Source: https://patents.google.com/patent/US20030055441A1/en
Timestamp: 2018-12-11 16:46:37
Document Index: 796621702

Matched Legal Cases: ['art 28', 'art 28', 'art 28', 'art 38', 'art 47', 'art 49', 'art 49', 'art 49', 'art 59', 'art 60', 'arts 59', 'arts 59', 'arts 59']

US20030055441A1 - Mechanical anastomosis system for hollow structures - Google Patents
US20030055441A1
US20030055441A1 US10162261 US16226102A US2003055441A1 US 20030055441 A1 US20030055441 A1 US 20030055441A1 US 10162261 US10162261 US 10162261 US 16226102 A US16226102 A US 16226102A US 2003055441 A1 US2003055441 A1 US 2003055441A1
US8182498B2 (en )
On the other hand, as already mentioned before, it is possible to make a bypass by means of surgery. To this end an artery (arteria mammaria interna) or a vein from the leg (vena saphena magna) may be used, for example. An anastomosis is thereby made in the coronary artery, distally of the constriction or occlusion. The interconnection between the vessels is then manually sutured by means of 8 to 20 stitches. Said anastomosis may be a side-to-side or an end-to-side anastomosis. The natural origin of the arteria mammaria interna is usually preserved, so that such a bypass will directly be functional. A bypass made of a vena saphena magna will have to be sutured separately in the aorta (the so-called proximal anastomosis). Due to the small diameterof coronary arteries (1-3 mm), it is generally decided to stop the heart in order to be able to carry out the anastomosis precisely and safely. The blood circulation is kept going by a heart-lung machine during this time. Although this is a well-tried and reasonably safe method, it has certain drawbacks. Thus, the use of the heart-lung machine has a number of side effects for the patient, as a result of which recovery following surgery takes more time. Moreover, the necessary disposables for the heart-lung machine are costly. [0004]
FIGS. [0024] 7-12 are views corresponding with FIGS. 1-6 of a second embodiment of the device according to the invention.
FIG. 13 is a side view of an applicator for use with the device according to FIGS. [0025] 7-12, showing the starting position thereof.
FIG. 14 is a perspective view of the applicator of FIG. 13, with the device according to FIGS. [0026] 7-12, which is shown in the starting position thereof, in mounted position thereon.
FIGS. [0028] 16-21 are views corresponding with FIGS. 1-6 of a third embodiment of the device according to the invention.
FIGS. [0029] 22-24 are views corresponding with FIGS. 13-15 of an applicator for use with the device according to FIGS. 16-21.
FIG. 25 is a schematic side view, partially in sectional view, of an alternative applicator for use with the device according to FIGS. [0030] 1-6 or 7-12.
FIGS. [0033] 28-30 are sectional views and elevational views respectively corresponding with FIGS. 25-27 of a variant of an applicator for use with a device according to FIGS. 16-21.
FIGS. [0034] 31-33 are partially cut-away side views of another variant of the applicator, for example for use with a device according to FIGS. 1-6 or 7-12, showing three different positions thereof.
FIGS. [0039] 1-6 show a first embodiment of a device for making anastomoses between hollow structures, in particular arteries or veins, by mechanical means.
As is apparent from a comparison between FIGS. [0042] 4-6 and 1-3, the diamond-shaped structures 4 are deformed to a straighter shape, seen in circumferential direction, wherein the vertices comprising the pin-shaped elements 5, 6 have been moved closer together, such that the points 7 of pin-shaped elements 5, 6 of one pair engage each other. This movement of points 7 of pin-shaped elements 5 and 6 towards each other can be used for joining together or clamping together the walls of the hollow structures for the purpose of making the anastomosis, as will be explained in more detail hereafter.
FIGS. [0046] 7-12 show a second embodiment of the device for making an anastomosis by mechanical means, wherein annular element 1 is a single, sinusoidal, elongated element 8, which expands in circumferential direction. Just like the elongated elements 2 and 3 of the first embodiment, the sinusoidal, elongated element 8 according to this second embodiment has a length dimension which is greater than the circumferential dimension of the annular element in the starting position thereof, and said length dimension of element 8 is at least equal to the circumferential dimension of the annular element in the joining position.
