Patent Application
20240197507
The present invention relates to a catheter device for transluminally delivering a self-expanding tubular implant to a site in a body, a method of making a shape memory alloy tube for a catheter device for transluminally delivering a self-expanding tubular implant to a site in a body and a method of assembling a catheter assembly for transluminally delivering a self-expanding tubular implant to a site in a body.
Catheter devices are known. Catheter devices may comprise an inner catheter and a sheath. An implant for delivery to a site in the body is loaded onto the inner catheter. To deliver the stent, the sheath is pulled back. The implant may be compressed on the inner catheter.
In such conventional catheter devices, it has been found that it is difficult to maintain a firm grip of the compressed implant on the inner catheter during retraction of the sheath. In particular, it has been found that this is the case if the implant or a covering on the implant weight varies, as is generally the case due to material and process tolerances. Implants that are too large or heavy may lead to too much compression and the associated deployment forces may exceed the strength limit of the delivery system joints, leading to delivery system failure. Further, it has been found that implants that are relatively small or lightweight may lose grip on the inner catheter and therefore, may be retracted along with the sheath, constituting a complete failure to deploy or significantly worse, a partially deployed implant.
In US 2010/0274226 A1 fingers are provided on the inner catheter. When the sheath is retracted the implant can be damaged as it slips over the inner catheter or the implant may compress axially and seize within the sheath such that deployment becomes impossible.
To address this problem, it is known to provide an elastic silicone sleeve on the inner catheter over which a section of a fine metal wire braid is placed to improve the grip.
The silicone sleeve is intended to give radial flexibility and accommodate tolerance related changes in the dimension and/or covering weight of the implant without a great deal of change in the radial compression of the catheter device (assembly) and hence without a great deal of change in the deployment force.
A disadvantage of this arrangement is that while silicone is a very soft and flexible material, i.e. well suited to conform, the wall thickness of the sleeve is very thin due to space constraints and the mechanical behavior of silicone can be described as linearly elastic. Therefore, increasing compression leads to increasing push-back, even though at a slow rate compared to stiffer materials, and thus requires a higher deployment force.
It is an object of the invention to provide a catheter device that will address at least one of the above-mentioned problems.
In accordance with one aspect of the invention, there is provided a catheter device for transluminally delivering a self-expanding tubular implant to a site in a body, the device comprising: an inner catheter comprising a cylindrical distal end component with a wall, wherein the cylindrical distal end component is arranged, in use, to be received within the lumen of the implant; and a sheath, coaxial with the inner catheter, wherein the sheath is arranged to sheath the implant until, in use, the sheath is withdrawn proximally, relative to the implant and the inner catheter, to release (deploy) the implant at the site, wherein the cylindrical distal end component includes a first plurality of implant retention elements, which, during withdrawal of the sheath protrude radially outwardly from the cylindrical distal end component to engage a radially inward facing surface of the implant to restrain the implant from being carried by the sheath proximally, relative to the cylindrical distal end component, characterized in that: the first plurality of implant retention elements are formed from a portion of the wall of the cylindrical distal end component, and in that: the first plurality of implant retention elements are configured to utilise a shape memory effect to assume a radially outwardly protruding configuration to engage the radially inward facing surface of the implant prior to the withdrawal of the sheath.
In this way, the plurality of retention features improves implant retention on the inner catheter over a wider range of implant weight and implant and catheter device component dimensions.
In one embodiment, the design of the plurality of retention elements is such that a hinge portion is in the plateau area (region) of the stress-strain curve of the material of the plurality of retention elements when engaged with the implant, so that the retention elements exert more or less the same force on the implant regardless of how much they protrude (deflect) from the cylinder, so it is not critical how much they deflect.
The properties of the plurality of retention elements ensures relatively constant friction and retention force by unidirectional elements, by virtue of a first plurality of implant retention elements, or bidirectional elements, by virtue of a first and a second plurality of implant retention elements, on the outside of the inner catheter. On account of the plateau area in the stress-strain curve of the material of the plurality of retention elements, these elements can accommodate varying degrees of radial displacement whilst exerting a constant radial force regardless of the degree to which the plurality of retention elements protrude from the inner catheter. In this way a relatively constant radial stress condition is ensured. Thus, relatively constant friction and deployment forces over a range of implant weight and implant and delivery system component dimensions are achieved. Thus, enhancing deployment reliability.
In one embodiment, at least one of the first plurality of implant retention elements is a flap arranged to extend distally from a root line in the cylindrical distal end component. In this way, the implant is prevented from moving in a proximal direction.
