WO2009118719A1 - Device for affixing prosthesis to a vessel - Google Patents
Device for affixing prosthesis to a vessel Download PDFInfo
- Publication number
- WO2009118719A1 WO2009118719A1 PCT/IL2008/000398 IL2008000398W WO2009118719A1 WO 2009118719 A1 WO2009118719 A1 WO 2009118719A1 IL 2008000398 W IL2008000398 W IL 2008000398W WO 2009118719 A1 WO2009118719 A1 WO 2009118719A1
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- WO
- WIPO (PCT)
- Prior art keywords
- vessel
- frontal
- prosthesis
- graft
- groups
- Prior art date
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
- A61B17/115—Staplers for performing anastomosis in a single operation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
- A61B17/1114—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis of the digestive tract, e.g. bowels or oesophagus
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
- A61B2017/1107—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis for blood vessels
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
- A61B17/115—Staplers for performing anastomosis in a single operation
- A61B2017/1157—Staplers for performing anastomosis in a single operation applying the staples radially
Definitions
- the present invention is generally within the field of medicine, particularly pertaining to vascular surgeries during which a prosthesis is introduced into a vessel and secured at the internal vessel wall.
- the present invention refers to devices and methods used during surgical operations associated with treating large vessels, e.g. for treating the superficial femoral artery by inserting a prosthesis, e.g. graft into the artery without opening the abdominal and thoracic cavities. Such surgical operations may be used instead of bypass surgery. It should be borne in mind, however, that the present invention is not limited merely to affixing a prosthesis to the internal wall of the superficial femoral artery. The present invention also can be used in surgical operations associated with introducing other prostheses in other vessels, for example the brachial artery or any other large vessels which have an internal diameter of at least 5 mm, preferably 6-8 mm.
- J. Parodi discloses systems and methods for securing a single stitch inside the vascular lumen in US Pat. 6336933, EP 1308131 Al, and US Pat. Appl. 2003/0023248.
- J. Parodi discloses an applicator, which can be set up inside a vessel for affixing a prosthesis to the vessel wall.
- US Pat. 7125412 discloses an apparatus that allows affixing a prosthesis to the aorta wall using staples.
- an incision is cut in the aorta wall, the apparatus is inserted into the aorta, and the prosthesis is affixed to the aorta wall.
- this apparatus can be employed only in the course of such a surgical operation.
- this apparatus requires the use of an external support means for reliably securing the staple edges. Otherwise, without the external support, it is not possible to reliably secure a prosthesis in vessels having thin walls with thickness of 0.2-0.4 mm.
- an alternative method of vessel treatment known as an "endovascular prosthesis," whereby the endo-prosthesis (e.g., a woven polyester tube with a reinforcing inner metal frame) is set into a vessel, e.g., into an aneurism.
- This method does not require incision of the vessel or the tissue, which surrounds the vessel.
- This method may be used in patients for whom a surgical operation may be not recommended for any reason as well as in patients who prefer not to go through a surgical operation.
- a stent-graft endo-prosthesis
- a stent-graft is used to strengthen a weak vessel wall and to prevent the vessel's rupture.
- the endo-prosthesis is brought into the vessel using a dedicated delivering catheter (e.g., a long, tube-like device). Implanting of the endoprosthesis is carried out under local/epidural anesthesia or narcosis. To cany out the procedure of endovascular prosthesis, only two small cuts are made at the upper part of each hip.
- a dedicated delivering catheter e.g., a long, tube-like device.
- Endovascular prosthesis treatment is an efficient alternative in the treatment of aneurisms of large vessels such as those which may form on the abdominal part of the aorta. This method allows:
- US patent application 60/908,787 filed on 29 March 2007, is capable of affixing stent-grafts to the aorta wall after the stent-graft is inserted into the aorta during an endovascular procedure.
- US patent application 60/908,787 is incorporated herein by reference in its entirety.
- the device described in US patent application 60/908,78 comprises a body with a longitudinally displaceable push member as well as a single working head preloaded with staples for affixing the stent-graft and is fitted with a plurality of pivoting wings that carry the staples.
- the wings may be swiveled when the push member is longitudinally displaced in a distal direction such that upon swiveling, the wings approach the internal surface of the stent- graft and stretch it in a radial direction.
- the working head is provided with pivoting levers that also may be swiveled by the push member at the end of its distal displacement such that the staples are forced by the levers to exit out from the working head and to protrude radially through the stent-graft wall, through the vessel wall, and eventually to affix one end of the stent-graft to the vessel wall.
- the staples meet stretched walls of the stent-graft that function as support. This support allows a reliable securing of the stent-grafts within a vessel.
- the above device is suitable only for securing prostheses that are brought in place by a dedicated catheter.
- Prostheses such as grafts, which are used to shunt large vessels, can't be brought into place by a dedicated catheter and require use of the same instrument to deploy the prosthesis as that which secures the prosthesis at the vessel wall.
- the above-mentioned device is not suitable since its working head has only a limited amount of preloaded staples. This amount is sufficient for securing only one graft end.
- the endovascular prosthesis procedure should be repeated with a fresh device, which is reloaded with new portion of staples, which is not always possible.
- a device for affixing a prosthesis e.g., graft
- a vessel which is based on the operating principle of devices used for securing stent-grafts in small vessels, but at the same time is preferably capable of securing grafts in large vessels, having diameter of at least about 5 mm (for example).
- An object of some of the embodiments of the invention is to provide a device which will be suitable for affixing two opposite ends of a graft to a vessel by the same device during a single endovascular prosthesis procedure.
- Another object of some of the embodiments of the invention is to provide a device which enables reliable, fast and convenient affixing of a graft to a large vessel.
- Yet another object of some of the embodiments of the present invention is to provide a device which is provisionally connectable to both graft ends so as to enable bringing the graft in place together with the device and then affixing one end of the graft. After completing this stage, the opposite end of the graft is disconnected from the device and the device is displaced along the vessel to the opposite end of the graft, and then this end of the graft is affixed to the vessel.
