CA2216952C - Pull back stent delivery system - Google Patents

Pull back stent delivery system Download PDF

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Publication number
CA2216952C
CA2216952C CA002216952A CA2216952A CA2216952C CA 2216952 C CA2216952 C CA 2216952C CA 002216952 A CA002216952 A CA 002216952A CA 2216952 A CA2216952 A CA 2216952A CA 2216952 C CA2216952 C CA 2216952C
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CA
Canada
Prior art keywords
shaft
medical device
pull back
inner shaft
middle pull
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 - Fee Related
Application number
CA002216952A
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French (fr)
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CA2216952A1 (en
Inventor
Connie Del Toro
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Boston Scientific Scimed Inc
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Scimed Life Systems Inc
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Filing date
Publication date
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Publication of CA2216952A1 publication Critical patent/CA2216952A1/en
Application granted granted Critical
Publication of CA2216952C publication Critical patent/CA2216952C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/9517—Instruments specially adapted for placement or removal of stents or stent-grafts handle assemblies therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters

Abstract

A delivery system (30) for implantation of a medical device in a vessel which has three concentric shafts (32, 34, 36), an inner shaft (36) for carrying a medical device (38), a middle pull back shaft (34) and an outer stiffening shaft (32). The inner and outer shafts are connected together at the proximal end (40) of the delivery system to preclude the inner shaft from moving axially relative to the outer shaft as the middle pull back shaft is retracted. This allows for accurate placement of the medical device.

Description

Pull Back Stent Delivery System Back:tround of the Invention 1. Field of the Invention .
The present invention relates to an improved delivery system for delivering and deploying a medical device, such as a stmt. More specifically, the invention relates to a delivery system for more accurate placement of a medical device such as a stent when using a pull back delivery system.
2. Description of the Related Art Stents and delivery systems for deploying stents are highly developed and well known field of medical technology. Stems have many well known uses and applications. A stmt is a prosthesis which is generally tubular and which is expanded radially in a vessel or lumen to maintain its patency. Stents are widely used in body vessels, body canals, ducts or other body lumens.
Stems, stent-grafts and the like are commonly delivered using a catheter delivery system. A common type of delivery system for delivering a self expanding stent is called a pull back delivery system. This type of delivery system utilizes two catheters or shafts which are concentrically arranged, one around another. The stent is carried axially around the distal end of the inner catheter or shaft. The stent is carried to the delivery site on the distal end of the delivery device, held in its compressed delivery position by the outer shaft or catheter. Once at the desired placement site, the outer shaft is pulled back, releasing the stmt to self expand.
In testing, applicant's have observed that the portion of the catheter outside the body is typically not straight, but is curved during pull back.
The frictional forces caused by pulling back the outer catheter or shaft cause the curve of the entire device to flatten out, which causes the distal end of the inner shaft or catheter to be urged forward. This undesired forward movement of the inner shaft ' often leads to inaccurate placement of the stmt.
Another factor which can lead to placement inaccuracy are curves inside the body. A common and well known type of delivery is a contralatera.l insertion approach, where the distal end of the delivery device is placed on the opposite illiac from the original insertion site. In this case, the pull back delivery systems can also cause the curve placed inside the illiac vessels to straighten out or.
flatten slightly as the outer catheter or shaft is pulled back. This also causes undesired forward movement of the inner shaft, which can lead to inaccurate placement of the stmt.
Schneider's WALLSTENT~ product with UnistepTM delivery system utilizes a stainless steel tube as the inner shaft for the portion of the delivery system outside the body, and a plastic flexible tube as the inner shaft inside the body. The stainless steel tube prevents the proximal end of the device from curving outside the .
body. This device prevents placement error from the curve flattening out outside the body, but does not prevent placement error from a curve flattening out inside the body.
Also, the Schneider approach may require different lengths of stainless steel tubing depending on the type of procedure, such as an ipsilateral femoral artery insertion versus a contralateral insertion, or a biliary duct insertion.
In the prior art, Garza et al., US 4,665,918, discloses a prosthesis system and method for implanting a prosthesis within a vessel. The device provides a generally tubular prostheses member having an unobstructed central passageway. The prosthesis member is positioned in a contracted condition between a delivery catheter and an outer sheath, and expands outwardly responsive to removal of the sheath. See Figures 9;~-13 b.
Further in the prior art, Heyn et al., US 5,201,757, discloses an apparatus having medial region deployment of radially self expanding stems. The apparatus includes proximal 24 and distal 30 sleeves covering the distal end of and inner catheter 44, both of which hold down, or contains the proximal and distal end portions of the stent. These sleeves abut one another and cooperate to separate to release the stent. The sleeves are movable axially away from one another by a control structure at the proximal end of the apparatus. As discussed in col. 6, lines 13-34, finger grip 56 is mounted to tubular section 58 which is mounted to the proximal end of outer catheter 20,24. This grip controls the axial movement of outer catheter/shaft 20 and 24. Another finger grip 60 is mounted to tubular section 62 which is slidable mounted to section 58. The proximal tubular section 66 in connected to end mernber 68 at its proximal end and fixed to the proximal end of inner catheter 44.
Member 72 . ._, : ;. ~ -, C' L~ '~~