In a further embodiment, the cylindrical distal end component includes a second plurality of implant retention elements, which are configured to utilise a shape memory effect to protrude radially outward from the cylindrical distal end component to engage a radially inward facing surface of the implant to restrain the implant from being carried distally, relative to the cylindrical distal end component. In this way, the implant is prevented from moving in a distal direction. With both distal and proximal flaps, the implant can be prevented from moving in both directions.
Hereinbelow, in a distal flap (a first retention element), the flap is arranged to extend distally from a root line in the cylindrical distal end component. In this way, the implant is prevented from moving in a proximal direction. Accordingly, in a proximal flap (a second retention element), the flap is arranged to extend proximally from a root line in the cylindrical distal end component. In this way, the implant is prevented from moving in a distal direction.
In a further embodiment, the cylindrical distal end component is made of nitinol. In this way, the reliability of the deployment of the implant is enhanced, since nitinol has a rather flat plateau area in its stress-strain curve, that is, it can accommodate strain changes with relatively little stress changes. This material characteristic of, in particular, nitinol, results in a first and/or second plurality of retention elements that can accommodate diameter changes with relatively small radial force changes, making the degree of compression forces of the implant less dependent on the degree of spatial compression of the implant. Furthermore, the first and/or second plurality of retention elements, in one embodiment, are incorporated in the wall of the nitinol inner catheter member, rather than added on top of an existing inner catheter material. In this way, space is saved and can therefore, be used to accommodate the implant. In other words, more space is available in the catheter device for the implant.
In a yet further embodiment, at least one flexible section comprises a plurality of staggered circumferentially extending slits to form a cardanic joint. In this way, the slits endow the component with enhanced bending ability, thereby facilitating advance of the distal end of the device along especially tortuous lumens to hard to reach implant sites in the body.
In a yet further embodiment, at least the first plurality of retention elements and the second plurality of retention elements are disposed in the same implant retention section. In this way, the reliability to deploy short implants is enhanced.
In a further embodiment, the first and second plurality of retention elements are arranged circumferentially around the cylindrical distal end component in at least one row, wherein the first and second plurality of retention elements alternate along at least one row. In this way, the reliability to deploy short implants is further enhanced, since this arrangement allows for adjustment of the location of the implant (relative to the sheath, not relative to the inner catheter member) in both proximal and distal directions.
In a further embodiment, the first plurality of retention elements is disposed at a location on the cylindrical distal end component that is arranged to be received by a distal region of the implant.
In a yet further embodiment, the second plurality of retention elements are disposed at a location on the cylindrical distal end component that is arranged to be received by a proximal region of the implant.
In this way, the reliability to deploy long implants is enhanced, since, whichever way the implant is moved by pushing or pulling the inner catheter during implant (stent) position adjustment, it is ensured that the implant is pulled, rather than pushed, thus preventing buckling and seizing within the outer sheath.
A further advantage of the present invention is that it addresses a problem associated with deploying long and flexible self-expanding implants, such as vascular implants, such as nitinol stents or expanded polytetrafluoroehthylene (ePTFE) covered nitinol stents from a pull-back outer sheath type delivery system.
In an embodiment of the invention, the first and/or second plurality of retention elements are configured so that a force exerted on the implant by the first and/or second retention elements, respectively, within a range of deflection of the hinge is substantially the same over the range of deflection. In this way, regardless of the deflection, the force exerted on the implant is the same, therefore tolerances are not so critical. Further, the space required for the first and/or second retention elements is minimized in the radial direction, to thus minimize the radial dimensions of the catheter device.
In a further embodiment, the first plurality of implant retention elements are able to lie within the wall thickness. In this way, the and/or second retention elements require no space of their own, therefore, the diameter of the catheter device is yet further reduced.
According to a further aspect of the invention, there is provided a method of making a shape memory alloy tube for a catheter device for transluminally delivering a self-expanding tubular implant to a site in a body, the method comprising: forming a hinge in the shape memory alloy tube, deforming the shape memory alloy tube by deflecting a portion of the shape memory alloy tube around the hinge, and setting the deformed portion by heating the shape memory alloy, so that the shape memory alloy, at body temperature, can assume a configuration in which the portion is radially outwardly deflected from the shape memory alloy tube around the hinge.
According to a yet further aspect of the invention, there is provided a method of assembling a catheter assembly for transluminally delivering a self-expanding tubular implant to a site in a body, the catheter assembly comprising: an inner catheter comprising a shape memory alloy tube, a sheath and a self-expanding implant, the method comprising the steps of: assembling the self-expanding implant on the shape memory alloy tube, wherein in the assembling step, the shape memory alloy tube is at a temperature which allows it to accommodate predominantly by martensite twinning, the radially inward pressure imposed on it by the self-expanding implant.
