Delivery and administration of compositions using interventional catheters

• US 8,613,721 B2
• Filed: 11/14/2008
• Issued: 12/24/2013
• Est. Priority Date: 11/14/2007
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Limited (Boston Scientific Corporation)
• Original Assignee: Medrad Incorporated (Bayer AG)
• Inventors: Wulfman, Edward I.
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): STOHR, LEAH C
• Application Number:
  US12/742,903
• Publication Number:
  US 20100324472A1
• Time in Patent Office: 1,866 Days
• Field of Search: 604/22, 604 9601-107, 606 32- 45, 606/128
• US Class Current: 604/96.01
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 2017/22061 for spreading elements apart
• CPC Class Codes: A61B 2017/22082 after introduction of a substance
• CPC Class Codes: A61B 2017/320733 with a flexible cutting or scraping element, e.g. with a whip-like distal filament member
• CPC Class Codes: A61B 2017/320741 for stripping the intima or the internal plaque from a blood vessel, e.g. for endarterectomy
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 2025/109 having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

Systems and methods for delivery of therapeutic and/or diagnostic compositions to an interventional site having diseased or newly treated tissue are provided. Integrated interventional catheter systems incorporating surfaces coated with a therapeutic composition, or tissue penetration members for scoring or disrupting tissue prior to or during administration of a therapeutic composition are provided. Infusion of therapeutic composition(s) may also be provided.

Claims

1. A system for removing unwanted material from a body lumen or cavity comprising:

(a) a catheter;

(b) an operating head positioned at or near a distal end of the catheter;

(c) at least one infusion port provided near the distal end of the catheter and in proximity to the operating head;

(d) a plurality of tissue penetration members provided as bristle-like structures having a stiffness sufficient to score tissue as they are moved with respect to the tissue and located in proximity to the at least one infusion port, wherein the plurality of tissue penetration members is adapted to contact tissue within a body lumen or cavity to promote uptake of a composition infused through the at least one infusion port, and

(e) an inflatable structure adapted to adjust from a smaller diameter delivery condition to a larger diameter deployed condition, wherein the at least one infusion port is provided in the inflatable structure.

2. The system of claim 1, wherein the at least one tissue penetration member is provided on the inflatable structure.

3. The system of claim 2, wherein the inflatable structure incorporates a plurality of surface protuberances on its outer surface that produce fissures in tissue to enhance uptake of a therapeutic and/or diagnostic composition infused through the at least one infusion port.

4. A system for removing unwanted material from a body lumen or cavity comprising:

(a) a catheter;

(b) an operating head positioned at or near a distal end of the catheter;

(c) at least one infusion port provided near the distal end of the catheter and in proximity to the operating head; and

(d) a plurality of tissue penetration members provided in conjunction with the operating head and located in proximity to the at least one infusion port, wherein the tissue penetration members are provided on the operating head as wires or comb-like structures associated with the surfaces of blades forming the operating head and are adapted to contact tissue within a body lumen or cavity to promote uptake of a composition infused through the at least one infusion port.

5. A system for removing unwanted material from a body lumen or cavity comprising:

(a) a catheter;

(b) an operating head positioned at or near a distal end of the catheter;

(c) at least one infusion port provided near the distal end of the catheter and in proximity to the operating head; and

(d) a plurality of tissue penetration members provided as bristle-like structures having a stiffness sufficient to score tissue as they are moved with respect to the tissue and located in proximity to the at least one infusion port, wherein the plurality of tissue penetration members is adapted to contact tissue within a body lumen or cavity to promote uptake of a composition infused through the at least one infusion port, and wherein the plurality of tissue penetration members is mounted on a supporting structure and adjustable between a smaller delivery condition and an enlarged treatment condition.

6. The system of claim 5, wherein the bristle-like structures are mounted for movement in relation to the supporting structure.

7. The system of claim 5, wherein the plurality of tissue penetration member is coated with a therapeutic and/or diagnostic composition that is adapted to be released during contact with tissue.

8. A method for administering a therapeutic and/or diagnostic composition to an internal lumen or cavity prior to, during or following an interventional procedure, comprising:

(a) delivering a working head of an interventional catheter having a plurality of tissue penetration members provided as wires or comb-like structures associated with surface of blades forming the operating head to the site of the interventional procedure;

(b) operating the working head to at least partially displace or remove an obstruction from an internal lumen or cavity;

(c) contacting tissue penetration members mounted on the working head of the the interventional catheter to tissue at the site of the interventional procedure prior to, simultaneously with or following operation of the working head; and

(d) administering a therapeutic and/or diagnostic composition to the site of the interventional procedure during or following contacting of the tissue penetration members to the tissue at the site of the interventional procedure.

9. The method of claim 8, wherein the therapeutic and/or diagnostic composition is administered to the site of the interventional procedure through an inflatable member having at least one infusion port.

10. The method of claim 8, wherein the site of the interventional procedure is selected from the group consisting of:

blood vessels and vascular cavities, gastrointestinal cavities, lumens or cavities in male and female reproductive organs and the urinary tract, gas exchange cavities, and nasal and sinus cavities.

11. The method of claim 8, additionally comprising enlarging an opening in an obstructed or partially obstructed lumen or cavity as part of the interventional procedure.

12. The method of claim 8, wherein the working head is selected from the group consisting of ablation system using RF energy, high frequency ultrasound energy, lasers, high pressure fluids, thermal or electrical energy.

13. The method of claim 8, wherein the working head comprises a coring mechanism, a cutter mechanism, an abrasive mechanism, a scraping mechanism or an excision mechanism.