-2a-is mounted on the distal end of section 66 and to the proximal end of section 62, fixing thcae two section together relative to one another. Therefore, when grip 60 and sections 62 and 66, which are affixed together by member 72, move axial, inner catheter 44, which is affixed to section 66, also moves axially. By moving finger grip 56 proximately, outer catheter 20, and thus sleeve 24, are moved proximately away from distal sleeve 24, the movement of which is controlled by inner catheter 44. Distal movement of finger grip 60, which controls inner catheter 44, moves distal sleeve 30 distally to fully deploy the stmt.
There remains a need in the art for a stmt delivery system which prevents axial movement of one catheter shaft from causing forward movement of the other catheter shaft, which will allow for accurate placement of a medical device.
Summary of the Invention T'he inventive delivery device includes a catheter which is comprised of three concentric shafts. A medical device such as a self-expanding stmt is held in a reduced delivery configuration for insertion and transport through a body lumen to a predetermined site for deployment. The stmt is carried axially around the inner shaft and is held in its reduced delivery configuration by the middle shaft.
An outer shaft is used to stiffen the delivery device so that the arc of the inner shaft will not change outside of the body when the middle shaft is pulled back to release the stmt to self-expand. The outer shaft is connected to the inner shaft at the proximal end of the device, which stiffens the delivery system so that the inner shaft will not be urged forward as the middle shaft is pulled backward.
According to one aspect, the present invention provides a delivery system for implantation of a rne~dical device in a vessel, comprising:
a medical device:. and elongate flexible catheter means having proximal and distal ends for delivering a medical dc:vi.ce to a predetermined location in a vessel of a patient, the elongate flexible catheter means being further comprised of:
an inner shaft which carries the medical device near its distal end, a middle pull back shaft concentrically arranged around the inner shaft, the medicall device being carried between the inner shaft and middle -2b-pull back shaft, and an outer stiffening shaft concentrically arranged around the middle pull back shaft, and a manifold stabilizer connected to both the inner and outer shafts, the inner and out°r shafts as a result being permanently connected to their proximal ends to prevent any axial movement of the inner shaft with rcapect to the outer shaft, whereby the medical device is delivered at the desired site by pulling on the proximal. end of the middle pull back shaft, which deploys the medical device, and where the outer stiffening shaft connection to the inner shaft prevent axial movement of the firmer shaft with respect to the outer stiffening shaft, thereby preventing the distal end of the inner shaft from being urged forward during delivery and therefore allowing for more accurate placement of the medical device.
According to another aspect of the present invention, there is provided a delivery system for implantation of a medical device in a vessel, comprising:
an elongate flexible catheter means having proximal and distal ends for delivering a medical device to a predetermined location in a vessel of a patient, the elongate flexible catheter means being further comprised of:
an inner shaft;
a middle pull back shaft concentrically arranged around the inner shaft, whereby the medical device may be carried between the inner shaft and middle pull back shaft; and an outer stiffening shaft concentrically arranged around the middle pull back shaft;
a manifold stabilizer connected to both the inner and outer shafts, the inner and outer shafts as a result being permanently connected to prevent any axial movement of the inner shaft with respect to the outer shaft, wherein the middle pull back shaft is retractable relative to the inner shaft and the stiffening shaft by pulling on the proximal end of the middle pull back shaft, and wherein the outer stiffening shaft connection to the inner shaft prevents axial movement of the firmer shaft with respect to the outer stiffening shaft.

