278] The first needle (30) and the second needle (40) are configured to move together when an actuator of the device (1) is actuated.

[0279] 95. A device (1) according to any one of the preceding aspects, wherein the first needle (30) and / or the second needle (40) has a sharp distal end, preferably wherein the distal end has a blunt portion and a sharp portion, more preferably wherein the blunt portion is provided by a chamfered or rounded edge segment.

[0280] 96. The device (1) according to any of the preceding aspects, wherein the distal ends of the first and second snare sleeves (61, 62) are provided with one or more notches (63).

[0281] 97. The device (1) according to any one of the preceding aspects, wherein the at least one first needle (30) and / or the at least one second needle (40) comprises a proximal portion and a distal portion, wherein the distal portion is more flexible than the proximal portion.

[0282] 98. The device (1) according to any one of the preceding aspects, wherein the at least one first needle (30) and / or the at least one second needle (40) comprises a distal portion made of nitinol and / or a proximal portion made of stainless steel, nitinol or titanium.

[0283] 99. A device (1) according to any one of the preceding aspects, wherein the at least one first needle (30) and / or the at least one second needle (40) includes a curved portion, preferably wherein the side walls of the first needle and / or the second needle (30) are provided with a plurality of slots and / or struts along the curved portion, more preferably wherein the slots are made by laser cutting.

[0284] 100. The device (1) according to any one of the preceding aspects, wherein the first needle (30) and / or the second needle (40) has an outer diameter of 0.65 mm to 0.8 mm and / or an inner diameter of 0.5 mm to 0.65 mm.

[0285] 101. A device (1) according to any one of the preceding aspects, wherein the device (1) is configured to inject a fluid through the at least one first needle (30) and / or the at least one second needle (40), preferably wherein the fluid contains a growth factor, an anesthetic and / or a glue.

[0286] 102. The device (1) according to any one of the preceding aspects, wherein the device (1) further comprises at least two first needles (30) and at least two second needles (40).

[0287] 103. The device (1) according to any of the preceding aspects, wherein the first and / or second snare sleeve (61, 62) is a polymer tube.

[0288] 104. A device (1) according to any one of the preceding aspects, wherein the first snare (71) is configured to be closed by pushing the first snare sleeve (61) distally toward the slender shaft (10) to push the first needle (30), and wherein the second snare (72) is configured to be closed by pushing the second snare sleeve (62) distally toward the slender shaft (10) to push the second needle (30, 40).

[0289] 105. The device (1) according to any one of the preceding aspects, wherein the distal end of the snare (71, 72) has an elliptical shape, an arrow shape and / or a tear shape.

[0290] 106. A method of suturing an opening in tissue using a device according to any one of the preceding aspects.

Claims

1. A device (1) for closing a tissue opening (101) in a tissue (100), the tissue at least partially extending around a body cavity or lumen (105), the device (1) comprising: An elongated shaft (10) having a proximal end (11), a distal end (12) and extending along a longitudinal axis (A L ), the elongated shaft (10) being configured to be inserted into the tissue opening (101) in the tissue (100), the elongated shaft (10) comprising at least one first needle guide (13) and at least one second needle guide (13), each needle guide (13) having an exit opening (14) at a distal end thereof; at least one first hollow needle (30) and at least one second hollow needle (40), each of the first and second needles (30, 40) being configured to translate in a distal and radially outward direction along a corresponding one of the needle guides (13) and to push the corresponding one of the needle guides (13) from a retracted position to an extended position; and At least one first snare (71) is configured to be ejected from the distal opening of the at least one first hollow needle (30), and at least one second snare (72) is configured to be ejected from the distal opening of the at least one second hollow needle (40).

2. The device according to claim 2, wherein The at least one first snare (71) is configured and shaped to extend in a radially inward direction toward the elongated shaft (10) when pushed out of the distal opening of the at least one first hollow needle (30), and / or wherein, The at least one second snare (72) is configured and shaped to extend in a radially inward direction toward the elongated shaft (10) when pushed out of the distal opening of the at least one second hollow needle (40).

3. The device according to claim 1 or 2, wherein: The device further comprises: at least one first snare sleeve (61) configured to be ejected from a distal opening of the first needle (30); and At least one second snare sleeve (62) is configured to be ejected from the distal opening of the second needle (40).

4. The device according to any one of claims 1 to 3, wherein The device (1) further comprises at least one first suture portion (51) and is configured to arrange the first suture portion (51) within the first snare (71) when the first snare (71) is pushed out of the distal opening of the first needle (30), preferably, wherein the first suture portion (51) is a first suture end, and At least one second suture portion (52) and configured to arrange the second suture portion (52) within the second snare (72) when the second snare (72) is pushed out of the distal opening of the second needle (40), preferably, wherein the second suture portion (52) is a second suture end, preferably, wherein the first and second suture portions (51, 52) form a common suture (50), preferably, wherein the first and second suture portions (51, 52) are the first end and the second end of the suture (50).

