Delivery device and method of delivery

• US 9,433,520 B2
• Filed: 01/19/2016
• Issued: 09/06/2016
• Est. Priority Date: 01/29/2015
• Status: Active Grant

• Current Assignee: Intact Vascular, Inc. (Koninklijke Philips N.V.)
• Original Assignee: Intact Vascular, Inc. (Koninklijke Philips N.V.)
• Inventors: Longo, Michael
• Primary Examiner(s): TANNER, JOCELIN C
• Application Number:
  US15/000,437
• Publication Number:
  US 20160220399A1
• Time in Patent Office: 231 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/10 for applying or removing wound clamps, e.g. containing only one clamp or staple A61B17/076 takes precedence; containing multiple wound clamps A61B17/068; Wound clamp magazines containers, packaging elements or packages specially adapted for particular articles or with special means for dispensing contents B65D83/00, B65D85/00
• CPC Class Codes: A61F 2/844 folded prior to deployment
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• 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 2002/826 more than one stent being applied sequentially
• CPC Class Codes: A61F 2002/91566 connected trough to trough
• CPC Class Codes: A61F 2002/91583 by a bridge, whereby at least one of its ends is connected along the length of a strut between two consecutive apices within a band
• CPC Class Codes: A61F 2002/9511 the retaining means being filaments or wires
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61M 29/00 Dilators with or without means for introducing media, e.g. remedies instruments for performing visual medical inspections of cavities or tubes of the body A61B1/00

Abstract

A delivery device can provide sequential delivery of a plurality of intraluminal devices or tacks held in a compressed state on the delivery device. Delivery platforms on the delivery device can hold a tack in a compressed position and be positioned between annular pusher bands that may also be radiopaque markers. The annular pusher bands can be made of wire or sections of material to increase flexibility while remaining radiopacity. A post deployment dilation device can be included. The post deployment dilation device can be a plurality of expansion filaments, a bellows, or a balloon. A tack deployment method can include allowing a self-expanding tack to expand, aligning the post deployment dilation device under the tack, and causing the post deployment dilation device to expand radial to push outward on the tack.

Claims

1. A delivery device comprising:

an inner shaft having a first diameter;

a distal annular band surrounding and fixed to the inner shaft;

a proximal annular band surrounding and fixed to the inner shaft, wherein the distal annular band and the proximal annular band have a second diameter that is larger than the first diameter

a delivery platform defined by a proximal end of the distal annular band and a distal end of the proximal annular band, wherein the delivery platform is configured to receive a self-expanding intraluminal device between the distal annular band and the proximal annular band and around the inner shaft for deployment from the delivery device into a vessel;

an outer sheath positioned on and slidable over the inner shaft and the delivery platform, the outer sheath having a pre-deployment position covering the delivery platform, and at least one delivery position where the outer sheath is withdrawn exposing the delivery platform and at least one of the distal annular band and the proximal annular band; and

a post dilation deployment device comprising;

a deployment platform fixed with respect to the inner shaft; and

a plurality of expansion filaments radially spaced around the inner shaft, each expansion filament of the plurality of expansion filaments having a first end fixed with respect to an end of the deployment platform, the plurality of expansion filaments having a pre-actuated position having a pre-deployment diameter and an actuated position having a deployment diameter larger than the pre-deployment diameter;

wherein the delivery platform comprises a plurality of expansion filament recesses, wherein each expansion filament of the plurality of expansion filaments is paired with one expansion filament recess of the plurality of expansion filament recesses;

wherein the post dilation deployment device is configured to apply a radial force to an inner surface of the self-expanding intraluminal device after deployment of the self-expanding intraluminal device so as to improve at least one of expansion of the self-expanding intraluminal device and seating of the self-expanding intraluminal device in the vessel.

2. The delivery device of claim 1, wherein the plurality of expansion filaments are configured to lie within the plurality of expansion filament recesses when in the pre-actuated position such that the plurality of expansion filaments lie substantially below a surface of the deployment platform.

