Transluminal delivery system
10369032 ยท 2019-08-06
Assignee
Inventors
- Martin Wubbeling (Mannheim, DE)
- Daniel Dietrich (Karlsruhe, DE)
- Erhard Elsasser (Pfintzal/Berghausen, DE)
- Beate Walter (Stutensee, DE)
Cpc classification
A61F2/95
HUMAN NECESSITIES
Y10T29/49863
GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
A61F2220/0025
HUMAN NECESSITIES
A61F2/966
HUMAN NECESSITIES
International classification
Abstract
A transluminal delivery system and a method of assembling. The system includes a cylindrical, inner-catheter component and a retractable sheath surrounding the component and defining a space between the component and the sheath to receive a self-expanding luminal prosthesis between the component and the sheath. The inner-catheter component may include at least one sleeve having fibers, at least one connected sleeve portion connected to the inner catheter, and at least one unconnected sleeve portion slidably engaging the inner catheter such that when the sheath retracts, the unconnected portion expands and sleeve fibers engage the prosthesis's luminal surface, wherein the engagement opposes proximal stent movement.
Claims
1. A transluminal delivery system for deploying a stent in a patient, comprising: a retractable sheath positioned over the stent; and an inner catheter positioned through a lumen of the stent, the inner catheter comprising: a tubular portion having an abluminal surface; and a cylindrical braid element positioned over the abluminal surface of the tubular portion, the cylindrical braid element comprising: an inner surface contacting the abluminal surface of the tubular portion over an entire length of the cylindrical braid element; a proximal region bonded to the abluminal surface of the tubular portion; and an unbonded distal end slidably disposed on the abluminal surface of the tubular portion.
2. The transluminal delivery system according to claim 1, wherein the proximal region of the cylindrical braid element is adjacent a proximal end of the stent prior to deployment of the stent.
3. The transluminal delivery system according to claim 2, further comprising a collar connected to the retractable sheath and a pulling member, wherein a proximal end of the proximal region of the cylindrical braid element is adjacent the collar prior to deployment of the stent.
4. The transluminal delivery system according to claim 2, wherein a distal end of the cylindrical braid element is within the lumen of the stent prior to deployment of the stent.
5. The transluminal delivery system according to claim 1, wherein the cylindrical braid element is a first braid element, and wherein the inner catheter further comprises a second braid element having a second proximal region bonded to the abluminal surface of the tubular portion, and a second unbonded distal end slidably disposed on the abluminal surface of the tubular portion.
6. The transluminal delivery system according to claim 1, wherein the cylindrical braid element comprises a plurality of filaments formed from at least two different materials.
7. The transluminal delivery system according to claim 6, wherein one of the at least two different materials is polyurethane.
8. The transluminal delivery system according to claim 1, wherein the cylindrical braid element is enclosed in a thin polymer matrix.
9. The transluminal delivery system according to claim 1, wherein the cylindrical braid element comprises a plurality of filaments having a non-circular cross-section.
10. The transluminal delivery system according to claim 1, wherein the abluminal surface of the tubular portion of the inner catheter is roughened.
11. The transluminal delivery system according to claim 1, wherein the cylindrical braid element distal of the proximal region is 5 mm.
12. A transluminal delivery system for deploying a stent in a patient, comprising: a retractable sheath positioned over the stent; and an inner catheter positioned through a lumen of the stent, the inner catheter comprising: a tubular portion having an abluminal surface; and two or more cylindrical braid elements positioned over the abluminal surface of the tubular portion, each of the two or more cylindrical braid elements comprising: an inner surface contacting the abluminal surface of the tubular portion over an entire length thereof; a proximal region bonded to the abluminal surface of the tubular portion; and an unbonded distal end slidably disposed on the abluminal surface of the tubular portion.
13. The transluminal delivery system according to claim 12, wherein the two or more cylindrical braid elements comprise a first cylindrical braid element, a second cylindrical braid element, and a third cylindrical braid element.
14. The transluminal delivery system according to claim 13, wherein the proximal region of the first cylindrical braid element is adjacent a proximal end of the stent prior to deployment of the stent.
