Medical apparatus and method for closing an aperture in a tissue
The present invention relates to a medical apparatus for closing an aperture, an incision, a puncture, a passage through tissue and/or a communication with a blood vessel or other body lumen (short: aperture) of a tissue of a patient, the medical apparatus comprising a closing device holder, for releasably receiving one or more closing devices; and a retracting unit to come into contact with opposite sides of the aperture and for retracting them and/or for spreading the aperture causing it to change its shape into a slit or a slit-like or a more slit-like aperture or to spread or to augment the dimension or diameter of the aperture in at least one or in exactly one dimension of the aperture.
1 . A medical apparatus for closing an aperture in a tissue of a patient, wherein the tissue defines at least part of a blood vessel or other body lumen, the medical apparatus comprising:
closing device holders, each for releasably receiving one or more closing devices, wherein each of the one or more closing devices comprises a staple or a clip made at least partly of a deformable shape memory alloy and/or having a self-expanding shape memory section within the closing device holders in a stressed state such that when the one or more closing devices is manipulated to exit a distal end of the respective closing device holder during use of the medical apparatus, the one or more closing devices releases its stress, or part of it; and
a retracting unit configured to come into contact with opposite sides of the aperture and for retracting the opposite sides of the aperture and/or for spreading the aperture causing the aperture to change its shape into a slit, wherein a multitude of arms are provided to act as the retraction unit or as part thereof;
wherein the medical apparatus comprises one or more bars or other protrusions that are arranged between or adjacent to openings of the closing device holders for discharging the one or more closing devices, the one or more bars or other protrusions being arranged to protrude over an opening area of at least one of the openings,
wherein the closing device holders and the multitude of arms of the retracting unit are configured to be inserted into the aperture such that the one or more closing devices, when received in the closing device holders, is deployable, from the distal end of the respective closing device holder, inside of the blood vessel or other body lumen so as to close the aperture from inside of the blood vessel or other body lumen.
2 . The medical apparatus according to claim 1 , the retracting unit comprising:
at least one retracting device holder; and
at least one retracting device, at least partially received in the at least one retracting device holder,
wherein the at least one retracting device is at least partially releasably received in the at least one retracting device holder;
wherein the at least one retracting device is arranged in a moveable or slidable manner with respect to the at least one retracting device holder.
3 . The medical apparatus according to claim 2 , comprising a deploying device configured to be at least partially releasably received in a lumen of the at least one retracting device holder.
4 . The medical apparatus according to claim 3 , wherein the at least one retracting device holder or its lumen exhibits, assumes or shows a first shape or a first cross section being a circular cross-section with a cross section diameter (D R ), while positioning the retracting unit into the aperture, and a second shape or a second cross section being an oval cross section with a main axis length (D N ) larger than the cross section diameter (D R ) and being an elliptical cross section with two symmetry axes, main axis and minor axis, after pulling the deploying device, partly or completely, out of the at least one retracting device holder.
5 . The medical apparatus according to claim 4 , wherein a shape of one of the closing device holders or of its cross section assumes mainly the second shape or features the second cross section, corresponds to it and/or has an oval cross section.
6 . The medical apparatus according to claim 3 , wherein one of the closing device holders is, at least partially releasably, received in the at least one retracting device holder, and translationally movable in a longitudinal direction of one of the closing device holders.
7 . The medical apparatus according to claim 2 , wherein the at least one retracting device is positioned at the distal tip, distal end or distal end section of the at least one retracting device holder, wherein the at least one retracting device and the at least one retracting device holder are designed integrally with each other and/or connected to each other in a non-releasable manner.
8 . The medical apparatus according to claim 7 , wherein the at least one retracting device comprises the multitude of arms that comprises or consists of a first arm and a second arm, the first arm and the second arm being positioned or provided parallel to each other at least while or before positioning the retracting unit into the aperture.
9 . The medical apparatus according to claim 8 , wherein the first arm and the second arm are arranged at the surface of a deploying device and/or in contact with it while advancing the at least one retracting device to the aperture, and wherein the first arm and the second arm are expanded, in a passive manner and/or without using a motor, manual assistance and/or a mechanism, to a retracting state for retracting the aperture after pulling the deploying device out from the at least one retracting device holder.
