CA2060067A1 - Stent delivery system - Google Patents

Stent delivery system

Info

Publication number
CA2060067A1
CA2060067A1 CA002060067A CA2060067A CA2060067A1 CA 2060067 A1 CA2060067 A1 CA 2060067A1 CA 002060067 A CA002060067 A CA 002060067A CA 2060067 A CA2060067 A CA 2060067A CA 2060067 A1 CA2060067 A1 CA 2060067A1
Authority
CA
Canada
Prior art keywords
catheter
sheath
stent
distal end
proximal
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.)
Abandoned
Application number
CA002060067A
Other languages
French (fr)
Inventor
Lilip Lau
William M. Hartigan
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.)
Abbott Cardiovascular Systems Inc
Original Assignee
Individual
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Priority to CA002372820A priority Critical patent/CA2372820A1/en
Publication of CA2060067A1 publication Critical patent/CA2060067A1/en
Abandoned legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/97—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve the outer sleeve being splittable
    • 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
    • A61F2/958—Inflatable balloons for placing 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
    • A61M2025/0183—Rapid exchange or monorail catheters
    • 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
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1081—Balloon catheters with special features or adapted for special applications having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths

Abstract

ABSTRACT OF THE DISCLOSURE

The invention is directed to a stent delivery method and system which generally includes an elongated delivery sheath and a catheter disposed within an inner lumen of the sheath having an expandable member on its distal extremity.
An expandable stent is mounted on the expandable member of the catheter. A
manipulating device is provided on the proximal end of the delivery system to effect relative axial movement between the sheath and the catheter so as to expose the stent mounted on the expandable member on the catheter within a body lumen such as a coronary artery and allow the expansion of the stent by the expansion of the expandable member. The delivery sheath has a first port in its distal end and a second port in the sheath wall proximally disposed from the distal end of the sheath. The catheter likewise has a first port in its distal end and a second port proximally disposed from the distal end of the catheter. An inner lumen extends within the distal portion of the catheter between the first and second ports and slidably receives a guiding member such as a guidewire. This system allows the stent to be delivered over a guidewire previously advanced to the desired location within a body lumen.

Description

2~ 37 BACKGROUND OF THE INVENTIQN

This invention relates to devices and a method for the treatment of heart disease and particularly to endo-arterial prosthesis, which are commonly called stents.

Several interventional treatment modalities are presently used for heart disease including balloon and laser angioplasty3 atherectomy and by-pass surgery.

In typical balloon angioplas~ procedures a guiding catheter having a preformed distal tip is percutaneously introduced through the femoral artely into the cardiovascular system of a patient in a conventional Seldinger technique andadvanced within the cardiovascular system until the distal tip of the guiding catheter is seated in the ostium of a desired coronary artery. A guidewire is positioned within an inner lumen of a dilatation catheter and then both are advanced through the guiding catheter to the distal end thereo~. The guidewire is first advanced out of the distal end of the guiding catheter into the patient's coronaly vaseulature until the distal end of the guidewire crosses a lesion to be dilated, then the dilatation catheter having an inflatable .. . .. ~ .. .. .

2~5~ 7 balloon on the distal portion thereof is advanced into the patient's coronary anatomy over the previously introduced guidewire until the balloon of the dilatation catheter is properly posieioned across the lesion. Once in position across the Icsion, the balloon which is made of relatively inelastic materials is inflated to a predetermined siæ with S radiopaque liquid at relatively high pr~ssures (e.g. greater than 4 atmospheres) to compress the arteriosclerotic plaque of the lesion against the inside of the artery wall and to otherwise expand the inner lumen of the artery. The balloon is then deflated so that blood flow can be resumed through the dilated artery and the dilatation catheter can be removed therefrom. Further details of dilatation eatheters, guidewires, and devices associated Iherewith for angioplasty procedures can be found in IJ.S. Patent 4,323,071 (Simpsvn-Robert); U.S. Patent 4,439,185 (Lundquist); U.S. Patent 4,516,972 ~amson); U.S. Patent 4,538,622 (S~mson et al.); U.s. Patent 4,554,929 ~Samson etal.); U.S. Patent 4,616,652 (Simpson~; U.S. Patent 4,638,805 (Powell); and U.S.
Patent 4,748,982 (Horzewski et al.) which are hereby incorporated herein in their eneirety by reference thereto.