WO 96/31174 PCT/US96/04'744 Brief Description of the Drawings A detailed description of the invention is hereafter described with specific reference being made to the drawings in which:
Figure 1 is a prior art delivery device having two shafts concentrically S arranged and with an arc outside the body;
Figure 2 shows the arc outside the body of the prior art delivE:ry device of Figure 1 flattening out as the outer shaft or catheter is pulled back to release the stent;
Figure 3 shows the arc inside the body of a prior art delivery device during a contralateral insertion, with the flattening of the arc during deployrr~ent shown in silhouette;
Figure 4 is a sectional view of the inventive delivery system, showing the stmt undeployed;
Figure 5 is a sectional view of the inventive delivery system o:f Figure 3, showing the stmt deployed;
Figure 6 schematically shows the arc outside the body of the inventive delivery system with the stmt undeployed, and Figure 7 schematically shows the arc unchanged outside the body of the inventive delivery system with the stent deployed.
Descrit~tion of the Preferred Embodiments While this invention may be embodied in many different forms, there are shown in the drawings and described in detail herein specific preferred embodiments of the invention. The present disclosure is an exemplification of the principles of the invention and is not intended to limit the invention to the paWicular embodiments illustrated.
Figure 1 shows a prior art stmt delivery system, shown generally at 10, which is comprised of two concentrically arranged catheters, shafts or manifolds. The inner shaft is shown at 12 and the outer shaft is shown at 14.
A
medical device such as a self expanding stent (not shown) is carried axially around the inner shaft 12 and is held in its reduced delivery configuration by the outer shaft 14. The stmt is carried near the distal end 16 of the delivery system 10.
Reference numeral 18 shows schematically the separation between the portion of the device which is outside the body and the portion of the device which is inside the body.
Reference numeral 20 shows the arc outside the body prior to deployment of the stmt.
Figure 2 shows the prior art device of Figure 1 after the outer manifold or shaft has been pulled back to allow the stmt to self expand and deploy.
Figure 2 shows that arc 20 has flattened out as the outer shaft 14 is pulled back and inner shaft 12 moves forward.
Figure 3 shows the distal end of a prior art device during a contralateral insertion. As the medical device is deployed, the arc at 22 flattens out from its predeployment position to its deployed position, shown in silhouette at 24.
Referring now to Figures 4 and 5, the inventive deployment system is shown schematically and generally referred to as 30. The outer stiffening shaft is referred to at 32, the middle pull back shaft is referred to at 34 and the inner shaft is referred to at 36. The inner shaft 36 can function as the lumen for a guide wire.
A medical device, such as self expanding stmt 38 is shown in the delivery position in Figure 4, carried axially around' inner shaft 36 and held in its reduced delivery configuration by middle pull back shaft 34. The outer shaft 32 and inner shaft are connected together by manifold stabilizer 40 at the proximal end of the device.
It is important that the two shafts are connected together far enough apart to provide enough room for the middle pull back shaft to be fully retracted to completely release the stent 38 to self expand, as shown in Figure 5. By connecting the outer shaft 32 and the inner shaft 36 with manifold stabilizer 40, the inner shaft 36 is held in position during pull back of the middle pull back shaft 34, thereby preventing any flattening of the outside the body arc or the inside the body arc during deployment.
The inventive delivery system provides for accurate placement of the medical device.
Referring now to Figures 6 and 7, the inventive delivery device 30 is shown prior to deployment and after deployment. Figure 7 shows that the manifold stabilizer 40 prevents any flattening of arc 20 as middle pull back shaft 34 is retracted to allow the stmt 38 to self expand (shown in Figure 5). Similarly, the inventive delivery device will prevent any flattening of the arc inside the body, shown in Figure 3, during a contralateral insertion.

