CA2074521C - Device having a prosthesis implanted in a patient - Google Patents
Device having a prosthesis implanted in a patientInfo
- Publication number
- CA2074521C CA2074521C CA002074521A CA2074521A CA2074521C CA 2074521 C CA2074521 C CA 2074521C CA 002074521 A CA002074521 A CA 002074521A CA 2074521 A CA2074521 A CA 2074521A CA 2074521 C CA2074521 C CA 2074521C
- Authority
- CA
- Canada
- Prior art keywords
- prosthesis
- catheter
- meshwork
- probe
- cover
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2002/9505—Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2002/9505—Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
- A61F2002/9511—Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument the retaining means being filaments or wires
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0063—Three-dimensional shapes
- A61F2230/0091—Three-dimensional shapes helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
Abstract
The device comprises a prosthesis designed as a hollow body which is compressed against the action of restoring forces to a reduced cross section - compared with its expanded in-use shape and it is held in this position by means of an unravellable cover. Once the cover has been unravelled, the prosthesis expands automatically to assume the appropriate cross sectional shape for its in-use position. The cover, which may take the form of a crocheted meshwork, extends over the entire length of the prosthesis and consists of at least one continuous thread and at least one unravelling line. The prosthesis, which is held in the radially compressed position by the cover, can be advanced along a guide wire or it may be mounted in an axially fixed manner on the leading end of a probe or of a catheter.
Description
-2- 207452~
Device with a prosthesis for implantation in the body of a patient The invention relates to a device with a prosthesis, in the forrn of a hollow body, which can be implanted in the body of a patient, especially in 5 a blood vessel or in another body cavity; the said prosthesis can be compressed, by overcoming the action of shape-restoring spring forces, to a reduced cross-sectionai size compared with its - expanded - size when in use; once the forces holding the prosthesis in its compressed state are removed, the prosthesis autornaticaliy expands to assume the cross 10 sectional dimensions appropriate to the site where it is used.
Devices of this type are already known and are used for the percutaneous implantation of, in particular, vascular prostheses. Prostheses with an enlargeable lumen which are introduced percutaneously can either be expanded mechanically by means of a known balloon catheter from a 15 small radius to the larger radius in order to hold open the lumen in a vessel, or, after being compressed prior to implantation, they expand again by themselves under the action of the force exerted by compressed and therefore pretensioned springs.
Various systems are know by means of which self-expanding spring-20 loaded vascular prostheses can be introduced into the body of a patient andthen, by removing the restraining force, can be implanted and anchored in the vessel.
In the most commonly used method, which is described in ~P-A-0 183 372, an endoprosthesis in the form of a tubular hollow body is 25 compressed to a reduced cross section and then, while still compressed, is inserted using a pusher device through a catheter which has previously been inserted into the vessel, until the prosthesis reaches its correct position in the vessel. However, the disadvantage of this system is that a considerable amount of force is needed to push the prosthesis through the catheter 30 because of the large frictional forces acting against it.
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i 207~52~
Device with a prosthesis for implantation in the body of a patient The invention relates to a device with a prosthesis, in the forrn of a hollow body, which can be implanted in the body of a patient, especially in 5 a blood vessel or in another body cavity; the said prosthesis can be compressed, by overcoming the action of shape-restoring spring forces, to a reduced cross-sectionai size compared with its - expanded - size when in use; once the forces holding the prosthesis in its compressed state are removed, the prosthesis autornaticaliy expands to assume the cross 10 sectional dimensions appropriate to the site where it is used.
Devices of this type are already known and are used for the percutaneous implantation of, in particular, vascular prostheses. Prostheses with an enlargeable lumen which are introduced percutaneously can either be expanded mechanically by means of a known balloon catheter from a 15 small radius to the larger radius in order to hold open the lumen in a vessel, or, after being compressed prior to implantation, they expand again by themselves under the action of the force exerted by compressed and therefore pretensioned springs.
Various systems are know by means of which self-expanding spring-20 loaded vascular prostheses can be introduced into the body of a patient andthen, by removing the restraining force, can be implanted and anchored in the vessel.
In the most commonly used method, which is described in ~P-A-0 183 372, an endoprosthesis in the form of a tubular hollow body is 25 compressed to a reduced cross section and then, while still compressed, is inserted using a pusher device through a catheter which has previously been inserted into the vessel, until the prosthesis reaches its correct position in the vessel. However, the disadvantage of this system is that a considerable amount of force is needed to push the prosthesis through the catheter 30 because of the large frictional forces acting against it.
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ln another method (to which no reference could be found in the patent literature) a sheath covering the endoprosthesis and keeping it compressed is then retracted at the implantation site. Here again, it is disadvantageous that large frictional forces have to be overcome. In 5 addition, the tubular system created by the sheath covering the pros~hesis is extremely rigid and this makes it very difficult for the system to pass through twists and turns in the vessel when it is being inserted.
In a further system (US Patent 4 732 152) a woven and resilient prosthesis is held in the compressed state by a double sheath which is 10 seaied at the distal end. This sheath is withdrawn from the compressed prosthesis in the same way that a person removes a sock from their foot. In order to reduce the resulting friction, the space between the two sheaths can be filled with a liquid. Although this system may at first appear elegant because of the way in which it reduces the frictional resistance, it is in fact 15 extremely cumbersome to use and requires two persons to manipulate it.
In contrast, the purpose of the invention is to create a device, which is particularly simple and easy to use, for implanting a prosthesis, and in particular a vascular prosthesis, having the form of a hollow body.
This task has been solved in the following manner. In the device 20 described in the preamble to Patent Claim 1 the prosthesis is surrounded by an unravellable cover, consisting of at least one continuous thread, and compressed to a reduced cross section; and at least one unravelling line extends away from the cover holding the prosthesis in iJIS radially compressed position, and the thread of which the cover is made can be 25 retracted.
Therefore, in the device according to the invention, the prosthesis is held in its radially compressed position by this externai cover and it does not expand into its desired configuration, under the action of the pretensioning force generated by the compression, until this unravellable cover is 30 removed.
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The cover may in particular be a meshwork made by crocheting, tying, knotting or some other means of making meshes.
Advantageously, the prosthesis, which i5 held in the radially compressed state by means of an unravellable cover, can be mounted and 5 advanced on a probe, such as a flexible guide wire. Using a device o~ ~his configuration, implantation is carried out by inserting the guide wire in the known manner into a vessel an~ then advancing the prosthesis, while radially cornpressed, along the guide wire; this can be done, for example, by using a sleeve, which is also advanced along the guide wire and which 10 engages against the end of the prosthesis opposite from the leading end of the prosthesis.
In another embodiment, on the other hand, the prosthesis, which is held radially compressed by the unravellable cover, is mounted in an axially fixed manner on the leading end of a probe. Th;s probe may be, in 15 particular, a catheter which is advanced along a guide wire.
Even when the compressed prosthesis is axially firmly mounted on the leading end of a probe or a catheter, it is still simple to carry out the implantation ~y advancing the probe or catheter, with the prosthesis mounted at its tip, for example while monitoring progress on an X-ray 20 screen, until the implantation site is reached; here the cover, which is made for example of an encircling meshwork, is unravelled, the prosthesis is released, and it expands automatically to assume its correct implanted posltlon .
When the prosthesis is arranged at the leading end of a probe or a 25 catheter, it has proved advantageous to mount the prosthesis on a non-slip substrate surrounding the probe or the catheter, so that no undesired slipping or sliding can occur while the thread material of which the meshwork is formed is being removed.
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207~21 Advantageously, the self-expanding prosthesis may be a tubular structure made by crocheting or knitting or by some other method of producing a mesh fabric, using metal or plastic thread material which is well tolerated by body tissues. This tube is compressible against the action of 5 pretensioning forces and, once the restraining ~orces have been removed, it expands automatically into and retains its expanded shape at the implantation site.
In a further logicai refinement of a prosthesis having a mesh structure, successive rows of meshes can be made alternately of resorbable 10 and non-resorbable thread material. In this way, within a predetermined time following impiantation, the resorbable material dissolves and only the parts of the prosthesis made of non-resorbable thread material are left behind in the body of the patient. These remaining sections form rings of successive open loops. This avoids any thread crossings which could exert undesired 15 shear forces on the tissues surrounding and growing around the prosthesis.
In the case of this last discussed refinement, it is also possible to embed medication in the resorbable thread material so that the prosthesis forms a depot for medication which is gradually released as the resorbable thread material progressively dissolves.
A particularly advantageous embodirnent of the invention is characterized by the design of the tubular meshwork which holds the prosthesis in th0 compressed state, wherein after each encirclernent of the prosthesis the rows of meshes change direction, and when successive rows of meshes are unravelled the thread sections which form the stitches detach themselves from the prosthesis by unravelling alternately from left to right and from right to left.
The advantage of this embodiment is that the successive rows of meshes, encircling the prosthesis alternately from left to right and from right to left, can be unravelled without the thread material becoming wrapped around the prcbe or catheter on which the prosthesis is mounted, or ~: .: . . .
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-6- ~074521 without becoming twisted, which would create friction and thus make it difficult to continue withdrawing the thread material.
In the aforementioned embodi~ent, it has also proved advantageous if the unravellable loops or knots of the successive rows o~ meshes 5 surrounding the prosthesis are arranged opposite each oth~r or sne behind the other in a substantially axial row.