- Fig.l is a general isometric view of a device of the invention.
- Fig.2 is a general isometric view of a device of the invention carrying a graft.
- Fig.3 shows how a device of the invention is manually operated when a handle portion is gripped by an operator's hand.
- Fig.4 shows schematically the human leg and femoral artery, into which a graft can be inserted and affixed.
- [0025J Fig.5 shows how a device of the invention is brought towards the artery and is ready for inserting in the artery through an incision made at a proximal end of the hip.
- Fig.6 shows a device of the invention after it has been introduced into the artery with its working portion brought to a distal end of the artery.
- Fig.7 is an enlarged view of the distal end of the artery with a working portion of the device inside.
- Fig.8 shows how a device of the invention is being operated when a working portion is at the distal end of the artery.
- Fig.9 is an enlarged view of a distal end of the device of the invention when frontal staples are being pushed by a working portion.
- Fig.10 shows evacuation of a working portion from the artery after the distal end of the graft has been affixed and the proximal end of the graft has been disconnected.
- Fig.l 1 is an enlarged view of the proximal end of the artery with a working portion inside.
- Fig.12 is an enlarged view of the proximal end of the artery with rear staples protruding into the wall of the artery.
- Fig. 13 shows evacuation of a working portion from the vessel.
- Fig.14 is an exploded view of a device of the invention.
- Fig.15 is a side view of a working portion and a rear handle portion.
- Fig.16 is an exploded view of a working portion with front and rear groups of pivoting elements.
- Fig.17 is a cross-section A-A of Fig.15.
- Fig.18 is a cross-section B-B of Fig.15.
- Fig.19 is an enlarged isometric cross-section view of a working portion showing a pushing rod.
- Fig.20 is an enlarged view of a working portion
- Fig. 21 shows a pushing rod.
- Fig. 22 shows a forward head of a pushing rod.
- Fig.23 shows a pushing rod protracting into a working portion.
- Fig.24 shows an initial stage of actuating a front group of pivoting elements.
- Fig.25 shows a final stage of actuating a front group of pivoting elements.
- Fig.26 shows a working portion in a second working stage when a pushing rod has been retracted proximally and rotated.
- Fig.27 shows an initial stage of actuating rear groups of pivoting elements.
- Fig.28 shows a final stage of actuating frontal groups of pivoting elements.
- Fig.29 is a partially cross-sectioned isometric view of a handle portion.
- Fig.30 is an isometric view of an external guiding bushing.
- Fig.31 is an isometric view of a collet member.
- Fig.32 is an isometric view of a inner guiding bushing.
- Fig.33 shows a rear handle portion being locked by a latch.
- Fig.34 shows a rear handle portion in a first working position.
- Fig.35 shows a rear handle portion in a second working position.
- Fig.36 shows a rear handle portion after an external bushing has been displaced distally.
- Fig.37 shows a rear handle portion in a position when the pushing rod is retracted and turned by the torsion spring.
- Fig.38 shows a handle portion being ready for protracting a pushing rod and actuating a rear groups of pivoting elements.
- Fig.39 shows a handle portion during actuating a rear group of pivoting elements.
- a device 10 comprising a frontal working portion 12, a rear handle portion 14, and an intermediate barrel portion 16.
- the working portion may be activated and consecutively affixes two opposite ends of a graft to an internal wall of a vessel.
- the graft is preferably put on the barrel portion such that the graft preferably extends along both the barrel portion and the working portion and covers them.
- the graft may be a pliable tube made of a plastic material having good compatibility with the bodily tissues.
- the elastic properties of the graft material preferably ensure that when the graft is put on the barrel portion, the graft adjoins the barrel portion preferably without (however) exerting pressure on it.
- the graft includes an outside diameter of at least about 5 mm and a wall thickness of about 0.2 mm.
- An example of a suitable plastic material for grafts may be Teflon or PTFE (PolyThetraFluorEthylene).
- the outside diameter of grafts which can be reliably affixed to the femoral artery (for example) by a device according to some embodiments of the present invention, may be between about 6-8 mm.
- the length dimension of the graft depends on the vessel to which the graft has to be affixed. In practice, it may vary between about 300 and 500 mm. Accordingly, the length of the barrel portion may be at least 300 mm, according to some embodiments.
- the barrel portion when using the device, may be brought within a vessel, where the graft has to be affixed.
- the device In Fig.l, the device is shown without the graft; and in Fig.2, the device is shown with the barrel portion carrying a graft 18 put thereon.
- Two opposite ends of the graft may be provisionally connected to the device such that a proximal end 20 of the graft may be provisionally connected to the handle portion 14, and a distal end 22 of the graft is provisionally connected to the working portion 12. It will be discussed below that upon affixing the distal end of the graft, the proximal end may no longer provisionally connect to the handle portion; and thus relative displacement of the barrel portion along the vessel becomes possible.
- FIG.3 it is shown how an operator's hand 24 can hold the handle portion.
- the handle portion is provided with two opposite handles 26, 28 which can be pressed to approach each other to operate the device and to activate the working portion.
- a removable swiveling latch 30 which locks the handles when brought into an upright position.
- Fig.3 the device is shown as ready for operation, except the handle portion is locked by the latch 30 and can be unlocked to bring one handle close to the other handle.
- the device allows introduction of a graft into the femoral artery (for example) and affixing the graft preferably at two ends of the internal wall of the artery. This is preferably affected first at a distal end 34 of the artery and then at a proximal end 36 of the artery.
- the device allows delivering the graft inside the femoral artery by introducing the barrel portion where the graft surrounds the barrel portion.
- the barrel portion may be introduced through a transversal incision 38 cut in the hip portion near the proximal end 36.
- Fig. 5 shows the device gripped by an operator's hand and brought towards the leg to carry out the endovascular prosthesis procedure according to some embodiments.
