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EP-3367929-B1 - SYSTEMS FOR THROMBECTOMY

EP3367929B1EP 3367929 B1EP3367929 B1EP 3367929B1EP-3367929-B1

Inventors

  • SHAMAY, NOAM
  • PLIS, Ronen Ariel
  • COHEN, SHAHAR

Dates

Publication Date
20260513
Application Date
20161026

Claims (14)

  1. A medical system (100) for anchoring into at least one corpus located in tubular organ, the system comprising a handling and manipulation apparatus (HMA) (102) and a corpus anchoring unit (104) operable thereby, the HMA being configured for manipulating the corpus anchoring unit into engagement with said corpus; the corpus anchoring unit (104) comprising: a deployment wire (106) defining a proximal-distal axis, at least two generally cylindrical elongated bodies (116) that are spaced apart along said deployment wire (106), each of said bodies (116) having a proximal end and a distal end and being constituted by at least one wound coiled thread in its deployment state, each of said bodies having a fixed end at either the proximal or distal end and having a free, opposite end (118) that is configured for deploying into at least one deployed state in which each of the threads unwinds in the general radial direction while tracing, during deployment, a generally helical path, and at least two axially displaceable tip tools (120), each mounted onto the deployment wire (106) and associated with the free end (118) of the bodies (116) such that axial displacement of the tip tool (120) forces the wound coiled threads to unwind into the at least one deployed state; the HMA (102) being configured to axially displace the deployment wire (106); characterized in that the threads of at least one of the cylindrical elongated bodies are coiled to permit helical unwinding movement in one rotational direction upon axial displacement of its corresponding tip tool, and the threads of at least one consecutive cylindrical body along the proximal-distal axis are coiled to permit their helical unwinding movement in an opposite rotational direction upon axial displacement of its corresponding tip tool; and each of said bodies (116) being configured to unwind at a force applied thereto upon axial displacement of the tip tool (120), said force being the same or different than that applied onto other bodies.
  2. The system of claim 1, wherein said bodies are arranged such that (i) odd bodies having free ends at respective distal ends, while even bodies having free ends at respective proximal ends, or (ii) odd bodies having free ends at respective proximal ends, while even bodies having free ends at respective distal ends.
  3. The system of claim 1 or 2, wherein (i) bodies having a distal free end are fixed to said deployment wire and bodies having a proximal free end are floating, or (ii) bodies having a proximal free end are fixed to said deployment wire and bodies having a distal free end are floating; optionally wherein fixed bodies are associated with floating tip tools, and floating bodies are associated with fixed tip tools.
  4. The system of any one of claims 1 to 3, wherein said corpus anchoring unit comprises at least one pair of said generally cylindrical elongated bodies spaced apart along said deployment wire, each of said bodies having a proximal end and a distal end, and being constituted by at least one wound coiled thread in its deployment state, a first of the pair of bodies being a proximal body with a proximal fixed end and a distal free end and a second of the pair of bodies being a distal body with a distal fixed end and a proximal free end, the free end of each body being configured for deploying into a deployed state in which each of the threads unwinds in the general radial direction while tracing, during deployment a generally helical path, and at least one pair of axially displaceable tip tools, each mounted onto the deployment wire and being associated with the body's free end, such that axial displacement of the tip tool forces the wound coiled threads of each of the pairs of bodies to unwind into said at least one deployed state.
  5. The system of claim 4, wherein unwinding of the coiled threads of said pair of bodies causes entanglement of the unwound threads of one of the bodies in the deployed state into the unwound threads of the other body of said pair in the deployed state, optionally wherein the unwound threads of said pair of bodies form a cage structure, optionally wherein the length of the first body of said pair of bodies is larger than the length of the second body of said pair of bodies.
  6. The system of any one of claims 1 to 5, wherein the tip tool is configured to simultaneously unwind all of the wound coiled threads in its associated body.
  7. The system of any one of claims 1 to 6, wherein said wound coiled threads are made of a shape-memory metal or alloy.
  8. The system of any one of claims 1 to 7, wherein the threads are dimensioned to exert a radial force of no more than 1N (in a conduit having a diameter of 2 mm) on an internal surface of the tubular organ.
  9. The system of any one of claims 1 to 8, further comprising at least one of a closed tube (130) and at least one embolic protection element selected from an occlusion balloon displaceable over the wire, a filter displaceable over the wire, and a protective sleeve.
  10. The system of any one of claims 1 to 9, wherein said tip tool (120) having an ellipsoid shape, such that the longitudinal axis of the tip tool coincides with the deployment wire, and wherein the maximal diameter of the tip tool is larger than the internal diameter of the associated body, optionally wherein at least one of the tip tools comprises a radiopaque marker.
  11. The system of any one of claims 1 to 10, wherein the external surface of at least one of the bodies is enveloped by a polymeric layer (214) along a portion of the body's length for limiting the extent of unwinding of the coiled threads.
  12. The system of any one of claims 1 to 11, wherein the tubular organ is selected from a blood vessel, fallopian tubes, urinary tract, ureter, urethra, biliary tract, bile ducts, gastrointestinal tract, airways and any other anatomical lumen.
  13. A kit for assembly of the system of any one of claims 1 to 12, the kit comprising a handling and manipulation apparatus (HMA) (102), at least one deployment wire (106), a plurality of generally cylindrical elongated bodies (116), each body being constituted by at least one shape-memory metal or alloy wound coiled thread; and a plurality of tip tools (120); optionally comprising a plurality of spacers and/or embolic protection element, optionally wherein the kit further comprises means for associating the deployment wire with (i) the HMA, (ii) the bodies, and/or (iii) the tip tools.
  14. A system of any one of claims 1 to 12 for use in removing a corpus from a tubular organ, optionally wherein the tubular organ is selected from a blood vessel, fallopian tubes, urinary tract, ureter, urethra, biliary tract, bile ducts, gastrointestinal tract, airways and any other anatomical lumen.