A major problem which can occur during balloon angioplasty procedures is the formation of intimal flaps which can collapse and occlude the artery when the balloon is deflated at the end of the angioplasty proc~dure. Another major problem characteristic of balloon angioplasty procedures is the large number of patients which are subject to restenosis in the treated arlery. In the case of restenosis, the treated artery may again be subjected to balloon angioplasty or to other treatments such as by-pass surgery, if additional balloon angioplasty procedures are not warranted. However, in the event of a partial or total occlusion of a coronary artery by the collapse of a .

~ Q~ ;7 dissectèd arte~ial lining after the balloon is deflated, the patient is put in an extremely dangerous situation requiring immediate medical attention, particularly in the coronary arteries.

S A major f~us of resent development work in the treatment of heartdisease has been directed to endoprosthetic devices called stents. Stents are generally cylindrically shaped intravaseular dences which are placed within a damaged artery to hold it open. The device can be used to prevent restenosis and to ma~ntain the patency of blood vessel immediately after intravascular treatments. In some sllcumstances, they can also be used as the primary treatment devise where they are expanded to dilate a stenosis and then left in place.

lE~owever, the rapid and effective delivery of a stent to the desired location within the patient's vasculature has been found to be dif~lcult, particularly in those situations in whieh an intimal flap has occluded an artery. Attempts to advance a stent into regions of coronary arteries occlu~led by dissected arterial linings have not been vely successful.

I~NO basic methods and systems have been developed for delivering stents to desi~ed locations wi~hin body lumens. One method and system involws eompressing or othenvise reducing the diameter of an expandable stent, disposing the ~mpressed stent within a lumen provided in the distal end of a hlbular ca~heterjadvancing the catheter ~hrough ~he patient's vasculature until the distal end of the ~atheter is immediately adjacent to the desired vascular location and Ihen pushing the :

; ,~ . ~, . ... .

2~ 57 stent oùt the distal end of the catheter into the desired location. Once out of the catheter, the compressed stent expands or is expandecl to thereby hold opell the artery or other body lumen into which it is placed.

Another method and system involYes disposing a compresse(l or othenvi~e small diameter stent about an expandable member such as a balloon on the distal end of a catheter, advancing the catheter through the patient's vascular system un~l the stent is in the desir~d location within a blood vessel and then expanding the expandable member on ~he catheter to expand the stent within the blood vessel. The expanded expandable member is ~hen contracted and the catheter withdrawn, leaving the expande~ stent within the blood vessel holding opcn the passageway thereof.

The following references illustrate various types of stents and stent delivery systems. The lis~ is meant to be exemplary not exhaustive on the subJect.
U.~. 3,86g,956 U.S. 4,733,665 U.~. 4,856,516 U.S. 4,503,569 IJ.S. 4,7~0,849 U.~. 4,878,906 U.S. 4.512,338 U.S. 4,762,12~ U.S. 4,~86,062 U.S. 4,553,545 U.~. 4,768,507 U.S. 4,907,~36 U.S. 4,560,374 U.S. 4,795,458 U.S. 4,913,14I
U.S. 4,655,771 U.S. 4,80~,~82 IJ.~. 4,923,464 U.S. 4,6659918 U.~. 4,83n,~3 U.S. ~,950,227 2~91~7 What has been needed and heretofore unavailable is a stent delivery system which can be quickly and easily used in a wide variety of situations and particularly in emergency situations where a dissected arterial lining has collapsed and has occluded the flow of blood to a vital organ. The present invention satisfies this need.

~ilJMMARY OF THE INVE~Q~

This invention is directed to an improved stent delivery system which can quickly and easily position a stent into an occluded region of a blood vessel.

