Tracheobronchial implantable medical device and methods of use

• US 9,833,342 B2
• Filed: 10/06/2015
• Issued: 12/05/2017
• Est. Priority Date: 08/21/2006
• Status: Expired due to Fees

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Lim, Florencia, Suh, Mary, Stamberg, Barbara, Huang, Bin
• Primary Examiner(s): Sharma, Yashita
• Assistant Examiner(s): Preston, Rebecca
• Application Number:
  US14/876,661
• Publication Number:
  US 20160022449A1
• Time in Patent Office: 791 Days
• Field of Search: None
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2/186 Nose parts
• CPC Class Codes: A61F 2/20 Epiglottis; Larynxes; Tracheae combined with larynxes or for use therewith tracheae, bronchi per se A61F2/04 ; tracheostomy tubes A61M16/0465
• CPC Class Codes: A61F 2/844 folded prior to deployment
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2/885 comprising a coil including a plurality of spiral or helical sections with alternate directions around a central axis
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2/962 having an outer sleeve
• CPC Class Codes: A61F 2002/043 Bronchi
• CPC Class Codes: A61F 2002/044 Oesophagi or esophagi or gullets
• CPC Class Codes: A61F 2002/046 Tracheae
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/0015 differing in density or specific weight
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0028 : differing in fibre orientations
• CPC Class Codes: A61F 2250/0039 : differing in diameter
• CPC Class Codes: A61F 2250/0067 : Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers

Abstract

Devices and methods for treating a diseased tracheobronchial region in a mammal. The device can be a stent which can include a sustained-release material such as a polymer matrix with a treatment agent. The stent can be bioabsorbable and a treatment agent can be incorporated therewith. A treatment method can be delivery of a stent to a tracheobronchial region by a delivery device such as a catheter assembly.

Claims

1. A method comprising:

delivering a bioabsorbable stent to a tracheobronchial region of a mammal, wherein a treatment agent is disposed on or within at least a portion of the stent, and the treatment agent (a) is subjected to controlled release and (b) treats at least one of granulation tissue formation, mucous plugging and inflammation; and

positioning the stent in the tracheobronchial region by self-expanding the stent within a trachea or a bronchi of the mammal and anchoring a proximal end and a distal end of the stent to a wall of the trachea or the bronchi to prevent stent migration, wherein the proximal end and the distal end of the stent have a pitch of from 60 to 100 picks per inch, and the pitch of the proximal end and the distal end is greater than a pitch of a central portion of the stent such that a radial strength at the proximal end and the distal end is greater than the central portion and anchors the stent to the wall of the trachea or the bronchi.

2. The method of claim 1 wherein the treatment agent is combined with a polymer matrix forming a mixture and the mixture is coated on at least one of an abluminal or a luminal surface of the stent.

3. The method of claim 2 wherein the polymer matrix is selected from the group consisting of polyglycolide, polylactide, and copolymers and combinations thereof.

4. The method of claim 1 wherein the treatment agent is incorporated within the body of the stent.

5. The method of claim 1 wherein the bioabsorbable stent comprises a material selected from the group consisting of polylactide, polyglycolide, polycaprolactones, and copolymers and combinations thereof.

6. The method of claim 1 wherein the treatment agent is an anti-inflammatory.

7. The method of claim 6 wherein the anti-inflammatory is selected from the group consisting of prednisone, oxymetholone, oxandrolone, methanodrostenolone, ibuprofen, diclofenac, diflunisal, fenoprofen, aspirin, sulindac, naproxen, indomethacin, piroxicam, ketoprofen, tolmetin and azapropazonelast.

8. The method of claim 1 wherein the controlled release is from about 2 to about 24 months.

9. The method of claim 1 wherein the stent comprises a cylindrical body, wherein an outer diameter of the proximal end and an outer diameter of the distal end are greater than an outer diameter of the central portion.

10. The method of claim 1 wherein the stent comprises a cylindrical body, wherein the proximal end and the distal end have a greater pitch angle than the central portion.

11. The method of claim 10 wherein the central portion has a pitch of between 40 to 90 picks per inch.

12. The method of claim 10 wherein the proximal end and the distal end have a pitch angle of between 50 degrees and 90 degrees and the central portion has a pitch of angle of about 25 degrees to about 70 degrees.

13. The method of claim 1 wherein the treatment agent is part of a multi-layer coating disposed on at least a portion of the stent, and wherein the multi-layer coating comprises (i) a treatment layer comprising the treatment agent, (ii) a primer layer for improving adhesion of an adjacent layer, and (iii) a biocompatible finishing layer for improving a biocompatibility of the multi-layer coating.

14. A method comprising:

delivering a bioabsorbable stent to a tracheobronchial region of a mammal, wherein a treatment agent is disposed on or within at least a portion of the stent, and the treatment agent (a) is subjected to controlled release and (b) treats at least one of granulation tissue formation, mucous plugging and inflammation; and

positioning the stent in the tracheobronchial region by self-expanding the stent within a trachea or a bronchi of the mammal, and wherein the stent comprises a proximal concentric end region, a middle concentric region and a distal concentric end region, and a pitch of the proximal concentric end region and the distal concentric end region is greater than a pitch of the middle concentric region such that a radial strength at the proximal concentric end region and the distal concentric end region is greater than the middle concentric region and anchors the stent to the wall of the trachea or the bronchi, and the pitch of the middle concentric region is between 40 to 90 picks per inch.

15. The method of claim 14 wherein the bioabsorbable stent is self-expanding.

16. The method of claim 14 wherein the proximal concentric end region and the distal concentric end region have a pitch of between 60 to 100 picks per inch.

17. The method of claim 14 wherein the proximal concentric end region and the distal concentric end region have an outer diameter of from about 5 mm to about 25 mm.

18. The method of claim 14 wherein the proximal concentric end region and the distal concentric end region have an outer diameter of from about 5 mm to about 25 mm, and an outer diameter of the middle concentric region is less than the outer diameter of the proximal concentric end region and the distal concentric end region.

19. The method of claim 14 wherein the middle concentric region comprises an outer diameter of from about 3.5 mm to about 25 mm.