Methods of implanting a prosthesis and treating an aneurysm

• US 8,740,963 B2
• Filed: 06/08/2006
• Issued: 06/03/2014
• Est. Priority Date: 09/03/2003
• Status: Active Grant

• Current Assignee: Bolton Medical, Inc. (Terumo Corporation)
• Original Assignee: Bolton Medical, Inc. (Terumo Corporation)
• Inventors: Arbefeuille, Samuel, Berra, Humberto, Barbre, Carol, Moore, Michael
• Primary Examiner(s): Erezo, Darwin
• Assistant Examiner(s): YABUT, DIANE D
• Application Number:
  US11/449,337
• Publication Number:
  US 20060276872A1
• Time in Patent Office: 2,917 Days
• Field of Search: 623/1.11, 623/1.12
• US Class Current: 623/1.12
• 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, comprising the steps of:

a) axially locking an apex release lumen, a sheath lumen and a curved guidewire lumen located within the apex release lumen with respect to an outer catheter, wherein an inner sheath extends from a distal end of the sheath lumen and radially about the prosthesis, at least one of the apex release lumen and the sheath lumen constraining a proximal stent of the prosthesis and wherein the apex release lumen is within the sheath lumen and the sheath lumen is within the outer catheter;

b) rotationally locking the apex release lumen, the sheath lumen and the curved guidewire lumen, whereby they rotate together and independently of the outer catheter;

c) threading the apex release lumen, the sheath lumen and the curved guidewire lumen onto a guidewire and directing the apex release lumen, the sheath lumen and the curved guidewire lumen into a patient to place the outer catheter in an aorta of the patient at a point distal to the treatment site at a distance that is greater than the length of the prosthesis;

d) axially unlocking the apex release lumen, the sheath lumen and the curved guidewire lumen with respect to the outer catheter;

e) advancing the apex release lumen, the sheath lumen and the curved guidewire lumen distally out of the outer catheter in the aorta toward the patient'"'"'s heart whereby the advancement of the apex release lumen, the sheath lumen and the curved guidewire lumen causes rotation of the prosthesis to thereby rotationally align the prosthesis at the treatment site, thereby delivering the prosthesis to the treatment site in proper rotational alignment; and

f) axially locking the apex release lumen and the curved guidewire lumen relative to the outer catheter, whereby the sheath lumen can move axially relative to the apex release lumen and the outer catheter; and

g) retracting the inner sheath in a proximal direction to at least partially implant the prosthesis in the vessel.

2. The method according to claim 1, wherein the inner sheath is of a more flexible material than that of the outer catheter.

3. The method according to claim 1, wherein the apex release lumen and the sheath lumen are advanced distally out of the outer catheter and into the thoracic aorta.

4. The method according to claim 3, wherein the prosthesis includes a supporting rod, whereby advancement of the rotationally locked apex release lumen, the sheath lumen and the curved guidewire lumen causes rotational alignment of a longitudinal support member of the prosthesis along a superior longitudinal line of a portion of the thoracic aorta.

5. A method of implanting a prosthesis in a patient at a treatment site, comprising the steps of:

a) axially locking an apex release lumen, a sheath lumen and a curved guidewire lumen located within the apex release lumen with respect to an outer catheter, wherein an inner sheath extends from a distal end of the sheath lumen and radially about the prosthesis, the inner sheath constraining the prosthesis and wherein the apex release lumen is within the sheath lumen and the sheath lumen is within the outer catheter;

b) rotationally locking the apex release lumen, the sheath lumen and the curved guidewire lumen, whereby they rotate together and independently of the outer catheter;

c) threading the apex release lumen, the sheath lumen and the curved guidewire onto a guidewire and directing the apex release lumen and the sheath lumen into a patient to place the outer catheter into an aorta of the patient;

d) axially unlocking the apex release lumen, the sheath lumen and the curved guidewire lumen with respect to the outer catheter;

e) advancing the apex release lumen, the sheath lumen and the curved guidewire lumen distally out of the outer catheter in the aorta toward the patient'"'"'s heart, whereby the advancement of the apex release lumen, the sheath lumen and the curved guidewire lumen causes rotation of the prosthesis to thereby rotationally align the prosthesis at the treatment site, thereby delivering the prosthesis to the treatment site in proper rotational alignment;

f) axially locking the apex release catheter and the curved guidewire lumen relative to the outer catheter, whereby the sheath lumen can move axially relative to the apex release lumen and the outer catheter; and

g) retracting the sheath lumen and the inner sheath to release the prosthesis from the inner sheath.