- Fig. 6 shows the barrel portion after it has been protracted in a distal direction, designated by an arrow D. As shown, the barrel portion has been protracted distally within the artery until the working portion 12 of the device approaches the distal end 32 of the artery where the distal end of the graft preferably is affixed. The device is shown ready for affixing the graft. According to some embodiments, the following exemplary method may be used to affix a graft using the device. The operator unlocks the handle portion by swiveling the latch and pressing the handles so as to actuate the working portion.
- Fig.7 shows the distal end 22 of the graft located within the artery and being delivered there by the barrel portion.
- the graft is provisionally connected to the working portion by a surgical fastener, e.g. staple 42 slightly protruding into wall 40.
- the working portion may be loaded with two groups of staples, which which may comprise frontal groups and rear groups (for example).
- the staple 42 shown in Fig.7 belongs to one of the frontal groups of staples.
- the frontal group of staples preferably affixes the distal end of the graft and the rear groups of staples preferably affixes the proximal end of the graft.
- the handle portion 14 may be operated by the operator's hand 24 which presses the handles 26,28 so as to activate the working portion 12.
- the staple 42 of the frontal group and preferably along with the other staples (not shown), protrude out of the working portion until the staples pierce the wall 40 of the graft and a wall 44 of the artery.
- the staples may then secure the distal end 32 of the graft 18 at the distal end 34 of the artery 32. It should be appreciated that, according to some embodiments, upon the staples protruding, the staples escape the working portion; releasing the distal end of the graft from the working portion.
- the handle portion Upon release of the working portion from the distal end of the graft, the handle portion is also preferably disconnected from the proximal end of the graft; and at this point the barrel portion is free to be displaced proximally from the artery, leaving the graft inside the artery with the its distal end affixed to the distal end of the artery.
- the mechanism responsible for protrusion of the frontal group of staples is discussed in more detail below.
- the working portion 12 of the device is shown retracted from the artery 32 in a proximal direction, designated by an arrow P.
- the operator has not yet operated the handle portion, which is still in the operator's hand 24.
- the handle portion may be operated by the operator's hand to activate the working portion.
- the working portion is shown such that a rear staple 46 together, with the rest of the staples, may forcibly protrude towards the wall 44 of the artery.
- the staple pierces the wall 40 of the graft and the wall 44 of the artery and thus affixes the proximal end 20 of the graft at the proximal end 36 of the artery.
- An example of this situation can be seen in Fig.12 staples of the rear group are not shown).
- the graft is secured within the artery and the barrel portion 16 may be evacuated from the artery 32 by retracting it in the proximal direction P as shown in Fig.13.
- the device comprises the working portion 12, the handle portion 14, and the barrel portion 16.
- the working portion 12 comprises a main body portion 48 preferably adapted to accommodate therein a plurality of pivoting wings and pivoting levers, which may be divided into frontal groups and rear groups.
- the frontal and rear groups are respectively preferably intended to displace a plurality of the frontal staples and a plurality of the rear staples towards the vessel wall and thus to subsequently affix the distal and the proximal end of the graft to the vessel wall.
- Fig. 14 partially shows one such frontal group of wings and levers, designated by a common numeral 50.
- the rear group of wings and levers is not shown.
- the frontal end of the main body portion may be closed by a plug 52, which may be securable on the main body portion by fasteners (e.g., screws) 54, 56 or fastening means.
- the handle portion may comprise lower handle 26 and upper handle 28.
- the handle 26 can be pivoted about an axle 58 upon manually pressing the handles together.
- the upper handle 28 may be provided with' a lever arm 60 terminating in end 62.
- the lower handle 26 may be provided with a tubular housing 64 which may be connected to the handle 26 via an intermediate portion 66.
- the lever arm 60 is preferably accommodated within the intermediate portion 66, with the possibility for displacement therein such that upon pressing the handles, the end 62 can reciprocate within the housing 64.
- the handle portion may be further provided with the swiveling latch 30, which is intended for preventing the handles from inadvertent encroachment.
- the latch When the handle portion is assembled and the device is ready for operation, the latch may be forcibly held in a locked up-right position by a spring 68. To operate the device, the handles can be unlocked by moving the latch against the spring 68 from the up-right position to a horizontal position.
- Some embodiments of the handle portion may further comprise a spring guide shaft 70, an inner guiding bushing 72, a collet member 74, a biasing spring 76, and an external guiding bushing 78.
- a plurality of fasteners (e.g., screws or other fastener types/means) 80 may be provided for securing the collet member and/or the other elements of the handle portion at the housing 64.
- the barrel portion may comprise a pushing rod 82, a barrel 84, and an entry port 86.
- Figs.15, 16, 17 and 18 illustrate the construction of the working portion, according to some embodiments.
- Fig.15- shows a side view of the device with two cross-sectional planes A-A and B-B drawn through the frontal and the rear groups of the wings and levers.
- Fig.16 depicts an exploded view of the working portion with its main elements, which may comprise a main body portion 48 accommodating therein, for example, the frontal and rear groups of wings and levers.
- the main body portion may include a tubular shape, which may include appropriate longitudinally directed cut outs for receiving at least one of and preferably both of the frontal and the rear groups of wings and levers.
- a bore may be provided which extends through the main body and preferably receives therein the pushing rod and preferably provides for the pushing rod's linear and/or rotational displacement within the main body portion.
- the main body portion can accommodate three frontal groups of wings and levers and three rear groups of wings and levers.
- Fig.16 an exploded view of one frontal group is shown, namely a frontal group 90 and one rear group, namely a rear group 92.
- Plug 52 with fasteners 54, 56 is also shown.
- the main body portion is provided with longitudinal cut-outs, in which the frontal and the rear groups of the wings and levers reside with the possibility for pivoting.
- the frontal group 90 is shown to reside in one of the cut-outs 94.
- the rear group 92 is shown to reside in another cut-out 96 (for example).
