WO2016024235A1 - Multi-stage imaging aid (mia) - Google Patents

Multi-stage imaging aid (mia) Download PDF

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Publication number
WO2016024235A1
WO2016024235A1 PCT/IB2015/056138 IB2015056138W WO2016024235A1 WO 2016024235 A1 WO2016024235 A1 WO 2016024235A1 IB 2015056138 W IB2015056138 W IB 2015056138W WO 2016024235 A1 WO2016024235 A1 WO 2016024235A1
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WO
WIPO (PCT)
Prior art keywords
marker
marker support
deployed state
distal
proximal
Prior art date
Application number
PCT/IB2015/056138
Other languages
French (fr)
Inventor
Assaf Klein
Hadar GILBOA
Gil Hefer
Original Assignee
Medivalve Ltd.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Medivalve Ltd. filed Critical Medivalve Ltd.
Publication of WO2016024235A1 publication Critical patent/WO2016024235A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12027—Type of occlusion
    • A61B17/12031—Type of occlusion complete occlusion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
    • A61B17/12172—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure having a pre-set deployed three-dimensional shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/06—Devices, other than using radiation, for detecting or locating foreign bodies ; determining position of probes within or on the body of the patient
    • A61B5/065—Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe
    • A61B5/066—Superposing sensor position on an image of the patient, e.g. obtained by ultrasound or x-ray imaging
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4887—Locating particular structures in or on the body
    • A61B5/489—Blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6851—Guide wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0108—Steering means as part of the catheter or advancing means; Markers for positioning using radio-opaque or ultrasound markers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00778—Operations on blood vessels
    • A61B2017/00783—Valvuloplasty
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/03—Automatic limiting or abutting means, e.g. for safety
    • A61B2090/033—Abutting means, stops, e.g. abutting on tissue or skin
    • A61B2090/036—Abutting means, stops, e.g. abutting on tissue or skin abutting on tissue or skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3904—Markers, e.g. radio-opaque or breast lesions markers specially adapted for marking specified tissue
    • A61B2090/3912—Body cavities
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3966—Radiopaque markers visible in an X-ray image
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0098—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers

Definitions

  • MIA MULTI-STAGE IMAGING AID
  • Embodiments of the present invention relate to devices for imaging internal features of the body.
  • the aortic valve is located in the wall of the left ventricle at the entrance of the aorta and operates to prevent blood pumped by the left ventricle into the aorta from flowing back into the heart.
  • the aortic valve may become leaky or blocked, causing a condition known as aortic insufficiency. In such patients, replacement of the aortic valve may be recommended.
  • Transcatheter Aortic Valve Implantation is a procedure in which a patient's defective aortic valve is replaced with a prosthetic valve in a procedure using a catheter, rather than in a procedure involving sternotomy, opening the patient's chest cavity. Advantages of TAVI over sternotomy include reduced risk of medical complication and shorter recovery times.
  • a difficulty in performing TAVI is ensuring proper placement of the prosthetic valve, in the place of the defective valve. Improper placement of the prosthetic heart valve may not cure the patient's aortic valve complication, and may even cause harm to the patient by blocking proper blood flow and cause additional complications.
  • This difficulty in performing TAVI stems from the fact that heart tissue is difficult to visualize using standard imaging procedures that are typically employed to guide a surgeon in performing the procedure.
  • An aspect of an embodiment of the invention relates to providing apparatus, hereinafter referred to as a multistage imaging aid (MIA), for positioning markers that are readily imaged using a conventional medical imaging modality on a surface of an internal body tissue to aid in identifying the surface and making a location of the surface visible using the imaging modality.
  • the markers may be referred to as tissue markers, and may be held in place by a marker support.
  • An exemplary surface which may be identified using an MIA is the surface of the aortic valve and/or tissue surrounding the aortic valve.
  • Previous intracorporeal imaging aids have been described in WO 2013/153470, incorporated herein by reference.