Description

TECHNOLOGICAL FIELD The present disclosure relates to anchoring and retrieval of a corpus in an organ of a subject, in particular narrow tubular organs such as small blood vessels. BACKGROUND ART References considered to be relevant as background to the presently disclosed subject matter are listed below: [1] Nogueira et al., AJNR 2009, 30, 649-661[2] Grunwald et al. The American Journal of Neuroradiology 2011, 32, 238-243[3] Mordasini et al. The eJournal of the European Society of minimally invasive Neurological Therapy, 2012: 1238000077[4] US 7,766,921[5] US 8,715,227[6] US 6,685,722[7] WO 2013/054324[8] Gralla et al., Am J Neuroradiol 2006, 27, 1357-1361[9] WO 2011/130256[10] Gory et al., Am J Neuroradiol 2013, 34, 2192-2198[11] Levy et al., Am J Neuroradiol 2006, 27, 2069-2072[12] WO 2009/086482[13] WO 2015/061365 Acknowledgement of the above references herein is not to be inferred as meaning that these are in any way relevant to the patentability of the presently disclosed subject matter. BACKGROUND The removal of blood clots and plaque from blood vessels by use of minimally invasive procedures is nowadays a well-established practice. A stroke event associated with a blood clot occurs as a result of disturbance in the blood vessels supplying blood to the brain, leading to sudden death of brain cells. This can be due to ischemia (lack of glucose and oxygen supply) caused by thrombosis (~80% of strokes) or due to a hemorrhage (~20% of strokes). The annual prevalence of stroke is estimated to be 15 million people worldwide and it is one of the leading causes of death (~10% of all deaths) and long-term disability. Furthermore, stroke is one of the most costly health problems in America and the Western world, with estimated direct and indirect costs of $38.6 billion annually. The majority of the damage caused by a stroke is due to secondary stroke damage which threatens the functionally of the impaired region that surrounds the infarct core; the ischemic penumbra. Early medical intervention (for re-canalization) can inhibit this process and reduce the risk for irreversible neurological damage. The goal of treatment for stroke resulting from thrombus remains the same: safe and rapid re-establishment of oxygenated blood flow to the affected tissue. Guidelines and protocols for the treatment of ischemic stroke are, for example, those published by the American Society of Neurology and the American Society of Neurosurgeons or The European Stroke Organization (ESO). More specifically, the pharmacologic standard of care for ischemic stroke patients to date is by intravenous (IV) tissue plasminogen activator (rt-PA). Improvement in re-canalization rate may be achieved when rt-PA is used intra-arterially (IA) within 6 hours of symptom onset, in patients with occlusions in a large-vessel (e.g., middle cerebral artery), or patients who have contraindications for the use of IV thrombolysis. However, this treatment may increase the risk for intracranial hemorrhage and is currently not approved for use worldwide. Beyond the failure rates of thrombolytic therapy, it is also limited in the time window for treatment and indicated population. Therefore, in patients who have either failed IV rt-PA therapy or who are either ineligible for or have contraindications to IV rt-PA use, or are out of the therapeutic window when medical support can be initiated, neurothrombectomy devices have been used for the re-establishment of blood flow. Various mechanical approaches to fragment or retrieve clots have been utilized and reported in the clinical literature. These include, inter alia, endovascular (intracranial) thrombectomy, endovascular thromboaspiration, mechanical thrombus disruption and thrombus entrapment devices [1-6]. Intracranial thrombectomy may provide rapid flow restoration with a potentially lower likelihood of clot fragmentation and distal embolism, lessens and even preclude the use of chemical thrombolytics - thus reducing the risk of neurotoxicity and intracranial hemorrhage. By avoiding the use of chemical thrombolytics, it could be possible to extend the treatment window to 8 hours and beyond. In addition, re-canalization occurs without the disruption of the blood-brain-barrier. For example, some systems are based on deployment of devices in a collapsed state, that are expanded for retrieval of the blood clot once inserted into the blood vessel [4]. Others comprise a plurality of strands, and have contracted and expanded configurations [5-7, 9]. Previously described is a method, a system, and a device for the anchoring of and into a corpus disposed distally in a conduit by engaging a stranded tube with the corpus and unwinding the wound threads of the stranded tube into unwound threads [7]. Other devices have applicability in through-out the body, including clearing of blockages within the vasculature, by addressing the factional resistance on the obstruction prior to attempting to translate and/or mobilize the obs