- the remaining frontal and rear groups of wings and levers may also reside within respective longitudinal cut outs, see for example the frontal group 98.
- the frontal group 90 may include a pivoting wing 100 provided with a longitudinal slot 102, a pivoting lever 104, and a frontal slotted element 106, which may be securable at the wing by one or more fasteners (e.g., screws) 108, 110 (for example).
- the pivoting wing may include an elongated shape, which may terminate at one side thereof by a root end 112 provided with a hole 114 for receiving a pivot axle.
- the wing may terminate at the opposite side thereof by a butt end 116 having a cut out 118. This cut out may be configured and dimensioned such that a U-shaped staple 42 can be loaded into the cut out when the frontal group 90 is being assembled and deployed in the cut out 94.
- the pivoting lever 104 When the device is assembled, the pivoting lever 104 may be located in the slot 102 , which allows pivoting of the lever.
- the frontal slotted element may include a couple of holes 109, 111; and in the butt end of the wing, there may be provided corresponding threaded bores.
- the staple preferably remains in place since, when the fasteners 108,110 are threaded, the frontal element 106 may close the staple and apply elastic force thereon due to a slot 113 made in the frontal slotted element 106. By virtue of this, the staple is pressed towards the butt end and remains substantially in place. At the same time, this elastic force, according to some embodiments, does not prevent the possibility for radial sliding of the staple along the cut out 118, and thus the staple can be forced to exit from the wing when the lever 104 pivots.
- the pivoting lever 104 may include a rear end 120 which may be provided with a hole 124 and curved side 122.
- the pivoting lever may be provided with a front end 126, which preferably exerts a pushing force on the frontal staple 42 when the lever is urged to pivot.
- a longitudinal slot 128 may be provided in the wing body such that the root end 112 of the wing 100 can be deployed in this slot, which allows for forcible pivoting of the wing.
- a pivot axle 130 is provided and a depression 132 is made in the main body portion.
- a hole 134 may be included in the depression such that when the wing 100 and the lever 104 are deployed in the main body portion, the holes 114, 124 and 134 align to allow insertion of the pivot axle 130.
- main body portion Within the main body portion (according to some embodiments) are preferably deployed altogether three frontal groups of wings and levers and three rear groups of wings and levers. AU these groups are preferably designed and assembled similarly to what has been discussed above with reference to the frontal group 90.
- the frontal groups are located in the frontal region of the main body portion and may be symmetrically distributed along its circumference with an interval of 120 degrees.
- An exploded view of the rear group 92 is shown in Fig. 16. It should be appreciated that the group 92 may be arranged similarly to the frontal group 90. For the sake of brevity, only some of elements of the rear group 92 are described further.
- 92 includes rear staple 46, a rear pivoting wing 101, and a rear pivoting lever 105 having a front end 127 and a curved side 122' and a slotted element 107.
- Three such rear groups may be provided and they are deployed in the rear region of the main body portion behind the frontal groups and are remote therefrom.
- the rear groups may also be symmetrically distributed along the circumference of the main body portion with an interval of about 120 degrees (for example), however they are preferably located in such a manner that each rear group is displaced at about 60 degrees (for example) with respect to each frontal group such that, in some embodiments, none of the rear groups is aligned with any of the frontal groups.
- the plug 52 may be secured at a forward end 136 of the main body portion by fasteners 54, 56, which pass through corresponding holes 138, 140 and are threaded into corresponding threaded bores 142, 144 made in the forward end.
- the plug has a cover portion 146, in which the holes 138, 140 may be provided and may include a cone stem portion 148, which protrudes into the main body portion via a window 149 in the forward end.
- the direction of the cone portion may be selected in such a manner that when the fasteners 54, 56 have been fastened in the main body portion, the cone portion pushes the front ends of the levers of the frontal groups and urges the levers to pivot in a clockwise direction (for example). This in turn urges the staples loaded in the frontal wings to slightly protrude out of the working portion.
- a graft may be placed on the barrel portion such that it also covers the working portion. Therefore, fastening of fasteners 54, 56 and pivoting of the frontal levers may be associated with the protrusion of frontal staples from the working portion into the graft. This preferably provides provisional connection of the graft to the working portion as mentioned above with reference to Fig.2.
- Fig. 17 is a cross-sectional view taken along plane A-A shown in Fig.15.
- three groups of frontal wings 100, 100', 100" are shown as well as a plurality of frontal staples 42,42',42" and front ends 126,126',126" of the respective frontal levers.
- the above elements may be symmetrically distributed on the circumference of the main body portion with an interval of about 120 degrees (for example).
- the frontal staples preferably slightly protrude from the working portion into graft 18, thus providing provisional connection between the distal end of the graft and the working portion.
- Fig. 18 is a cross-sectional view taken along plane B-B shown in Fig.15.
- the above elements of frontal groups may be symmetrically distributed along the circumference of the main body portion with an interval of about 120 degrees (for example).
- each rear group is preferably different from the frontal group, i.e., each rear group (for example) is preferably displaced at about 60 degrees (for example) with respect to each frontal group, such that none of the rear groups is in alignment with any of the frontal groups.
- none of the rear staples protrudes into graft 18 (as shown).
- Fig. 19 shows that securing the plug 52 on the forward end 136 of the main body portion, in some embodiments,causes the cone portion 148 to approach front ends of the frontal levers and to urge them to pivot about their respective pivot axles.
- the levers pivot in respective slots made in the respective wings. The pivoting motion of the levers force the frontal staples to slightly protrude out of the main body portion such that sharpened ends of the staples pierce the wall of the graft 18.
- frontal staple 42, 42', wings 100, lever 104 are also shown.
- Fig. 19 also shows some elements of the rear groups, such as rear staple 46, one rear wing 101, and rear lever 105.
- a rearmost portion 151 of the main body portion may be configured with a circular slot 150, which receives a forward most end 152 of the barrel.