15. The transluminal delivery system according to claim 14, further comprising a collar connected to the retractable sheath and a pulling member, wherein a proximal end of the proximal region of the first cylindrical braid element is adjacent the collar prior to deployment of the stent.
16. The transluminal delivery system according to claim 13, wherein a distal end of each of the first, second, and third cylindrical braid elements is within the lumen of the stent prior to deployment of the stent.
17. The transluminal delivery system according to claim 12, wherein at least one of the two or more cylindrical braid elements comprises a plurality of filaments formed from at least two different materials.
18. The transluminal delivery system according to claim 17, wherein one of the at least two different materials is polyurethane.
19. The transluminal delivery system according to claim 12, wherein at least one of the two or more cylindrical braid elements is enclosed in a thin polymer matrix.
20. The transluminal delivery system according to claim 12, wherein the abluminal surface of the tubular portion of the inner catheter is roughened.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) For a better understanding of the invention, and to show more clearly how the same may be carried into effect, reference will now be made, by way of example, to the accompanying drawings, in which:
(2)
(3)
(4)
(5)
DETAILED DESCRIPTION
(6) The schematic drawing of
(7) Absent any other structure, then any proximal movement of the sheath 12 will carry the stent with it because the stent is a self-expanding stent and so is continuously pressing on the luminal surface of the sheath 12. To stop the stent 10 moving proximally with the sheath 12, it has been conventional to employ an annular element 20 that can conveniently be termed a stopper. The stopper element 20 also runs back to the not-shown hand unit, through a shaft 22 that will of course be in endwise compressive stress during the time period when the sheath 12 is being retracted and the stopper 20 is required to stop the stent moving proximally with the sheath 12. By contrast, the pulling element 16 during this time period will be in endwise tensile stress.
(8) One can see immediately from
(9) Turning to
(10) Clearly, this assembly technique can bring advantages relative to the basic system of
(11) Looking now at drawing
(12) The inner catheter 30 has an abluminal surface to which is bonded in length portion 33 an end portion 34 of a cylindrical braided element 36 that fits snugly around the external diameter of the inner catheter shaft 30. Most of the length of the braid 36 is free to slide on the abluminal surface of the inner catheter 30, the exception being in the end zone 33. It will be appreciated that when one pulls the inner catheter 30 from left to right in
(13) Now, turning to
(14) Although
(15) It is conventional to use a cylindrical braid when a degree of springiness is desired, such as in the child's toy called the Chinese Finger or a self-expanding stent after Wallsten. Here, however, one is looking for a braid that has some capability to crumple or concertina, which is almost the opposite of the quality of springiness.
(16) As ever, materials and dimensions are chosen deliberately on the basis of optimizing fitness for purpose. Here, one will contemplate the ideal number of filament crossing points per unit of axial length of the cylindrical braid and the possibility to blend different materials in the filament weave. One possibility is to incorporate filaments of polyurethane as damping filaments. A homogeneous or heterogeneous mixture of filaments selected from steel, nitinol or other alloys may form the braid, and heat-treating of some or all of these materials may be used to desirably tune the mechanical properties of the braid. The braid itself may be enclosed in a very thin polymer matrix, for example polyurethane. Possibly, it will be effective to use filaments of non-circular cross section, rough-surfaced or with corners (square or hexagon cross-section, for example) to enhance frictional engagement with the stent and inner catheter during stent release. It may be effective to roughen the abluminal surface of the inner catheter beneath the braid.