The stent delivery system of the invention includes an elongated sheath having an inncr lumen extending therein, a first port in its distal end which is adapted to receive a guidewire and a second port spaced proximally from the distal end of the deliYery sheath which is also adapted to receive a guidewire, both of the ports being in fluid communication with the inner lurnen of the sheath. The delivery system also include~ an intravascular ca~heter slidably disposed within the inne~ lumen of the delivery sheath which has an expandable rnember on the distal extremity thereof, such as an inflatable balloon, which is adapted to receive an expandable stent on the exterior 2Q thereof. The catheter has a first port in its distal end adapted to receive a guidewire and a second port spac~d proximally from the distal end of the catheter adapted to receive a guidewire, with both of these ports being in communication wlth an inner lumen extending within the interior of ~he catheter. The second guidewire receiYing port should be spaced proximally from the expandable member on the d;~tal extremity . . ,,- . f , ~ - .
.. . .

2~ ,7 of the catheter. Means may be provided to adjust the relative axial positions of the catheter and sheath to expose the expandable stent on the expandable member of the catheter so that the stent can be expanded against the blood vessel wall by expanding the expandable member.

S ' ' Preferably, both the delivery sheath and the intravascular catheter have slits in the walls thereof which extend distally from their proximal ports to facilitate the removal of these deviees from the guidewire upon the withdrawal of the delivery system from the patient's vascular system after the delivery of a stent.
1~ ' .
In a typical situation, the guidewire used to deliver a dilatation catheter through the patient's vascular system to a stenotic region therein is left disposed within the patient after the dilatation Gath~ter has been removed therefrom. To maintain access to the stenotic region, the distal end of the guidewire should be left crossing the 3tenotic region where the stent is to be placed. The proximal end of the guidewire, which extends out of the patient, is inserted through the port in the distal end of the intravascular catheter which has a stent mounted on the expandable member. The intravascular catheter is disposed within the inner lumen of the delivery sheath with the distal end of the catheter extending out the port in the distal end of the delivesy sheath to facilitate the insertion of the proximal end of the guidewire. The relative axial position between tho delivery sheath and intravascular catheter are adjusted so that the expandable membe~ on the distal extremity of the intravascular catheter with the expandable stent mounted thereon is pulled back into the inner lumen of ~he delivery sheath. The delivery sheath and the catheter ~herein are then advanced through the 2~ 7 patient's vascular system, preferably through a guiding catheter which extends from outside the patient to the ostium of the desired coronary artery, until the stent mounted on the expandable member of the intravascular catheter is positioned within the stenotic region of the patient's blood vessel.

The relative axial positions of the delivery sheath and the intravascular catheter having the stent thereon is adjusted to urge the distal end of the vascular catheter out the distal end of the sheath to expose the expandable stent. Either the ~atheter can be advanced distally with respect to the sheath or the sheath can be withdrawn proximally with respect to the catheter or both movements can be employed.
Once the stent is completely out of the delivery sheath, the expandable member on the intravascular catheter can be expanded to expand the stent against stenotic mass within the blood vessel. After expanding the stent, the expandable member on the vascular catheter is contracted so that the catheter can be removed from the patient's blood vessel leaving ~e expanded stent in its deslred position therein.

The delivery sheath and the intravascular catheter may be withdrawn together or the sheath may be withdrawn first followed by withdrawal of the catheter.
They are removed over the guidewire until the proximal guidewire port on the sheath 2û and/or the catheter exits the proximal end of the guiding catheter, the sheath and the catheter can be peeled away from the guidewire with the guidewire sliding through the slits which extend distally from the proximal ports thereof. The sheath ~d the intravascular catheter are pulled proximally out of the proximal end of the guiding catheter a sufficient distance to expose the guidewire. The e~posed section of the , - , , -, Z~ )5 guidewire is secured, e.g. manually held, in place so that the sheath and the intravascular catheter can be pulled off the proximal end of the guidewire.