FIGS. [0049] 13-15 show an embodiment of an applicator which can be used for that purpose. The applicator is provided with a preferably rigid, shank-like element 13, on the proximal end of which means are provided for manipulating the applicator, such as a grip, and on the distal end of which a head 14 is formed. Head 14 is provided with two axially spaced-apart hubs 15, 16, one of which, for example hub 16, is capable of axial movement, which movement is controlled from the proximal end of shank-like element 13. Rigid arms 17 are arranged on hubs 15 and 16 in a star-like fashion, wherein pairs of associated arms 17 of the two hubs 15 and 16 present at corresponding circumferential positions are pivotally interconnected in a point some distance away from their free ends. Arms 17 are also pivotally connected to hubs 15 and 16, with the pivots extending tangentially with respect to shank-like element 13. In this manner clips are formed, as it were.
FIGS. [0051] 16-21 show a third embodiment of the device according to the invention, which can be used for intraluminal placement in the case of a side-to-side anastomosis, but in particular also for extraluminal placement in the case of an end-to-side anastomosis.
When the device according to FIGS. [0054] 16-21 and the applicator according to FIGS. 22-24 are used for making a side-to-side anastomosis, annular element 1 is placed intraluminally, and the pin-shaped elements 20 are passed through the vessel walls in places surrounding the openings that have been formed by incisions. When the pin-shaped elements 20 are subsequently bent radially outwards, it is no longer possible to remove annular element 1, because elongated element 19 is positioned inwardly of the wall of one vessel and the radially projecting pin-shaped elements 20 are positioned inwardly of the wall of the other vessel.
FIGS. [0056] 25-27 show a variant of the applicator according to FIGS. 13-15 which is suitable for placing an annular element 1 of a device of the type as shown in FIGS. 1-6 (shown at the bottom of FIGS. 25 and 27) or in FIGS. 7-12 (shown at the top of FIGS. 25 and 27). Also in this embodiment, a head 14 is attached to the shank 13 of the applicator. Said head 14 possesses a blunt end part 28 in this embodiment, which is fixed to shank 13 and also to a housing 29. The fixed connection between shank 13 and housing 29 is schematically illustrated by means of pin 30. A number of slots, eight in the illustrated embodiment, are circumferentially provided, in regularly spaced-apart relationship, in end part 28 and in housing 29. Said slots 31 are wide enough for receiving wedges 32, whereby it is important that slots 31 in end part 28 have the same angle of inclination as the distal front face 33 of wedges 32. Wedges 32 are radially held together by an elastic annular band 34. A control element 35 in the shape of a hollow shaft which can be slid over shank 13 comprises a bevelled front face 36 at the distal end, which is capable of cooperation with a complementary bevel 36′ on the proximal end of wedges 32. The angle of inclination of bevel 36′ and the front face 36 is smaller than that of the distal front face 33 of wedges 32.
FIGS. [0058] 28-30 show a variant of the applicator according to FIGS. 22-24, which can be used in combination with an annular element 1 of the type according to FIGS. 16-21. The head 14 of this variant comprises a hollow shaft 37, with a blunt end part 38 present at the distal end thereof. Rectangular openings 39 (eight, for example) are provided in regularly spaced-apart relationship in the circumference of hollow shaft 37. Said hollow shaft 37 can move axially with respect to a housing 40, whose distal end surface 41 can serve as an anvil for annular element 1. Wedges 42 are placed in openings 39, which wedges are pivoted to the hollow shaft by means of resiliently flexible plates 43, in such a manner that wedges 42 can move outwards about a substantially tangential axis, from their starting position (FIG. 28) in openings 39 to a joining position (FIG. 30) in the direction of housing 40. Said movement is effected by moving a control element 44 in the form of a bar comprising a bevelled point 45 in forward direction, as a result of which the wedges are tilted outwards through 90°, in which joining position they are locked by the circumference of said control element 44. When housing 40 is moved axially forward with respect to hollow shaft 37, in the direction of wedges 42, the pin-shaped elements 20 of annular element 1 will come into contact with the wedges 42, and the pin-shaped elements 20 will be deflected outwards in a desired manner by the specially formed cavities 46 present in said wedges so as to fix annular element 1 of the device to the vessel walls. Wedges 42 will return to the starting position when control element 44 is withdrawn, and the applicator can be removed. In principle it would also be possible to effect direct deflection of pin-shaped elements 20 through expansion of wedges 42.
FIGS. [0059] 31-36 show another variant of an applicator, which can for example be used for inserting the device according to FIGS. 1-6 or 7-12. The applicator is therefore arranged for effecting a radial expansion of annular element 1 of the device and subsequently clamping together the joining means, such as pin-shaped elements 5, 6 or 10, 11, in axial direction or deforming them in some other manner. The difference with the preceding embodiments of the applicator is the fact that the embodiment according to FIGS. 31-36 is arranged for effecting the radial and axial deformations of the device in two separate steps. First the annular element 1 is radially expanded, and then the joining means are moved to their joining position. The advantage of this embodiment is the fact that the joining means are prevented from closing prematurely and thus missing part of the vessel wall.