In another important embodiment of the invention, the unravelling line extends from the mesh surrounding the leading end of the prosthesis and thus the prosthesis progressively expands into its implanted position, 10 starting at its distal end, as the meshwork is unravelled.
In this further embodiment of the invention, the thread material can never come between the already expanded section of the prosthesis and, for example the wall of a vessel, as the meshwork is unravelled and the thread withdrawn. Instead, the thread material runs at all times along the still intact15 meshwork and thus in the zone where the prosthesis is still compressed.
The ends of the thread material of which the meshwork is made up can be secured by means of untieable knots, such as slip-knots, and thus be held in place regardless of the fact that they can be undone. One particularly simple means of axially fixing the prosthesis on a probe, or on a catheter 20 acting as a probe, consists of elamping the end of the thread forming the meshwork and one end mesh in holes on the probe or on the catheter, but in such a way that they can be released from this position by pulling on the unravelling line. However, the start of the thread may also be clamped between the probe and a sleeve mounted thereon.
The meshwork is particularly securely held, but nonetheless easy to unravel, if a loop extends from the knot of the first mesh on the unraveiling side of the meshwork and passes throu~h a hole; and in the area of the said knot one end of this loop merges into the unravelling line. In this way, the .
"' - ' ' , ~' ', said loop can be pulled through the aforernentioned knot and thereafter all the meshes making up the meshwork can be unravelled one after the other.
According to another logical embodiment oF the invention, the prosthesis can also be held in its radially compressed position by means of 5 meshwork fitted Trom the distal end of the probe or catheter and ext~ndiny over the tip of the prosthesis, and by means of another meshwork fitted in the opposite direction, namely from the proximal end, and extending over the end meshes of the first meshwork. It has proved advantageous, in this case, for the two meshworks to be unravelled in opposite directions by the 10 unravelling lines, starting in each case from their loop-shaped end meshes.
With such a configuration, when the prosthesis mounted on a probe or catheter has been correctly positioned in a vessel, the meshwork fitted from the distal end is unravelled first, starting by removing the end mesh furthest away from the distal end and proceeding gradually until this 15 meshwork has been completely unravelled and the thread material has been withdrawn. Next, the meshwork applied from the proximal end is unravelled, starting with the end mesh pointing towards the distal end, and then progressing towards the proximal end. It can be seen that when the two meshworks are unravelled in this manner, the self-expanding prosthesis 20 gradually and progressively expands, from its distal to its proximal end, to occupy its intended implantation site.
In another important configuration, the cover holding the prosthesis in its radially compressed position consists of axially spaced loops encircling the prosthesis, wherein thread material from a thread running longitudinally 25 through the inside of the prosthesis is passed at intervals through a hole inthe prosthesis, and the ends of the loops are taken back into ~he interior of the prosthesis through other holes peripherally adjacent to the first holes, and a warp thread also running longitudinally inside the prosthesis is passed through the ends of the IQOPS, thereby holding them in their encircling 30 position. It can be seen that, in this configuration, the prosthesis is released by withdrawing the warp thread from the end sections of ~he loops and 207~521 finally the thread material forming the ioops, as well as the warp thread, can be simp!y withdrawn.
In a similar embodiment of the invention, the cover retaining the prosthesis in its radially compressed position consists of axially spaced 5 loops encirclin~ the prosthesis, wherein thread material From a thrcad running longitudinally through the prosthesis is drawn through holes in ~he prosthesis, and the ends of the loops are taken back in~o the interior of the prosthesis through holes axially spaced from the first-mentioned holes, and are secured in position by passing through the end of each loop extending 10 into the interior oF th~ prosthesis another loop, formed by the thread material runnin~ inside the prosthesis; this second loop is then taken to the outside of the prosthesis by passing it through the next hole following in the axial direction, and it is then again passed around the prosthesis and the end of the loop is passed in the same way back through a hole and into the 15 prosthesis and is secured in this position. In this configuration, as well, it is a simple matter to unravel the cover holding the prosthesis in its radially compressed position by means of the thread, of which the loops encircling ~he prosthesis are made up, which extends from the last loop.
In the interest of ensuring particularly tight encirclemen~ and thus 20 compression of the prosthesis, it has also proved advantageous to make the meshwork from shrinkable thread material. The unravellable meshwork may also consist of several threads running parallel to each other.
In another important embodiment of the invention, at least one other cover is provided between the prosthesis and the cover holding the 25 prosthesis in the radially compressed state; this other cover loosely surrounds the prosthesis and, when the outer cover is unravelled, it permits partial expansion of the prosthesis and can itself then be unravelled.
In this embodiment, therefore, a cover, which may take the form of a meshwork, is directiy but loosely fitted, i.e. with a sertain amount of play, 30 on the prosthesis; and the prosthesis and this inner cover are tightly ~ ,~ .: : ,. , ~ a 7 ~
surrounded by an outer cover which holds the prosthesis, together with the other sheath fitted directly over it, in the radially compressed position.
Consequently, the prosthesis is, as it were, wrapped in tWD layers and once the outer cover has been unravelled the prosthesis may expand only within 5 the limits allowed by the inner cover. Final implantation is then achi~ved by unravelling the inner cover, i.e. in stages.
It goes without saying that it is possible to provide several meshworks, each surroundillg the others with a certain amount of play, so that the prosthesis can be allowed to expand in several successive stages.
Within the scope of the invention, the intervening spaces between the meshes in a meshwork surrounding the prosthesis and holding it in the compressed state may be filled and smoothed out with gelatine, or a similar substance, which dissolves in the body of a patient. This makes it easier to insert such a device.
According to another embodiment, at least ons end of the prosthesis can be encircled in the compressed state by a sleeve; because of the axial shortening of the prosthesis which occurs when the latter expands, this end is then pulled out of the sleeve encircling it. Such a sleeve may be firmly mounted on the probe or on a catheter with its open side facing towards the 20 prosthesis, e.g. at the distal end. This achieves a smooth transition at the front end of the prosthesis, seen in ths direction of insertion, and it simplifies the insertion of the prosthesis.
In the interest of obtaining better fixation of the prosthesis on a prohe or on a catheter used for that purpose, the end of the prosthesis facing 25 away from the leading end may abut against a radially projecting step or shoulder or against a sleeve mounted on the probe or catheter.
in another embodiment of the invention, in which a catheter is used as the probe, the unravelling lins is passed through a hole in the wall of the :. . .:
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207~521 catheter near the end of the prosthesis and into the lumen of the catheter, then runs through ~he lumen and extends beyond the end of the catheter.
However, it is also possible to use a double-lumen catheter as the probe, wherein one lumen is used for advancing the catheter alon~ a guide 5 wire and the unravelling line is passed through the other lumen.
When a single- or double-lumen catheter is used as the probe, wherein the unravelling line passes through the lumen of the catheter, there is no possibility of the walls of the vessels or other body cavities into which the prosthesis is implanted being damaged by the unraveliing line or by the 10 thread material which is withdrawn through the catheter lumen when the meshwork is unravelled.
It has aiso proved advantageous to provide the unravelling line and/or thread material of the meshwork with a friction-reducing lubricant.
Also, at least the unravelling line may be made from a metal thread, 15 or it may be treated with an admixture of metal so that it shows up well on an X-ray image.
Finally, according to another embodiment, the prosthesis which is held in its radially compressed position by means of the unravellable cover may also - in the expanded state after removal of the sheath - assume a 20 trumpet-shaped configuration at its proximal end. This configuration of the prosthesis is important when the latter is implanted at a point where one vessel branches from another, because there is always a risk of the prosthesis sliding into the branching vessel. But, the trumpet-shaped enlargement at the proximal end effectively prevents such slippage during 25 implanting, when the cover surrounding the prosthesis is unravelled, starting at the proximal end.
207~21 An embodiment of the device according to the invention will be explained below on the basis oF the attached drawing. The diagrammatic views presented are as follows:
Fig. 1: depicts a catheter with a vascular prosthesis mounted on its distal end and held radially pretensioned in a compressed position by a cover in the form of a tubular, unravellable crocheted meshwork;
Fig. 2: illustrates the formation of an initial mesh in the crocheted cover surrounding the prosthesis, using a loop brought around the vascular prosthesis from the Fight-hand side;
Fig. 3: is a diagram similar to Fig. 2 and illus~rates the formation of the next mesh linking up with the starting mesh and encircling the vascular prosthesis from the left-hand side;
Fig. 4: in a view similar to Fig. 1 depicts a device in which the vascular prosthesis mounted on the catheter is held radially pretensioned in its compressed position by means of unravellable crocheted covers fitted frorn the distal and proximal ends respectively;
Fig. 5: shows the device as seen in Fig. 4, but simply with the crocheted cover Fitted from the distal end;
Fig. 6: shows the device as seen in Fig. 4 merely with the crocheted cover fitted from the proximal end, and omitting the crocheted cover shown in Fig. 5;
Fig. 7: depicts, by itself, a vascular prosthesis held in a radially compressed position by means of encircling loops;
207~521 Fig. 8: is a view, similar to that in Fig. 7, of a prosthesis, wherein the loops holding the latter in a radially compressed position are formed by crocheting, and Fig. 9: is a view of an unrolled s~ction of a vascular prosthesis made of knitted fabric In the device 10 illustrated in Fig. 1, an elongated catheter 11 with a continuous lumen is used as the probe; and the ca~heter is advanced by means of the lumen, along a guide wire inserted in known manner into a 10 vessel. Near the distal end 12 of the catheter 11 is mounted a prosthesis 15 which is held in a compressed position under radial pretension by means of a crocheted meshwork covering 14; after the restraining force of the meshwork has been removed, the prosthesis expands au~omaticaliy to assume its intended irnplanted position. The prosthesis may, for example, 15 consist of a knitted tube which can be compressed radially, against a restorative spring force into a position where it ~ightly encloses the catheter close to its distal end.