3. The delivery device of claim 1, wherein the plurality of expansion filament recesses transition to a plurality of expansion filament lumens substantially at a proximal end of the delivery platform.

4. The delivery device of claim 1, wherein the first end is a distal end of each expansion filament of the plurality of expansion filaments that is fixed at a distal end of the deployment platform.

5. The delivery device of claim 4, wherein a proximal end of each expansion filament of the plurality of expansion filaments is configured to be pushed distally and cause radial expansion of the plurality of expansion filaments as the proximal end of each expansion filament of the plurality of expansion filaments moves toward the distal end of each expansion filament of the plurality of expansion filaments.

6. The delivery device of claim 1, further comprising a sliding ring positioned over and around the deployment platform, wherein the sliding ring is configured to reside between the deployment platform and the outer sheath.

7. The delivery device of claim 6, wherein a distal end of each expansion filament of the plurality of expansion filaments is fixed to the sliding ring, and wherein the sliding ring is configured to be pulled proximally to cause radial expansion of the plurality of expansion filaments.

8. The delivery device of claim 1, further comprising a first and a second deployment platform radiopaque band.

9. The delivery device of claim 1, further comprising an expansion control member configured to control expansion of the post dilation deployment device.

10. The delivery device of claim 9, wherein the expansion control member is located at a proximal end of the delivery device.

11. The delivery device of claim 1, wherein at least a portion of the plurality of expansion filaments is made of at least one of an elastic polymer, an elastic metal, and Nitinol.

12. The delivery device of claim 1, further comprising a self-expandable intraluminal device positioned around the delivery platform.

13. The delivery device of claim 1, comprising a second post dilation deployment device.

14. The delivery device of claim 1, wherein the post dilation deployment device is positioned between a distal tip of the delivery device and the delivery platform.

15. The delivery device of claim 1, wherein the post dilation deployment device is part of the delivery platform.

16. The delivery device of claim 1, comprising a plurality of delivery platforms.

17. The delivery device of claim 16, comprising a plurality of post dilation deployment devices.

18. The delivery device of claim 17, wherein each of the plurality of delivery platforms is paired with one of the plurality of post dilation deployment devices.

19. The delivery device of claim 1, further comprising a polymer covering surrounding the plurality of expansion filaments, the plurality of expansion filaments forming a frame.

20. A delivery device comprising:

an inner shaft having a first diameter;

a distal annular band surrounding and fixed to the inner shaft;

a proximal annular band surrounding and fixed to the inner shaft, wherein the distal annular band and the proximal annular band have a second diameter that is larger than the first diameter

a delivery platform defined by a proximal end of the distal annular band and a distal end of the proximal annular band, wherein the delivery platform is configured to receive a self-expanding intraluminal device between the distal annular band and the proximal annular band and around the inner shaft for deployment from the delivery device into a vessel;

an outer sheath positioned on and slidable over the inner shaft and the delivery platform, the outer sheath having a pre-deployment position covering the delivery platform, and at least one delivery position where the outer sheath is withdrawn exposing the delivery platform and at least one of the distal annular band and the proximal annular band; and

a post dilation deployment device comprising;

a deployment platform fixed with respect to the inner shaft; and

a plurality of expansion filaments radially spaced around the inner shaft, each expansion filament of the plurality of expansion filaments having a first end fixed with respect to an end of the deployment platform, the plurality of expansion filaments having a pre-actuated position having a pre-deployment diameter and an actuated position having a deployment diameter larger than the pre-deployment diameter;

wherein the inner shaft comprises a guidewire lumen and a plurality of expansion filament lumens, wherein the guidewire lumen is positioned substantially at a center of the inner shaft and the plurality of expansion filament lumens are positioned radially around the guidewire lumen, wherein the plurality of expansion filament lumens are configured to contain at least a portion of the plurality of expansion filaments;

wherein the post dilation deployment device is configured to apply a radial force to an inner surface of the self-expanding intraluminal device after deployment of the self-expanding intraluminal device so as to improve at least one of expansion of the self-expanding intraluminal device and seating of the self-expanding intraluminal device in the vessel.