5. The device according to claim 4, wherein the first and / or second suture portion (51, 52) is releasably retained in at least one suture holder (55) near the distal end of the shaft (10), preferably: wherein the first and / or second suture portions (51, 52) are configured to be pulled out from the suture retainer (55), and even more preferably, wherein the length of the first and / or second suture portions (51, 52) extending into the shaft (10) is configured to be pulled in a proximal direction to release the first and / or second suture portions (51, 52) from the suture retainer (55); and / or in, The device (1) is configured to allow the first suture portion (51) to be released only after the first snare (71) is pushed out of the first needle (30), and / or the second suture portion (52) to be released only after the second snare (72) is pushed out of the second needle (40).

6. The device according to claim 5, wherein The first and / or second suture portions (51, 52) are configured to protrude radially outward and / or bend when released from the elongated shaft (10).

7. The device (1) according to any one of claims 4 to 6, wherein Segments of the first and / or second suture portions (51, 52) are stored within the lumen (15) of the shaft.

8. The device according to any one of claims 1 to 7, wherein the device (1) further comprises a support structure (20) at the distal end (12) of the elongated shaft (10), the support structure (20) being configured to move between a first contracted configuration and a second expanded configuration, the support structure (20) being configured to expand in the body cavity or lumen (105), wherein The support structure (20) in the second expanded configuration is configured to be pressed against the second tissue layer (104), preferably in a proximal direction from within the cavity (105), more preferably by pulling the elongated shaft (10) in the proximal direction, wherein the first needle (30) is configured to penetrate the second tissue layer (104) along a first trajectory, the first trajectory being oriented relative to the longitudinal axis (A) L ) extends obliquely and radially outwardly from the corresponding exit opening (14) toward the support structure (20) through the second tissue layer (104), and the second needle (40) is configured to penetrate the second tissue layer (104) along a second trajectory that is perpendicular to the longitudinal axis (A) L ) extend obliquely and radially outwardly toward the support structure (20) from the corresponding exit opening (14) through the second tissue layer (104).

9. The device (1) according to claim 8, wherein the device (1) further comprises at least one expandable pushing member (80), the at least one expandable pushing member (80) being configured to push the first tissue layer (103) out of the first trajectory and the second trajectory, the pushing member (80) being configured to move between a radially contracted configuration and a radially expanded configuration, preferably, wherein the device (1) is configured to move the pushing member (80) from the contracted configuration to the expanded configuration by squeezing the pushing member in the longitudinal direction of the shaft (10), wherein when the pushing member (80) is in the expanded configuration, at least a portion of the first trajectory and the second trajectory extends through a cavity formed between the pushing member (80) and the slender shaft (10).

10. The device (1) according to claim 9, wherein the at least one pushing member (80) is formed as a pushing member basket (83), preferably, wherein the pushing member basket (83) is a nitinol basket, more preferably, wherein the pushing member basket (83) is formed integrally and / or monolithically with the support basket (24) forming the support structure (20); and / or more preferably, wherein the pushing member basket (83) and the support basket (24) forming the support structure (24) are connected by a longitudinal axis (A) L ) is connected to one or more pillars extending therefrom.

11. The device (1) according to any one of claims 1 to 10, wherein The distal end of the device (1), preferably the distal end (12) of the slender shaft (10) is atraumatic, preferably, wherein the distal portion of the device (1), preferably the distal end (12) of the slender shaft (10) includes a plurality of recesses or openings (18), wherein each of the recesses or openings (18) is configured to at least partially receive a corresponding snare (71, 72) of the snares (71, 72) when the snares (71, 72) are pushed out of the corresponding snare sleeve (61, 62).

12. The device (1) according to any one of claims 1 to 11, wherein the at least one first needle (30) and / or the at least one second needle (40) comprises a proximal portion and a distal portion, wherein the distal portion is more flexible than the proximal portion, and / or wherein the device (1) further comprises at least two first needles (30) and at least two second needles (40).

13. The device (1) according to any one of claims 1 to 12, wherein The distal ends of the first and second snare sleeves (61, 62) are provided with one or more notches (63).

14. The device (1) according to any one of claims 1 to 13, wherein The first snare (71) is configured to be closed by pushing the first snare sleeve (61) distally toward the slender shaft (10) to push the first needle (30), and wherein the second snare (72) is configured to be closed by pushing the second snare sleeve (62) distally toward the slender shaft (10) to push the second needle (30, 40), preferably, wherein the distal ends of the snares (71, 72) have an elliptical shape, an arrow shape and / or a teardrop shape.

15. A method of suturing an opening in tissue using the device according to any one of claims 1 to 14.

Images