(17) The inventor contemplates that braid lengths of as little as 5 mm (or even less) may be fully effective to accomplish the desired effect. That is to say that the axial length of the unbonded portion of the braid (not including the portion which is bonded to the inner catheter 30) need only be 5 mm in length, possibly even shorter, depending on the particular application for which it is being used. The same will apply to other non-braided tubular anti-sliding components and sleeves, such as the sleeve 50 of
(18) Indeed, as the length of such braided and non-braided sleeves is increased, so too is the extent to which the sleeves will nick up or crumple, as well as the extent to which their
(19) thickness will increase, as the unbonded portions slide along the abluminal surface of the inner catheter 30. In certain circumstances, where the anti-sliding sleeve is of significant length, this can generate undesirably large radial forces acting radially inwardly on the inner catheter 30 and radially outwardly on the surrounding stent 10 and sheath 12. Where the radial forces are too large, retraction of the sheath 12 and proper positioning and placement of stent 10 may be inhibited, and there is a risk of damaging one or more of the inner catheter 30, stent 10 or sheath 12. Such consequences are counter to the objective of spreading the compressive forces which hold the stent 10 in position on the inner catheter 30 along the axial length of the stent 10, rather than having concentrated forces at the location of a stopper annulus 20 as described in relation to
(20) To this end, a shorter length of anti-sliding sleeve is preferred, and it is furthermore proposed to provide two or more of the anti-sliding sleeves along the length of the inner catheter 30 within the lumen of the stent 10, depending on the length of the stent 10 to be delivered and the forces involved. Currently, the use of two or three anti-sliding sleeves is preferred, for most stent delivery applications. Of course, the anti-sliding sleeves may all be of the same configuration, or different lengths and types of sleeves may be used at different positions along the length of the inner catheter 30 within the lumen of stent 10. For example, a mixture of braided and non-braided sleeves may be used in the same transluminal catheter delivery system. Different materials or combinations of materials may be selected for use in each individual anti-sliding sleeve, as appropriate.
(21) Turning to
(22) Turning to
(23) Turning now to a third embodiment, as shown in
(24) If desired, the abluminal surface of the inner catheter of the third embodiment (and even the abluminal surface of the braid of the first embodiment) could be rendered filamentous, to take advantage of the idea of the second embodiment as well.
(25) Another embodiment of the invention is shown in
(26) It will be appreciated that the arrangement of
(27) Although it has been proposed to crimp the stent 10 and load the stent 10 into a sheath 12, prior to then drawing the inner catheter 30 axially into the delivery system within the lumen of the stent 10 (as denoted by arrows F in
(28) Specifically, after crimping the stent 10 to its reduced diameter, one has first to load the stent 10 into the sheath 12. One way to do this is to push the stent 10 axially from within the crimping device into an adjacently disposed and aligned sheath, for example using a pusher configured like the inner catheter 30 of
(29) It would be preferable, instead, to crimp the stent 10 down directly onto the inner catheter 30 having the anti-sliding component. The inner catheter 30 with the anti-sliding component may then be used to push the crimped stent 10 into the sheath 12, without needing to use a separate pusher or to carry out a separate step of inserting the inner catheter 30 with the anti-sliding sleeve into the lumen of stent 10 after it has been installed in the sheath 12.
(30) Although this is possible with the inner catheters 30 of
(31) It is therefore contemplated to use the inner catheter 30 of
(32) In order to deploy the stent 10 using such a system, the sheath 12 is then retracted proximally by pulling on pulling element 16, which places the inner catheter 30 in compression. The sheath 12 tends to draw the stent 10 proximally, which in turn causes the sleeve 66 to ruck up towards the bonded proximal end portion 64 of the sleeve 66. The sleeve 66 thereby engages the inner lumen of the stent 10, as in the embodiments already described, to effectively push the stent 10 against the sheath retraction force and hold the stent 10 in place as it expands upon release from the sheath 12. In this way, as the stent 10 is deployed, the interaction between the rucked zone and the luminal surface of the stent 10 prevents significant proximal sliding relative to the inner catheter 30, and allows precise deployment.
(33) In this embodiment, the cylindrical element 66 is advantageously PET tubing so that the end portions 64 and 65 may be secured on the inner catheter by heat-shrinking while the sliding portion remains free to translate and crumple (nick up) as required.