  • Previously disclosed intracorporeal imaging aids comprised marker supports which were configured to transform from a collapsed state to a deployed state within an orifice of the human body.
  • structure of the human anatomy in some patients in which the intracorporeal imaging aid was being used would prevent transformation of the marker support from a collapsed to a deployed state.
  • the marker support would contact the inner wall of the heart while undergoing transformation and presenting a large radial diameter.
  • embodiments of the invention relate to MIA comprising a guidewire and a marker support configured to have three states: a collapsed state, a semi-deployed state and a deployed state.
  • the marker support the filaments lie within a relatively small radial distance from the axis (relative to the semi-deployed state) and may lie along the axis of the MIA, substantially parallel to the MIA.
  • the MIA may be transferred from outside of the body of a patient to inside the body of the patient via the patient' s vascular system.
  • a marker support may be transformed from a collapsed state to a semi-deployed state outside of the human body.
  • the marker support in the semi-deployed state may then be introduced into a narrow catheter which may be introduced into a human heart, without destroying the structural integrity of the marker support.
  • the marker support may then be transformed from the semi-deployed state to the deployed state inside the heart by removal of the narrow catheter.
  • a marker support comprises a distal collar at the marker support's distal end, a proximal collar at the marker support's proximal end, and a plurality of filaments connecting the proximal collar and the distal collar.
  • the filaments may each comprise a tissue marker.
  • the tissue marker may be situated on the marker support approximately mid- way along the length of the filament between the proximal and distal collars.
  • the filaments may each further comprise a weakening. In a semi-deployed state, the marker support may be radially compressed to a relatively small radial diameter (relative to the deployed in a configuration in which each filament is reversibly "folded over" at its weakening. Upon decompressing the marker support, the weakening may open such that the marker support reverts to a deployed state. The weakening may be situated approximately mid-way along the length of the filament between the proximal and distal collars.
  • MIA having a marker support in which control of configuration of the marker support may be controlled by alternate movement of a proximal collar and of a distal collar relative to a guidewire using a control tube, while the marker support is located in the human body.
  • MIA comprises a dual-clipping mechanism configured to enable multiple stages of engagement between a guidewire and a control tube.
  • the dual-clipping mechanism is configured to allow for transformation of a marker support from a deployed state to a collapsed state after use of the marker support within an internal cavity of an organism.
  • the dual-clipping mechanism may assist a user in collapsing a marker support within a patient, for example, with the heart of a patient. Upon collapse of the marker support, the MIA may be easily and quickly removed from the body of the patient.
  • each support filament is processed so that each filament may assume a loop- shape in which proximal and distal ends of the filament are located close to each other.
  • processing the filament to assume the loop deployment shape comprises annealing the filament on a suitable jig, mandrel or die that maintains the filament in the loop deployment shape during annealing and/or shape setting by heat treatment.
  • the filament is formed from a suitable shape memory or superelastic alloy treated to remember the loop deployment shape.
  • the MIA may be moved proximally toward a tissue surface inside the body to be located so that regions of loops containing tissue markers, the regions known as abutment regions, and their respective markers abut the tissue.
  • An image of at least three markers acquired using a suitable medical imaging modality may be used to locate and determine orientation of the markers, and thereby determine orientation of a plane along which the surface of the abutted tissue substantially lies.
  • an MIA may be used to determine orientation of a planar region of tissue in which the aortic valve of a patient undergoing TAVI is located. Location of the planar region may be determined with relatively small risk of a support loop lodging in a commissure of the aortic valve because the support loops of a deployed MIA lie in general, transverse to the valve commissures.
  • the marker support may further comprise a proximal deployment marker at its proximal end (either on a filament portion or on a collar) and a distal deployment marker at its distal end (either on a filament portion or on a collar.)
  • the distance between the proximal marker and distal marker may be identified using an imaging modality to determine if the marker support is in a deployed state or in a collapsed state.
  • relative motion between proximal marker and distal marker may be identified using an imaging modality to determine if the marker support is properly placed against a surface of an internal body tissue.