The delively system ~f the invention can effectively deliver a stent to a S desired location within a patient's blood vessel, it can allow the stent to be secured within the desired location, and ~he can be easily and quickly removed. These and other advantages of ~he invention will become more apparent from the following detailed description of the invention, when taken in conjunction with the accompanying exemplary drawings.
' ' "
BRIEF DESCRIPI ION OF THE DRAWINGS

Fig. 1 is a partial lon~itudinal cross-sectional view of a s~ent delivery system which emb~dies features of the invention.
Fig. 2 is a top view of the delivery sheath shown in Fig. 1.

Fig. 3 is a transverse cross-sectional view taken along the lines 3-3 shown in Fig. 1.
Fig. ~ is a transverse cross-seetional view taken along the lines 4-4 shown in Fig. 1.

Fig. 5 illustrates a stent mounted on the outer sur~ace of a balloon of 2~ 7 :
the dilatation catheter shown in Fig. 1.

Fig. 6 illust~ates the advaneement of the stent deliv~y system shown in ~ig. S into an artery which has been damaged by an intravascular proc~ure such S as an angioplas~.

Fig. 7 illus~rates ~he inflation of ~he balloon on the dilatation catheter shown in Fig. 1 which expands the stent mounted on the exteAor thereof.

Pig. 8 illustrates the expanded stent disposed within a damaged arteIial section maintaining the patency thereof.

Fig. 9 is a partial cross-sectional view of the manipulato~ shown in Fig. 1 .
Fig. 10 is a perspective view of an alternative manipulator mounted on the proximal end of the delivery system shown in Fig. 1.

Fig. 11 is a plan view of the manipulator shown in Fig. 10.
Fig. 12 is an elevational view, partially in section, of the manipulator shosvn in Fig. 10.

,, , . . . .. ~

~5~S7 DETA~LED DESCRIlYrIQN Q~F THE INVENTION

Figs. 1-4 illustrate a stent delivery system which emboclies features of the invention. Generally, the delivery system includes a delivery sheath 10 which has S an inner lumen 11 and a dilatation catheter 12 disposed within the inner lumen 11 which has an elongated catheter body 13 and a balloon 14 on the distal portion of the catheter body. A manipulating device lS is provided on ~be distal end of the delive~y system which i5 employed to effect relative axial or longitudinal movement between the delivery sheath 10 and the dilatation catheter 12. An expandable stent 16, which is to be deliv~red within a patientls body lumen, is mounted on the exterior of the balloon 14.

The delivery sheath 10 has a distal port 17 in its distal end which is in fluid communication with the inner lumen 11 and a proximal port 18 disposed proximally to the distal port. A slit 19 extends from the pro~imal port 18 to a location just proximal to the distal port 17.

The dilatation catheter 12 has a distal port 20 and a ploximal port 21 which are in fluid communication with a first inner lumen 22 extending within the distal por~ion of the catheter 12 and being adapted to slidably receive a guidewire therein.
A slit 23 extends from the proximal port 21 to a location 24 proximal to the proximal end of balloon 14. The proximal end of the guidewire receiving lumen 22 is provided with a ramp 25 to guide the proximal end of guidewire 26 out the proximal port 21 in the catheter 12 when the catheter is mounted onto the guidewire as will be discussed :

- . ~ " -2(;!~0~7 hereinafter. A second, much longer inner lumen 27 is provided within the catheter body 13 to direct inflation fluid from the proximal end of the catheter body to the interior of the balloon 14.

S Proximal to the proximal port 21 in the Mtheter body 13 is a stiffening member 28 which is disposed in third inner lumen 29 provided within the catheter body 13. As shown in the drawings, the third inner lumen 29 and the first inner lumen 22 may be the same lumen with a plug 30 separating the two lumens. The rarnp 25 is on the distal side of the plug 30.

