System and method for clot amelioration

• US 10,342,573 B1
• Filed: 01/16/2018
• Issued: 07/09/2019
• Est. Priority Date: 12/05/2016
• Status: Active Grant

• Current Assignee: Walzman Innovations, LLC
• Original Assignee: Walzman Innovations, LLC
• Inventors: Walzman, Daniel Ezra
• Primary Examiner(s): Farrar, Lauren P
• Application Number:
  US15/732,955
• Publication Number:
  US 20190216494A1
• Time in Patent Office: 539 Days
• CPC Class Codes: A61B 17/12031 complete occlusion
• CPC Class Codes: A61B 17/12113 within an aneurysm
• CPC Class Codes: A61B 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/1214 Coils or wires
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/12177 comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• CPC Class Codes: A61B 17/22032 having inflatable gripping elements balloon catheters A61M25/10
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• 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 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/00893 pharmaceutically effective
• CPC Class Codes: A61B 2017/00898 expandable upon contact with fluid
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2017/1209 detachable by electrical current or potential, e.g. electroactive polymer
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2017/22079 with suction of debris
• CPC Class Codes: A61B 2017/22084 stone- or thrombus-dissolving
• CPC Class Codes: A61B 2017/320716 : comprising means for preventing embolism by dislodged material
• CPC Class Codes: A61B 2090/3966 : Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 2217/005 : with suction drainage system
• CPC Class Codes: A61B 2217/007 : with irrigation system
• CPC Class Codes: A61F 2/852 : Two or more distinct overlapping stents
• CPC Class Codes: A61F 2/91 : made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2002/823 : Stents, different from stent-grafts, adapted to cover an aneurysm
• CPC Class Codes: A61F 2002/826 : more than one stent being applied sequentially
• CPC Class Codes: A61F 2220/0033 : made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2250/0063 : Nested prosthetic parts
• CPC Class Codes: A61L 2430/06 : for cartilage reconstruction, e.g. meniscus
• CPC Class Codes: A61L 29/145 : Hydrogels or hydrocolloids
• CPC Class Codes: A61L 29/16 : Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61L 31/022 : Metals or alloys
• CPC Class Codes: A61L 31/04 : Macromolecular materials
• CPC Class Codes: A61L 31/10 : Macromolecular materials
• CPC Class Codes: A61L 31/125 : having a macromolecular matrix
• CPC Class Codes: A61L 31/14 : Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 31/145 : Hydrogels or hydrocolloids
• CPC Class Codes: A61L 31/146 : Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/16 : Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61M 2025/0057 : Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
• CPC Class Codes: A61M 2210/125 : Heart
• CPC Class Codes: A61M 25/10 : Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

Abstract

A treatment of a medical difficulty associated with the formation or presence of a blood clot in a blood vessel, commonly known as “thrombectomy.” Said treatment may be achieved by introducing and positioning through a single lumen a device capable of macerating, irrigating and aspirating as well as supporting structures proximal to the distal end of said device. Said device is introduced via a blood vessel, and deployed at a treatment site. The macerator is then operated to dislocate thrombus, clot, or other occlusive materials at the target site, the irrigating element is then operated to continue to dislocate thrombus, clot, or other occlusive materials at the target site, and the aspirating element is used to collect and remove the disruptive materials from the target site.

Claims

1. A medical device for ameliorating thrombi, comprising at least three channels including embedded lumens adapted for insertion into a blood vessel, comprising:

(a) an inner channel,

including, a proximal tip, a distal tip, and at least one macerating element capable of both expanding and collapsing;

at least one distal irrigation element adapted to irrigate a blockage, and

at least one proximal opening irrigation element communicating via a dedicated lumen, terminating at an irrigation source outside a patient'"'"'s body;

(b) an intermediate channel,

including a distal aperture and a proximal end;

wherein said at least one macerating element is affixed to said inner channel at at least one connection point, and attached to said intermediate channel at an attachment point; and

including at least one distal aspiration opening adapted to aspirate debris, and at least one proximal aspiration opening communicating via at least one dedicated lumen, terminating at an aspiration control device outside said patient'"'"'s body,

(c) an outer sheath,

including at least one distal hole adapted to aspirate debris via said at least one distal aspiration opening, and at least one proximal opening hole communicating via at least one dedicated lumen, terminating at said aspiration control device,

and at least one slit to allow said at least one maceration element to emerge from said inner channel through said intermediate channel and said outer sheath toward a wall of said blood vessel;

wherein said outer sheath is disposed within said blood vessel, having said at least one distal opening hole adapted to aspirate debris and said at least one proximal hole communicating with said aspiration control device;

wherein said intermediate channel slides along the exterior surface of said inner channel,

wherein said inner channel and said intermediate channel are adapted to rotate together 360°

, and

wherein said inner channel and said intermediate channel incorporate an interlocking element adapted to prevent rotation of said inner channel relative to said intermediate channel, as well as to facilitate the longitudinal movement of said inner channel.

2. The medical device of claim 1, further including at least one balloon disposed proximally to said at least one distal hole.

3. The medical device of claim 1, said distal tip further including at least perforation;

wherein said perforation is adapted to irrigate said blockage, and said proximal tip communicates via said dedicated lumen terminating at said irrigation source outside said patient'"'"'s body, and

wherein said at least one perforation is disposed distally to said at least one connection point and proximally to said attachment point and areas therebetween, said at least one perforation and said distal tip communicate by said dedicated lumen with said proximal tip to allow injection of fluid therethrough from outside said patient'"'"'s body.

4. A method for ameliorating a blockage of an artery using the device of claim 1, comprising the steps of:

(a) inflating a balloon to occlude blood flow proximally to said blockage,

(b) disrupting said blockage by mechanical maceration, and

(c) alternating irrigation and aspiration proximally to said blockage to remove liberated debris.

5. The method of claim 4, wherein said blockage is a thrombus.

6. The method of claim 4, wherein said blockage is an embolus.

7. The method of claim 4, wherein said blockage is stenosis.

8. A method for ameliorating clots in a blood vessel using the device of claim 1, comprising the steps of:

(a) inserting distal end of said device in said blood vessel;

(b) moving said device longitudinally along said blood Vessel until at least one perforation is distal to a target area, and at least one maceration element is disposed within said target area;

(c) deploying said at least one maceration element;

(d) rotating said at least one maceration element;

(e) activating fluid infusion via said at least one perforation;

(f) aspirating using outer sheath;

(g) terminating rotation of said at least one maceration element;

(h) retracting said at least one maceration element;

(i) deactivating said fluid infusion;

(j) deactivating aspiration; and

(k) withdrawing said medical device from said blood vessel.