  • a packaged MIA is provided.
  • the MIA can be maintained in the semi-deployed state during packaging and shipping using a configuration tube so that the MIA can be employed upon removal from packaging and inserted into a catheter hub, without first transforming the MIA to another state.
  • Fig. 1A depicts an exploded view of an MIA in a collapsed, dissembled configuration according to embodiments of the invention
  • Fig. IB depicts an MIA in a semi-deployed configuration according to embodiments of the invention
  • FIG. 1C depicts an MIA in a deployed configuration according to embodiments of the invention
  • Fig. ID depicts an MIA in a deployed configuration according to embodiments of the invention
  • Fig. IE depicts an MIA in a deployed configuration according to embodiments of the invention
  • FIGs. 2A-2F depict geometries of weakening segments of marker supports according to embodiments of the invention.
  • FIGs. 3A-3B depict clipping mechanisms in open (3A) and closed (3B) configurations according to embodiments of the invention
  • FIGs. 4A-4B depict clipping mechanisms in open (4 A) and closed (4B) configurations according to embodiments of the invention.
  • Figs. 5A-5B depict a packaged MIA according to embodiments of the invention.
  • MIAs according to embodiments of the invention are useful in imaging a patient's aortic valve and in aiding in replacement thereof. MIAs according to embodiments of the invention may be used to aid in medical procedures performed in a minimally invasive manner, obviating the need for large incisions.
  • cardiovascular structures such as vessels, arteries, veins, branches, occlusions, blockages, chambers and valves may be visualized.
  • Gastrointestinal structures such as the throat, esophagus, stomach, duodenum, intestines, colon and blockages therein may also be visualized.
  • Pulmonary structures such as trachea, bronchi and thorax may also be visualized.
  • Uro-gynecological structures such as the ureter, bladder, cervix, uterus, fallopian tubes and blockages may also be visualized.
  • prosthetic valves In addition to prosthetic valves, other medical devices may be positioned with devices according to embodiments of the invention including but not limited to, stents, catheters, balloon catheters, pace makers, radioactive medicines, therapeutics, cameras, laparoscopes and endoscopes.
  • MIAs according to embodiments of the invention may be used to direct laparoscopic or endoscopic surgery or to visualize target anatomical structures with directed energy therapies such as radiation therapy.
  • distal refers to a direction away from the opening in the body along the axis of a guidewire or catheter used to insert the MIA.
  • proximal refers to a direction towards the opening in the body along the axis of a guidewire or catheter.
  • FIG. 1A depicts an MIA 10 in a collapsed, partially dissembled configuration.
  • MIA 10 comprises a guidewire 12, a control tube 14, a marker support 18 and a fastener 40.
  • Marker support 18 may comprise a distal end 32 and a proximal end 20.
  • Marker support may comprise filaments 22, which are each connected to distal end 32 and a proximal end 20.
  • marker support 18 comprises 3 filaments 22.
  • Marker support may comprise tissue markers 24, weakenings 30, distal marker 28 and proximal marker 26.
  • Guidewire 12 may have a protective covering 62 near its distal end and is shaped to form a loop 60 at its distal end.
  • Guidewire 12 may comprise a distal lock 50 having a female connector
  • Fastener 40 is configured to be slidably attached to guidewire 12.
  • Fastener 40 comprises a distal connector 46 at its distal end and a proximal connector 44 at its proximal end.
  • Control tube 14 is configured to be slidably attached to guidewire 12, external to guidewire 12.
  • Control tube 14 may comprise a thickening 15 near its distal end and a distal connector 42 at its distal end.
  • Marker support 18 may be configured to be external to guidewire 12 and fused at its distal end 32 to fastener 40. Marker support 18, at its proximal end 20 may be external to control tube 14. Marker support 18 may be slidably attached at its proximal end 20 to control tube 14 at a section of control tube 14 proximal relative to thickening 15.
