CA2440487C - Delivery system for delivering a self-expanding stent - Google Patents

Delivery system for delivering a self-expanding stent Download PDF

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Publication number
CA2440487C
CA2440487C CA002440487A CA2440487A CA2440487C CA 2440487 C CA2440487 C CA 2440487C CA 002440487 A CA002440487 A CA 002440487A CA 2440487 A CA2440487 A CA 2440487A CA 2440487 C CA2440487 C CA 2440487C
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CA
Canada
Prior art keywords
stent
self
delivery system
end portion
retraction
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
Application number
CA002440487A
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French (fr)
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CA2440487A1 (en
Inventor
Oliver Ruetsch
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Abbott Laboratories Vascular Enterprises Ltd
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Abbott Laboratories Vascular Enterprises Ltd
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Publication date
Application filed by Abbott Laboratories Vascular Enterprises Ltd filed Critical Abbott Laboratories Vascular Enterprises Ltd
Publication of CA2440487A1 publication Critical patent/CA2440487A1/en
Application granted granted Critical
Publication of CA2440487C publication Critical patent/CA2440487C/en
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Expired - Lifetime legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod

Abstract

The invention refers to a delivery system (1) for delivering a self-expanding scent (2) to a predetermined location in a body lumen, the delivery system comprising: - a catheter body (3) having proximal and distal ends (5, 4), the catheter body (3) being adapted for transporting the stent (2) to a predetermined site in said body lumen for deployment; - the stent (2) being carried by said catheter body (3) near the distal end (4); - a retractable outer sheath (6) surrounding the scent (2) and containing the scent (2) in a delivery configuration where the stent (2) has a reduced radius along its entire axial length (L E); and - a proximal retraction handle (7) connected to the proximal end (5) of the catheter body (3), wherein: - the sheath (6) comprises: - an outer tube (8) having a distal end portion (9) surrounding the stent (2) along its entire length (L E) and having a proximal end portion (10) being connected to the retraction handle (7); and - a separate inner tube (11) being disposed concentrically within the outer tube (8) and having a distal end portion (12) surrounding the scent (2) only along a part (L p) of its entire length (L E).

Description

I

Description The present invention relates to a delivery system for deli-vering a self-expanding stent to a predetermined location in a body lumen.

Such a delivery system is known from WO 98/23241.

Delivery systems for deploying endovascular stent grafts, self-expanding stents or balloon expandable stents are well-known in the field of medical technology. As has been ex-plained in the before-mentioned citation a self-expanding stent is a stent which expands from a compressed delivery po-sition to its original diameter when released from the deliv-ery device, exerting radial force on the constricted portion of the body lumen to re-establish patency. One common self-expanding stent is manufactured of nitinol, a nickel-titanium shape memory alloy, which can be formed and annealed, deformed at a low temperature, and recalled to its original shape with heating, such as when deployed at body temperature in the body.

One important factor in delivering the stent is a controlled precise retraction of the retractable outer sheath. What is needed is a delivery system which provides for a controlled and precise retraction of the retractable outer sheath and en-abled the physician to accurately determine proper positioning of the stent, as well as track the retraction of the outer sheath.

Known delivery systems suffer, however, from the draw-back that the retraction forces are often too high, especially in cases where the stents are covered with layers made from body-
2 compatible materials or the like so that the friction forces between the stent and the outer sheath may become excessively high.

It is therefore an object underlying the present invention to provide a delivery system for delivering a self-expanding stent that is able to overcome the before-mentioned draw-back so that a smooth retraction of the retractable outer sheath is possible.

The solution of this object is achieved by the features of claim 1.

The delivery system according to the present invention com-prises a retractable outer sheath that is divided into an outer tube and a separate inner tube. Said tubes are disposed concentrically with respect to each other. The outer tube sur-rounds and covers the stent along its entire length whilst the separate inner tube surrounds the stent only partly, as espe-cially only along about 50 % of its entire length.

This simple and effective arrangement results in the advantage that the surface between the stent and the outer sheath is re-duced by a remarkable percentage, especially up to 50 %, so that the retraction forces become significantly smaller.

The dependent claims contain advantageous embodiments of the present invention.

A specifically advantageous embodiment provides for an ar-rangement of stop members. One of said stop members can be disposed at the distal end of a retraction tube of the retrac-tion handle whilst the second stop member is disposed at the proximal end portion of the inner tube. So, upon operation of
3 the retraction handle the outer tube is retracted and after a predetermined length of retraction the stop members engage each other so that also the inner tube can be retracted upon only one operation of the retraction handle so that the physi-cian can deploy the stent with the same kind of operation as with conventional delivery systems but much smoother and with lower retraction forces. This facilitates an exact position=of the stent as the stent is prevented from being longitudinally compressed.

According to the present invention, the outertube may be a co-extruded tubing, e. g. made from polyamid whilst the inner tubing is preferably made from polyethylene.

In general, the materials of the tubes are to be chosen from combinations of materials that result in low friction resis-tance or are tubings comprising layers with low friction coef-ficients.