The invention, and various embodiments thereof, will further be explained on the basis of examples, with reference made to the drawings, in which:
In the drawings and in the detailed description hereinbelow, like reference signs denote like features. The invention is exemplified in the embodiments described below. The invention is not limited to these embodiments, which are schematically shown.
Hereinbelow, reference is made to the terms “proximal” and “distal”. Where reference is made to a “proximal” component or part of a component, it is to be understood to refer to a component or part of a component that is disposed at a location towards a location of the device handle. Whereas, where reference is made to a “distal” component or part of a component, it is to be understood to refer to a component or part of a component that is disposed away (remote) from a location of the device handle.
When deploying a self-expanding implant, for example, a nitinol implant such as a stent or a ePTFE covered stent graft, from its compressed state inside a sheath of a pull back type delivery system, the friction force generated between the retracting outer sheath and the implant, pointing to proximal (i.e. in the direction of the device handle) is typically balanced by axial compression forces in the inner catheter 2. The inner catheter 2 leads all the way to the device handle and typically also serves as a lumen to accommodate a guide wire over which the delivery system is tracked from an entry point into the body to the implant target site in the body, often through arteries or veins, and also, depending on the target site through other body ducts.
Conventionally, transferring the friction force from the implant 20 to the inner catheter 2 may be achieved by a collar on the inner catheter that is placed proximal to the implant. When the sheath is retracted the implant is moved back against the collar and the force is transmitted from the proximal implant end to the collar, and thus the inner catheter, and thus back to the delivery system handle. The inventor has found that when attempting to deploy, in particular, long and flexible implants, the implant tends to buckle under the axial compression and seize within the sheath, preventing successful deployment. Moreover, transmission of the entire implant sheath friction force through the proximal end of an ePTFE covered implant may lead to damage of the delicate ePTFE covering if the covering extends beyond the metal frame of the covered implant.
It has been found that a more reliable deployment is achieved with an arrangement whereby the transmission of the force from the implant to the inner catheter is through a part or parts of the entire interface between the inside of the compressed implant and the outside of the inner catheter. It has been found that in order to achieve this, based purely on friction, a significantly relatively higher coefficient of friction is required between the inside of the implant and the outer side of inner catheter than the coefficient of friction between the outside of the compressed implant and the inside of the sheath. In practice, every effort is made to keep friction as low as possible on the outside of the implant. It has been found, however, that it is difficult to achieve a high enough differential between a relatively low coefficient of friction on the “implant outer surface to a sheath” interface and a relatively high coefficient of friction on the “implant inner surface to the inner catheter” interface, in order to securely prevent any motion of the implant relative to the inner catheter when the sheath is retracted. It has been found that grip on the inner catheter can be augmented by appropriately structuring the surface of the inner catheter such that shape lock occurs between features on the inside of the implant, such as bare stent strut edges or compressed covering folds, and the structures on the outer surface of the inner catheter.
However, since the level of force required to retract the sheath is not only a function of the coefficient of friction between the implant and the sheath, but is also a function of the level of radial force between the implant and the sheath, it is desired to keep radial force as low as possible. This may be achieved, for example, by minimizing the degree of compression of the implant, which can be achieved by maximizing the space for accommodating the implant in the device. On the other hand, a minimum level of radial compression of the implant is required to ensure there is sufficient friction between the implant and the inner catheter. This degree of implant compression has to be kept within a defined range and should also take into account dimensional tolerances of the components involved, variations in the dimensions of the implant and the covering weight or dimensional changes of the implant and covering weight or dimensional changes of the implant and delivery system components caused by aging, changes in temperature and humidity or outside mechanical forces caused by device handling, such as during removal from the packaging, prepping and tracking through tortuous anatomy.
The catheter device 10 comprises an inner catheter 2. The inner catheter 2 may comprise a cylindrical distal end component 4 with a wall 6. The cylindrical distal end component 4 may be arranged, in use, to be received within a lumen of the implant 20. The catheter device 10 may further comprise a sheath 8. The sheath 8 is coaxial with the inner catheter 2. The sheath 8 is arranged to sheath the implant 20 until, in use, the sheath 8 is withdrawn proximally, relative to the implant 20 and the inner catheter 2, to release (deploy) the implant 20 at the site. The site is at a distal location. The implant 20 is typically located on the inner catheter at a distal location.