14. The method of claim 8, wherein therapeutic and/or diagnostic composition comprises a composition selected from the group consisting of:

anti-thrombogenic compositions;

antioxidants;

angiogenic compositions and factors;

anti-angiogenic compositions and factors;

compositions that block smooth muscle cell proliferation;

anti-inflammatory compositions;

calcium entry blockers;

antineoplastic compositions;

antiproliferative compositions;

antimitotic compositions;

immunosuppressant compositions;

antimicrobial compositions;

anesthetic compositions;

nitric oxide donors;

anti-coagulants;

vascular cell growth promoters;

vascular cell growth inhibitors;

cholesterol-lowering compositions;

vasodilating compositions;

compositions that interfere with endogenous vasoactive mechanisms;

survival genes; and

polynucleotide sequences.

15. A system for removing unwanted material from a body lumen or cavity comprising:

(a) a catheter;

(b) an operating head positioned at or near a distal end of the catheter;

(c) at least one infusion port provided near the distal end of the catheter and in proximity to the operating head;

(d) a plurality of tissue penetration members provided as bristle-like structures having a stiffness sufficient to score tissue as they are moved with respect to the tissue and located in proximity to the at least one infusion port, wherein the plurality of tissue penetration members is adapted to contact tissue within a body lumen or cavity to promote uptake of a composition infused through the at least one infusion port; and

(e) an aspiration port in or in proximity to the operating head and an aspiration system communicating with the aspiration port for removal of debris from a site of intervention.

16. The system of claim 15, wherein the operating head comprises a material removal device employing a coring or cutter mechanism, an abrasive mechanism, a scraping mechanism, or an ablation mechanism.

17. A method for administering a therapeutic and/or diagnostic composition to an internal lumen or cavity prior to, during or following an interventional procedure, comprising:

(a) delivering the working head of an interventional catheter to the site of the interventional procedure;

(b) operating the working head to at least partially displace or remove an obstruction from an internal lumen or cavity;

(c) contacting tissue penetrating structures mounted on a component of the interventional catheter to tissue remaining at the site of the interventional procedure prior to, simultaneously with or following operation of the working head, wherein the tissue penetrating structures are bristle-like structures having a stiffness to score tissue as they are moved with respect to the tissue and wherein the tissue penetrating structures are coated with a therapeutic composition; and

(d) administering a therapeutic and/or diagnostic composition to the site of the interventional procedure during or following contacting of the tissue penetrating structures to the tissue at the site of the interventional procedure.

18. The method of claim 17, wherein the working head comprises a coring mechanism, a cutter mechanism, an abrasive mechanism, a scraping mechanism or an excision mechanism.

19. A method for administering a therapeutic and/or diagnostic composition to an internal lumen or cavity prior to, during or following an interventional procedure, comprising:

(a) delivering the working head of an interventional catheter to the site of an interventional procedure, wherein the working head is selected from the group consisting of ablation system using RF energy, high frequency ultrasound energy, lasers, high pressure fluids, thermal or electrical energy;

(b) operating the working head to at least partially displace or remove an obstruction from an internal lumen or cavity;

(c) contacting tissue penetrating structures mounted on a component of the interventional catheter to tissue remaining at the site of the interventional procedure prior to, simultaneously with or following operation of the working head, wherein the tissue penetrating structures are bristle-like structures having a stiffness to score tissue as they are moved with respect to the tissue; and

(d) administering a therapeutic and/or diagnostic composition to the site of the interventional procedure during or following contacting of the tissue penetrating structures to the tissue at the site of the interventional procedure.

20. The method of claim 19, wherein the tissue penetrating structures are hollow and additionally comprising administering a therapeutic and/or diagnostic composition through the tissue penetrating structures when they contact tissue remaining at the site of the interventional procedure.

21. The method of claim 19, wherein the site of the interventional procedure is selected from the group consisting of:

blood vessels and vascular cavities, gastrointestinal cavities, lumens or cavities in male and female reproductive organs and the urinary tract, gas exchange cavities, and nasal and sinus cavities.

22. The method of claim 19, additionally comprising enlarging an opening in an obstructed or partially obstructed lumen or cavity as part of the interventional procedure.

23. The method of claim 19, wherein therapeutic and/or diagnostic composition comprises a composition selected from the group consisting of:

anti-thrombogenic compositions;

antioxidants;

angiogenic compositions and factors;

anti-angiogenic compositions and factors;

compositions that block smooth muscle cell proliferation;

anti-inflammatory compositions;

calcium entry blockers;

antineoplastic compositions;

antiproliferative compositions;

antimitotic compositions;

immunosuppressant compositions;

antimicrobial compositions;

anesthetic compositions;

nitric oxide donors;

anti-coagulants;

vascular cell growth promoters;

vascular cell growth inhibitors;

cholesterol-lowering compositions;

vasodilating compositions;

compositions that interfere with endogenous vasoactive mechanisms;

survival genes; and

polynucleotide sequences.

24. A method for administering a therapeutic and/or diagnostic composition to an internal lumen or cavity prior to, during or following an interventional procedure, comprising:

(a) delivering the working head of an interventional catheter to the site of interventional procedure;

(b) operating the working head to at least partially displace or remove an obstruction from an internal lumen or cavity;

(c) contacting tissue penetrating structures mounted on a component of the interventional catheter to tissue remaining at the site of the interventional procedure prior to, simultaneously with or following operation of the working head, wherein the tissue penetrating structures are bristle-like structures having a stiffness to score tissue as they are moved with respect to the tissue; and

(d) administering a therapeutic and/or diagnostic composition to the site of the interventional procedure during or following contacting of the tissue penetrating structures to the tissue at the site of the interventional procedure, wherein the therapeutic and/or diagnostic composition is administered to the site of the interventional procedure through an inflatable member having at least one infusion port.