The prosthesis 15 is enclosed by a crocheted meshwork 14, made from one continuous thread, in which the successive meshes encircle the 20 prosthesis alternately on one side and then the other, i.e. alternately from right to left or left to right. The initial section 17 of the thread material, which is arranged ahead of the first mesh 16 at the distal end 12 of the catheter 11, is drawn through a slit 18 in the wall of the catheter; it is wedged in the said slit and then taken through the lumen of the catheter 25 and led out beyond the distai end of the catheter. An unravellable loop 22 isdrawn through a knot 21 which ties off the final rnesh 20 at the opposite end from the distal end; the said loop is drawn through two axially spaced slits 23, 23' in the wall of the catheter, and thus is also axially tightly clamped .
30The free end of the thread drawn through the knot 21 of the said final mesh 20, forms an unravelling line 24, running along the length of the .
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207~2~
catheter 11, by means of which the loop 22 hetd clamped in the catheter is unravelled by drawing it through the said end knot, and then gradually the meshes of the crocheted meshwork encircling the prosthesis and keeping it compressed can also be unravelled. Since the meshes enclrcle the 5 prosthesis 15 from right to left and left to right, the thread detaches itselffrom the mesh knots alternately on the right and Icft side of the catheter as the mesh unravels; and after the last mesh at the distal end is unravelled, the initial section 17 of the thread material can be withdrawn from the slit 18 where it is clamped at the distal end 12 of the catheter 1 1.
Figs. 2 and 3 show in enlarged view the way in which the meshes are formed, with the catheter 15 being encircled alternatingly from the back and from the front; for the sake of simplicity, in these Figures the catheter is shown as a rigid tubular object. After the initial section 17 of the thread material has been secured by clamping it in the slit 18, as shown in Fig. 1, 15 the thread is wrapped around the catheter, then a loop 26 is pulled through under the thread; then, from the free thread material 27 a mesh is forrned, taken around the back of the catheter and then drawn through the loop 26;
the section of mesh drawn through the aforementioned loop 26 forms in turn a loop 28 for making the next mesh in ~he sequence. Fig. 2 shows in 20 solid lines the free thread material 27 before it is drawn through the loop 26, and the broken lines depict it after it has been pulled through this loop, and they also depict the formation of loop 28 for the next mesh.
To form the next mesh, which is shown in Fig. 3, the free thread material, taken from position 31 in fact of the catheter, is drawn through 25 the previously formed loop 28, thereby forming ano~her loop 30 in the manner indicated by the dotted lines; this method of forming loops and meshes by means of thread material drawn alternately behind and in front of the catheter and through the appropriate loop, is continued until the prosthesis mounted on the catheter is covered over its entire length by a 30 crocheted meshwork.
~07~521 The end mesh 20 is formed by drawing the loop 22 through the associated end loop or through a knot 21 formed by tightening this loop;
then, as illustrated schematically in Fig. 1, the loop 22 is drawn through and clamped in the two slits 23, 23' spaced a certain axial distance apart in the 5 wall of the catheter. The remaining thread material then forms the unravelling line 24 which extends from the loop of the end mesh 20 and permits ~he encircling crocheted meshwork to be unravelled; when this happens, the thread material from the unravelled meshes detaches itself alternately first on the one side and then on the other side of the prosthesis 10 15, and as a result the prosthesis is released and permitted to expand under the action of the pretension ~uilt up by the radial compression caused by the fitting of the meshwork covering.
Also in the embodiment 40 shown in Fig. 4, a prosthesis 45 is mounted near the distal end 42 of an elongated catheter 41 and is held 15 compressed under radial pretension. This is achieved by the crocheted meshworks 46, 47, each shown separately in Figs. 5 and ~ respectively.
Like the catheter 11 in the embodiment shown in Fig. 1, the catheter 41 is also advanced along a ~uide wire which has been previously positioned in the vessel, and in this manner the prosthesis 45 mounted on the catheter 20 can be positioned correctly in the vessel before being implanted by unravelling the meshwork.
The two crocheted meshworks shown holding the prosthesis 45 compressed in Fig. 4 are applied one after the other, starting with meshwork 46 frorn the distal end. The other meshwork 47 is fitted from the 25 proximal end and then covers the end of the first meshwork 46.
Fig. 5 shows that the catheter 41 is fitted at its distal end vvith a silicon sleeve 43 which serves to fix the starting section 48 of the thread from which the first meshwork is crocheted. For this purpose, the starting section 48 of this thread is drawn under the silicon sleeve 43. Next, the first 30 rneshes 49 are crocheted onto the calheter 41 in the manner described above in conjunction with Figs. 1 to 3, and these meshes provide a firm : , .
207~2~
anchorage on the catheter for the first meshwork.The subsequent meshes 5û extend over the end of the prosthesis 41 pointing towards the distal end of the catheter, compressing this end of ~he prosthesis under radial pretension, while simultaneously axially fixing the prosthesis on the 5 catheter, as shown in Fig. 5. A last mesh 51 of this crocheted meshwork 46 is then laid down on the outside of ~he prosthesis 45, and from this mesh extends the thread 52 which serves as a line for unravelling the meshes in the said meshwork.
Fig. 6 illustrates the fitting of the second crocheted meshwork 47 10 starting from the proximal end. The start 55 of the thread material of which this meshwork is made up is again fixed by passing it under a silicon sleeve 54 fitted on the catheter 41. Next some meshes 56 are crocheted onto the catheter towards the distal end, and these are followed by further meshes 57 which encircle the prosthesis 41, while simultaneously compressing it 15 radially, and they extend over and thereby secure the meshes 50, 51 of the first meshwork 46 facing away from the distal end of the meshwork 46. A
last mesh 58 of the meshwork 47 applied from the proximal end is then drawn under the silicon sleeve 43 fitted at the distal end of the catheter and thus secured. Furthermore, the thread ~0 extends away from the distally 20 oriented end mesh of the meshwork 47, which is applied from the proximal end, ànd this thread is used to unravel the meshes of the crocheted meshwork.
The prosthesis 45 in the embodiment illustrated in Figs. 4 to 6, like the embodiment seen in Figs. 1 to 3, is held compressed under radial 25 pretension on the catheter 41, and once the crocheted meshworks 46, 4 have been removed, it expands automaticaliy to occupy its intended location. Once the prosthesis mounted on the catheter has been introduced into a vessel and correctly positioned therein, it is implanted by first removing the meshwork 46 which has been applied from the distal end.
30 This is done by unravelling the meshes in this meshwork by means of the unravelling line 52, so that first the mesh 51, which is overlain by the distal end of the meshwork applied from the proximal end, and then gradually the meshes 50 and 49 adjoining towards the distal end are unravelled, until finally the first mesh adjacent to the silicon sleeve 43 is unravelled and the start of the thread 48 is withdrawn from beneath the silicon sleeve.
The end of the prosthesis 45 pointing towards the distal end o~ the 5 catheter is released by unravelling the meshwork 46 which is applied from the distal end; when this happens, this end of the prosthesis expands radially due to the pretensioning forces inherent in the prosthQsis, while the remainder of the prosthesis is still held compressed by the crochete~
meshwork 47 applied from the proximal end. The partially expanded 10 prosthesis 45 is axially fixed on the one hand by the adhesion between the catheter and the prosthesis, and on the other by a silicon sleeve 62, against which the prosthesis is axially supported, mounted at the proximal end of the prosthesis 45 on the catheter ~1.
Once the first croclleted meshwork 46 is unravelled, the meshwork 15 47 applied from the proximal end is also unravelled, namely by means of the unravelling line 60 extending away from the end mesh 58 at the distal end.
It can be seen that by pulling on the unravelling line, to start with the loop 58 held beneath the silicon sleeve 43 at the distal end will be unravelled and the meshes 57 and 56 will be progressively unravelled from the distal end to 20 the proximal end, and the prosthesis 45 will expand radially and come to rest against the walls o~ a vessel which requires to be fitted with a prosthesis. Once the unravelling process is complete, the end 55 of the thread hetd beneath the silicon sleeve 54 at the proximal end is withdrawn.
The prosthesis 45 is then detached ~rom the catheter and the latter can be 25 withdrawn in a simple manner from the vessel.
The prosthesis 70 illustrated in Fig. ~ is also tubular in shape and selF-expanding. It may be made of a mesh fabric, e.g. of knitted structure. The prosthesis is provided with pairs of holes 71, 72 arranged at approximately equal axia! distances from one another. Loops 74 encircle the prosthesis on 30 the outside and serve to hold the prosthesis in its radially compressed state.
Each loop consists of thread material from a thread 7~ running Isngitudinal!y , ., : . .
.-.... ... ~ .. ..
