Multiple sclerosis therapeutic methods using therapeutic delivery devices and systems

• US 9,066,685 B2
• Filed: 12/29/2011
• Issued: 06/30/2015
• Est. Priority Date: 12/31/2010
• Status: Active Grant

• Current Assignee: Volcano Corporation (Koninklijke Philips N.V.)
• Original Assignee: Volcano Corporation (Koninklijke Philips N.V.)
• Inventors: Brown, Joe E., Margolis, Marja Pauliina, Gaddis, Mary L.
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): STOHR, LEAH C
• Application Number:
  US13/340,573
• Publication Number:
  US 20120220982A1
• Time in Patent Office: 1,279 Days
• Field of Search: 604/509, 604/103.01, 604/103.02, 604/505
• US Class Current: 1/1
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 18/245 for removing obstructions in blood vessels or calculi
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/0212 using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2090/3735 Optical coherence tomography [OCT]
• CPC Class Codes: A61B 2090/3784 both receiver and transmitter being in the instrument or receiver being also transmitter
• CPC Class Codes: A61B 5/0066 Optical coherence imaging
• CPC Class Codes: A61B 5/02007 Evaluating blood vessel condition, e.g. elasticity, compliance
• CPC Class Codes: A61B 6/507 for determination of haemodynamic parameters, e.g. perfusion CT
• CPC Class Codes: A61B 8/06 Measuring blood flow measuring volume flow in general G01F, e.g. G01F1/66, G01F1/72; measuring speed of fluids in general G01P5/00
• CPC Class Codes: A61B 8/0891 for diagnosis of blood vessels
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/463 characterised by displaying multiple images or images and diagnostic data on one display composite display in devices for short-range imaging with acoustic waves G01S7/52074
• CPC Class Codes: A61B 8/488 involving Doppler signals
• CPC Class Codes: A61B 8/5223 for extracting a diagnostic or physiological parameter from medical diagnostic data for algorithms to analyse biomedical images G06T7/0012
• CPC Class Codes: A61B 8/5246 combining images from the same or different imaging techniques, e.g. color Doppler and B-mode
• 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 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 25/104 : used for angioplasty
• CPC Class Codes: G16H 50/30 : for calculating health indices; for individual health risk assessment

Abstract

Methods and devices are disclosed that, in various embodiments and permutations and combinations of inventions, diagnose and treat Multiple Sclerosis or associated symptoms. In one series of embodiments, the invention consists of methods and devices for identifying patients whose Multiple Sclerosis or associated symptoms are caused or exacerbated, at least in part, by blockages of one or more of the patient'"'"'s internal jugular veins (IJV) or azygous veins (AZV). In some instances, stenoses or other flow limiting structures or lesions in the patient'"'"'s affected veins are identified. Further, in some instances the nature of such lesions and whether there is a significant disruption of blood pressure, or both, is ascertained. In some embodiments, methods and devices for applying one or more therapies to the blockages in the patient'"'"'s IJV or AZV veins are provided.

Claims

1. A method of treating multiple sclerosis, comprising:

providing a treatment device comprising a therapy agent delivery catheter capable of applying a therapeutic agent to a lesion of a vein through the therapy agent delivery catheter to dissolve fibrin or thrombus present at or causing the lesion or otherwise treat the lesion, the therapy agent delivery catheter including an intravascular ultrasound (IVUS) component adjacent to a therapeutic delivery component, wherein the IVUS component is configured to image the vein and wherein the therapeutic delivery component is configured to apply the therapeutic agent to the lesion of the vein;

identifying at least one venous outflow obstruction site of a patient based on images obtained from the IVUS component of the therapy agent delivery catheter;

assessing the at least one venous outflow obstruction site to determine whether the at least one venous outflow obstruction site causes significant narrowing of the vein, wherein venous outflow obstruction sites causing significant narrowing of the vein are identified for treatment with the therapeutic agent via the therapeutic delivery component of the therapy agent delivery catheter;

verifying the at least one venous outflow obstruction site by determining a pressure gradient across the at least one venous outflow obstruction site, the pressure gradient being calculated as a ratio of a pressure distal to the at least one venous outflow obstruction site and a pressure in the superior vena cava; and

applying the treatment device to an identified venous outflow obstruction site of the vein to treat multiple sclerosis symptoms of the patient, including applying the therapeutic agent to the identified venous outflow obstruction site to increase a cross-sectional area of a lumen of the vein.