- the slot 150 and the end 152 may be threaded such that the barrel can be detachably connected to the main body portion. It should be appreciated that upon the graft 18 being placed on the barrel, it may cover the working portion as well as the barrel. Furthermore the pushing rod 82 is shown extended through the working portion.
- Fig. 20 depicts how sharpened ends 420, 420', 420" of the frontal staples slightly protrude into a wall of the graft 18 that is put over the working portion, thus providing the provisional connection between the graft and the working portion, according to some embodiments. It also can be appreciated that the staples may be retained between butt ends of the respective wings and slotted frontal elements. One may also appreciate that similar combinations of elements exist in all frontal groups of pivoting wings and levers.
- Pivoting ofthe levers causes protrusion ofthe staples in a radial direction towards the graft wall and preferably results in affixing the graft to the vessel.
- the pushing rod 82 is depicted and may comprise a shaft portion 154, a rear end 156 and a forward head 158.
- the shaft portion may be long and relatively thin; and in order to render it sufficiently rigid, it is divided into a plurality of regions 160 of a larger diameter D, preferably interspersed with a plurality of regions 162 of a smaller diameter d.
- the length ofthe regions 160 may be 1 and the length ofthe regions 162 may be L. In practice, the length 1 can be equal with the length L.
- the pushing rod can be manufactured from metallic or plastic material, e.g. from stainless steel 316L or from Polycarbonate.
- the length ofthe shaft portion may be about 530 mm
- the length 1 ofthe regions 160 and the length L ofthe regions 162 may be about 30 mm
- the diameter D may be about 4-5 mm
- the diameter d may be about 1.5-2 mm.
- the forward head is situated adjacent to the region 162, and may comprise a cylindrical rear portion 166 having diameter D, as the regions 160 ofthe shaft portion.
- the reminder ofthe head portion may also have diameter D; and in the bulk thereof, three symmetrically arranged longitudinal recess zones 168, 170, 172 may be included.
- the recess zones are preferably delimited by three respective non-recessed zones 174, 176 and 178, such that recess zone 168 may be delimited by adjacent non-recessed zones 174 and 178; recess zone 170 may be delimited by adjacent non-recessed zones 174, 176; and recess zone 172 may be delimited by adjacent non-recessed zones 176, 178.
- the recessed zones and the non-recessed zones are preferably arranged symmetrically on the circumference ofthe forward head such that they are spaced from each other by about 60 degrees (for example).
- Each recess zone may be defined by a ledge 180 and a ledge 182, which may be arranged as steps having vertical walls 184, 186.
- the recess zones and the non-recessed zones are preferably configured in such a manner that when the pushing rod is forcibly advanced along the working portion, the recess zones are situated (preferably at all times) between either the frontal groups or the rear groups of pivoting wings and levers; thus, preferably with no engagement between the recess zones and the pivoting elements.
- the outside diameter D of the working head may be selected in such a manner that the circumference of the non-recessed zones may engage the wings and levers either of the frontal groups or of the rear groups and therefore, may actuate them and urge the wings and levers to pivot (for example).
- Figs. 23-28 show the working portion 12 after it has been brought into a vessel, e.g., in artery 44.
- the graft 18 is put on the barrel 84 and covers the working portion (for example).
- the forward most end 152 of the barrel 84 may be threaded into the rear most portion 151 of the main body portion, which receives the forward head 158 of the pushing road.
- Fig. 23 shows a situation when the graft is brought into the vessel with the aim of affixing the distal end of the graft to a position in the vessel. This situation has been depicted already with reference to Fig. 6.
- the forward head of the pushing rod is at an initial position, in which it neither engages the rear groups nor the frontal groups of the wings and levers (for example).
- Wing 100 and lever 104 of the frontal group, as well as wing 101 and lever 105 of the rear group, are seen as being received (preferably fully) within the respective cut-outs of the main body portion and are not pivoted yet.
- Frontal staple 42 protrudes slightly into graft 18, for example, after plug 52 has been secured at the forward end 136 of the main body portion to provide provisional connection between the graft and the working portion. In this embodiment, the graft is not yet affixed to the vessel.
- the rear staples in such an embodiment, do not protrude into the graft.
- Fig. 24 shows a situation in which the pushing rod has been further advanced distally by the handle portion.
- the advancement mechanism is described below.
- the pushing rod may be angularly oriented within the barrel in such a manner that when the pushing rod is displaced distally, the circumference of the non-recessed zones of the forward head 158 engages the wings of the frontal groups and causes them to pivot clockwise (for example).
- Fig. 24 shows how the wing 100 has been pivoted outside of the working portion by the circumference of the non-recessed zone 178. Also shown, the pivoted wing has stretched the graft in radial direction (for example). During pivoting, the wing 100 preferably does not displace the frontal staple 42.
- the lever 104 has not yet been pivoted, according to the present embodiment, and remains in the same position within the wing as shown in Fig. 23.
- the rear groups of the pivoting wings were not actuated since they are not aligned with the frontal groups. They are arranged within the working portion in such a manner that, during advancement of the pushing rod, the recessed zones of the forward head preferably freely pass along the rear groups without engaging them, thus not actuating the wings and the levers. Pivoting wing 101 and pivoting lever 105 are shown located within the working head and not actuated yet. It will be appreciated, although not shown, that all three rear groups of wings and levers have not been actuated yet and remain so far in place.
- Fig. 25 shows a third position of the pushing rod 82, according to some embodiments, in which it has been advanced distally still further, such that its forward head approached curved side 122 of the lever 104 and caused it to pivot. Due to the pivoting, the front end 126 of the lever 104 forces the frontal staple 42 to displace from the cut-out provided in the butt end of the wing. The staple may be displaced towards the graft wall to an extent that, at the end of the lever pivoting motion, it pierces the vessel wall. By virtue of this provision, the distal end of the graft becomes affixed to the vessel. It is not shown in Fig. 25, but is shown in Fig.