  • Distal connector 46 and female connector 52 may be a male/ female clipping system which may, upon application of force, be engaged or disengaged. Although distal connector 46 is pictured as having a male configuration and female connector 52 is pictured as having a female configuration, these configurations may be reversed.
  • Distal connector 42 and proximal connector 44 may be a male/ female clipping system which may, upon application of force, be engaged or disengaged. Although distal connector 42 is pictured as having a female configuration and proximal connector 44 is pictured as having a male configuration, this configuration may be reversed.
  • Marker support 18 may be formed from metals such as stainless steel, shape memory alloys, superelastic alloys, titanium alloys, surgical steel, zirconium alloys, niobium alloys, tantalum alloys, polymers or other flexible and medically safe materials. According to an embodiment of the invention, marker support 18 is made from a nickel-titanium alloy. Marker support 18 may be formed, for example by cutting filaments using laser cutting techniques or by using wires or filaments optionally attached to collars. Marker support 18 may be shaped in its deployed position (shown in figure 1C) by shape setting in its deployed position. After being collapsed, marker support 18 may revert to its deployed position upon release of tension between distal and proximal ends of marker support 18 or by pushing proximal end and distal end towards each other.
  • metals such as stainless steel, shape memory alloys, superelastic alloys, titanium alloys, surgical steel, zirconium alloys, niobium alloys, tantalum alloys, polymers or other flexible
  • marker support 18 is shaped, for example by annealing, in a manner that each filament comprises a single strand deformed to a position capable of forming a loop comprising an abutment region, which may be located at the proximal end of marker support 18 when it is in deployed configuration.
  • Tissue marker 24, distal marker 28 and proximal marker 26 may all be formed from a radio-opaque material, preferably material which is easily discernible from native human tissue when using imaging techniques such as fluoroscopy, computed tomography (CT), ultrasound, magnetic resonance imaging (MRI), positron emission tomography (PET).
  • CT computed tomography
  • MRI magnetic resonance imaging
  • PET positron emission tomography
  • a marker may be formed from stainless steel, ceramic, titanium alloy, tungsten, zirconium, silver, platinum, tantalum or gold.
  • Marker 24 may be located, as in Fig. 1 A collapsed configuration, midway between distal end 32 and proximal end 20 of marker support 18.
  • Weakening 30 may be located, as in Fig. 1A slightly proximal to marker 24 on each filament 22.
  • weakening 20 may be located slightly distal relative to marker 24 on each filament 22.
  • marker 24 in a collapsed configuration, may be located at between about 40% and 60% of the length between proximal end 20 and distal end 32 of marker support.
  • weakening 30 in a collapsed configuration, may be located at between about 30% and 70% of the length between proximal end 20 and distal end 32 of marker support.
  • Guide wire 12 and control tube 14 may be formed using guide wires and control tubes known in the art.
  • loop 60 may have a curved tip to allow for positioning in the left ventricle without puncturing heart tissue.
  • loop 60 may be coated with a protective coating 62, for example, a coated wire, to prevent puncturing of heart tissue. Positioning of loop 60 in the left ventricle limits further movement of guidewire 12 in the distal direction.
  • FIG. IB depicts MIA 10 in an assembled semi-deployed state, inside a catheter 16.
  • transition of marker support 18 from a collapsed position in which marker support filaments are parallel to axis of MIA 10, as shown in Fig. 1A to a semi-deployed state as shown in Fig. IB can be made by moving distal end 32 and proximal end 20 of marker support 18 closer to each other. This movement causes loops to be formed by filaments 22. Each filament folds at weakening 30.
  • Marker support 18, along with guidewire 12 and control tube 14 may be introduced into catheter 16.
  • MIA 10 may be introduced into a human body through catheter 16 in a position as shown in Fig. IB.
  • Fig. IB MIA 10 is shown in a position in which proximal connector 44 of fastener 40 is engaged with distal connector 42 of control tube 14. Distal end 32 of marker support 18 is shown fused to fastener 40. Movement of control tube 14 in either the proximal or the distal direction relative to guidewire 12 within catheter 16 will move semi-deployed marker support 18 in the same direction as control tube 14.