In FIGS. [0060] 31-36, shank-like element 13, head 14 and detainer 23 can be distinguished. An end portion 47 having a convex end surface is formed on the distal end of shank-like element 13, whilst end part 47 is wedge-shaped or conical on proximal side 48. Besides shank-like element 13 and detainer 23, a third, relatively movable part 49 is provided, which can be moved both with respect to shank-like element 13 and with respect to detainer 23 from a control position outside the body. Part 49 and/or detainer 23 are circumferentially provided with a number of radially extending slots 50 for movably accommodating, at least in part, an equal number of arms 51. Arms 51 can move between the innermost starting position, in which they abut against a conical surface 52 of movable part 49, and an outermost joining position, in which they abut against the inner wall of detainer 23 (FIGS. 32, 33). Arms 51 comprise an outwardly curved deflection surface 53 near their distal ends, which is to mate with pin-shaped elements of annular element 1, which may be provided round arms 51, adjacently to deflection surfaces 53. An elastic band 54 (see FIGS. 35, 36) may extend through radial notches 55 present near the distal ends of arms 51, which band functions to cause arms 51 to spring back to an inward position.
With the applicator according to FIGS. [0063] 37-40, the isovolumetric behaviour of some elastic and readily deformable material, such as rubber, is utilized for the radial expansion of annular element 1 of the device. The axial compression of the material will result in axial contraction and, if inward deformation is not possible, to radially outward expansion. In the illustrated embodiment, an isovolumetric core 57 is provided, on which annular element 1 of the device can be placed. Head 14 of said applicator furthermore comprises a sleeve 58 which is axially movable with respect to shank-like element 13, which sleeve comprises an end part 59 capable of cooperation with an end part 60 of shank-like element 13. Pivoted radial supports 61 are connected to the associated end parts 59, 60, they support circumferentially provided plates 62, which are held together by an associated elastic band 63, which also provides the return force. By moving the end parts 59, 60 together, the plates 62 are moved from the original sloping position as shown in FIGS. 38, 40 to an eventual joining position as shown in FIGS. 37, 39, wherein said plates extend practically perpendicularly to shank-like element 13. The facing surfaces of plates 62 are then capable of deforming the joining means upon further movement of end parts 59, 60 towards each other when the isovolumetric core 57 is compressed and the annular element is expanded thereby and, as already mentioned before, the joining means are moved to their joining position. This embodiment of the applicator is suitable for drastic miniaturisation.
1. A system for making anastomoses between hollow structures by mechanical means, characterized by a device in the shape of an annular or tubular element comprising circumferentially provided means for joining the abutting walls of the hollow structures together, as well as an applicator for moving said annular or tubular element in position and activating the joining means thereof.
2. A device for use in the system for making anastomoses between hollow structures by mechanical means according to claim 1, characterized by an annular or tubular element comprising joining means provided circumferentially thereon for joining the abutting walls of the hollow structures together.
3. A device according to claim 2, wherein said joining means comprise a number of pin-shaped elements which are circumferentially provided on said annular element, which pin-shaped elements can be moved or deformed between a starting position and a joining position.
4. A device according to claim 3, which is intended for intraluminal side-to-side anastomosis, wherein respectively two pin-shaped elements are provided at the same position, seen in circumferential direction, wherein at least the free ends of two associated pin-shaped elements are spaced apart in the starting position, seen in axial direction, whilst they have been moved together in the joining position.
5. A device according to any one of the preceding claims, which is intended for intraluminal placement, wherein said annular element can be permanently deformed from a first diameter in the starting position to a second, larger diameter in the joining position.
6. A device according to claim 5, wherein said annular element is made up of at least one elongated element having a length dimension which is greater than the circumferential dimension of said annular element in the first diameter and which is at least equal to the circumferential dimension of said annular element in the second diameter, which element extends along a line which deviates from a contour line in the first diameter and which can be straightened so as to extend along a line which resembles the contour line more closely.
7. A device according to claim 6, wherein said elongated element extends sinusoidally or in a different, zigzag-like fashion.
8. A device according to claims 5 and 7, wherein two zigzag-like elements are arranged side by side in axial direction, which elements are interconnected near their vertices facing each other, and wherein the pin-shaped elements are fixed to the vertices that face away from each other.