WO 96/31174 PCTlUS96/04744 This completes the description of the preferred and alternate embodiments of the invention. It is to be understood that even though numerous characteristics and advantages of the present invention have been set forth in. the foregoing description, together with the details of the structure and function of the ' S invention, the disclosure is illustrative only and changes may be made in detail, especially in matters of shape, size and arrangement of parts within the principals of the invention, to the full extent indicated by the broad, general meaning of the terms in which the appended claims are expressed. Those skilled in the art may recognize other equivalents to the specific embodiment described herein which are intended to be encompassed by the claims attached hereto.

Claims (16)

WHAT IS CLAIMED IS:
1. A delivery system for implantation of a medical device in a vessel, comprising:
a medical device; and elongate flexible catheter means having proximal and distal ends for delivering a medical device to a predetermined location in a vessel of a patient, the elongate flexible catheter means being further comprised of:
an inner shaft which carries the medical device near its distal end, a middle pull back shaft concentrically arranged around the inner shaft, the medical device being carried between the inner shaft and middle pull back shaft, an outer stiffening shaft concentrically arranged around the middle pull back shaft, and a manifold stabilizer connected to both the inner and outer shafts, the inner and outer shafts as a result being permanently connected to their proximal ends to prevent any axial movement of the inner shaft with respect to the outer shaft, whereby the medical device is delivered at the desired site by pulling on the proximal end of the middle pull back shaft, which deploys the medical device, and where the outer stiffening shaft connection to the inner shaft prevents axial movement of the inner shaft with respect to the outer stiffening shaft, thereby preventing the distal end of the inner shaft from being urged forward during delivery and therefore allowing for more accurate placement of the medical device.
2. The delivery system of claim 1 wherein the inner and outer shafts are connected together far enough apart to allow the middle pull back shaft to retract a distance at least as great as the axial length of the medical device to be delivered.
3. The delivery system of claim 1 wherein the inner shaft provides a lumen for a guide wire.
4. The delivery system of claim 1 wherein the medical device is a self-expanding stent.
5. ~A delivery system for implantation of a medical device in a vessel, comprising:
an elongate flexible catheter means having proximal and distal ends for delivering a medical device to a predetermined location in a vessel of a patient, the elongate flexible catheter means being further comprised of:
an inner shaft;
a middle pull back shaft concentrically arranged around the inner shaft, whereby the medical device may be carried between the inner shaft and middle pull back shaft; and an outer stiffening shaft concentrically arranged around the middle pull back shaft;
a manifold stabilizer connected to both the inner and outer shafts, the inner and outer shafts as a result being permanently connected to prevent any axial movement of the inner shaft with respect to the outer shaft, wherein the middle pull back shaft is retractable relative to the inner shaft and the stiffening shaft by pulling on the proximal end of the middle pull back shaft, and wherein the outer stiffening shaft connection to the inner shaft prevents axial movement of the inner shaft with respect to the outer stiffening shaft.
6. A stent delivery system comprising:
a catheter having an inner shaft and an outer shaft extending between a proximal end and a distal end, said shafts being permanently connected at their proximal ends;
a stent carried by the catheter; and cover means surrounding the stent and constructed and arranged for retraction to expose the stent for release from the catheter;
the catheter being constructed and arranged to receive at least part of the cover means interiorly within said outer shaft thereof upon retraction of the cover means.
7. A delivery system for implantation of a medical device in a vessel, comprising:
a medical device; and elongate flexible catheter means having proximal and distal ends for delivering a medical device to a predetermined location in a vessel of a patient, the elongate flexible catheter means being further comprised of:
an inner shaft which carries the medical device near its distal end;
a middle pull back shaft concentrically arranged around the inner shaft, the medical device being carried between the inner shaft and middle pull back shaft, and an outer stiffening shaft concentrically arranged around the middle pull back shaft, the inner and outer shafts being permanently connected at their proximal ends to prevent axial movement of the inner shaft with respect to the outer shaft, whereby the medical device is delivered at the desired site by pulling on the proximal end of the middle pull back shaft, which deploys the medical device, and where the outer stiffening shaft connection to the inner shaft prevents axial movement of the inner shaft with respect to the outer stiffening shaft, thereby preventing the distal end of the inner shaft from being urged forward during delivery and therefore allowing for more accurate placement of the medical device.
