Mechanical apparatus and method for deployment of expandable prosthesis

• US 5,755,708 A
• Filed: 05/15/1996
• Issued: 05/26/1998
• Est. Priority Date: 12/09/1994
• Status: Expired due to Fees

• Current Assignee: Jerome Segal
• Original Assignee: Jerome Segal
• Inventors: Segal, Jerome
• Primary Examiner(s): Buiz, Michael Powell
• Assistant Examiner(s): Gring, N. Kent
• Application Number:
  US08/647,696
• Time in Patent Office: 741 Days
• Field of Search: 604/104, 604/202, 604/53, 604/107, 604/106, 606/194
• US Class Current: 604/107
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/30448 using adhesives
• CPC Class Codes: A61F 2002/828 Means for connecting a plurality of stents allowing flexibility of the whole structure
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61M 2025/1068 having means for varying the length or diameter of the deployed balloon, this variations could be caused by excess pressure
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A mechanical prosthesis deployment device for enlarging a flow passage of a vessel by delivering and deploying an expandable stent or prosthesis within an obstruction in the vessel. The prosthesis deployment device comprises a cylindrically shaped expansion member adapted to be disposed within the expandable prosthesis and includes a means engaged to the expansion member for altering the distance between the proximal end and the distal end of the expansion member thereby transforming the expansion member between a diametrically contracted configuration and a diametrically expanded configuration.

The present method comprises the steps of advancing the expansion member to the obstruction in a vessel and applying opposed forces on said expansion member in an axial direction to move the expansion member to an expanded configuration wherein the expansion member exerts radial force on said prosthesis and said prosthesis is expanded and implanted into the vessel.

Another method comprises the steps of advancing the expansion member to the obstruction in a vessel and applying opposed forces on said expansion member in an axial direction to move the expansion member to an expanded configuration wherein the expansion member exerts radial force on a previously deployed prosthesis and said prosthesis is further expanded and implanted into the vessel.

Claims

1. A device for intraluminal delivery and deployment of a stent or prosthesis positioned within a body passageway and enlarging a flow passage in a vessel carrying flowing blood which comprises:

a substantially cylindrical shaped expansion member having a first end and a second end, said first end being a distance from said second end;

an altering means engagable to said first end and said second end of said expansion member for altering said first distance therebetween to move said expansion member between a first configuration wherein said expansion member is characterized by a first diameter and a second configuration wherein said expansion member is characterized by a second diameter, said second diameter being greater than said first diameter;

said expansion member having an interior flow passage extending therethrough with a diameter and a longitudinally extending central axis for permitting the passage of blood through said expansion member; and

said altering means including an outer flexible elongate tubular member having proximal and distal extremities, said distal extremity of the outer flexible elongate tubular member being secured to the first end of said expansion member and an inner flexible elongate tubular member having proximal and distal extremities and having sufficient rigidity for causing elongation of the expansion member, said distal extremity of the inner flexible elongate tubular member being secured to the second end of said expansion member.

2. A device as recited in claim 1 wherein said expansion member comprises a first plurality of flexible elongate elements helically wound in a first direction of rotation and a second plurality of flexible elongate elements helically wound in a second direction of rotation to form a braid.

3. A device as recited in claim 2 wherein each flexible elongate element has a circular cross section defined by a diameter and said diameter is in a range of approximately 0.001 to 0.010 inches.

4. A device as recited in claim 1 further comprising a coating, said coating being placed on said expansion member.

5. A device as recited in claim 4 wherein said coating is polyurethane.

6. A device as recited in claim 4 wherein said coating is silicone.

7. A device as recited in claim 1 further comprising a retaining means for maintaining said stent or prosthesis in a fixed position on said expansion member prior to expanding said prosthesis within said body passageway.

8. In combination with an expandable stent or prosthesis, a device for deploying an expandable stent or prosthesis positioned within a body passageway which comprises:

a cylindrical shaped expansion member adapted to be disposed within said expandable stent or prosthesis, said expansion member having a proximal end and a distal end, said proximal end being a distance from said distal end;

a means engaged to said proximal end and said distal end for altering said distance between said proximal end and said distal end of said expansion member, said altering means capable of transforming said expansion member between a first configuration wherein said expansion member is characterized by a first diameter and a second configuration wherein said expansion member is characterized by a second diameter, said second diameter being greater than said first diameter;

an elongated outer tubular member, said outer tubular member having a proximal end and a distal end, said outer tubular member formed with a lumen which extends longitudinally therein over essentially the entire length thereof, said proximal end of said expansion member engaged with said distal end of said outer tubular member; and

an elongated inner tubular member coaxially disposed within said outer tubular member, said inner tubular member having a proximal end and a distal end, said proximal end of the inner tubular member engaged with said proximal end of said outer elongated tubular member and said distal end of said inner tubular member connected to said distal end of said expansion member.