A detailed description of the invention is described below with a specific reference being made to the drawings in which:
Fig. 1 is a schematically simplified view of the distal end portion of the delivery system according to the pre-sent invention, Fig. 2 is a schematically simplified view of the proximal end portion of the delivery system according to the present invention, and Fig. 3 is a schematically simplified view, similar to Fig.
1, of the distal end portion of the second embodi-ment of the delivery system according to the present invention.
4 While this invention may be embodied in many different forms, there is shown in the drawings and described in detail herein a specific preferred embodiment of the invention. The present disclosure is an exemplification of the principles of the in-vention and is not intended to limit the invention to the par-ticular embodiment illustrated.

Figs. 1 and 2 show side views of the inventive delivery system 1.

The delivery system 1 is intended for delivering a self-expanding stent 2 shown in Fig. 1.

The delivery system 1 comprises a catheter body 3 having a proximal end 5 and a distal end 4. The catheter body 3 is adapted to transport the stent 2 to a predetermined site in a body lumen for deployment that is not shown in Figs. 1 and 2.
The catheter body 3, furthermore, comprises a metal and/or a metal-polymeric and/or a polymere shaft 18 that extends from the proximal end 5 to the distal end 4.

The delivery system 1, furthermore, comprises a retractable outer sheath 6 shown in Figs. 1 and 2 that surrounds the stent 2 and contains the stent 2 in a delivery configuration where the stent 2 has a reduced radius along its entire length LE
shown in Fig. 1.

Fig. 2 shows a proximal retraction handle 7 that may be con-figured as an integral part of a so-called tuohy borst valve.
The handle 7 is disposed at the proximal end 5 of the catheter body 3 as shown in Fig. 2.

According.to the present invention the sheath 6 is a combina-tion of an outer tube 8 and a separate inner tube 11. The outer tube 8 has a distal end portion 9 that surrounds the stent 2 along its entire length LE as can be learned from Fig_ 1.

The outer tube 8, furthermore, comprises a proximal end por-tion 10 being connected to the retraction handle 7, e.g. by an adhesive connection.

The separate inner tube 11 is disposed concentrically within the outer tube 8 and does concentrically surround metal shaft 18 of catheter body 3. The inner tube 11 comprises a distal end portion 12 surrounding the stent 2 only along a part Lp of its entire length LE as can be seen form Fig. 1. This configu-ration significantly reduces the friction forces between the stent 2 and the outer sheath 6 so that the forces for retrac-tion of the outer sheath 6 become remarkably smaller in com-parison to conventional delivery systems.

The handle 7 of the preferred embodiment shown in figs. 1 and 2 comprises a retraction tube 13 that is connected at its dis-tal end 14 to the proximal end portion 10 of the outer tube 8.
The retraction tube 13 comprises a stop member 15 at its dis-tal end 14 (see Fig. 2). Said stop member 15 can be configured as an annular ring extending inwardly from the inner periphery of retraction tube 13.

As can be seen from Fig. 2 the retraction tube 13 concentri-cally surrounds the proximal end portion 5 of catheter body 3 and proximal end portion 16 of the inner tube 11.

The inner tube 11, in turn, comprises a stop member 17 at its proximal end portion 16_ Said stop member 17 may also be con-figured as an annular ring extending outwardly from the outer periphery of inner tube 11.

As can be seen from Fig. 2 the stop members 15 and 17 are adapted to be engaged with one another upon retraction of han-dle 17. When operating said retraction tube 13 of handle 7_ i.n the direction of arrow A in Fig. 2 outer tube 8 is pulled back in the direction of arrow B shown in Fig. 1 sliding partly on inner tube 11 as said inner tube 11 covers only a part of stent 2. Upon engagement of stop members 15 and.17 inner tube 11 is also pulled back in the direction of arrow B shown in Fig. 1 so that stent 2 can be released and deployed at a pre-determined site in a body lumen.

Fig. 3 depicts a second embodiment of a delivery system 1 ac-cording to the present invention. All parts of this embodiment being similar to the embodiment of Figs. 1 and 2 are desig-nated by the same reference numerals.

The basic difference between the embodiment of Fig. 1 and Fig.
3 is to be seen in the fact that the inner tube 11 is fixed at a fixing portion 19 to shaft 18 shortly after stent 2 is seen in the direction of arrows X and Y. To retract inner tube 11, with this embodiment, it is possible to retract shaft 18 after having retracted the outer tube 8.

