Pull back stent delivery system with pistol grip retraction handle

• US 5,968,052 A
• Filed: 11/27/1996
• Issued: 10/19/1999
• Est. Priority Date: 11/27/1996
• Status: Expired due to Term

• Current Assignee: Boston Scientific Corporation
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: DeVries, Robert B., Sullivan, Roy III
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US08/753,641
• Time in Patent Office: 1,056 Days
• Field of Search: 606/108, 606/191, 606/198, 606/195, 606/194, 606/206, 604/96
• US Class Current: 623/1.11
• 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

Abstract

A stent delivery system for delivering a self-expanding stent to a predetermined location in a vessel includes a catheter body having an axial guidewire lumen and a pull-wire lumen. A medical device such as a self-expanding stent is held in a reduced delivery configuration for insertion and transport through a body lumen to a predetermined site for deployment. The stent is carried axially around the catheter body near its distal end and held in its reduced configuration by a retractable outer sheath. A proximal retraction handle is connected to the proximal end of the catheter body and includes a pistol grip trigger engaging a rachet mechanism, which is connected to a pull-wire which extends through the pull-wire lumen and is connected to the retractable outer sheath.

Claims

1. A delivery system for delivering a medical device to a predetermined location in a body lumen, the delivery system comprising:

a catheter body having proximal and distal ends, the catheter body having an axial guidewire lumen and a pull-wire lumen, the catheter body for transporting a medical device to a predetermined site in a body lumen for deployment;

a medical device having proximal and distal ends carried by the catheter body near the distal end of the catheter body;

a retractable outer sheath having proximal and distal ends and surrounding the medical device and containing the medical device in a delivery configuration where the medical device has a reduced radius along its entire axial length;

a proximal retraction handle connected to the proximal end of the catheter body, the handle including a pistol grip trigger engaged with a rachet mechanism, the ratchet mechanism being connected to a pull-wire, the pull-wire extending through the pull-wire lumen to the distal end of the catheter body where it is connected to the retractable outer sheath,

whereby the medical device is delivered by squeezing the pistol grip trigger, which causes the ratchet mechanism to retract the pull-wire, which retracts the retractable outer sheath, enabling deployment.

2. The delivery system of claim 1 wherein the medical device is a self-expanding stent.

3. The delivery system of claim 1 wherein the medical device is a balloon expandable stent.

4. The delivery system of claim 1 wherein the medical device is a vena cava filter.

5. The delivery system of claim 1 wherein the medical device is a endovascular stent graft.

6. The delivery system of claim 1 wherein the ratchet mechanism is comprised of:

a rack driver comprised of a rack tab connected to a rack, the rack tab and rack constructed and arranged to form a through channel in the rack driver, the rack being further constructed and arranged to engage a gear;

an elongate strip having top and bottom sides and proximal and distal ends, the strip extending through the channel in the rack driver, the distal end of the strip being connected to the pull-wire, the top side of the strip further including a plurality of stops spaced apart on the strip to form a detent between each pair of adjacent stops, the stops being constructed and arranged such that the detents are each spaced a predetermined distance apart, and

the rack driver further including a flexible ratcheting pawl which is constructed and arranged to lockingly engage with a detent on the strip such that as the rack driver is moved proximally the strip is moved proximally, but when the rack driver is moved distally the pawl disengages from the strip to permit the rack driver to move distally without movement of the strip distally;

the ratchet mechanism interacting with a strip spring and a trigger spring to retract the pull-wire proximally;

the strip spring being connected to the proximal retraction handle and further including a locking portion which is constructed and arranged to lockingly engage with a detent of the strip to prevent the strip from moving distally, but which disengages with the strip to permit the strip to move proximally;

the trigger spring being connected to the proximal retraction handle and the trigger, the trigger spring having an open normal position and a compressed position, the trigger spring moving the trigger from the compressed position to the normal position when a squeezing force moving the normally open trigger to its compressed position is released;

whereby each complete squeeze of the pistol grip trigger rotates the gear engaging portion of the trigger, which rotates the gear and causes the rack driver and strip to move proximally a predetermined distance until the strip spring lockingly engages with the distally adjacent detent on the strip, retracting the outer sheath a predetermined distance and locking the strip spring to prevent the outer sheath from moving distally, and wherein upon release of the trigger the trigger spring moves the trigger to its normally open position, causing the rack driver to move distally a predetermined distance while the strip remains stationary, and where repeatedly squeezing the trigger retracts the outer sheath over the entire axial length of the medical device to fully deploy the medical device.

7. The delivery system of claim 6 wherein the pull wire is connected to a pull ring which is connected to the retractable outer sheath.