2~7~
inside the prosthesis and drawn through holes 71; the thread then forms a loop which tightly encircles the prosthesis and the end of the loop 76 is then drawn back inside the prosthesis through a hole 72 paired with the corresponding hole 71. The loops are secured in the encircling posi~ion 5 shown in Fig. 7 by means of a warp thread 78 passing throu0h the ends o~
the loops 76 inside the prosthesis.
The advantage of the embodiment according to Fig. 7 is that the prosthesis 70 is radially compressed by these encircling loops 74, which are spaced at substantialiy equal axial distances frorn each o~her and have no 10 external knots, but instead are form~?d by a thread 75 running longitudinallyinside the prosthesis and held tightly in place by means of the warp thread 78 also running longitudinally inside the prosthesis.
The prosthesis according to Fig. 7 is mounted, radially compressed, near the distal end of a catheter in the same way as described above in 15 conjunction with Figs. 1 to 6 and it is implanted in a vessel ~y advancing the catheter. Once it has been correctly positioned in the vessel, the prosthesis is implanted in a simple manner by Yvithdrawing the warp thread 78 from the ends 76 of the loops 74, whereupon the prosthesis 70 expands radially under its own pretensioned spring force to assume its intended 20 implanted position. The thread 75 used to form the loops can then also be withdrawn in a simple manner.
The embodiment illustrated in Fig. 8 differs from the embodiment according to Fig. 7 in that the axially spaced loops 7~' encircling the prosthesis 70' are formed by crocheting. For this purpose, thread rnaterial 25 from the thread 75 running longitudinally inside the prosthesis is drawn out through a hole 71' in the prosthe~is and wrapped around the prosthesis as a loop 74', and also the loop end 76' of the thread is again taken back inside the prosthesis through a hole 72' axially spaced from the aforementioned hole 71. Thread material is then drawn through the end of the loop 76' 30 inside the prosthesis to form a further loop which is then taken to the exterior through a hole 71' following in the axial direction, and it is then also , , , - . ,. ~
207~521 wrapped around the prosthesis as loop 74', and the loop end which is taken back inside the prosthesis through a further hole 72' ;s secured in the same way as in the case of the first loop.
Fig. ~ illustrates an unrolled section of a vascular prosthesis ~0 made 5 of a knitted fabric in which alternatingly a thread 81 made frorn resorbable material and a thread 82 made of non-resorbable material are knitted together with each other. The non-resorbable thread material may, for example, be tantalum.
The advantage of such a prosthesis is that, after a certain amount of 10 time has elapsed following implantation, the resorbable thread material will be dissolved and all that is left behind in the patient's body are the non-biodegradable components. These remaining components form encircling rings consisting of a series of open loops. This design avoids thread crossings which might exert unnecessary shear forces on the tissues 15 surrounding and growing around the prosthesis.
Prostheses according ~o Fig. 9 may also be designed in a simple manner to act as medication depots, by embedding in the resorbable thread material medical agents which are released when this material breaks down.
.
- . : ~ , , - .
., . ., , . ~ . , .
.
In a further system (US Patent 4 732 152) a woven and resilient prosthesis is held in the compressed state by a double sheath which is 10 seaied at the distal end. This sheath is withdrawn from the compressed prosthesis in the same way that a person removes a sock from their foot. In order to reduce the resulting friction, the space between the two sheaths can be filled with a liquid. Although this system may at first appear elegant because of the way in which it reduces the frictional resistance, it is in fact 15 extremely cumbersome to use and requires two persons to manipulate it.
In contrast, the purpose of the invention is to create a device, which is particularly simple and easy to use, for implanting a prosthesis, and in particular a vascular prosthesis, having the form of a hollow body.
This task has been solved in the following manner. In the device 20 described in the preamble to Patent Claim 1 the prosthesis is surrounded by an unravellable cover, consisting of at least one continuous thread, and compressed to a reduced cross section; and at least one unravelling line extends away from the cover holding the prosthesis in iJIS radially compressed position, and the thread of which the cover is made can be 25 retracted.
Therefore, in the device according to the invention, the prosthesis is held in its radially compressed position by this externai cover and it does not expand into its desired configuration, under the action of the pretensioning force generated by the compression, until this unravellable cover is 30 removed.
. - . . . .
,, ~ ' -'~ : ., 207~2~
The cover may in particular be a meshwork made by crocheting, tying, knotting or some other means of making meshes.
Advantageously, the prosthesis, which i5 held in the radially compressed state by means of an unravellable cover, can be mounted and 5 advanced on a probe, such as a flexible guide wire. Using a device o~ ~his configuration, implantation is carried out by inserting the guide wire in the known manner into a vessel an~ then advancing the prosthesis, while radially cornpressed, along the guide wire; this can be done, for example, by using a sleeve, which is also advanced along the guide wire and which 10 engages against the end of the prosthesis opposite from the leading end of the prosthesis.
In another embodiment, on the other hand, the prosthesis, which is held radially compressed by the unravellable cover, is mounted in an axially fixed manner on the leading end of a probe. Th;s probe may be, in 15 particular, a catheter which is advanced along a guide wire.
Even when the compressed prosthesis is axially firmly mounted on the leading end of a probe or a catheter, it is still simple to carry out the implantation ~y advancing the probe or catheter, with the prosthesis mounted at its tip, for example while monitoring progress on an X-ray 20 screen, until the implantation site is reached; here the cover, which is made for example of an encircling meshwork, is unravelled, the prosthesis is released, and it expands automatically to assume its correct implanted posltlon .
When the prosthesis is arranged at the leading end of a probe or a 25 catheter, it has proved advantageous to mount the prosthesis on a non-slip substrate surrounding the probe or the catheter, so that no undesired slipping or sliding can occur while the thread material of which the meshwork is formed is being removed.
. ~ :
207~21 Advantageously, the self-expanding prosthesis may be a tubular structure made by crocheting or knitting or by some other method of producing a mesh fabric, using metal or plastic thread material which is well tolerated by body tissues. This tube is compressible against the action of 5 pretensioning forces and, once the restraining ~orces have been removed, it expands automatically into and retains its expanded shape at the implantation site.
In a further logicai refinement of a prosthesis having a mesh structure, successive rows of meshes can be made alternately of resorbable 10 and non-resorbable thread material. In this way, within a predetermined time following impiantation, the resorbable material dissolves and only the parts of the prosthesis made of non-resorbable thread material are left behind in the body of the patient. These remaining sections form rings of successive open loops. This avoids any thread crossings which could exert undesired 15 shear forces on the tissues surrounding and growing around the prosthesis.
In the case of this last discussed refinement, it is also possible to embed medication in the resorbable thread material so that the prosthesis forms a depot for medication which is gradually released as the resorbable thread material progressively dissolves.
A particularly advantageous embodirnent of the invention is characterized by the design of the tubular meshwork which holds the prosthesis in th0 compressed state, wherein after each encirclernent of the prosthesis the rows of meshes change direction, and when successive rows of meshes are unravelled the thread sections which form the stitches detach themselves from the prosthesis by unravelling alternately from left to right and from right to left.
The advantage of this embodiment is that the successive rows of meshes, encircling the prosthesis alternately from left to right and from right to left, can be unravelled without the thread material becoming wrapped around the prcbe or catheter on which the prosthesis is mounted, or ~: .: . . .
. - :, : ., .
-6- ~074521 without becoming twisted, which would create friction and thus make it difficult to continue withdrawing the thread material.
In the aforementioned embodi~ent, it has also proved advantageous if the unravellable loops or knots of the successive rows o~ meshes 5 surrounding the prosthesis are arranged opposite each oth~r or sne behind the other in a substantially axial row.
In another important embodiment of the invention, the unravelling line extends from the mesh surrounding the leading end of the prosthesis and thus the prosthesis progressively expands into its implanted position, 10 starting at its distal end, as the meshwork is unravelled.
In this further embodiment of the invention, the thread material can never come between the already expanded section of the prosthesis and, for example the wall of a vessel, as the meshwork is unravelled and the thread withdrawn. Instead, the thread material runs at all times along the still intact15 meshwork and thus in the zone where the prosthesis is still compressed.
The ends of the thread material of which the meshwork is made up can be secured by means of untieable knots, such as slip-knots, and thus be held in place regardless of the fact that they can be undone. One particularly simple means of axially fixing the prosthesis on a probe, or on a catheter 20 acting as a probe, consists of elamping the end of the thread forming the meshwork and one end mesh in holes on the probe or on the catheter, but in such a way that they can be released from this position by pulling on the unravelling line. However, the start of the thread may also be clamped between the probe and a sleeve mounted thereon.
The meshwork is particularly securely held, but nonetheless easy to unravel, if a loop extends from the knot of the first mesh on the unraveiling side of the meshwork and passes throu~h a hole; and in the area of the said knot one end of this loop merges into the unravelling line. In this way, the .
"' - ' ' , ~' ', said loop can be pulled through the aforernentioned knot and thereafter all the meshes making up the meshwork can be unravelled one after the other.
According to another logical embodiment oF the invention, the prosthesis can also be held in its radially compressed position by means of 5 meshwork fitted Trom the distal end of the probe or catheter and ext~ndiny over the tip of the prosthesis, and by means of another meshwork fitted in the opposite direction, namely from the proximal end, and extending over the end meshes of the first meshwork. It has proved advantageous, in this case, for the two meshworks to be unravelled in opposite directions by the 10 unravelling lines, starting in each case from their loop-shaped end meshes.