- the cut-out 118 made in the butt end 116 of the wing 100 may be configured with a flaring exit.
- This configuration which is better seen in Figures 17, 18, causes the sharpened ends of the staple to slightly bend outside when the staple exits from the working portion. The bent ends eventually render affixing of the graft to the vessel more reliable. Furthermore, the protrusion of the staple ends within the graft may be facilitated in that the graft remains stretched in a radial direction by the wing when the staple pierces it. It will also be appreciated that all groups of the wings and levers can be designed with flaring exit.
- Fig. 26 shows a situation when the barrel portion and the working portion are brought to the proximal end of the vessel and the device is ready for affixing the proximal end of the graft to the proximal end of the vessel according to some embodiments. After the distal end of the graft has been affixed, the proximal end of the graft preferably disconnects from the handle portion.
- the barrel portion is then free for retracting proximally along the graft until the working portion is brought to a new location, which is the proximal end of the graft to be affixed to the proximal end of the vessel.
- the pushing rod may be forcibly rotated within the barrel portion to an extent that, upon distal protracting of the barrel portion, the non-recessed zones engage and actuate the rear groups of the wings and levers.
- Fig. 26 shows that the pushing rod protracted distally in a position in which it is close to the wing 101.
- the lever 105 may be engaged and actuated, which, in turn, may result in protruding the rear staple 46 into graft 18 and then into vessel wall 44.
- Fig. 26 also shows that upon bringing the working portion to the new location, the wing 100 and lever 104 of the frontal groups may return to the non-pivoted position and may be fully received in the main body portion. It should be appreciated that all three frontal groups have returned to the same non-pivoted position.
- Fig. 27 shows the pushing rod after it has been further protracted, in which the forward head 158 engages the wing 101 to cause its pivoting outside of the working portion, according to some embodiments.
- the pivoting motion is associated with stretching the graft 18 in a radial direction as explained above in connection with Fig. 25.
- the lever 105 may not yet be actuated and the rear staple 46 remains in place. It will be appreciated that despite describing only elements of one rear group , all three rear groups have been engaged and actuated simultaneously and in a similar way.
- Fig. 28 shows a still further advanced position of the pushing rod, in which its forward head 158 contacts the curved side 122' of the lever 105, according to some embodiments. This urges the lever to pivot with respect to wing such that forward end 127 of the lever pushes the rear staple 46 to protrude into graft 18, to pierce the vessel 44 and eventually to affix the proximal end of the graft to the proximal end of the vessel. It will be appreciated that despite describing only elements of one rear group, all three rear groups have been engaged and actuated simultaneously and in a similar way.
- Fig. 29 shows the handle portion when it is assembled and the graft when it is placed over the barrel.
- the rear end of the graft may be provisionally connected to the handle portion.
- the handle portion may comprise housing 64 with the intermediate portion 66 receiving therein the lever arm 60.
- the lever arm can pivot within the intermediate portion upon pressing or release of handles 26, 28.
- spring guide shaft 70 Within the housing is located spring guide shaft 70 with the biasing spring 76 put thereon.
- An abutment disc 188 may be located between the proximal end of the spring and the upper end 62 of the lever arm.
- the arrangement is such that when the handles are brought closer together, the upper end 62 of the lever arm may advance distally within the housing against the spring; and when the handles are released, the upper end of the lever arm may be forced by the spring to retract proximally.
- the disc may be connected to the disc guide shaft 70, and thus relative rotational displacement is allowed between the spring guide shaft and the upper end of the lever arm.
- a limit screw 190 (for example) may be provided, which, upon threading into a rear wall 192 of the housing, protrudes towards the end 62 of the lever arm. The extent of retraction of the lever arm can be adjusted by the limit screw.
- a torsion spring 196 may be provided, which one end is connected by a fastener (e.g., screw) to the forward end 194 of the housing and which second end is connected by a fastener (e.g., screw) 200 to a rear end 202 of the guide shaft 70.
- the rear end of the inner guiding bushing 72 may be connected to the spring guide shaft 70 such that release of the torsion spring is associated with forcible clockwise rotation of the inner guiding bushing 72 together with the spring guide shaft 70.
- the inner guiding bushing and the spring guide shaft are rotated by the torsion spring relative to the other elements of the handle portion, i.e., relative to the collet member and to the external guiding bushing.
- fasteners 80, 80' Secured at the forward end 194 by fasteners (e.g., screws) 80, 80' may be a rear end of the collet member 74.
- the rear end of the pushing rod 82 may be connected with the forward end of the spring guide shaft 70 such that either reciprocating longitudinal displacement or rotational displacement of the guide shaft 70 is transferred to the pushing rod 82.
- Fig. 29 shows that the handle portion, which may comprise the inner guiding bushing 72, the collet member74 and the external guiding bushing 78, which may surround the pushing rod.
- a forward bushing 204 may be provided, through which the pushing rod passes.
- the forward bushing is preferably secured within the collet member by one or more fasteners (e.g., screws) 206, 208.
- the forward bushing may function as a slide bearing in which the pushing rod can. longitudinally reciprocate and rotate. It is seen also that the rearmost end of the barrel 84 may be secured within the forward bushing 204 and that the graft 18 may be placed on the barrel.
- the proximal end 20 of the graft may be fastened between the barrel and a forward most end 210 of the collet member 74. Therefore, the graft may be provisionally connected to the handle portion. It will be apparent further that the graft disconnects from the handle portion when the handles are brought closer together, causing the external guiding bushing to be protracted distally with respect to the collet member.
- the handle portion may be fitted with a guiding screw 212 (for example), which may include a lower portion protruding within a longitudinal slot made in the collet member. Due to the guiding screw, it is preferably ensured that the external guiding bushing linearly displaces along the collet member.
- the handle portion may be fitted with a pushing pin 214, secured within a depression made in the forward most end of the spring guide shaft 70.
- Fig. 30 shows the external guiding bushing 78.