Claims (16)

The embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows:
1. A self-expanding stent delivery system for delivering a self-expanding stent to a predetermined location in a body lumen, the self-expanding stent delivery system comprising:
a catheter body having a proximal end and a distal end, the catheter body being configured and arranged to carry the stent near the distal end of the catheter body for transporting the stent to the predetermined location in the body lumen for deployment;

a retractable outer sheath configured and arranged to surround the stent and contain the stent in a delivery configuration such that the stent has a reduced radius along its entire axial length; and a proximal retraction handle connected to the proximal end of the catheter body, the retractable outer sheath comprising:

an outer tube having a distal end portion configured and arranged to surround the stent along the entire length of the stent and further having a proximal end portion connected to the retraction handle; and a separate inner tube disposed concentrically within the outer tube and having a distal end portion configured and arranged to surround the stent only along a proximal part of the entire length of the stent, the inner tube having a proximal end portion housed in the retraction handle, retraction of the handle causing the distal end portion of the outer tube to recede from the stent and from the distal end portion of the inner tube.
2. The self-expanding stent delivery system according to claim 1, wherein the handle comprises a retraction tube connected at its distal end to the proximal end portion of the outer tube.
3. The self-expanding stent delivery system according to claim 2, wherein the retraction tube comprises a stop member at its distal end.
4. The self-expanding stent delivery system according to claim 3, wherein the retraction tube concentrically surrounds the proximal end of the catheter body and a proximal end portion of the inner tube.
5. The self-expanding stent delivery system according to claim 2, wherein the retraction tube concentrically surrounds the proximal end of the catheter body and a proximal end portion of the inner tube.
6. The self-expanding stent delivery system according to claim 5, wherein the inner tube comprises a stop member at its proximal end portion that is adapted to be engaged with the stop member of the retraction tube upon the retraction of the handle.
7. The self-expanding stent delivery system according to claim 6, wherein the inner tube surrounds the stent along about 40% to 60% of the entire length of the stent.
8. The self-expanding stent delivery system according to claim 1, wherein the inner tube surrounds the stent along about 40% to 60% of the entire length of the stent.
9. The self-expanding stent delivery system according to of claim 1, wherein the stent is configured as a stent graft or a covered stent.
10. The self-expanding stent delivery system according to claim 1, wherein the separate inner tube is fixed to a shaft of the catheter body.
11. A self-expanding stent delivery system comprising:
a self-expanding stent;
a catheter body having a shaft, a proximal end, and a distal end, the catheter body being configured and arranged to carry the stent near the distal end of the catheter body for transporting the stent to a predetermined site in a body lumen for deployment;

a retractable outer sheath configured and arranged to surround the stent and contain the stent in a delivery configuration such that the stent has a reduced radius along its entire axial length; and a proximal retraction handle connected to the proximal end of the catheter body, the retractable outer sheath comprising:
an outer tube having a distal end portion configured and arranged to surround the stent along the entire length of the stent and further having a proximal end portion connected to the retraction handle; and a separate inner tube disposed concentrically within the outer tube and having a distal end portion configured and arranged to surround the stent only along a proximal part of the entire length of the stent, the inner tube having a proximal end portion affixed to the shaft proximally of the stent, retraction of the handle causing the distal end portion of the outer tube to recede from the stent and from the distal end portion of the inner tube.
12. The self-expanding stent delivery system according to claim 11, wherein the stent is configured as a stent graft or a covered stent.
13. The self-expanding stent delivery system according to claim 11, wherein the handle comprises a retraction tube connected at its distal end to the proximal end portion of the outer tube.
14. The self-expanding stent delivery system according to claim 13, wherein the retraction tube comprises a stop member at its distal end.
15. The self-expanding stent delivery system according to claim 13, wherein the retraction tube concentrically surrounds the proximal end of the catheter body and the proximal end portion of the inner tube.
16. The self-expanding stent delivery system according to claim 11, wherein the inner tube surrounds the stent along about 40% to 60% of the entire length of the stent.
CA002440487A 2002-09-09 2003-09-08 Delivery system for delivering a self-expanding stent Expired - Lifetime CA2440487C (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP02020170A EP1396239B1 (en) 2002-09-09 2002-09-09 Delivery system for delivering a self-expanding stent
EP02020170.3 2002-09-09

Publications (2)

Publication Number Publication Date
CA2440487A1 CA2440487A1 (en) 2004-03-09
CA2440487C true CA2440487C (en) 2010-01-12

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Family Applications (1)

Application Number Title Priority Date Filing Date
CA002440487A Expired - Lifetime CA2440487C (en) 2002-09-09 2003-09-08 Delivery system for delivering a self-expanding stent

Country Status (6)

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US (2) US7175650B2 (en)
EP (1) EP1396239B1 (en)
JP (1) JP4611624B2 (en)
AT (1) ATE281800T1 (en)
CA (1) CA2440487C (en)
DE (1) DE60201905T2 (en)

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RU2651695C2 (en) * 2012-12-11 2018-04-23 Караг Аг Stent applicator

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Also Published As

Publication number Publication date
DE60201905D1 (en) 2004-12-16
EP1396239B1 (en) 2004-11-10
US20070106367A1 (en) 2007-05-10
US7850724B2 (en) 2010-12-14
EP1396239A1 (en) 2004-03-10
CA2440487A1 (en) 2004-03-09
JP4611624B2 (en) 2011-01-12
DE60201905T2 (en) 2005-11-10
JP2004261571A (en) 2004-09-24
ATE281800T1 (en) 2004-11-15
US20040117000A1 (en) 2004-06-17
US7175650B2 (en) 2007-02-13

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