As illustrated in Figs. 1 and 8, the manipulator 15 on the proximal end of the delivery system has a housing 31 with an interior chamber 32, a cap 33 rotatably mounted onto the di~tal end of the housing 31, an elongated drive member 34 which has male threads on the exterior thereof and which is at least partially disposed within the inte~ior chamber 32 and a Luer lock 35 which is fixed within the proximal end of the housing 31. The proximal end 36 of the sheath I0 is secured to the distal end 37 of the elongated drive member 34 which extends out of the distal end of the housing 31. As shown in more detail in Fig. 8s the proximal end 38 of th~ catheter body 13 passes through passageway 39 in the elongated dnve member 34 and is fixed within ~he Luer lock 35 by suitable means such as adhesive. The cap 33 which is rotatably mounted onto the distal end of the housing 31 is provided with an inner threaded collar 40 adapted to threadably engage the threaded extenor of the elongated dnving member 34. Rotation of the cap 31 axially moves the driving rnember 34 to tllereby ef~ect relative axial movement between the sheath 10 and the dilat~ion ~atheter 12.

. .

~, ~ , , - - . .

ZC?5~ ;7 In a typical situation, the stent delivery systern of the invention is used after an intravascular procedure has damaged a patient's arterial lining to such an extent that the lining needs support to prevent it from collapsing into the arterial passageway and thereby preventing sufficient blood llow through the blood vessel. In these S situations there will usually be a guidewire 26 (or other guiding member) in place extending across the damaged section of the artery such as shown in Fig. 6. The proximal end of the guidewire 26, which exten~s out of the patient duAng the entire procedure, is inserted through the distal port 20 in the distal end of the catheter 12 and advanced proximally through the first inner lumen 22 until the proximal end of ~he guidewire impac~s the ramp 25 and is thereby directed through the proximal port 21.

The dilatation catheter 12 is preferably positioned within the inner lumen 11 of the delivery sheath 10 so that at least a significant portion of the proximal port 18 in the sheath is in alignment with the proximal port 21 of the dilata~ion catheter.
In this manner, proximal advancement of the guidewire 26 through the inner lumen 22 will also direct the proximal end of ~he guidewire out the proximal port 18 in the delivery sheath 10. The proximal end of the guidewire 26 may theh be manually held to maintain the position of the guidewire within the patient's vasculature, while the stent delivery system Is advanced over the guidewire system. The advancement of the stent delivery system continues untll the distal ends of the catheter and sheath extend adjacent to or across the damaged arteAal site. At this point in the procedure, the manipulator 15 on the proximal end of the delivery system is actuated by rotating the cap 33 on the proximal end of the housing 31 to move the sheath 10 proximally with rçs~ect to the cathete~ 12 and ~hereby expose the stent 16 mounted on the b~loon 14.
.

., - , , ;
-. , ,, . .. .. .

2C6~
When the balloon and the stent mounted thereon are properly placed within the darnaged artery, inflation ~luid is directed under substantial pressure through the Luer loclc 35 and the inflation lumen 27 in the catheter body 13 to the interior of the balloon 14, expanding the balloon and simultaneously expanding the stent 16 against the blood S vessel wall as shown in Fig. 7. The delivery system, both the sheath 10 and the catheter 12, may then be removed from the patient along with the guidewire 2~, leaving the expanded stent 16 within the darnaged arterial section as shown in Fig. 8 tomaintain the patency thereof.

The housing 31 of the manipulator 15 can be held in the palm of the physician's hand, with the thumb and index finger thereof used to rotate cap 33 and thereby cause the necessary relative motion between the sheath 10 and dilatationcatheter 12 to expose the stent 16 mounted on the balloon 14. The physician can operate an inflation device, such as described in U.S.Patent 4,439,18S, with his or her free hand to in3ect inflation fluid through Luer lock 35 into the interior of the balloon 14 to inflate the b~lloon and thereby expand the stent 16 while h~lding the delivery system in place with the other hand. Upon deflating the balloon 14, the m~nipulator 15 can again be actuated by the physician rotating cap 33 with the t;ngers of the hand holding the manipulator 15 to pull the dilatation catheter 12 back into the distal end of the sheath 10 (or pushing the distal end of the sheath over the distal end of the dilatation catheter 12, depending upon the perspective) and then the entire assembly, including the guidewlre 26 can be removed ~rom the patient.