10 . The medical apparatus according to claim 2 , comprising a connector to be connected, or an integral part of, the at least one retracting device holder, providing an opening for advancing a deploying device and/or one of the closing device holders into an inner lumen of the at least one retracting device holder.
11 . The medical apparatus according to claim 10 , wherein at least one of the inner lumen of the at least one retracting device holder, or of a cross section thereof, and the opening area of the opening comprise sections that both delimit an at least partially round shape and sections that delimit an at least partially oval shape.
12 . The medical apparatus according to claim 1 , the retracting unit comprising at least
a retracting device having at least one of:
a first side and an opposite second side,
the multitude of arms comprising or consisting of a first arm and a second arm,
a first retracting device and a second retracting device,
a first retracting device holder and a second retracting device holder and
a first engaging device and a second engaging device;
and
a mechanism for moving the first side apart or away from the second side, the first arm apart or away from the second arm, the first retracting device apart or away from the second retracting device, the first retracting device holder apart or away from the second retracting device holder and/or the first engaging device apart or away from the second engaging device.
13 . The medical apparatus according to claim 1 , wherein the closing device holders are arranged to remain, at least in parts, parallel to each other throughout the closing of the aperture or to part or deviate from each other when being advanced towards the aperture and/or out of a closing member.
14 . The medical apparatus according to claim 1 , wherein a delivery support for assuring—or assisting in—that the closing device holders deviate or part from each other when being advanced towards the aperture and/or out of a closing member is provided.
15 . The medical apparatus according to claim 1 , wherein at the outer or lateral sides of a closing member, of the closing device holders or of delivery support bumpers or spacers are arranged.
16 . The medical apparatus according to claim 1 , comprising a handle member, wherein the handle member comprises a sleeve or another element having a guide slot.
17 . The medical apparatus according to claim 16 , wherein the handle member, a knob or the sleeve itself comprises an elastic element or a spring arranged to guide a pin through a turning point of the guide slot.
18 . The medical apparatus according to claim 1 , wherein at least one of the multitude of arms comprises two legs surrounding or circumscribing at least one opening or middle opening between them.
19 . The medical apparatus according to claim 1 , wherein at least one opening of the retracting unit through which at least one of the multitude of arms exit in use of the medical apparatus has a width that is smaller than its length.
20 . The medical apparatus according to claim 19 , wherein at least one of the at least one opening of the retracting unit through which the at least one of the multitude of arms exits has an oval opening area or cross section.
21 . The medical apparatus according to claim 1 , comprising:
the one or more closing devices including a closing device comprised in one of the closing device holders.
22 . The medical apparatus according to claim 21 , wherein the closing device has two arms, wherein at least one of the arms has a or one first bending direction and a or one second bending direction.
23 . The medical apparatus according to claim 22 , wherein in a closed state of the closing device or the aperture, the end or tip of a first one of the arms points away from a second one of the arms, whereas the end or tip of the second arm points away from the first arm.
24 . A method for closing an aperture of a tissue, encompassing the steps:
providing a medical apparatus according to claim 1 , comprising a retracting device holder, a retracting device comprising the multitude of arms comprising or consisting of a first arm and a second arm, and a deploying device, wherein the retracting device is positioned at the distal tip, end or end section of the retracting device holder or attached to the latter;
inserting the deploying device into a lumen of the retracting device holder;
pushing forward both the deploying device and the retracting device holder comprising the retracting device up to the aperture until at least parts of the first arm and the second arm are positioned inside the aperture;
pulling the deploying device back and out of the lumen of the retracting device holder;
inserting one of the closing device holders having the one or more closing devices into the lumen of the retracting device holder, so that the distal opening or openings of one of the closing device holders for discharging the one or more closing devices from one of the closing device holders is/are positioned at the aperture;
pushing out, releasing or bringing out the one or more closing devices for closing the aperture.
25 . A method for closing an aperture of a tissue, encompassing the steps:
providing a medical apparatus according to claim 1 ;
closing the aperture by means of the medical apparatus.