9. A device as recited in claim 8, wherein said inner tubular member is formed with a lumen which extends longitudinally therein essentially the entire length thereof, for receiving a guidewire.

10. In combination with an expandable stent or prosthesis, a device for intraluminal delivery and deployment of an expandable stent or prosthesis positioned within a body passageway which comprises:

a cylindrical shaped expansion member adapted to be disposed within said expandable prosthesis having a proximal end and a distal end, said proximal end being a distance from said distal end;

a means for altering said distance between said proximal end and said distal end of said expansion member, said altering means capable of transforming said expansion member between a first configuration wherein said expansion member is characterized by a first diameter and a second configuration wherein said expansion member is characterized by a second diameter, said second diameter being greater than said first diameter;

an elongated outer tubular member, said outer tubular member having a proximal end and a distal end, said outer tubular member formed with a first lumen which extends longitudinally therein over essentially the entire length thereof, said first lumen being continuous with a first opening located within said outer tubular member, said first opening located near said distal end of said outer tubular member, and said proximal end of said expansion member engaged with said distal end of said outer tubular member; and

an elongated inner tubular member coaxially disposed within said outer tubular member, said inner tubular member having a proximal end, a distal end and a distal portion, said inner tubular member formed with a second lumen for receiving a guidewire which extends longitudinally therein over said distal portion thereof, said second lumen continuous with a second opening located within said distal portion of said inner tubular member, said proximal end of said inner tubular member engaged with said proximal end of said outer tubular member, and said distal end of said inner tubular member engaged with said distal end of said expansion member.

11. In combination with an expandable stent or prosthesis, a device for intraluminal delivery and deployment of a stent or prosthesis positioned within a body passageway which comprises:

an expansion member for carrying said stent or prosthesis, said expansion member being moveable between a first configuration wherein said member is defined by a first dimension extending in a radial direction, and a second configuration wherein said member is defined by a second dimension extending in said radial direction; and

means for applying opposed forces on said expansion member in an axial direction to move said expansion member between said first configuration and said second configuration;

said expansion member having an interior flow passage extending therethrough with a diameter and a longitudinally extending central axis for permitting the passage of blood through said expansion member; and

said means for applying opposed forces including an outer flexible elongate tubular member having proximal and distal extremities, said distal extremity of the outer flexible elongate tubular member being secured to the first end of said expansion member and an inner flexible elongate tubular member having proximal and distal extremities, said distal extremity of the inner flexible elongate tubular member being secured to the second end of said expansion member.

12. A device as recited in claim 11 wherein said second dimension is greater than said first dimension.

13. A device as recited in claim 11 wherein said expansion member comprises a first plurality of flexible elongate elements helically wound around the longitudinal axis of said expansion member.

14. A device as recited in claim 11 further comprising a second plurality of flexible elongate elements disposed coaxially with said first plurality of flexible elongate elements, and wherein said first plurality of flexible elongate elements has a first direction of rotation and said second plurality of flexible elongate elements has a second direction of rotation.

15. A device as recited in claim 11 further comprising a means for maintaining said prosthesis in a fixed position on said expansion member prior to deployment within said body passageway.

16. A method for intraluminal delivery and deployment of an expandable stent or prosthesis within a body passageway which comprises the steps of:

placing said stent or prosthesis over an expansion member, said expansion member being moveable between a first configuration wherein said member is defined by a first dimension extending in a radial direction, and a second configuration wherein said member is defined by a second dimension extending in said radial direction;

advancing said expansion member, with said prosthesis engaged upon, to a predetermined site in the body passageway; and

applying coaxially opposed forces on said expansion member in an axial direction to move said expansion member between said first configuration to said second configuration wherein said expansion member exerts radial force on said prosthesis and said prosthesis is expanded and implanted into said predetermined site.

17. A method as recited in claim 16 which further comprises the step of positioning a guidewire in the body passageway, and wherein said advancing step is accomplished by threading said expansion member over said guidewire.

18. A method for further expanding a stent or prosthesis previously deployed in a predetermined site within a body passageway which comprises the steps of:

advancing an expansion member to said predetermined site, said expansion member being moveable between a first configuration wherein said member is defined by a first dimension extending in a radial direction, and a second configuration wherein said member is defined by a second dimension extending in said radial direction; and

applying opposed forces on said expansion member in an axial direction to move said expansion member between said first configuration to said second configuration wherein said expansion member exerts radial force on said prosthesis and said prosthesis is further expanded and implanted into said predetermined site.

19. A method as recited in claim 18 which further comprises the step of positioning a guidewire in the body passageway, and wherein said advancing step is accomplished by threading said expansion member over said guidewire.