2. The method of claim 1, wherein the therapeutic agent delivery catheter has a catheter body with a distal end, a proximal end, a central lumen through which a guide wire may be passed, an outer surface, a balloon and a balloon lumen.

3. The method of claim 2, wherein applying the treatment device to the identified venous outflow obstruction site of the vein includes visualizing the identified venous outflow obstruction site with the IVUS component to determine the efficacy of applying the treatment device to treat the multiple sclerosis symptoms of the patient.

4. The method of claim 2, wherein the balloon of the provided treatment device is porous to the therapeutic agent to allow the therapeutic agent to be exuded from the balloon.

5. The method of claim 4, wherein the therapeutic agent is chosen from the group consisting of tissue plasminogen activator, urokinase, streptokinase, collagenace, hepranoids and any other fibrinolytic or direct anti-thrombin drug.

6. The method of claim 5, wherein the balloon lumen of the catheter of the provided treatment device is configured to receive the therapeutic agent to facilitate introduction of the therapeutic agent into the balloon.

15. The method of claim 1, wherein the central lumen of the catheter extends to a distal tip of the catheter.

7. A multiple sclerosis therapeutic method, comprising:

providing a treatment device that includes;

a catheter having a proximal portion, a distal portion, a central lumen extending along a length of the catheter between the proximal and distal portions, and an off-set lumen extending along the length of the catheter between the proximal and distal portions;

a balloon coupled to the distal portion of the catheter such that the balloon is in fluid communication with the off-set lumen of the catheter such that a therapeutic agent can be introduced into the balloon through the off-set lumen, wherein the therapeutic agent is configured to dissolve fibrin or thrombus present at a lesion of a vein and wherein the balloon is configured to facilitate application of the therapeutic agent from the balloon to the lesion when the balloon is positioned adjacent the lesion; and

an intravascular ultrasound (IVUS) component adjacent to the balloon, wherein the IVUS component is configured to image the vein;

identifying at least one venous outflow obstruction site of a patient based on images obtained from the IVUS component;

assessing the at least one venous outflow obstruction site to determine whether the at least one venous outflow obstruction site causes significant narrowing of the vein, wherein venous outflow obstruction sites causing significant narrowing of the vein are identified for treatment with the therapeutic agent via the balloon;

verifying the at least one venous outflow obstruction site by determining a pressure gradient across the at least one venous outflow obstruction site; and

applying the treatment device to an identified venous outflow obstruction site of the vein to treat multiple sclerosis symptoms of the patient, including inflating the balloon adjacent to the identified venous outflow obstruction site to apply the therapeutic agent to the identified venous outflow obstruction site to increase a cross-sectional area of a lumen of the vein.

8. The method of claim 7, wherein the central lumen of the catheter of the provided treatment device is sized and shaped to receive a guidewire.

9. The method of claim 7, wherein applying the treatment device to the identified venous outflow obstruction site of the vein includes visualizing the identified venous outflow obstruction site with the IVUS component to determine the efficacy of applying the treatment device to treat the multiple sclerosis symptoms.

10. The method of claim 7, wherein the balloon of the provided treatment device is porous to the therapeutic agent to allow the therapeutic agent to be exuded from the balloon.

11. The method of claim 10, wherein the therapeutic agent is chosen from the group consisting of tissue plasminogen activator, urokinase, streptokinase, collagenace, hepranoids and any other fibrinolytic or direct anti-thrombin drug.

12. The method of claim 11, wherein the off-set lumen of the catheter of the provided treatment device is configured to receive the therapeutic agent to facilitate introduction of the therapeutic agent into the balloon.

13. The method claim 7, wherein the pressure gradient is calculated as a ratio of a pressure distal to the at least one venous outflow obstruction site and a pressure in the superior vena cava.

14. The method of claim 7, wherein the central lumen of the catheter extends to a distal tip of the catheter.