The alternahve manipulator 50 illustrated in ~igs. 10-12 generally .
.
- . , .
.. ~

2(?~
includès a housing Sl with an interior chamber 52 and a slidable element 53 with a depending portion 54 which extends through a slot SS in the~ wall of the housing and is secured to the proximal end of the sheath 10 which extends throu~h an openingprovided in the distal end of the housing. The catheter 12 extends out the proximal end of the sheath 10, out an opening in the proximal end of the housing 51 and into a Luer lock 56 secured to the proximal end of the housing. l'he proximal end of the catheter 12 is secured within the Luer lock 56 to be in fiuid communication with the inner inflation lumen 27 of the catheter so that inflation fluid can be injected through the Lu~r lock to the interior of the balloon 14 on the catheter to expand the balloon and the stent 16 mounted thereon. As is evident from Fig. 10, movement of element 53 on the exterior of the housing S1 will effect the relative axial movement between the delivery sheath 10 and the catheter 12 required to expose the stent 16 mounted on the balloon 14. The slot SS has narrowed portions near both ends thereof which have widths just lightly smaller than the depending element S4 so that the position of the slidable element 53 can be locked.The underside of the housing 51 may be provided with an undulated surface 57 whîch is adapted to receive the fingers of an operator to facilitate the gripping thereof.

The dimensions of the dilatation catheter will generally follow the dimensions of dilatation catheters used in angioplasty procedures in the same artenal location. Typically, the length of a catheter for use in the coronary arteries is about lS0 cm, the outer diameter of the catheter shaft is about 0.035 inch ~0.89 mm), the length of the balloon is typically about 2 cm and the inflated diameter about 1 to about 8 mm.

.: :
:

)57 The materials of construction may be selected from those used in conventional balloon angi~plasty catheters, such as those described in the patents inco~>orated by re~erence. The delivery sheath will generally be slightly shorter than the dilatation catheter, e.g. by about the length of the manipulating device 15 or 50, with an inner diameter large enough to accomm~late the dilatation catheter and allow the catheter free longitudinal movement the~ein. The shedth and the catheter shaft can be made of conventional polyethylene tubing.

While the present invention has been descnbed herein in terms of delivering an expandable stent to a desir~d location within a patient's blood vessel, the delivery system can be employed to deliver stents to locations within other body lurnens such as urethra or Fallopian tubes so that the stents can be expanded to maintain the patency of these body lumens. Various changes and improvements may also be made to the invention without departing from the scope thereof.

Claims (14)