6. The method of claim 5, wherein a proximal portion of the prosthesis is fixed at an apex capture device at proximal apices of a stent component of the prosthesis, the apex capture device including:

a) a distal apex head fixedly connected to a distal end of the curved guidewire lumen, the distal apex head having;

i) a distal portion with a proximal end; and

ii) a proximal portion having an exposed side facing distally that is disposed in a plane substantially perpendicular to a longitudinal axis of the apex release lumen and defining stopping surface portions, and

b) a proximal apex body fixedly connected to a distal end of the apex release lumen and having fingers extending toward the distal apex head in a distal direction, the fingers defining at least in part an interior cavity shaped to receive the proximal portion of the distal apex head therein, and

the proximal apex body and the distal apex head being formed to hold at least one apex of the stent component of the prosthesis therebetween and, together, defining a stent captured state in which the proximal portion of the distal apex head is received in the interior cavity of the proximal apex body.

7. The method of claim 5, wherein the prosthesis is further constrained by the apex release lumen and further including the step of releasing the prosthesis from the apex release lumen.

8. A method for treating an aneurysm of a patient by deploying a prosthesis from a delivery device, comprising the steps of:

a) advancing an outer catheter locked in a neutral position of the delivery device with respect to an apex release lumen, a sheath lumen and a curved guidewire lumen located within the apex release lumen, wherein an inner sheath extends from a distal end of the sheath lumen and radially about a prosthesis within the outer catheter, wherein the apex release lumen is within the sheath lumen and the sheath lumen is within the outer catheter, the outer catheter, the apex release lumen, the sheath lumen and the curved guidewire lumen moving along a guidewire through an arterial access to a treatment site in an aorta of the patient;

b) rotationally locking the apex release lumen, the sheath lumen and the curved guidewire lumen, whereby they rotate together and independently of the outer catheter;

c) axially unlocking the apex release lumen, the sheath lumen and the curved guidewire lumen relative to the outer catheter, thereby shifting the delivery device from the neutral position to an advancement position;

d) advancing the apex release lumen, the sheath lumen and the curved guidewire lumen distally out of the outer catheter in the aorta toward the patient'"'"'s heart to thereby deliver the prosthesis to the treatment site, whereby advancing the inner sheath, the apex release lumen and the curved guidewire lumen causes rotation of the prosthesis to thereby rotationally align the prosthesis at the treatment site;

e) axially unlocking the sheath lumen from the apex release lumen and locking the apex release lumen and the curved guidewire lumen relative to the outer catheter, whereby the sheath lumen can move axially relative to the apex release lumen and the outer catheter to thereby shift from the advancement position to a deployment position of the delivery device;

f) partially retracting the sheath lumen, thereby partially retracting the inner sheath from the prosthesis to partially deploy the prosthesis, the prosthesis being fixed at an apex capture device of the delivery device at proximal apices of a stent component of the prosthesis, the apex capture device including,

1) a distal apex head fixedly connected to a distal end of the curved guidewire lumen of the delivery device within the apex release lumen, the apex head having

i) a distal portion with a proximal end, and

ii) a proximal portion having an exposed side facing distally that is in a plane approximately perpendicular to a longitudinal axis of the apex release lumen, and defining stopping surface portions, and

2) a proximal apex body fixedly connected to a distal end of the apex release lumen and having fingers extending toward the distal apex head in a distal direction, the fingers defining an interior cavity shaped to receive the proximal portion of the distal apex head therein,

the proximal apex body and the distal apex head being formed to hold at least one apex of the stent component of the prosthesis therebetween and, together, defining a stent captured state in which the proximal portion of the distal apex head is received in an interior cavity of the apex capture device and the distal apex head approximately closes off the interior cavity along the longitudinal axis of the apex release lumen to capture at least one apex of the stent component of the prosthesis;

g) positioning the proximal end of the prosthesis within the aorta while the prosthesis is partially deployed;

h) retracting the sheath lumen and the inner sheath to fully expose the prosthesis within the aorta;

i) retracting the apex release lumen relative to the curved guidewire lumen, thereby releasing at least one apex of the stent from the stent captured state, whereby the stent expands to fix the proximal portion of the prosthesis and is released from the delivery device within the aorta; and

j) retracting the device from the aorta and the arterial access of the patient.

9. The method of claim 8, wherein the arterial access is a femoral artery.

10. The method of claim 8, wherein the aorta is a curved portion of the aorta.

11. The method of claim 10, wherein the curved portion of the aorta is a portion of a thoracic aorta.

12. The method of claim 11, wherein the prosthesis includes a longitudinal support member that extends substantially parallel to a longitudinal axis of the prosthesis, whereby advancement of the rotationally locked apex release lumen, the sheath lumen and the curved guidewire lumen causes rotational alignment of the prosthesis to thereby align the longitudinal support member with a superior longitudinal line of the curved portion of the aorta.

13. The method of claim 12, wherein the prosthesis further includes at least one radiopaque marker.

14. The method of claim 13, wherein the radiopaque marker is a D-shaped radiopaque marker.