With such a configuration, when the prosthesis mounted on a probe or catheter has been correctly positioned in a vessel, the meshwork fitted from the distal end is unravelled first, starting by removing the end mesh furthest away from the distal end and proceeding gradually until this 15 meshwork has been completely unravelled and the thread material has been withdrawn. Next, the meshwork applied from the proximal end is unravelled, starting with the end mesh pointing towards the distal end, and then progressing towards the proximal end. It can be seen that when the two meshworks are unravelled in this manner, the self-expanding prosthesis 20 gradually and progressively expands, from its distal to its proximal end, to occupy its intended implantation site.
In another important configuration, the cover holding the prosthesis in its radially compressed position consists of axially spaced loops encircling the prosthesis, wherein thread material from a thread running longitudinally 25 through the inside of the prosthesis is passed at intervals through a hole inthe prosthesis, and the ends of the loops are taken back into ~he interior of the prosthesis through other holes peripherally adjacent to the first holes, and a warp thread also running longitudinally inside the prosthesis is passed through the ends of the IQOPS, thereby holding them in their encircling 30 position. It can be seen that, in this configuration, the prosthesis is released by withdrawing the warp thread from the end sections of ~he loops and 207~521 finally the thread material forming the ioops, as well as the warp thread, can be simp!y withdrawn.
In a similar embodiment of the invention, the cover retaining the prosthesis in its radially compressed position consists of axially spaced 5 loops encirclin~ the prosthesis, wherein thread material From a thrcad running longitudinally through the prosthesis is drawn through holes in ~he prosthesis, and the ends of the loops are taken back in~o the interior of the prosthesis through holes axially spaced from the first-mentioned holes, and are secured in position by passing through the end of each loop extending 10 into the interior oF th~ prosthesis another loop, formed by the thread material runnin~ inside the prosthesis; this second loop is then taken to the outside of the prosthesis by passing it through the next hole following in the axial direction, and it is then again passed around the prosthesis and the end of the loop is passed in the same way back through a hole and into the 15 prosthesis and is secured in this position. In this configuration, as well, it is a simple matter to unravel the cover holding the prosthesis in its radially compressed position by means of the thread, of which the loops encircling ~he prosthesis are made up, which extends from the last loop.
In the interest of ensuring particularly tight encirclemen~ and thus 20 compression of the prosthesis, it has also proved advantageous to make the meshwork from shrinkable thread material. The unravellable meshwork may also consist of several threads running parallel to each other.
In another important embodiment of the invention, at least one other cover is provided between the prosthesis and the cover holding the 25 prosthesis in the radially compressed state; this other cover loosely surrounds the prosthesis and, when the outer cover is unravelled, it permits partial expansion of the prosthesis and can itself then be unravelled.
In this embodiment, therefore, a cover, which may take the form of a meshwork, is directiy but loosely fitted, i.e. with a sertain amount of play, 30 on the prosthesis; and the prosthesis and this inner cover are tightly ~ ,~ .: : ,. , ~ a 7 ~
surrounded by an outer cover which holds the prosthesis, together with the other sheath fitted directly over it, in the radially compressed position.
Consequently, the prosthesis is, as it were, wrapped in tWD layers and once the outer cover has been unravelled the prosthesis may expand only within 5 the limits allowed by the inner cover. Final implantation is then achi~ved by unravelling the inner cover, i.e. in stages.
It goes without saying that it is possible to provide several meshworks, each surroundillg the others with a certain amount of play, so that the prosthesis can be allowed to expand in several successive stages.
Within the scope of the invention, the intervening spaces between the meshes in a meshwork surrounding the prosthesis and holding it in the compressed state may be filled and smoothed out with gelatine, or a similar substance, which dissolves in the body of a patient. This makes it easier to insert such a device.
According to another embodiment, at least ons end of the prosthesis can be encircled in the compressed state by a sleeve; because of the axial shortening of the prosthesis which occurs when the latter expands, this end is then pulled out of the sleeve encircling it. Such a sleeve may be firmly mounted on the probe or on a catheter with its open side facing towards the 20 prosthesis, e.g. at the distal end. This achieves a smooth transition at the front end of the prosthesis, seen in ths direction of insertion, and it simplifies the insertion of the prosthesis.
In the interest of obtaining better fixation of the prosthesis on a prohe or on a catheter used for that purpose, the end of the prosthesis facing 25 away from the leading end may abut against a radially projecting step or shoulder or against a sleeve mounted on the probe or catheter.
in another embodiment of the invention, in which a catheter is used as the probe, the unravelling lins is passed through a hole in the wall of the :. . .:
: : .
207~521 catheter near the end of the prosthesis and into the lumen of the catheter, then runs through ~he lumen and extends beyond the end of the catheter.
However, it is also possible to use a double-lumen catheter as the probe, wherein one lumen is used for advancing the catheter alon~ a guide 5 wire and the unravelling line is passed through the other lumen.
When a single- or double-lumen catheter is used as the probe, wherein the unravelling line passes through the lumen of the catheter, there is no possibility of the walls of the vessels or other body cavities into which the prosthesis is implanted being damaged by the unraveliing line or by the 10 thread material which is withdrawn through the catheter lumen when the meshwork is unravelled.
It has aiso proved advantageous to provide the unravelling line and/or thread material of the meshwork with a friction-reducing lubricant.
Also, at least the unravelling line may be made from a metal thread, 15 or it may be treated with an admixture of metal so that it shows up well on an X-ray image.
Finally, according to another embodiment, the prosthesis which is held in its radially compressed position by means of the unravellable cover may also - in the expanded state after removal of the sheath - assume a 20 trumpet-shaped configuration at its proximal end. This configuration of the prosthesis is important when the latter is implanted at a point where one vessel branches from another, because there is always a risk of the prosthesis sliding into the branching vessel. But, the trumpet-shaped enlargement at the proximal end effectively prevents such slippage during 25 implanting, when the cover surrounding the prosthesis is unravelled, starting at the proximal end.
207~21 An embodiment of the device according to the invention will be explained below on the basis oF the attached drawing. The diagrammatic views presented are as follows:
Fig. 1: depicts a catheter with a vascular prosthesis mounted on its distal end and held radially pretensioned in a compressed position by a cover in the form of a tubular, unravellable crocheted meshwork;
Fig. 2: illustrates the formation of an initial mesh in the crocheted cover surrounding the prosthesis, using a loop brought around the vascular prosthesis from the Fight-hand side;
Fig. 3: is a diagram similar to Fig. 2 and illus~rates the formation of the next mesh linking up with the starting mesh and encircling the vascular prosthesis from the left-hand side;
Fig. 4: in a view similar to Fig. 1 depicts a device in which the vascular prosthesis mounted on the catheter is held radially pretensioned in its compressed position by means of unravellable crocheted covers fitted frorn the distal and proximal ends respectively;
Fig. 5: shows the device as seen in Fig. 4, but simply with the crocheted cover Fitted from the distal end;
Fig. 6: shows the device as seen in Fig. 4 merely with the crocheted cover fitted from the proximal end, and omitting the crocheted cover shown in Fig. 5;
Fig. 7: depicts, by itself, a vascular prosthesis held in a radially compressed position by means of encircling loops;
207~521 Fig. 8: is a view, similar to that in Fig. 7, of a prosthesis, wherein the loops holding the latter in a radially compressed position are formed by crocheting, and Fig. 9: is a view of an unrolled s~ction of a vascular prosthesis made of knitted fabric In the device 10 illustrated in Fig. 1, an elongated catheter 11 with a continuous lumen is used as the probe; and the ca~heter is advanced by means of the lumen, along a guide wire inserted in known manner into a 10 vessel. Near the distal end 12 of the catheter 11 is mounted a prosthesis 15 which is held in a compressed position under radial pretension by means of a crocheted meshwork covering 14; after the restraining force of the meshwork has been removed, the prosthesis expands au~omaticaliy to assume its intended irnplanted position. The prosthesis may, for example, 15 consist of a knitted tube which can be compressed radially, against a restorative spring force into a position where it ~ightly encloses the catheter close to its distal end.
The prosthesis 15 is enclosed by a crocheted meshwork 14, made from one continuous thread, in which the successive meshes encircle the 20 prosthesis alternately on one side and then the other, i.e. alternately from right to left or left to right. The initial section 17 of the thread material, which is arranged ahead of the first mesh 16 at the distal end 12 of the catheter 11, is drawn through a slit 18 in the wall of the catheter; it is wedged in the said slit and then taken through the lumen of the catheter 25 and led out beyond the distai end of the catheter. An unravellable loop 22 isdrawn through a knot 21 which ties off the final rnesh 20 at the opposite end from the distal end; the said loop is drawn through two axially spaced slits 23, 23' in the wall of the catheter, and thus is also axially tightly clamped .
30The free end of the thread drawn through the knot 21 of the said final mesh 20, forms an unravelling line 24, running along the length of the .