21. A delivery device comprising:

an inner shaft having a first diameter;

a distal annular band surrounding and fixed to the inner shaft;

a proximal annular band surrounding and fixed to the inner shaft, wherein the distal annular band and the proximal annular band have a second diameter that is larger than the first diameter

a delivery platform defined by a proximal end of the distal annular band and a distal end of the proximal annular band, wherein the delivery platform is configured to receive a self-expanding intraluminal device between the distal annular band and the proximal annular band and around the inner shaft for deployment from the delivery device into a vessel;

an outer sheath positioned on and slidable over the inner shaft and the delivery platform, the outer sheath having a pre-deployment position covering the delivery platform, and at least one delivery position where the outer sheath is withdrawn exposing the delivery platform and at least one of the distal annular band and the proximal annular band;

a post dilation deployment device comprising;

a deployment platform fixed with respect to the inner shaft; and

a plurality of expansion filaments radially spaced around the inner shaft, each expansion filament of the plurality of expansion filaments having a first end fixed with respect to an end of the deployment platform, the plurality of expansion filaments having a pre-actuated position having a pre-deployment diameter and an actuated position having a deployment diameter larger than the pre-deployment diameter;

an expansion control member configured to control expansion of the post dilation deployment device, wherein each expansion filament of the plurality of expansion filaments extends from a distal end of the deployment platform, proximally, to the expansion control member where they may be pushed distally to increase a diameter of the post dilation deployment device and pulled proximally to decrease the diameter of the post dilation deployment device; and

wherein the post dilation deployment device is configured to apply a radial force to an inner surface of the self-expanding intraluminal device after deployment of the self-expanding intraluminal device so as to improve at least one of expansion of the self-expanding intraluminal device and seating of the self-expanding intraluminal device in the vessel.

22. A delivery device comprising:

an inner shaft having a first diameter;

a distal annular band surrounding and fixed to the inner shaft;

a proximal annular band surrounding and fixed to the inner shaft, wherein the distal annular band and the proximal annular band have a second diameter that is larger than the first diameter

a delivery platform defined by a proximal end of the distal annular band and a distal end of the proximal annular band, wherein the delivery platform is configured to receive a self-expanding intraluminal device between the distal annular band and the proximal annular band and around the inner shaft for deployment from the delivery device into a vessel;

an outer sheath positioned on and slidable over the inner shaft and the delivery platform, the outer sheath having a pre-deployment position covering the delivery platform, and at least one delivery position where the outer sheath is withdrawn exposing the delivery platform and at least one of the distal annular band and the proximal annular band; and

a post dilation deployment device comprising;

a deployment platform fixed with respect to the inner shaft; and

a plurality of expansion filaments radially spaced around the inner shaft, each expansion filament of the plurality of expansion filaments having a first end fixed with respect to an end of the deployment platform, the plurality of expansion filaments having a pre-actuated position having a pre-deployment diameter and an actuated position having a deployment diameter larger than the pre-deployment diameter, wherein the plurality of expansion filaments extend proximally from a distal end of the deployment platform to a proximal end of the delivery device, extending across a surface of the deployment platform, entering a plurality of expansion filament lumens substantially at a proximal end of the deployment platform, extending through the plurality of expansion filament lumens, and exiting the plurality of expansion filament lumens substantially at a proximal end of the delivery device where they may be actuated using an expansion control member;

wherein the post dilation deployment device is configured to apply a radial force to an inner surface of the self-expanding intraluminal device after deployment of the self-expanding intraluminal device so as to improve at least one of expansion of the self-expanding intraluminal device and seating of the self-expanding intraluminal device in the vessel.