Treatment systems processes and devices addressing cerebral vasospasm/vasoconstriction

• US 9,808,359 B2
• Filed: 05/13/2016
• Issued: 11/07/2017
• Est. Priority Date: 09/30/2015
• Status: Active Grant

• Current Assignee: Neurvana Medical LLC
• Original Assignee: Neurvana Medical LLC
• Inventors: Ferrera, David A., Benjamin, Joshua, Bhogal, Pervinder, Sderman, Michael
• Primary Examiner(s): Dornbusch, Dianne
• Application Number:
  US15/154,927
• Publication Number:
  US 20170086992A1
• Time in Patent Office: 543 Days
• CPC Class Codes: A61B 6/504 for diagnosis of blood vessels, e.g. by angiography
• CPC Class Codes: A61F 2/844 folded prior to deployment
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/9528 for retrieval of stents
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2250/0059 temporary
• 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
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 2300/418 Agents promoting blood coagulation, blood-clotting agents, embolising agents
• CPC Class Codes: A61L 2300/42 Anti-thrombotic agents, anticoagulants, anti-platelet agents
• CPC Class Codes: A61L 31/022 Metals or alloys
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61L 31/18 Materials at least partially X-ray or laser opaque
• CPC Class Codes: A61L 33/0011 Anticoagulant, e.g. heparin, platelet aggregation inhibitor, fibrinolytic agent, other than enzymes, attached to the substrate
• CPC Class Codes: A61M 2025/0042 Microcatheters, cannula or the like having outside diameters around 1 mm or less
• CPC Class Codes: A61M 25/09 Guide wires

Abstract

Endovascular treatment of, for example, delayed cerebral vasospasm involves the placing of a microcatheter in the affected vessels followed by the teachings of the instant disclosure, which is clinically improved with comparison to slow infusion of a vasodilating compound. Systems, processes and self-expanding designed stents and stent-like members are featured and highlighted. The stents and stent-like members being retrieved, nothing is left in the vessel. Drug-eluting stents, resorbable stents and angiographically imagable coatings, including tantalum brushes over part or all of subject system components are also disclosed.

Claims

1. A treatment methodology for vasospasm secondary to another procedure, which comprises the steps listed in the order presented:

Emplacing a guide catheter system into a neurological image confirmed vasospasmed vessel;

Following said guide catheter with a self-expanding sheathed retrievable specialized stent, having radial force sufficient to dilatate the subject vessel;

Wherein the specialized stent comprising self-expanding modular units having a multiplicity of smaller cells, being open or closed celled and elongated longitudinally from distal to proximal ends;

Whereby the specialized stent is kept in place while a microcatheter (MC) is withdrawn to the level of a proximal end of the specialized stent, the specialized stent is thus deployed without being advanced or retracted;

The specialized stent is kept in place for at least about less than five minutes;

Resheathing of the specialized stent by advancing the MC while the specialized stent is kept immobile; and

Retraction of the MC to the Internal Carotid Artery (ICA) or Vertebral Artery (Vert Art) with the specialized stent still inside;

then Control angiography through the guiding catheter to confirm vessel status and optionally

Said procedure may be repeated in the same or other vessels to achieve long term dilatation of the vessel without vasospasm.

2. The improved treatment claim 1, herein, the specialized stent further comprising at last one device from the group consisting essentially of a drug eluting stent;

a bioresorbable stent (bioresorbable stents/scaffold made either from magnesium based material) and/or Polylactic acid based polymers;

a bare-metal self-expanding stent and chimeric combinations or hybrids of the same, whereby the procedure time lowers the potential for vessel rupture.

3. The improved treatment methodology of claim 2, further comprising:

a coating, marker, system for marking or covering which is radiopaque wherein the coating, marker, system for marking or covering is disposed partially over a portion only of the surface of any device associated herewith and the ability to inject Heparin and/or vasodilators during stent deployment;

providing long lasting cerebral vasodilation for patients with delayed vasospasm.

4. A method of treatment of cerebral vasospasm secondary to another procedure with a non-detachable specialized stent which comprises the steps listed in the order presented:

Emplacement of a guiding catheter within the Internal Carotid Artery (ICA) or Vertebral Artery (Vert Art) of a patient;

Heparinization of the patient to double Activated Clot Time (ACT)-level;

Performing a diagnostic angiogram in order to visualize the location and extent of the arterial spasm and exclude other pathologies that may be contraindications to the treatment;

Catheterizing the Middle cerebral artery (MCA), Anterior Cerebral Artery (ACerA) or (PCerA) at least to the M2, A2 or P2 segment with a microcatheter (MC) and microguidewire;

wherein in cases where this is not necessary or cannot be safely done the tip of the MC may be placed in the MI, A1 or PI;

Removal of the microguidewire;

Inserting the non-detachable specialized stent in the MC and advancement of the same to the tip of the MC;

Wherein the non-detachable specialized stent comprising self-expanding modular units having a multiplicity of smaller cells, being open or closed celled and elongated longitudinally from distal to proximal ends;

Whereby the non-detachable specialized stent is kept in place while the MC is withdrawn to the level of the proximal end of the non-detachable specialized stent, the non-detachable specialized stent is thus deployed without being advanced or retracted;

Control angiography through the guiding catheter;

The non-detachable specialized stent is kept in place for at least about 5 minutes;

Resheathing of the non-detachable specialized stent by advancing the MC while the non-detachable specialized stent is kept immobile; and

Retraction of the MC to the Internal Carotid Artery (ICA) or Vert Art with the non-detachable specialized stent still inside;

then Control angiography through the guiding catheter, optionally,

Said procedure may be repeated.

5. The method of treatment of claim 4, whereby said stent is self-expanding, and whereby Calcium (Ca+)-channel blockers are given in the MC during the stent deployment.

6. The stent defined in claim 5, wherein said medical device is removable, said device being retrieved, nothing is left in the vessel, yet long term vasodilation is achieved.

7. The stent defined in claim 6, wherein said medical device is atraumatic, low profile, radiopaque, and has a robust geometry along with being removable, said devices further comprising at least a drug covering or coating selected from the group of Everolimus;

Paclitaxel;

Sirolimus;

Corolimus and any related compounds, salts, moieties which potentially reduce risk of thrombosis, lumen loss and related challenges and/or the stent/stent-means is bioresorbable stents/scaffold made either from magnesium based material and/or Polylactic Acid-based (PLA'"'"'s) (polymer), that could be implanted for vasospasm as a treatment, which specifically designed high-radial force devices.