(34) Regarding the engagement between the anti-sliding sleeve component 66 and the inner lumen of the surrounding stent 10, as with the anti-sliding sleeves 36, 50, 76 of the other embodiments disclosed herein, it has been contemplated that where the anti-sliding sleeve is nicked up the sleeve material or braids may inter-engage with the interstices of the sent 10. However, for many stents, the interstices are not sufficiently open, with the stent in the crimped configuration, to allow for such inter-engagement. Indeed, for stents which are laser cut from a Nitinol tube, there are virtually no interstices in the stent structure in the crimped, reduced-diameter configuration. The engagement between the anti-sliding components and the stent inner luminal surface is, therefore, in most cases, simply a frictional engagement. By selecting suitable materials for the anti-sliding sleeves, a secure frictional engagement can be achieved. Moreover, by selecting a suitable material for the anti-sliding sleeve, the anti-sliding sleeve can present a soft bed onto which the stent 10 can be crimped, without damaging the stent 10 or any stent coating. By using a suitably pliable (soft) material, the frictional engagement between the anti-sliding component and the stent luminal surface can also be enhanced. If desired, an outer polymeric sleeve could be incorporated in or provided on the outside of a braided sleeve, the braided sleeve providing the material resilience to present a crumpling action and the sleeve improving the frictional engagement between the braided sleeve and the stent luminal surface (as compared to the frictional engagement between only a braided layer and the stent luminal surface). Incorporating a braided sleeve in a thin PUR matrix is contemplated.
(35) A further embodiment of the invention is now described with reference to
(36) In this embodiment, as shown in
(37) Stent 10 may be loaded onto inner catheter 30 by crimping the stent 10 down onto the inner catheter 30 slider 75 and sleeve 76, as for the embodiments described above. The stent remains at this stage substantially freely movable relative to the inner catheter. Such a configuration may be seen in
(38) When, during deployment of the stent 10, the correct position of the stent 10 is reached for it to be released from the sheath 12, proximal tension is applied to the pull element 77 causing the slider 75 to travel proximally relative to stent, catheter and bonded proximal portion 74 of the sleeve 76. As the sleeve 76 is compressed longitudinally between slider 75 and bonded proximal portion 74, it will expand in radial extent, for example by rucking up or crumpling, as explained with reference to the embodiments described above, to engage with the luminal surface of the stent 10. The more tension that is applied to the pull element 77, the closer the slider 75 approaches bonded proximal portion 74, and the greater the degree of interaction between the sleeve 76 and the luminal surface of the stent 10. Motion of the stent relative to the catheter will tend to strengthen this interaction further, in analogous ways to those described above with reference to the other embodiments. In this way, the stent 10 can be restrained on demand from motion relative to the catheter 30 by actuation of the pull element 77. Such a configuration may be seen in
(39) In some applications, it may even be desirable to make the process reversible, and allow the pull element 77 to have sufficient column strength to translate the slider 75 in the distal direction, returning the sleeve 76 to its previous uncrumpled configuration and relieving the stent 10 from the radial restraining force.
(40) In this embodiment, the sleeve 76 is advantageously PET tubing while the slider can be constructed as a PEBAX tube riding on an inner PI tube. Alternatively, a metal braid may be used as a sleeve, as in the embodiment of
(41) In connection with the embodiments described above, a stent receiving element may be provided on a portion of the unbonded sliding portion of the sleeve. Such is shown at the distal end of the sleeve 76 in
(42) Such receiving elements are also useful, even if the above steps are not taken during the manufacturing and assembly process, as they allow the nicking or crumpling behavior of the anti-sliding sleeve to be more accurately predicted and controlled, by guaranteeing that the sleeve 76 will crumple in the region between the receiving element 75 and the fixed portion 74 of the anti-sliding sleeve 76. Without a receiving element 75, portions of the anti-sliding sleeve 76 which were not in good contact with the stent 10 may not get nicked up during retraction of the sheath 12 (in the embodiments not using a pull element 77), or may not get nicked up evenly or uniformly along the length of the antisliding sleeve. Receiving element 75 is therefore useful in these respects.
(43) An important part of the routine work of stent delivery system designers is to select optimum materials for individual component parts of stent delivery systems. The present invention is no exception to this general rule. For the skilled reader of this specification, choice of materials is a matter of background knowledge and routine expertise. The skilled reader will be able readily to appreciate how the present inventive concept allows assembly of a catheter-type, transluminal stent delivery system that has minimal passing diameter and maximal management of the movement of the stent during release of the stent from the system, with minimal occurrence of unpredictable stress overloading of any part of the material of the stent being deployed.