8. The delivery system of claim 7 wherein the inner and outer shafts are connected together far enough apart to allow the middle pull back shaft to retract a distance at least as great as the axial length of the medical device to be delivered.
9. The delivery system of claim 7 wherein the inner shaft provides a lumen for a guide wire.
10. The delivery system of claim 7 wherein the medical device is a self-expanding stent.
11. A delivery system for implantation of a medical device in a vessel, comprising:
a medical device; and an elongate flexible catheter means having proximal and distal ends for delivering a medical device to a predetermined location in a vessel of a patient, the elongate flexible catheter means being further comprised of:
an inner shaft which carries the medical device nears its distal end;
a middle pull back shaft concentrically arranged around the inner shaft; and an outer stiffening shaft concentrically arranged around the middle pull back shaft, the inner and outer shafts being permanently connected at their proximal ends to prevent any axial movement of the inner shaft with respect to the outer shaft such that the shafts constitute a single delivery catheter, wherein the middle pull back shaft is retracted relative to the inner shaft and the stiffening shaft to deploy the medical device.
12. The delivery system of claim 11, wherein the inner and outer shafts are connected together far enough apart to allow the middle pull back shaft to retract a distance at least as great as the axial length of the medical device to be delivered.
13. The delivery system of claim 11, wherein the inner shaft provides a lumen for a guide wire.
14. The delivery system of claim 11 wherein the medical device is a self-expanding stent.
15. A delivery system for implantation of a medical device in a vessel, comprising:
a medical device; and an elongate flexible catheter means having proximal and distal ends for delivering a medical device to a predetermined location in a vessel of a patient, the elongate flexible catheter means being further comprised of:
an inner shaft which carries the medical device near its distal end;
a middle pull back shaft concentrically arranged around the inner shaft; and an outer stiffening shaft concentrically arranged around the middle pull back shaft, the inner and outer shafts being irremovably connected at their proximal ends such as to constitute a one piece single delivery catheter to prevent axial movement of the inner shaft with respect to the outer shaft, wherein the middle pull back shaft is retracted relative to the inner shaft and the stiffening shaft to deploy the medical device.
16. A delivery system for implantation of a medical device in a vessel, comprising:
a medical device; and an elongate flexible catheter means having proximal and distal ends for delivering a medical device to a predetermined location in a vessel of a patient, the elongate flexible catheter means being further comprised of:
an inner shaft;
a middle pull back shaft concentrically arranged around the inner shaft, whereby the medical device may be carried between the inner shaft and middle pull back shaft; and an outer stiffening shaft concentrically arranged around the middle pull back shaft;
a manifold stabilizer irremovably connected to both the inner and outer shafts, the inner and outer shafts as a result being connected such as to constitute a one piece construction in order to prevent any axial movement of the inner shaft with respect to the outer shaft such that the shafts constitute a single delivery catheter, wherein the middle pull back shaft is retracted relative to the inner shaft and the stiffening shaft by pulling on the proximal end of the middle pull back shaft, and wherein the outer stiffening shaft connection to the inner shaft prevents axial movement of the inner shaft with respect to the outer stiffening shaft.
CA002216952A 1995-04-05 1996-04-05 Pull back stent delivery system Expired - Fee Related CA2216952C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US08/417,385 1995-04-05
US08/417,385 US5571168A (en) 1995-04-05 1995-04-05 Pull back stent delivery system
PCT/US1996/004744 WO1996031174A1 (en) 1995-04-05 1996-04-05 Pull back stent delivery system

Publications (2)

Publication Number Publication Date
CA2216952A1 CA2216952A1 (en) 1996-10-10
CA2216952C true CA2216952C (en) 2004-08-24

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CA002216952A Expired - Fee Related CA2216952C (en) 1995-04-05 1996-04-05 Pull back stent delivery system

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US (2) US5571168A (en)
EP (1) EP0821574B1 (en)
JP (1) JPH11503054A (en)
AT (1) ATE202464T1 (en)
CA (1) CA2216952C (en)
DE (1) DE69613572T2 (en)
WO (1) WO1996031174A1 (en)

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