- the external bushing may be configured as a tube, in which one end may be opened and which opposite end may be provided with two separate, longitudinal slots 216, 218.
- the slots are preferably parallel to the longitudinal axis of the external guiding bushing and may be separated at the circumference of the bushing by 60 degrees.
- the width dimension of the slots may be selected to slightly exceed the outside diameter of the guiding pin 212 such that the pin can easily slide along the slots.
- a depression 220 may be provided, which terminates by a threaded bore 222 made in the wall of the bushing.
- the depression may be configured and dimensioned so as to fully receive the pushing pin 214.
- the opened end of the external guiding bushing may be configured with a lip portion 224. The lip portion may abut the forward-most end of the collet member such that the rear end of the graft is clamped between the collet member and the barrel.
- Fig. 31 shows the collet member 74.
- the collet member may comprise a rear end 202, which may be securable at the housing 64 of the handle portion.
- the collet member may include a stem portion 226, which may be configured as a tube in which a forward end may be provided with a plurality of longitudinal cuts 228-234 defining respective leaves 236-242.
- the inside diameter of the stem portion as well as the length and width dimension of the cuts may be selected in such a manner that when the handle portion is assembled and the external guiding bushing is put over the collet member, the leaves may be forcibly bent inwardly and clamp the rear end of the graft between the collet member and the barrel.
- the stem portion is preferably provided with an annular groove 246, into which the lip portion 224 of the bushing 78 snaps.
- Two parallel longitudinal slots 248, 250 may be cut in the rear part of the stem portion. The slots are preferably separated at the circumference of the stem portion by 60 degrees.
- the longitudinal slots preferably communicate adjacent to the rear end 202 of the collet member via a transversal slot 252. The width dimension of the longitudinal slots and of the transversal slot may be selected to slightly exceed the outside diameter of the guiding pin 212 such that it can easily slide along all the slots.
- the inner guiding bushing may be configured as a tube which one end 262 is faceted.
- a longitudinal slot 264 may be cut within the wall of the inner guiding bushing. The width dimension of the slot may be selected to slightly exceed the outside diameter of the guiding pin 212 such that it can easily slide along the slot.
- a hole 266 is shown in the rear part of the inner bushing member. This hole may be used to receive the fastener which connects one end of the torsion spring to the inner bushing member.
- Figs.33-39 show how some embodiments of the device may be used in practice (methods of use according to some embodiments of the invention).
- the device is shown ready for operation.
- the handles 26 and 28 may be locked by the latch 30.
- the graft 18 is put on the barrel portion and the working portion is assembled such that plug 52 causes the distal end 22 of the graft to be provisionally connected to the working portion by a plurality of the frontal staples.
- the handle portion may be assembled such that the lip portion of the external guiding bushing 78 presses on the forward-most end 210 of the collet member 74 and causes the proximal end of the graft to be provisionally fastened between the barrel 84 and the collet member.
- Pushing rod 82 is preferably not yet protracted towards the frontal groups of the wings and levers.
- Fig. 34 depicts a situation when the barrel portion with the graft is brought into a vessel, e.g., a femoral artery 32, in accordance with some embodiments of the invention.
- the latch may be removed and the handles may be pressed such that the lever arm 60 urges the spring guide shaft 70 against the biasing spring 76 to protract distally together with the pushing rod 82.
- the guiding pin 212 preferably slides in a distal direction along slot 218 made in the external guiding bushing 78 and along slot 250 made in the collet member.
- the recessed zones of the pushing rod passes along the rear groups of the wings and levers without engaging them.
- the pushing rod approaches the frontal groups of the wings, the non- recessed zones of the forward head approach them and cause them to pivot. This may be associated with tensioning of the graft wall as it has been explained above with reference to Fig.24.
- the length of the slot 218 may be selected in such a manner that when the wings have been pivoted, the guiding pin 212 still does not approach the distal end of the slot.
- Fig. 35 shows a step when the handles were brought closer such that they almost approached each other, in accordance with some embodiments of the invention. This is associated with additional protracting of the spring guide shaft 70 and of the pushing rod 82 in a distal direction.
- the pushing rod preferably engages and preferably actuates the levers of the frontal groups, as explained with reference to Fig. 24: i.e., it pushes a plurality of the frontal staples to protrude out of the working portion such that the staples penetrate the graft wall and the vessel wall and reliably affix the distal end of the graft to the distal end of the vessel.
- the length of the slot 218 may be deliberately selected in such a manner that when the guide shaft 70 has been protracted distally, the guiding pin 212 approaches distal end of the slot 218 and eventually pushes external bushing 78 in a distal direction until its lip portion escapes from the annular groove of the collet number.
- Fig. 35 shows that after the external bushing has been displaced distally, a gap 262 is provided between the end of the external bushing and the forward end 196 of the housing 64.
- Fig. 36 shows the situation when the external bushing 78 has been pushed by the pushing pin distally, and there is no connection between the handle portion and the proximal end 20 of the graft.
- Fig. 37 shows the situation when the barrel portion and the working portion have been brought to a location where the proximal end of the graft should be affixed, in accordance with some embodiments of the invention.
- the operator releases handles 26, 28 to allow the biasing spring 76 to forcibly retract the shaft 70 together with the pushing rod 82 proximally.
- the handles of the handle portion may be locked by the latch 30 swiveled in the upright position.
- torsion spring 196 urges the shaft 70 to rotate clockwise along with the inner guiding bushing and the pushing rod 82.
- the rotation movement is allowed since the gap 262 is provided between the external bushing and the housing 60, and thus, the guiding pin 212 is free to slide along the transversal slot made in the collet member.
- the length of the transversal slot 252 may be deliberately selected in such a manner that the pin slides circumferentially along the slot 252 from a first position, in which it has been aligned with the longitudinal slot 218, into a second position, in which it will be now aligned with the longitudinal slot 216.