9. A device according to claim 3, which is intended for making an intraluminal side-to-side anastomosis or an end-to-side anastomosis, wherein the pin-shaped elements extend at least substantially axially in the starting position and wherein said pin-shaped elements can be bent to the joining position deviating from the axial position, for example a substantially radial or tangential position or the like, so as to make a joint.
10. An applicator for use in the system according to claim 1, which is intended for placing the device according to any one of the claims 2-9, which applicator is provided with means for positioning said annular or tubular element and activating the joining means thereof.
11. An applicator according to claim 10, which is intended for placing the device according to claim 3, which applicator is provided with a, preferably rigid, shank-like element and with a head, which head can be adjusted in such a manner that the pin-shaped elements of the device are moved or deformed from the starting position to the joining position when said adjusting takes place.
12. An applicator according to claim 11, which is intended for placing the device according to claim 4, wherein said head is provided with means for moving associated pin-shaped elements towards each other.
13. An applicator according to claim 11 or 12, which is intended for placing the device according to any one of the claims 5-8, wherein the head of the applicator can also expand in radial direction from a first diameter to a second diameter.
14. An applicator according to claim 13, wherein said head is provided with two axially spaced-apart hubs comprising arms arranged in a star-like fashion thereon, which hubs are movable in axial direction with respect to each other, wherein the arms of the two hubs are pivotally interconnected at a point some distance away from their free ends so as to form clamps.
15. An applicator according to claim 13, wherein said head is circumferentially provided with a number of equally spaced elements, such as wedges, around which the device can be placed, and which can be moved axially and radially outwards by means of a control element, whereby the device is expanded in radial direction and contracted in axial direction.
16. An applicator according to claim 13, wherein said head is provided with an isovolumetrically deformable element, for example of rubber, on which the annular or tubular element of the device can be placed, and which can be axially contracted and be outwardly expanded so as to cause the device to expand in radially outward direction.
17. An applicator according to claim 16, wherein said head is provided with two axially spaced-apart hubs, which are axially movable with respect to each other, with a number of outwardly pivotable elements, which are equally spaced over the circumference, as well as the isovolumetric element, which is positioned inwardly thereof, present therebetween.
18. An applicator according to claim 11, which is intended for placing the device according to claim 9, which applicator comprises a shank-like element and a head, which is fitted with a detainer for stopping the device in axial direction, and axially movable deflector means for deflecting the pin-shaped elements.
19. An applicator according to claim 18, wherein said detainer is a hollow shaft or ring, and wherein said axially movable deflector means are provided with two axially spaced-apart hubs which are axially movable with respect to each other and to the detainer, on which hubs arms are arranged in a star-like fashion, wherein the arms of the two hubs are pivotally interconnected.
20. An applicator according to claim 18, wherein said detainer is a hollow shaft or ring, and wherein said axially movable deflector means are provided with a number of circumferentially provided, substantially radially disposed wedges on the hub, which are each capable of pivoting movement about a substantially tangential axis in the direction of said detainer.
21. An applicator for use in the system for making anastomoses between hollow structures by mechanical means according to claim 1, characterized by a shank-like element and by a head for supporting and activating the joining means provided thereon, in such a manner that said joining means are moved or deformed from the starting position to the joining position upon activation as a result of expansion of the head in radial direction from a first diameter to a second diameter and of axial contraction in two separate steps.
22. An applicator according to claim 21, wherein said head is provided with first, second and third parts which are capable of axial movement relative to each other, wherein relative movement of said first and said second parts causes the joining means to move in radial direction and wherein relative movement of said first and said third parts causes the joining means to contract in axial direction.
23. An applicator according to claim 21, wherein said head is circumferentially provided with a number of equally spaced elements, such as wedges, around which the device can be placed, which elements can be moved axially and radially outwards by means of a control element, whereby the device is expanded in radial direction and contracted in axial direction.
24. A method for making intraluminal side-to-side or side-to-end anastomoses between hollow structures by mechanical means, characterized by providing of an applicator and associated joining means for joining the abutting walls of the hollow structures together, placing said joining means round the applicator, inserting said applicator and said joining means into one of said hollow structures to a location internally of the abutting walls of the hollow structures, and activating said applicator, and thus the passing of said joining means through said abutting walls or the clamping of said joining means against said abutting walls for the purpose of keeping said abutting walls in sealing contact with each other.
25. A method according to claim 24, wherein joining means are used which are formed on a single annular or tubular element.
26. A method according to claim 24, wherein a number of loose staples are used as the joining means.
US20030055441A1 true true US20030055441A1 (en) 2003-03-20
US8182498B2 US8182498B2 (en) 2012-05-22