Method for implanting a prosthesis with a two-part expanding delivery system

• US 20060276872A1
• Filed: 06/08/2006
• Published: 12/07/2006
• Est. Priority Date: 09/03/2003
• Status: Active Grant

• Current Assignee: Bolton Medical, Inc. (Terumo Corporation)
• Original Assignee: Bolton Medical, Inc. (Terumo Corporation)
• Inventors: Berra, Humberto, Arbefeuille, Samuel, Moore, Michael, Barbre, Carol
• Granted Patent: US 8,740,963 B2
• Time in Patent Office: Days
• US Class Current: 623/1.110
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• 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 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/828 Means for connecting a plurality of stents allowing flexibility of the whole structure
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2002/9528 for retrieval of stents
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61M 25/0105 Steering means as part of the catheter or advancing means; Markers for positioning systems for detection of markers A61B
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: Y10T 29/49799 Providing transitory integral holding or handling portion
• CPC Class Codes: Y10T 74/18392 Crank, pitman, and crank

Abstract

A method of implanting a prosthesis in a patient at a treatment site includes providing a prosthesis delivery system with an inner sheath and an outer sheath. The prosthesis is loaded inside the inner sheath. The inner sheath containing the prosthesis is loaded within the outer sheath. The outer sheath is advanced in a patient towards the treatment site up to a given position at a distance from the treatment site. While retaining the outer sheath in the given position, the inner sheath is advanced out from the outer sheath to the treatment site to align the prosthesis with the treatment site and the inner sheath is retracted to at least partially implant the prosthesis at the treatment site. Upon completion of prosthesis implantation, both of the inner and outer sheaths are retracted from the patient.

Claims

1. A method of implanting a prosthesis in a patient at a treatment site, which comprises:

providing a prosthesis delivery system with an inner sheath and an outer sheath;

loading a prosthesis inside the inner sheath;

loading the inner sheath containing the prosthesis within the outer sheath;

advancing the outer sheath in a patient towards the treatment site up to a given position at a distance from the treatment site;

while retaining the outer sheath in the given position;

advancing the inner sheath out from the outer sheath to the treatment site to align the prosthesis with the treatment site; and

retracting the inner sheath to at least partially implant the prosthesis at the treatment site; and

upon completion of prosthesis implantation, retracting both of the inner and outer sheaths from the patient.

2. The method according to claim 1, which further comprises carrying out the advancing step by advancing the inner sheath out from the outer sheath to the treatment site to axially align the prosthesis with the treatment site and rotating the inner sheath to circumferentially align the prosthesis with the treatment site.

3. The method according to claim 1, which further comprises carrying out the advancing step by advancing the outer sheath towards the treatment site only up to a point at a distance from the treatment site greater than a length of the prosthesis.

4. The method according to claim 1, which further comprises carrying out the advancing step by advancing the outer sheath in vasculature of a patient towards a vascular treatment site.

5. The method according to claim 4, which further comprises carrying out the advancing step by advancing the outer sheath in aortic vasculature of the patient no closer to the heart than a celiac axis of the patient.

6. The method according to claim 4, which further comprises carrying out the advancing step by advancing the outer sheath in aortic vasculature of the patient to a point in the aorta no closer to a heart of the patient than a celiac axis of the patient.

7. The method according to claim 1, which further comprises providing the outer sheath with a length sufficient to reach only up to a celiac axis of a patient.

8. The method according to claim 1, which further comprises providing the outer sheath with a length no greater than a distance from the patient'"'"'s femoral arterial access site to the patient'"'"'s celiac axis.

9. The method according to claim 1, which further comprises carrying out the retracting step upon completion of prosthesis implantation by:

retracting the inner sheath into the outer sheath; and

subsequently retracting the outer sheath containing the inner sheath from the patient.

10. The method according to claim 1, which further comprises providing the inner sheath of a material relatively more flexible than a material of the outer sheath.

11. The method according to claim 1, which further comprises providing the prosthesis delivery system with an inner sheath that relatively more flexible than the outer sheath.

12. The method according to claim 1, which further comprises providing the inner sheath with a prosthesis holding inner diameter at least as great as an inner diameter of the outer sheath.

13. A method of implanting a prosthesis in a patient at a treatment site, which comprises:

axially locking a set of inner catheters with respect to an outer catheter, at least a portion of one of the inner catheters constraining the prosthesis;

threading the inner and outer catheters onto a guidewire and into a patient to place the outer catheter into an aorta of the patient only up to a point at a distance from the treatment site greater than a length of the prosthesis;

unlocking the inner catheters with respect to the outer catheter;

advancing the inner catheters distally out of the outer catheter in the aorta towards the patient'"'"'s heart to transport the prosthesis further upstream into the aorta;

unlocking the one inner catheter that is constraining the prosthesis from the remainder of the inner catheters; and

retracting the one inner catheter in a proximal direction to at least partially implant the prosthesis in the vessel.

14. The method according to claim 13, which further comprises carrying out the threading step by threading the inner and outer catheters into the patient at a femoral access site.

15. The method according to claim 13, which further comprises, before axially locking the inner catheters with respect to the outer catheter:

loading the prosthesis within a sheath connected to the one inner catheter, the sheath being smaller in diameter than the prosthesis to radially compress the prosthesis therein;

loading the inner catheters within the outer catheter to radially compress the sheath and to further radially compress the prosthesis; and

axially locking the inner catheters with respect to one another.

16. The method according to claim 15, which further comprises:

carrying out the loading step by additionally releasably connecting a distal portion of the prosthesis with a portion of one of the inner catheters different from the one inner catheter; and

after retracting the one inner catheter, finally deploying the prosthesis in the vessel by releasing the distal portion of the prosthesis from the portion.

17. The method according to claim 15, which further comprises providing the sheath from a relatively flexible material and the outer catheter from a relatively stiff material.

18. The method according to claim 13, which further comprises carrying out the advancing step by advancing the inner catheters distally out of the outer catheter and into the curved thoracic aorta.

19. The method according to claim 13, which further comprises, prior to unlocking the one inner catheter from the remainder of the inner catheters, rotating the axially locked inner catheters to place the prosthesis in a desired rotational implanting position.

20. The method according to claim 19, which further comprises:

providing the prosthesis with a supporting rod; and

carrying out the rotation step by rotating the prosthesis to approximately align the supporting rod along a superior longitudinal line of a curved portion of the thoracic aorta.

21. A method of implanting a prosthesis in a patient at a treatment site, which comprises:

axially locking a set of inner catheters with respect to an outer catheter, at least a portion of one of the inner catheters constraining the prosthesis;

threading the inner and outer catheters onto a guidewire and into a patient to place the outer catheter into an aorta of the patient no closer to the heart than approximately at the patient'"'"'s celiac axis;

unlocking the inner catheters with respect to the outer catheter;

advancing the inner catheters distally out of the outer catheter in the aorta towards the patient'"'"'s heart to transport the prosthesis further upstream into the aorta;

unlocking the one inner catheter that is constraining the prosthesis from the remainder of the inner catheters; and

retracting the one inner catheter in a proximal direction to at least partially implant the prosthesis in the vessel.