In the embodiment, the cylindrical distal end component 4 includes a first plurality of implant retention elements 14. The first plurality of implant retention elements 14 during withdrawal of the sheath 8 protrude radially outward from the cylindrical distal end component 4 to engage a radially inward facing surface of the implant 20 to restrain the implant 20 from being carried by the sheath 8 proximally, relatively to the cylindrical distal end component 4. In the embodiment, the first plurality of implant retention elements 14 are formed from a portion of the wall 6 of the cylindrical distal end component 4. Further, the first plurality of implant retention elements are configured to utilise a shape memory effect to assume a radially outwardly protruding configuration to engage the radially inward facing surface of the implant prior to the withdrawal of the sheath.
In particular, in order to maintain defined radial stress conditions in the space accommodating the implant 20 between the inside of the sheath 8 and the outside of the inner catheter 2, it is beneficial to have at least one element, preferably a plurality of implant retention elements 14, within that space that are able to assume varying degrees of radial deflection without a significant change in the radial force to achieve these states of varying degrees of radial deflection. The shape memory effect of the plurality of implant retention elements 14 achieve this result. Each of the plurality of implant retention elements 14 have a plateau area in its load-deformation (also referred to as stress-strain) curve. The implant retention elements are constructed from a wall 6 of the inner catheter 2. In one embodiment, the inner catheter 2 is a nitinol alloy. The implant retention element(s) 14 are configured to utilize at least one of a superelastic and a shape memory property of the nitinol alloy. Preferably, the cylindrical distal end component 4 is made of nitinol.
In one embodiment, at least one of the first plurality of implant retention elements 14 is a flap. The flap comprises a hinge 16. The flap is arranged to extend distally from a root line in the cylindrical distal end component 4. In this way, the implant 20 is prevented from moving in a proximal direction.
The cylindrical distal end component 4 may include a second plurality of implant retention elements 18 (see
The second plurality of implant retention elements 18 differ from the first plurality of implant retention elements 14 in as far as they are oriented in an opposite direction to the first plurality of implant retention elements 14. In particular, the flap is arranged to extend proximally from a root line in the cylindrical distal end component 4. In all other respects, in embodiments of the invention, they are the same as the first plurality of implant retention elements 14.
In embodiments comprising both a first and second plurality of implant retention elements 14, 18 for example, both distal and proximal flaps, the implant can be prevented from moving in both directions 31, 33.
The inner catheter 2 shown in
In one embodiment as shown in
With further reference to
With reference to
With reference to
In the embodiment of
A method of making a shape memory alloy tube, for example a nitinol tube, for a catheter device is now described. In one embodiment, the method comprises forming a hinge 16 in the shape memory alloy tube 2. The method further comprises deflecting a portion of the shape memory alloy tube around the hinge 16, and setting the deformed portion by heating the shape memory alloy. In the embodiment shown in
The shape memory alloy tube forms the inner catheter 2. The heat set portion of the alloy tube deflected around the hinge 16 forms the implant retention element 14.
The graph in
Since the shape memory alloy tube is heat set in the deflected position, once the alloy tube is heat set, there is zero stress at the hinge. The hinge portion of the heat set tube shown in
As shown in
According to an embodiment of the present invention, there is a method of assembling a catheter assembly for transluminally delivering a self-expanding tubular implant to a site in a body. The catheter assembly comprises an inner catheter 2 comprising a shape memory alloy tube 2, a sheath 8 and a self-expanding implant 20. The method comprises the steps of: assembling the self-expanding implant 20 on the shape memory alloy tube 2, wherein in the assembling step, the shape memory alloy tube 2 is at a temperature which allows it to accommodate predominantly by martensite twinning, the radially inward pressure imposed on it by the self-expanding implant 20. In this way, the shape memory alloy tube 2 is able to retain the self-expanding implant 20 on the inner catheter 2.
The overall number of implant retention elements, their size, their density, i.e. their circumferential and longitudinal spacing, the shape and roundness of their leading edge and their bending stiffness, which is determined by the design of the hinge 16, influence their ability to reliably anchor the implant on the inner catheter 2 while not damaging the delicate implant covering during loading, implant positioning, device handling, tracking and deployment. Depending on the particular application and implant to be deployed, the shape, number and arrangement etc. of the implant retention elements can be chosen accordingly. One arrangement is shown, by way of example, in
In a further embodiment, pluralities of at least the first and second plurality of implant retention elements 14, 18 are arranged along a length of the cylindrical distal end component 4, so that a force exerted on the implant 20 by the at least first and second plurality of implant retention elements 14, 18 is distributed evenly along a length of an implant 20.