1. A system for the delivery of an expandable stent within a body lumen over a guiding member comprising:
a) an elongated sheath having proximal and distal ends, an inner lumen extending therein, a first port in the distal end and a second port spaced proximally from the distal end, both of the ports being in fluid communication with the inner lumen;
b) an elongated catheter disposed within the inner lumen of the sheath having proximal and distal ends, an expandable member proximally adjacent to the distal end of the catheter which is adapted to receive on the exterior thereof an expandable stent, and an inner lumen which is adapted to slidably receive a guiding member therein and which extends between a first port in the distal end of the catheter and a second port spaced proximally from the distal end of the catheter, both of the ports being in fluid communication with the inner lumen of the catheter; and c) means to adjust the relative axial positions of the catheter and the sheath to expose the expandable member on the catheter so that upon the expansion of the expandable member an expandable stent disposed about the expandable member will thereby be expanded.
2. The stent delivery system of claim 1 wherein the sheath has a wall with a slit therein extending between the first and second ports thereof.
3. The stent delivery system of claim 1 wherein the catheter has a wall with a slit therein extending from the second port to a location proximal to the expandable member.
4. The stent delivery system of any one of the preceding claims wherein the means to adjust the relative axial positions of the dilatation catheter and the sheath includes a manipulator comprising:
an elongated housing having proximal and distal ends and an interior chamber;
a cap which has a threaded passageway therethrough and which is rotatably mounted on an end of the elongated housing; and a longitudinally movable drive member which has a threaded exterior, which is disposed at least partially within the interior chamber of the elongated housing and which has a distal end extending through the central passageway of the cap, rotation of the cap causing movement of the axial movement of drive member.
5. The stent delivery system of claim 4 wherein the longitudinally movable drive member has a central passageway which receives the proximal end of the catheter.
6. The stent delivery system of claim 5 wherein the proximal end of the catheter is fixed to the manipulator housing.
7. The stent delivery system of claim 5 wherein the sheath is fixed to the distal end of the longitudinally movable drive member which extends out the distal end of the manipulator.
8. A kit for the delivery of a stent within a body lumen comprising:
a) an elongated sheath having proximal and distal ends, an inner lumen extending therein, a first port in the distal end and a second port spaced proximally from the distal end, both of the ports being in fluid communication with the inner lumen;
b) an elongated catheter adapted to be disposed within the inner lumen of the sheath having proximal and distal ends, an expandable member proximally adjacent to the distal end of the catheter which is adapted to receive on the exterior thereof an expandable stent, an inner lumen which is adapted to receive a guiding member wherein and which extends between a first and second ports of the catheter; and c) means to adjust the relative axial positions of the catheter and the sheath to expose the expandable member so that upon the expansion thereof and expandable stent disposed about the expandable member will thereby be expanded.
9. The stent delivery system kit of claim 8 including an expandable stent which is adapted to be mounted on the exterior of the expandable member on the catheter.
10. The stent delivery system of claim 8 wherein the sheath has a wall with a slit therein extending between the first and second ports thereof.
11. The stent delivery system of claims 8, 9 or 10 wherein the catheter has a wall with a slit therein extending from the second port to a location proximal to the expandable member.
12. A method of delivering an expandable stent to a desired location within a patient's body lumen which has a guidewire disposed therein with a proximal end extending out of the patient, the method comprising:
a) providing an elongated sheath having proximal and distal ends, an inner lumen extending therein, a first port in the distal end and a second port spaced proximally from the distal end, both of the ports being in fluid communication with the inner lumen; and an elongated catheter disposed within the inner lumen of the sheath having proximal and distal ends, an expandable member proximally adjacent to the distal end of the catheter which has mounted on the exterior thereof an expandable stent, and an inner lumen which is adapted to slidably receive a guidewire therein and which extends between a first port in the distal end of the catheter and a second port spaced proximally from the distal end of the catheter, both of the ports being in fluid communication with the inner lumen of the catheter;
b) adjusting the relative axial positions of the elongated sheath and the catheter so as to at least partially align the proximal ports thereof;
c) positioning the guidewire within the inner lumen of the catheter which extends between the proximal and distal ports therein with a portion of the guidewire extending out the proximal ports of the sheath and the catheter;
d) advancing the sheath and the catheter over the guidewire through the body lumen to the desired location therein;
e) adjusting the relative axial positions of the sheath and the catheter to expose the expandable stent on the expandable member of the catheter within the desired location within the body lumen;
f) expanding the expandable member on the catheter to thereby expand the stent mounted thereon at the desired location within the body lumen;
g) contracting the expandable member on the catheter; and h) withdrawing the catheter and the sheath from the body lumen.
13. The method of claim 12 wherein the expandable member is a balloon and wherein inflation fluid is directed to the interior of the balloon to expand the balloon and thereby expand the stent mounted thereon.
14. The method of claim 12 wherein the expandable stent engages the wall defining the body lumen when it is expanded so as to maintain the patency thereof.
CA002060067A 1991-01-28 1992-01-27 Stent delivery system Abandoned CA2060067A1 (en)

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CA002372820A CA2372820A1 (en) 1991-01-28 1992-01-27 Intravascular stent delivery assembly

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US64746491A 1991-01-28 1991-01-28
US647,464 1991-01-28

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JP (3) JP3242688B2 (en)
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US6488694B1 (en) 2002-12-03
EP0505686B1 (en) 1996-11-13
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US5782855A (en) 1998-07-21
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US5507768A (en) 1996-04-16
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US6113607A (en) 2000-09-05
US6527789B1 (en) 2003-03-04

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