' ' ~, ,, ; ~
207~2~
catheter 11, by means of which the loop 22 hetd clamped in the catheter is unravelled by drawing it through the said end knot, and then gradually the meshes of the crocheted meshwork encircling the prosthesis and keeping it compressed can also be unravelled. Since the meshes enclrcle the 5 prosthesis 15 from right to left and left to right, the thread detaches itselffrom the mesh knots alternately on the right and Icft side of the catheter as the mesh unravels; and after the last mesh at the distal end is unravelled, the initial section 17 of the thread material can be withdrawn from the slit 18 where it is clamped at the distal end 12 of the catheter 1 1.
Figs. 2 and 3 show in enlarged view the way in which the meshes are formed, with the catheter 15 being encircled alternatingly from the back and from the front; for the sake of simplicity, in these Figures the catheter is shown as a rigid tubular object. After the initial section 17 of the thread material has been secured by clamping it in the slit 18, as shown in Fig. 1, 15 the thread is wrapped around the catheter, then a loop 26 is pulled through under the thread; then, from the free thread material 27 a mesh is forrned, taken around the back of the catheter and then drawn through the loop 26;
the section of mesh drawn through the aforementioned loop 26 forms in turn a loop 28 for making the next mesh in ~he sequence. Fig. 2 shows in 20 solid lines the free thread material 27 before it is drawn through the loop 26, and the broken lines depict it after it has been pulled through this loop, and they also depict the formation of loop 28 for the next mesh.
To form the next mesh, which is shown in Fig. 3, the free thread material, taken from position 31 in fact of the catheter, is drawn through 25 the previously formed loop 28, thereby forming ano~her loop 30 in the manner indicated by the dotted lines; this method of forming loops and meshes by means of thread material drawn alternately behind and in front of the catheter and through the appropriate loop, is continued until the prosthesis mounted on the catheter is covered over its entire length by a 30 crocheted meshwork.
~07~521 The end mesh 20 is formed by drawing the loop 22 through the associated end loop or through a knot 21 formed by tightening this loop;
then, as illustrated schematically in Fig. 1, the loop 22 is drawn through and clamped in the two slits 23, 23' spaced a certain axial distance apart in the 5 wall of the catheter. The remaining thread material then forms the unravelling line 24 which extends from the loop of the end mesh 20 and permits ~he encircling crocheted meshwork to be unravelled; when this happens, the thread material from the unravelled meshes detaches itself alternately first on the one side and then on the other side of the prosthesis 10 15, and as a result the prosthesis is released and permitted to expand under the action of the pretension ~uilt up by the radial compression caused by the fitting of the meshwork covering.
Also in the embodiment 40 shown in Fig. 4, a prosthesis 45 is mounted near the distal end 42 of an elongated catheter 41 and is held 15 compressed under radial pretension. This is achieved by the crocheted meshworks 46, 47, each shown separately in Figs. 5 and ~ respectively.
Like the catheter 11 in the embodiment shown in Fig. 1, the catheter 41 is also advanced along a ~uide wire which has been previously positioned in the vessel, and in this manner the prosthesis 45 mounted on the catheter 20 can be positioned correctly in the vessel before being implanted by unravelling the meshwork.
The two crocheted meshworks shown holding the prosthesis 45 compressed in Fig. 4 are applied one after the other, starting with meshwork 46 frorn the distal end. The other meshwork 47 is fitted from the 25 proximal end and then covers the end of the first meshwork 46.
Fig. 5 shows that the catheter 41 is fitted at its distal end vvith a silicon sleeve 43 which serves to fix the starting section 48 of the thread from which the first meshwork is crocheted. For this purpose, the starting section 48 of this thread is drawn under the silicon sleeve 43. Next, the first 30 rneshes 49 are crocheted onto the calheter 41 in the manner described above in conjunction with Figs. 1 to 3, and these meshes provide a firm : , .
207~2~
anchorage on the catheter for the first meshwork.The subsequent meshes 5û extend over the end of the prosthesis 41 pointing towards the distal end of the catheter, compressing this end of ~he prosthesis under radial pretension, while simultaneously axially fixing the prosthesis on the 5 catheter, as shown in Fig. 5. A last mesh 51 of this crocheted meshwork 46 is then laid down on the outside of ~he prosthesis 45, and from this mesh extends the thread 52 which serves as a line for unravelling the meshes in the said meshwork.
Fig. 6 illustrates the fitting of the second crocheted meshwork 47 10 starting from the proximal end. The start 55 of the thread material of which this meshwork is made up is again fixed by passing it under a silicon sleeve 54 fitted on the catheter 41. Next some meshes 56 are crocheted onto the catheter towards the distal end, and these are followed by further meshes 57 which encircle the prosthesis 41, while simultaneously compressing it 15 radially, and they extend over and thereby secure the meshes 50, 51 of the first meshwork 46 facing away from the distal end of the meshwork 46. A
last mesh 58 of the meshwork 47 applied from the proximal end is then drawn under the silicon sleeve 43 fitted at the distal end of the catheter and thus secured. Furthermore, the thread ~0 extends away from the distally 20 oriented end mesh of the meshwork 47, which is applied from the proximal end, ànd this thread is used to unravel the meshes of the crocheted meshwork.
The prosthesis 45 in the embodiment illustrated in Figs. 4 to 6, like the embodiment seen in Figs. 1 to 3, is held compressed under radial 25 pretension on the catheter 41, and once the crocheted meshworks 46, 4 have been removed, it expands automaticaliy to occupy its intended location. Once the prosthesis mounted on the catheter has been introduced into a vessel and correctly positioned therein, it is implanted by first removing the meshwork 46 which has been applied from the distal end.
30 This is done by unravelling the meshes in this meshwork by means of the unravelling line 52, so that first the mesh 51, which is overlain by the distal end of the meshwork applied from the proximal end, and then gradually the meshes 50 and 49 adjoining towards the distal end are unravelled, until finally the first mesh adjacent to the silicon sleeve 43 is unravelled and the start of the thread 48 is withdrawn from beneath the silicon sleeve.
The end of the prosthesis 45 pointing towards the distal end o~ the 5 catheter is released by unravelling the meshwork 46 which is applied from the distal end; when this happens, this end of the prosthesis expands radially due to the pretensioning forces inherent in the prosthQsis, while the remainder of the prosthesis is still held compressed by the crochete~
meshwork 47 applied from the proximal end. The partially expanded 10 prosthesis 45 is axially fixed on the one hand by the adhesion between the catheter and the prosthesis, and on the other by a silicon sleeve 62, against which the prosthesis is axially supported, mounted at the proximal end of the prosthesis 45 on the catheter ~1.
Once the first croclleted meshwork 46 is unravelled, the meshwork 15 47 applied from the proximal end is also unravelled, namely by means of the unravelling line 60 extending away from the end mesh 58 at the distal end.
It can be seen that by pulling on the unravelling line, to start with the loop 58 held beneath the silicon sleeve 43 at the distal end will be unravelled and the meshes 57 and 56 will be progressively unravelled from the distal end to 20 the proximal end, and the prosthesis 45 will expand radially and come to rest against the walls o~ a vessel which requires to be fitted with a prosthesis. Once the unravelling process is complete, the end 55 of the thread hetd beneath the silicon sleeve 54 at the proximal end is withdrawn.
The prosthesis 45 is then detached ~rom the catheter and the latter can be 25 withdrawn in a simple manner from the vessel.
The prosthesis 70 illustrated in Fig. ~ is also tubular in shape and selF-expanding. It may be made of a mesh fabric, e.g. of knitted structure. The prosthesis is provided with pairs of holes 71, 72 arranged at approximately equal axia! distances from one another. Loops 74 encircle the prosthesis on 30 the outside and serve to hold the prosthesis in its radially compressed state.
Each loop consists of thread material from a thread 7~ running Isngitudinal!y , ., : . .
.-.... ... ~ .. ..
2~7~
inside the prosthesis and drawn through holes 71; the thread then forms a loop which tightly encircles the prosthesis and the end of the loop 76 is then drawn back inside the prosthesis through a hole 72 paired with the corresponding hole 71. The loops are secured in the encircling posi~ion 5 shown in Fig. 7 by means of a warp thread 78 passing throu0h the ends o~
the loops 76 inside the prosthesis.
The advantage of the embodiment according to Fig. 7 is that the prosthesis 70 is radially compressed by these encircling loops 74, which are spaced at substantialiy equal axial distances frorn each o~her and have no 10 external knots, but instead are form~?d by a thread 75 running longitudinallyinside the prosthesis and held tightly in place by means of the warp thread 78 also running longitudinally inside the prosthesis.
The prosthesis according to Fig. 7 is mounted, radially compressed, near the distal end of a catheter in the same way as described above in 15 conjunction with Figs. 1 to 6 and it is implanted in a vessel ~y advancing the catheter. Once it has been correctly positioned in the vessel, the prosthesis is implanted in a simple manner by Yvithdrawing the warp thread 78 from the ends 76 of the loops 74, whereupon the prosthesis 70 expands radially under its own pretensioned spring force to assume its intended 20 implanted position. The thread 75 used to form the loops can then also be withdrawn in a simple manner.