The first and second plurality of implant retention elements 14, 18 are not necessarily arranged at the ends of the compressed implant 20, instead, there may be several pluralities arranged along the length of a long implant 20 to deal with the fact that a plurality of implant retention elements 14, 18 arranged under a distal end of a long implant 20 disengages from the implant 20 once its distal end is deployed, a further plurality of implant retention elements may therefore, be arranged further proximally, but not all the way at the most proximal end of the implant 20, is then arranged to take over the retention of the implant 20, whilst the sheath 8 is being withdrawn across the implant 20.
With further reference, for example, to
In other words, the cylindrical distal end component 4 comprises at least one implant retention section 30 having at least one of the first and/or second plurality of implant retention elements 14, 18 and at least one flexible section 32. Preferably, the at least one flexible section 32 comprises a plurality of staggered circumferentially extending slits 34 to form a cardanic joint. The slits 34 endow the inner catheter 2 with enhanced bending ability, thereby facilitating advance of the distal end of the catheter device along especially tortuous lumens to hard to reach implant sites in the body. The slits 34 may be laser cuts. In one embodiment, see
As seen in
In more detail, with reference to
The various shapes may be formed by laser cutting. The laser cuts 40 for each of the various shapes, respectively, are shown in
In an embodiment, the hinge portion 16 is substantially in a plateau area C (region) of the stress-strain curve of the material of the at least first and second plurality of implant retention elements 14, when engaged with the implant 20, so that the at least first and second plurality of implant retention elements 14 exert more or less the same force on the implant 20 regardless of how much they protrude (deflect) from the cylindrical distal end component 4.
With regard to the various shapes of the implant retention elements 14, 18 envisaged, in one embodiment, the flap 14 extends in an arc around the circumference of the cylindrical distal end component 4. As described above, the first and/or second retention elements 14, 18 may assume a configuration in which the first and/or second retention elements 14 are deflected about the hinge 16. The hinge 16 may be referred to as a hinge portion 16.
In one embodiment, the first and/or second plurality of retention elements 14, 18 are unpolished. In this way, an implant, in particular and for example, an uncovered stent, for example an uncovered nitinol stent, can be retained more effectively, since the relatively rough surface of the implant retention element 14 can more readily engage with the structure of the uncovered stent.
In embodiments, the first and/or second plurality of implant retention elements 14, 18 are able to lie within the wall thickness. In this way, the implant retention elements 14, 18 require no space of their own, therefore, the diameter of the catheter device is reduced.
With reference to
Further disclosure includes a catheter device for transluminally delivering a self-expanding tubular implant to a site in a body. The device comprises: an inner catheter comprising a cylindrical distal end component with a wall thickness, wherein the cylindrical distal end component is arranged, in use, to be received within the lumen of the implant. The catheter device further comprises: a sheath, coaxial with the inner catheter, wherein the sheath is arranged to sheath the implant until, in use, the sheath is withdrawn proximally, relative to the implant and the inner catheter, to release (deploy) the implant at the site, wherein the cylindrical distal end component includes a first plurality of implant retention elements, which, during withdrawal of the sheath protrude radially outwardly from the cylindrical distal end component to engage a radially inward facing surface of the implant to restrain the implant from being carried by the sheath proximally, relatively to the cylindrical distal end component. The first plurality of implant retention elements are able to lie within the wall thickness, and in that: the first plurality of implant retention elements have a shape memory and utilise a shape memory effect to assume, at body temperature, a radially outwardly protruding configuration effective to engage the radially inward facing surface of the implant prior to the withdrawal of the sheath. In this way, it is possible to achieve a more compact device.
In a further embodiment, the first plurality of implant retention elements lie within the wall thickness at a temperature at which the implant is stored on the inner catheter.
Having an austenite finish temperature (Af temperature) below body temperature may serve to reduce the force exerted onto the inner wall of a (covered implant) during storage of the device at room temperature. In such a case, loading of the implant is performed a temperature above Af, if it is desired to use the “grip” of the elements to transfer the implant from the closed crimp head to the sheath. During storage at a temperature below Af the radial force exerted is reduced which is beneficial as polymers show a time dependent deformation behaviour (creep) and as such, persistent pressure exerted by the retention elements onto the inside covering of the implant may lead to local damage of the covering.
When deploying the device at body temperature, above Af, the full radial force exerted by the retention elements is available.
The catheter device herein described can be used by a medical practitioner to deploy an implant 20 at an implant site in a body. Before use, the catheter device is stored in packaging (not shown). The practitioner removes the catheter device from the packaging. The practitioner advances the catheter device along a bodily lumen to the implant site. Once the implant site has been reached, the other sheath 8 is withdrawn in a proximal direction by the practitioner. By withdrawing the sheath 8, the implant 20 is deployed at the implant site.
The invention is not limited to the embodiments shown and described above.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2020/065920 | 6/9/2020 | WO |
