Integrated dual-function catheter system and method for balloon angioplasty and stent delivery

• US 5,634,928 A
• Filed: 05/09/1996
• Issued: 06/03/1997
• Est. Priority Date: 12/07/1994
• Status: Expired due to Term

• Current Assignee: David R. Fischell, Robert E. Fischell, Tim A. Fischell
• Original Assignee: David R. Fischell, Robert E. Fischell, Tim A. Fischell
• Inventors: Fischell, David R., Fischell, Robert E., Fischell, Tim A.
• Primary Examiner(s): Thaler, Michael H.
• Application Number:
  US08/647,294
• Time in Patent Office: 390 Days
• Field of Search: 606/108, 606/194
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2210/0019 operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61M 2025/0006 which can be secured against axial movement, e.g. by using a locking cuff
• CPC Class Codes: A61M 25/104 used for angioplasty
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

An integrated catheter system utilizes a balloon angioplasty catheter placed through a central passageway of a stent delivery catheter to enable balloon angioplasty and stent delivery to be accomplished with a single device. The integrated catheter system is able to perform dilatation of an arterial stenosis, placement of the stent at the site of the stenosis and then the angioplasty catheter balloon can be used to further embed the stent into the arterial wall. Balloon angioplasty, stent placement and stent embedding into the arterial wall are all accomplished while the catheter'"'"'s angioplasty balloon remains situated at the site of the stenosis. A conically shaped distal portion of the stent delivery catheter allows stent placement over the deflated balloon after balloon angioplasty even when intimal dissection causes an intimal flap to be pushed inwardly against the deflated balloon. A proximal portion of the integrated catheter system employs longitudinal motion constraining spacers to prevent the stent from being inadvertently positioned beyond the distal end of the balloon. The balloon of the balloon angioplasty catheter can be readily advanced through tortuous coronary arteries because the distal end of the stent delivery catheter can be placed back by 0.5 to 20 cm from the balloons proximal end during insertion. Thus, the stiffness of the stent and the stent delivery catheter do not add stiffness to the distal portion of the balloon angioplasty catheter, which stiffness can prevent catheter advancement through such tortuous vessels.

Claims

1. An integrated catheter system for performing a dilatation procedure within a vessel of a human body and for placement of a stent within that region of the vessel that underwent dilatation, the catheter system comprising:

a balloon angioplasty catheter having a distal end and a balloon located near the catheter'"'"'s distal end, the balloon having a proximal end fixedly attached to an elongated outer tube and a distal end attached to an elongated inner tube, the balloon being able to be inflated to an inflated state and deflated to a deflated state;

a first elongated cylindrical tube which is a pusher tube having a proximal end and a distal end and being adapted to move slideably over the balloon angioplasty catheter;

a second elongated cylindrical tube which is an outer sheath, the pusher tube being adapted to move slideably within the outer sheath which has a stent containment cavity containing a radially expandable stent situated near the sheath'"'"'s distal end, the stent containment cavity being bounded at its distal end by a distal portion of the outer sheath in the shape of a frustrum of a cone having a distal end that intersects the outer tube of the balloon angioplasty catheter at an acute angle, the stent containment cavity being bounded at its proximal end by the distal end of the pusher tube, said combined slideable pusher tube, said radially expandable stent and said outer sheath being slideably displace able in a distal direction over said balloon while maintaining said outer sheath distal end frustrum cone shape, the outer sheath and the pusher tube each having separate proximal pullback means adapted to lie outside the human body for pulling the sheath back relative to the pusher tube so as to release the radially expandable stent from the stent containment cavity so that the stent can be expanded radially outward against the vessel wall.

2. The catheter system of claim 1 wherein the balloon angioplasty catheter is of the "over-the-wire" design having a central lumen extending throughout the entire length of the balloon angioplasty catheter.

3. The catheter system of claim 2 further comprising a flexible guide wire adapted to be advanced through the central lumen of the balloon angioplasty catheter.

4. The catheter system of claim 1 wherein the distal end of the frustrum of a cone is adapted to be moved with a snug fit over the balloon when the balloon is in its deflated state.

5. The catheter system of claim 4 wherein the conically shaped distal portion includes at least one longitudinally placed slit to allow the outer sheath to be easily pulled back over the stent and over the pusher tube.

6. The catheter system of claim 1 wherein the pusher tube includes a radiopaque marker band at its distal end.

7. The catheter system of claim 1 wherein the radially expandable stent is a balloon expandable stent.

8. The catheter system of claim 1 wherein the radially expandable stent is a self-expanding stent.

9. The catheter system of claim 8 wherein the radially expandable stent is formed of a shape memory alloy, shape memory alloy being Nitinol.

10. The catheter system of claim 1 wherein the proximal pullback means is a Tuohy-Borst fitting.

11. The catheter system of claim 1 wherein the integrated catheter has four separate lumens, each lumen being accessible for flushing from the catheter'"'"'s proximal end.

12. The catheter system of claim 11 wherein three of the lumens are annular passageways and the central lumen is generally of a cylindrical geometry.

13. The catheter system of claim 1 wherein at least one radiopaque marker band is used to indicate the location of the stent containment cavity.

14. The catheter system of claim 1 further comprising a longitudinal displacement limiting means to prevent the inadvertent release of the stent beyond the distal end of the inflatable balloon.

15. The catheter system of claim 1 further comprising a longitudinal displacement limiting means to prevent the inadvertent release of the stent by disallowing inadvertent pullback of the outer sheath relative to the pusher tube.

16. The catheter system of claim 15 wherein the longitudinal displacement limiting means is a removable spacer.

17. A method for performing balloon angioplasty followed by placement of a self-expanding stent within a vessel of a human body, the method comprising the following steps:

(a) inserting an integrated catheter system including a catheter having a distal end, said catheter system including an inflatable balloon and a self expanding stent within a stent containment cavity all located near the catheter'"'"'s distal end into the vessel of a human body;

(b) performing balloon angioplasty dilatation at a site in the vessel;

(c) deflating the balloon and advancing the stent until it is situated over the deflated balloon, the balloon retaining its position generally within the dilatation site; and

(d) pulling back an outer sheath thus allowing the self-expanding stent to deploy at the dilatation site.

18. The method of claim 17 further comprising the step of reinflating the balloon so as to assist the stent in obtaining its fully deployed state.

19. A method for performing balloon angioplasty followed by stent placement within a coronary artery of a human body, the method comprising the following steps:

(a) inserting into the vessel of the human body an integrated catheter system consisting of a balloon angioplasty catheter coaxially placed within a stent delivery catheter, the stent delivery catheter having distal and proximal ends, the balloon angioplasty catheter having a distal section wherein an inflatable balloon is located, the balloon having distal and proximal ends;

(b) placing the stent delivery catheter'"'"'s distal end more than 0.5 cm back in a proximal direction from the proximal end of the balloon as the integrated catheter system is advanced through the coronary vascular so that the stiffness of the stent does not interfere with tracking of the distal section of the balloon angioplasty catheter over a flexible guide wire;

(c) advancing the integrated catheter system until the balloon angioplasty catheter is placed within a coronary artery stenosis;

(d) performing balloon angioplasty dilatation of the stenosis;

(e) deflating the balloon;

(f) advancing the stent over the deflated balloon; and

(g) pulling back an outer sheath thus allowing the stent to be deployed at the dilatation site.