The embodiment illustrated in Fig. 8 differs from the embodiment according to Fig. 7 in that the axially spaced loops 7~' encircling the prosthesis 70' are formed by crocheting. For this purpose, thread rnaterial 25 from the thread 75 running longitudinally inside the prosthesis is drawn out through a hole 71' in the prosthe~is and wrapped around the prosthesis as a loop 74', and also the loop end 76' of the thread is again taken back inside the prosthesis through a hole 72' axially spaced from the aforementioned hole 71. Thread material is then drawn through the end of the loop 76' 30 inside the prosthesis to form a further loop which is then taken to the exterior through a hole 71' following in the axial direction, and it is then also , , , - . ,. ~
207~521 wrapped around the prosthesis as loop 74', and the loop end which is taken back inside the prosthesis through a further hole 72' ;s secured in the same way as in the case of the first loop.
Fig. ~ illustrates an unrolled section of a vascular prosthesis ~0 made 5 of a knitted fabric in which alternatingly a thread 81 made frorn resorbable material and a thread 82 made of non-resorbable material are knitted together with each other. The non-resorbable thread material may, for example, be tantalum.
The advantage of such a prosthesis is that, after a certain amount of 10 time has elapsed following implantation, the resorbable thread material will be dissolved and all that is left behind in the patient's body are the non-biodegradable components. These remaining components form encircling rings consisting of a series of open loops. This design avoids thread crossings which might exert unnecessary shear forces on the tissues 15 surrounding and growing around the prosthesis.
Prostheses according ~o Fig. 9 may also be designed in a simple manner to act as medication depots, by embedding in the resorbable thread material medical agents which are released when this material breaks down.
.
- . : ~ , , - .
., . ., , . ~ . , .
.
Claims (33)
1. A device having a prosthesis designed as a hollow body which can be implanted in the body of a patient, in particular in a blood vessel or another body cavity, the said prosthesis being radially compressible against the action of restoring spring forces down to a reduced cross section compared with its -expanded - in-use dimension, and once the restraining forces holding the prosthesis compressed are removed, the prosthesis expands automatically to assume the cross sectional size appropriate to its in-use position, characterized in that the prosthesis (15, 45, 70, 70', 80) is surrounded by an unravellable cover (14, 46, 47, 74) consisting of at least one continuous thread, which compresses the prosthesis down to a reduced cross section, and at least one unravelling line (24, 52, 60, 75, 78), which extends away from the cover holding the prosthesis in its radially compressed state, and the thread forming the cover can be withdrawn.
2. A device according to Claim 1, characterized in that the cover holding the prosthesis (15, 45) in its radially compressed position is an unravellable meshwork (14, 46, 47).
3. A device according to Claim 1 or 2, characterized in that the prosthesis (15, 45, 70, 70', 80) held in a radially compressed state by the unravellable cover (14, 46, 47, 74) is mounted on and can be advanced along a probe (11, 41), for example a flexible guide wire.
4. A device according to Claim 1 or 2, characterized in that the prosthesis (15, 45, 70, 70', 80) held in a radially compressed state by the unravellable cover (14, 46, 47, 74) is mounted in an axially fixed manner at theleading end of the probe (11, 41).
5. A device according to Claim 4, characterized in that the probe, on the leading end (12) of which is mounted the prosthesis (15, 45, 70, 70', 80), is a catheter (11, 41) which can be advanced along a guide wire.
6. A device according to Claim 4 or 5, characterized in that the prosthesis (15, 45, 70, 70', 80) is mounted on the probe with a non-slip substrate being interposed between itself and the probe.
7. A device according to one of the Claims 1 to 5, characterized in that the prosthesis (15, 45, 70, 70', 80) is a tubular structure made by crocheting, knitting or some other means of producing a mesh fabric, using metal or plastic thread material which has good tissue compatibility, and the tubular structure is radially compressible against pretensioning forces, and after the restraining forces have been removed, it expands automatically to assume its in-use position and then retains its expanded shape.
8. A device according to one of the Claims 1 to 7, characterized in that due to the tubular configuration of the meshwork (14, 46, 47) holding the prosthesis (15, 45) in its compressed state, the meshes change direction after each encircling of the prosthesis, and when the meshes are unravelled one after the other the thread sections forming the meshes detach themselves from the prosthesis alternately from right to left and from left to right.
9. A device according to Claim 8, characterized in that the meshwork (14, 46, 47) surrounding the prosthesis (15, 45) is an unravellable tubular structure made by crocheting, tying or knotting, or any other means of producing a mesh.
10. A device according to one of the Claims 1 to 9, characterized in that the unravelling line (24, 52) extends away from the meshes encircling the leading end of the prosthesis (15, 45) and thus the prosthesis gradually and progressively attains its expanded form, starting at its leading edge, as the meshwork is unravelled.
11. A device according to one of the Claims 1 to 10, characterized in that the ends of the thread material of which the meshwork (14, 46, 47) is made up are secured by untiable knots, for example slip knots.
12. A device according to Claim 11, characterized in that the untieable knots of the meshes in the meshwork (14, 46, 47) which sequentially encircle the prosthesis (15, 45), are arranged opposite each other or one behind the other in a substantially axial row.
13. A device according to one of the Claims 4 to 12, characterized in that in each case the start of the thread material making up the meshwork (14, 45, 46) and an end mesh are secured to the probe or to the catheter (11, 41) used as a probe and they may be pulled out of their secured positions by means of the unravelling line (24, 52, 60).
14. A device according to Claim 13, characterized in that the start (17, 48, 55) of the thread material making up the meshwork (14, 46, 47) and the end mesh (22, 51, 58) are clamped in holes (18, 23, 23') in the probe or in the catheter used as a probe.
15. A device according to Claim 14, characterized in that the start (48, 55) of the thread material of which the meshwork (46, 47) is made is clamped between the probe or the catheter and an elastic sleeve (43, 54) fitted over the probe or the catheter.
16. A device according to one of the Claims 13 to 15, characterized in that a loop (22, 51, 58) secured to the probe or the catheter, extends away from the knot of the first mesh on the unravelling side of the meshwork (14, 46, 47), and one end of the loop merges in the area of the said knot into the unravelling line (24, 52, 60) which is used to unravel the loop by pulling it through the said knot.
17. A device according to one of the Claims 4 to 16, characterized in that the prosthesis (45) is held in the radially compressed state by means of a meshwork (46) applied from the distal end of the probe or the catheter (41) and extending to beyond the leading end of the prosthesis, and also by means of a meshwork (47) applied in the opposite direction, from the proximal end, and extending over the end meshes of the first meshwork.
18. A device according to Claim 17, characterized in that the two meshworks (46, 47) are unravellable in opposite directions, starting in each case from their loop-shaped end meshes (51, 58), using the unravelling line (52, 60).
19. A device according to Claim 1, characterized in that the cover holding the prosthesis in its radially compressed position consists of loops (74) encircling the prosthesis (70) at axial spacings from each other, and these loops are formed from thread material from a thread (75) running longitudinally inside the prosthesis and drawn through holes (71) in the prosthesis, and the ends (76) of the loops (74) are taken back inside the prosthesis through holes (72) adjacent to the first-mentioned holes in a peripheral direction, and a warpthread (78) also running longitudinally inside the prosthesis is passed through the ends of the loops, thereby holding the loops in their encircling positions.
20. A device according to Claim 1, characterized in that the cover holding the prosthesis (70') in its radially compressed position consists of axially spaced loops (74') encircling the prosthesis, and the loops are made of thread material from a thread (75') running longitudinally inside the prosthesisand drawn in each case through holes (71') in the prosthesis, and the ends (76') of the loops (74') are in each case taken back inside the prosthesis through holes (72') axially spaced from the first-mentioned holes, and each loop end (76') taken back inside the prosthesis is secured by passing through it a loop, formed from the thread material running inside the prosthesis, and this loop is taken to the outside of the prosthesis through a hole following in the axial direction and it is then wrapped around the prosthesis once more, and the end of this loop is taken back again inside the prosthesis in the same way through a hole and secured in that position.
21. A device according to one of the Claims 1 to 20, characterized in that shrinkable thread material is used to form the encircling cover (14, 46, 47, 74, 74') holding the prosthesis in the compressed state on the probe or on a catheter (11, 41) used as a probe.
22. A device according to one of the Claims 1 to 21, characterized in that the unravellable cover (14, 46, 47, 74) consists of several threads runningparallel to each other.
23. A device according to one of the Claims 1 to 22, characterized in that at least one other cover is arranged between the prosthesis (15, 45, 70, 70') and the cover (14, 46, 47, 74') holding the prosthesis in the radially compressed state, and this other cover fits loosely around the prosthesis thereby permitting partial expansion of the prosthesis when the outer cover is unravelled, after which it is itself unravelled.
24. A device according to one of the Claims 1 to 17 and 20 to 22, characterized in that the spaces between the meshes of the meshwork (14, 46, 47) encircling and holding the prosthesis in the compressed state are filledand smoothed out with gelatine, or a similar substance, which dissolves in the body of the patient.
25. A device according to one of the Claims 5 to 24, characterized in that at least one end of the prosthesis (15, 45, 70, 70') is gripped in the compressed state by a sleeve on the probe or on the catheter and is then withdrawn from the grip of the sleeve by the axial shortening which occurs upon expansion.
26. A device according to one of the Claims 4 to 25, characterized in that the end of the prosthesis (15, 45, 70, 70') opposite the leading end is braced against a radially projecting step or shoulder on the probe or against a sleeve (62) mounted on the latter.