8. The delivery system of claim 7 wherein the medical device is a self-expanding stent and further including:

first and second radiopaque marker bands connected to the catheter body at the distal end and respectively positioned near the distal and proximal ends of the stent, and which are utilized to position the stent at the desired position in the body lumen;

a stent stop connected to the catheter body just proximally of the stent for preventing the stent from moving proximally when the outer sheath is retracted and wherein the pull ring is connected to the outer sheath just proximally of the stent stop;

a third radiopaque marker band connected to the outer sheath and positioned over the pull ring;

a fourth radiopaque marker band connected to the catheter body approximately the axial length of the stent proximally of the pull ring,

whereby full release of the stent may be determined by observing the third radiopaque marker band move proximally until it reaches the fourth radiopaque marker band.

9. The stent delivery system of claim 8 wherein the pull wire lumen terminates just proximally of the fourth radiopaque marker band and the pull wire extends above the guidewire lumen of the catheter body to connect to the pull ring.

10. The stent delivery system of claim 9 wherein the proximal end of the retractable sheath is tapered and slidably seals to the catheter body proximally of the point where the pull-wire emerges from the pull-wire lumen.

11. The stent delivery system of claim 10 wherein the distal end of the catheter includes a smooth tapered atraumatic tip surrounding the guidewire lumen and where the retractable outer sheath abuts the tip when in a fully unretracted position to create a stent containment compartment.

12. The stent delivery system of claim 11 including a stent flushing lumen which opens axially into the stent containment compartment to permit the stent containment compartment to be purged of air by filling the stent containment compartment with fluid prior to introducing the stent delivery system into the body lumen.

13. The delivery system of claim 6 wherein the gear has a 2 to 1 ratio such that a 1 mm movement of the trigger retracts the outer sheath 2 mm, where the detents are located approximately 2 mm apart and where a complete squeeze of the trigger will retract the outer sheath approximately 20 mm.

14. The delivery system of claim 6 wherein the gear has a 1 to 1 ratio such that a 2 mm movement of the trigger retracts the outer sheath 2 mm, where the detents are located approximately 2 mm apart and where a complete squeeze of the trigger will retract the outer sheath approximately 10 mm.

15. The delivery system of claim 6 wherein the gear has a 1 to 2 ratio such that a 2 mm movement of the trigger retracts the outer sheath 1 mm, where the detents are located approximately 1 mm apart and where a complete squeeze of the trigger will retract the outer sheath approximately 5 mm.

16. The delivery system of claim 7 further including a second pull-wire lumen, each pull-wire lumen carrying at least one U-shaped pull-wire, where the legs of the at least one U-shaped pull-wire are connected to the ratchet mechanism and where a U loop portion of the at least one U-shaped pull-wire is looped through two attachment points on the pull ring, whereby retraction of the outer sheath is accomplished by having the pull-wires connected at a plurality of points on the pull ring to more evenly distribute the pulling force on the pull ring.

17. The delivery system of claim 7 further including a second pull-wire lumen and a second pull-wire connected to the ratchet mechanism, each pull-wire forming a U-shape with a U loop portion of the pull-wire looped through two attachment points on the pull ring and the 2 leg sections of the U-shaped pull-wire extending through the pull-wire lumen to attach to the ratchet mechanism, whereby retraction of the outer sheath is accomplished by having the pull-wires connected at four points on the pull ring.

18. The delivery system of claim 1 wherein the retractable outer sheath is made of a fluropolymer material which is transparent to visible light.

19. A method for delivering a medical device to a predetermined location in a body lumen, comprising the steps of:

providing the delivery system of claim 1;

moving the distal end of the catheter body to a delivery site;

delivering the medical device by retracting the retractable outer sheath which releases the medical device.

20. The method of claim 19 further including the step of filling the outer sheath with fluid to purge air prior to implantation.

21. A delivery system for delivering a medical device to a predetermined location in a body lumen, the delivery system comprising:

a catheter body having proximal and distal ends, the catheter body having an axial guidewire lumen and a pull-wire lumen, the catheter body for transporting a medical device to a predetermined site in a body lumen for deployment;

a medical device having proximal and distal ends carried by the catheter body near the distal end of the catheter body;

a retractable outer sheath having proximal and distal ends and surrounding the medical device and containing the medical device in a delivery configuration where the medical device has a reduced radius along its entire axial length;

a proximal retraction handle connected to the proximal end of the catheter body, the handle including a pistol grip trigger engaged with a retraction device which is connected to a pull-wire, the pull-wire extending through the pull-wire lumen to the distal end of the catheter body where it is connected to the retractable outer sheath, the pistol grip trigger being actuated by squeezing, which retracts the pull-wire a predetermined amount;

whereby the medical device is delivered by repeatedly squeezing the pistol grip trigger, which causes the controlled retraction of the pull-wire, which retracts the retractable outer sheath, enabling deployment.