- the longitudinal slots may be circumferentially separated from one another by about 60 degrees (for example), and thus, the pushing rod will be turned circumferentially by the torsion spring exactly to the same extent.
- the non-recessed zones of the forward head may now engage and actuate the rear groups of the wings and levers if the pushing rod is protracted distally.
- Fig.38 and Fig. 39 show a device of the invention during affixing the proximal end of the graft, in accordance with some embodiments of the invention.
- the latch 28 may be released and swiveled in a horizontal position such that the operator can press the handles 26,28 to bring them close. Pressing the handles may be associated with protracting the spring shaft 70 and the pushing rod 82 towards the rear groups of wings and levers.
- the spring shaft 70 is then free to protract distally since the guiding pin can now slide along the longitudinal slot 216 of the external bushing 78 and along longitudinal slot 248 of the collet member.
- the further protracting of the pushing rod may be associated with pivoting of the rear levers and affixing the graft by a plurality of rear staples 46 as seen in Fig. 39, as has been explained with reference to Fig. 25 and Fig. 35.
- the terms "stent”, “graft” or “stent-graft” refer to an intraluminal medical accessory serving as a prosthesis intended to be placed and secured in a body of a human or an animal patient.
- the term "vessel” refers to any hollow vessels or ducts or cavities available in a mammal body. Non-limiting examples of such passages are arteries, veins, intestines, etc.
- staple refers to an example of a surgical fastener, a fastener being capable of affixing a prosthesis to a vessel.
- affixing refers to the physical attachment of one object to another.
- pump refers to an example of an extender, an extender being capable of expanding, spreading or stretching forth.
Abstract
Description
Claims
Priority Applications (6)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
PCT/IL2008/000398 WO2009118719A1 (en) | 2008-03-23 | 2008-03-23 | Device for affixing prosthesis to a vessel |
EP08720023A EP2268210A1 (en) | 2008-03-23 | 2008-03-23 | Device for affixing prosthesis to a vessel |
CA2719345A CA2719345A1 (en) | 2008-03-23 | 2008-03-23 | Device for affixing prosthesis to a vessel |
AU2008353831A AU2008353831A1 (en) | 2008-03-23 | 2008-03-23 | Device for affixing prosthesis to a vessel |
CN2008801293962A CN102112065A (en) | 2008-03-23 | 2008-03-23 | Device for affixing prosthesis to vessel |
RU2010139759/14A RU2489102C2 (en) | 2008-03-23 | 2008-03-23 | Device for fixation of prosthesis to vessel |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
PCT/IL2008/000398 WO2009118719A1 (en) | 2008-03-23 | 2008-03-23 | Device for affixing prosthesis to a vessel |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2009118719A1 true WO2009118719A1 (en) | 2009-10-01 |
Family
ID=39938229
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/IL2008/000398 WO2009118719A1 (en) | 2008-03-23 | 2008-03-23 | Device for affixing prosthesis to a vessel |
Country Status (6)
Country | Link |
---|---|
EP (1) | EP2268210A1 (en) |
CN (1) | CN102112065A (en) |
AU (1) | AU2008353831A1 (en) |
CA (1) | CA2719345A1 (en) |
RU (1) | RU2489102C2 (en) |
WO (1) | WO2009118719A1 (en) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN114765947A (en) * | 2019-11-18 | 2022-07-19 | 巴克外科有限公司 | Anastomosis coupler |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE102017115898A1 (en) * | 2017-07-14 | 2019-01-17 | Jotec Gmbh | Intraluminal vascular prosthesis |
Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20050209685A1 (en) * | 2004-03-17 | 2005-09-22 | Shifrin Edward G | Graft delivery and anchoring system |
WO2005089059A2 (en) * | 2004-03-24 | 2005-09-29 | Shifrin Edward G | Laparoscopic aortic repair by intravascular devices |
WO2006082574A2 (en) * | 2005-02-01 | 2006-08-10 | Shifrin Edward G | Apparatus and method for delivery and double-ended fixation of vascular grafts or stent-grafts |
Family Cites Families (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
SU1713564A1 (en) * | 1989-07-03 | 1992-02-23 | Военно-Медицинская Краснознаменная Академия Им.С.М.Кирова | Surgical suturing apparatus |
-
2008
- 2008-03-23 EP EP08720023A patent/EP2268210A1/en not_active Withdrawn
- 2008-03-23 AU AU2008353831A patent/AU2008353831A1/en not_active Abandoned
- 2008-03-23 CA CA2719345A patent/CA2719345A1/en not_active Abandoned
- 2008-03-23 RU RU2010139759/14A patent/RU2489102C2/en not_active IP Right Cessation
- 2008-03-23 CN CN2008801293962A patent/CN102112065A/en active Pending
- 2008-03-23 WO PCT/IL2008/000398 patent/WO2009118719A1/en active Application Filing
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20050209685A1 (en) * | 2004-03-17 | 2005-09-22 | Shifrin Edward G | Graft delivery and anchoring system |
WO2005089059A2 (en) * | 2004-03-24 | 2005-09-29 | Shifrin Edward G | Laparoscopic aortic repair by intravascular devices |
WO2006082574A2 (en) * | 2005-02-01 | 2006-08-10 | Shifrin Edward G | Apparatus and method for delivery and double-ended fixation of vascular grafts or stent-grafts |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN114765947A (en) * | 2019-11-18 | 2022-07-19 | 巴克外科有限公司 | Anastomosis coupler |
CN114765947B (en) * | 2019-11-18 | 2023-11-14 | 巴克外科有限公司 | Anastomotic coupler |
Also Published As
Publication number | Publication date |
---|---|
RU2489102C2 (en) | 2013-08-10 |
CA2719345A1 (en) | 2009-10-01 |
EP2268210A1 (en) | 2011-01-05 |
CN102112065A (en) | 2011-06-29 |
RU2010139759A (en) | 2012-04-27 |
AU2008353831A1 (en) | 2009-10-01 |
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