27. A device according to one of the Claims 5 to 26, characterized in that when a catheter (11, 41) is used as the probe, the unravelling line (24, 52, 60) is taken through a hole in the catheter wall into the lumen of the catheter near one end of the prosthesis, and extends through the lumen to beyond the end of the catheter.
28. A device according to one of the Claims 5 to 27, characterized in that a double-lumen catheter is used as the probe on which the prosthesis (15, 45, 70, 70') is mounted, and one lumen is used for advancing the catheter along a guide wire, while the unravelling line for the meshwork encircling the prosthesis is passed through the other lumen.
29. A device according to one of the Claims 1 to 7, and 8 to 28, characterized in that in the prosthesis (80) made of mesh material, successive alternating rows of meshes are made from resorbable thread material (81) and non-resorbable thread material (82) respectively.
30. A device according to Claim 29, characterized in that medication is embedded in the resorbable thread material (81) and accordingly the prosthesis (80) is designed as a medication depot.
31. A device according to one of the Claims 1 to 30, characterized in that the unravelling line (24, 52, 60; 75, 78) and or the thread material forming the cover (14, 46, 47, 74) is treated with a friction-reducing lubricant.
32. A device according to one of the Claims 1 to 31, characterized in that at least the unravelling line (24, 52, 60; 75, 78) is made of metal thread or is treated with an admixture of metal which is opaque to X-rays.
33. A device according to one of the Claims 1 to 32 characterized in that the proximal end of the prosthesis (15, 45, 70) held in the compressed state by the unravellable cover (14, 46, 47, 74) expands to assume a trumpet shape in the expanded state, after removal of the cover.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE4037507 | 1990-11-26 | ||
| DEP4037507.2 | 1990-11-26 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2074521A1 CA2074521A1 (en) | 1992-05-27 |
| CA2074521C true CA2074521C (en) | 1998-06-09 |
Family
ID=6418905
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002074521A Expired - Lifetime CA2074521C (en) | 1990-11-26 | 1991-11-21 | Device having a prosthesis implanted in a patient |
Country Status (7)
| Country | Link |
|---|---|
| EP (1) | EP0513286B1 (en) |
| JP (1) | JP3410468B2 (en) |
| AT (1) | ATE132731T1 (en) |
| CA (1) | CA2074521C (en) |
| DE (2) | DE4137857A1 (en) |
| ES (1) | ES2084189T3 (en) |
| WO (1) | WO1992009245A1 (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB2488986A (en) * | 2011-03-08 | 2012-09-19 | Cook Medical Technologies Llc | Introducer assembly and carrier element for a medical device |
Families Citing this family (23)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5366504A (en) * | 1992-05-20 | 1994-11-22 | Boston Scientific Corporation | Tubular medical prosthesis |
| US5405378A (en) * | 1992-05-20 | 1995-04-11 | Strecker; Ernst P. | Device with a prosthesis implantable in the body of a patient |
| DE4221390C1 (en) * | 1992-06-30 | 1993-04-01 | Haindl, Hans, Dr.Med., 3015 Wennigsen, De | |
| US5306294A (en) * | 1992-08-05 | 1994-04-26 | Ultrasonic Sensing And Monitoring Systems, Inc. | Stent construction of rolled configuration |
| WO1994016629A1 (en) * | 1993-01-27 | 1994-08-04 | Instent Inc. | Vascular and coronary stents |
| EP0958795A3 (en) * | 1993-08-20 | 2001-04-04 | Kanji Inoue | Appliance to be implanted and device for introducing the collapsed appliance into a catheter |
| DE4424242A1 (en) | 1994-07-09 | 1996-01-11 | Ernst Peter Prof Dr M Strecker | Endoprosthesis implantable percutaneously in a patient's body |
| US6331188B1 (en) | 1994-08-31 | 2001-12-18 | Gore Enterprise Holdings, Inc. | Exterior supported self-expanding stent-graft |
| US6015429A (en) | 1994-09-08 | 2000-01-18 | Gore Enterprise Holdings, Inc. | Procedures for introducing stents and stent-grafts |
| EP0866677A4 (en) | 1995-12-14 | 1999-10-27 | Prograft Medical Inc | Stent-graft deployment apparatus and method |
| US6042605A (en) | 1995-12-14 | 2000-03-28 | Gore Enterprose Holdings, Inc. | Kink resistant stent-graft |
| US6551350B1 (en) | 1996-12-23 | 2003-04-22 | Gore Enterprise Holdings, Inc. | Kink resistant bifurcated prosthesis |
| US6352561B1 (en) | 1996-12-23 | 2002-03-05 | W. L. Gore & Associates | Implant deployment apparatus |
| US6224627B1 (en) * | 1998-06-15 | 2001-05-01 | Gore Enterprise Holdings, Inc. | Remotely removable covering and support |
| DE10045325A1 (en) | 2000-09-12 | 2002-04-04 | Alco Advanced Lightweight Cons | Highly flexible implant for intra- or endovascular applications (stent) and manufacturing processes |
| US20030050684A1 (en) | 2001-09-10 | 2003-03-13 | Abrams Robert M. | Internal restraint for delivery of self-expanding stents |
| CN201578402U (en) * | 2009-11-16 | 2010-09-15 | 南京微创医学科技有限公司 | Support introducer capable of precisely positioning |
| US9198787B2 (en) * | 2010-12-31 | 2015-12-01 | Cook Medical Technologies Llc | Conformable prosthesis delivery system and method for deployment thereof |
| CN106580514A (en) * | 2015-06-03 | 2017-04-26 | 常州新区佳森医用支架器械有限公司 | Implantation device of duodenum stent |
| JP2021526428A (en) * | 2018-06-14 | 2021-10-07 | ダブリュ．エル．ゴア アンド アソシエイツ，インコーポレイティドＷ．Ｌ． Ｇｏｒｅ ＆ Ａｓｓｏｃｉａｔｅｓ， Ｉｎｃｏｒｐｏｒａｔｅｄ | Single fiber restraint for implantable medical devices |
| CA3112802A1 (en) * | 2018-09-26 | 2020-04-02 | W. L. Gore & Associates, Inc. | Constraining systems and associated methods |
| JP2022502202A (en) * | 2018-10-05 | 2022-01-11 | ダブリュ.エル.ゴア アンド アソシエイツ, インコーポレイティドW.L. Gore & Associates, Incorporated | Restraint mechanism and related methods for selective deployment |
| WO2023163122A1 (en) * | 2022-02-28 | 2023-08-31 | Ｓｂカワスミ株式会社 | Catheter and delivery system |
Family Cites Families (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB1173811A (en) * | 1967-02-28 | 1969-12-10 | Meadox Medicals Inc | Surgical Implants |
| FR2333487A1 (en) * | 1975-12-02 | 1977-07-01 | Rhone Poulenc Ind | Implantable surgical tubing with sewable ends - has radially elastic wall including a fleece layer and reinforcement |
| EP0183372A1 (en) * | 1984-10-19 | 1986-06-04 | RAYCHEM CORPORATION (a Delaware corporation) | Prosthetic stent |
| US4878906A (en) * | 1986-03-25 | 1989-11-07 | Servetus Partnership | Endoprosthesis for repairing a damaged vessel |
| US4913141A (en) * | 1988-10-25 | 1990-04-03 | Cordis Corporation | Apparatus and method for placement of a stent within a subject vessel |
| CH678393A5 (en) * | 1989-01-26 | 1991-09-13 | Ulrich Prof Dr Med Sigwart |
-
1991
- 1991-11-16 DE DE4137857A patent/DE4137857A1/en not_active Withdrawn
- 1991-11-21 JP JP50030192A patent/JP3410468B2/en not_active Expired - Fee Related
- 1991-11-21 AT AT91920454T patent/ATE132731T1/en not_active IP Right Cessation
- 1991-11-21 EP EP91920454A patent/EP0513286B1/en not_active Expired - Lifetime
- 1991-11-21 DE DE59107252T patent/DE59107252D1/en not_active Expired - Lifetime
- 1991-11-21 ES ES91920454T patent/ES2084189T3/en not_active Expired - Lifetime
- 1991-11-21 WO PCT/EP1991/002194 patent/WO1992009245A1/en active IP Right Grant
- 1991-11-21 CA CA002074521A patent/CA2074521C/en not_active Expired - Lifetime
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB2488986A (en) * | 2011-03-08 | 2012-09-19 | Cook Medical Technologies Llc | Introducer assembly and carrier element for a medical device |
| GB2488986B (en) * | 2011-03-08 | 2013-07-10 | Cook Medical Technologies Llc | Introducer assembly and carrier element for a medical device |
Also Published As
| Publication number | Publication date |
|---|---|
| EP0513286A1 (en) | 1992-11-19 |
| WO1992009245A1 (en) | 1992-06-11 |
| CA2074521A1 (en) | 1992-05-27 |
| DE59107252D1 (en) | 1996-02-22 |
| JPH06503734A (en) | 1994-04-28 |
| JP3410468B2 (en) | 2003-05-26 |
| EP0513286B1 (en) | 1996-01-10 |
| DE4137857A1 (en) | 1992-05-27 |
| ATE132731T1 (en) | 1996-01-15 |
| ES2084189T3 (en) | 1996-05-01 |
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Legal Events
| Date | Code | Title | Description |
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| EEER | Examination request | ||
| MKLA | Lapsed | ||
| MKEC | Expiry (correction) |
Effective date: 20121202 |