  • MIA 10 may be advanced from outside the body to a relevant organ within the body such as the left ventricle for performance of a procedure involving visualization techniques, by introduction into a catheter 16 and by simultaneously advancing control tube 14 and guidewire 12 in the distal direction through the catheter.
  • MIA 10 Once MIA 10 has been advanced to the relevant organ, catheter 16 may be removed while maintaining control tube 14 and guidewire 12 in the same position while pulling proximally on catheter 16. Upon removal of catheter 16, MIA 10 may revert to a deployed state, as shown in Fig. 1C. [0054] Fig. 1C depicts MIA 10 in a deployed state. Once catheter 16 is removed, or after advancing the control tube, if needed, loops formed by filaments 22 of marker support 18 move in the radial direction away from the guidewire, as marker support 18 has been shaped to assume deployment shape as described above. In the deployed state, marker support 18 is ready for operation in a visualization technique.
  • MIA 10 is used in TAVI.
  • Guidewire 12 may be advanced to the point that loop 60 is lodged in the left ventricle of the heart and can no longer move in the distal direction.
  • marker support 18 transforms from the semi-deployed state to the deployed state in the orifice of the left ventricle, so that each loop is pointed generally in the proximal direction.
  • the tissue markers 24 are in a position in which they may be moved in the proximal direction to abut the aortic valve.
  • loops of marker support 18 have been formed outside of the body and compressed into a relatively narrow catheter having an internal diameter of about 0.5-12mm, preferably between about 0.9 and about 3mm, the loops maintain their structural integrity and revert to their position in the loop deployment shape as shown in Fig. 1C upon removal from catheter 16. Maintaining structural integrity of the loops assists the loops in proper positioning of tissue markers 24 and proper functioning of marker support 24. Maintaining structural integrity of the loops can be attributed to weakening 30.
  • marker support 18 Once marker support 18 has been deployed as in Fig. 1C, it may be positioned against aortic valve. Loops formed by filaments are substantially pointed in a substantially proximal direction. Marker support 18 may be positioned against aortic valve by moving control tube 14 proximally relative to guidewire 12. A medical practitioner may realize that marker support 18 is properly positioned, for example, through feeling increased resistance while moving control tube 14 proximally when abutment region of marker support 18 abuts against aortic valve.
  • proper placement of marker support 18 may be verified by an imaging modality to determine if distance between the proximal marker 26 and distal marker 28 corresponds to a predetermined distance associated between the markers in deployed state.
  • Proper placement of marker support 18 may be verified by imaging relative motion of proximal marker 26 in the direction of distal marker 28 upon gentle pulling of control tube 14 in the proximal direction, thereby slightly compressing marker support 18.
  • distal motion for example, by release of control tube 14, and allowing marker support 18 to spring back in the distal direction, proximal marker 26 moves away from distal marker 28.
  • TAVI Upon verification of proper positioning of marker support using imaging techniques such as fluoroscopy, CT, ultrasound, MRI and/or PET, TAVI may be performed. After performance of TAVI or another procedure, MIA 10 may be removed from the body.
  • marker support 18 is straightened to a collapsed configuration before MIA 10 is removed from the body.
  • Marker support may be straightened by pushing control tube 14 in the distal direction relative to guide wire 12, thereby sliding fastener 40 in the distal direction on guidewire 12 and thereby bringing distal connector 46 of fastener 40 closer to female connector 52 of distal lock 50.
  • Distal connector 46 may engage female connector 52 by application of force in the distal direction on control tube 14 (or alternatively, application of force by pulling guidewire 12 in the proximal direction.)
  • the engagement may be done in a protecting sleeve in order to prevent entrapment of biological tissue between the male and female conectors thereby preventing engagement. Further detail of protecting sleeves according to embodiments of the invention is provided below in connection to figs 3 A, 3B, 4A and 4B.
  • control tube 14 may be pulled in the proximal direction relative to guidewire 12. This motion may disengage proximal connector 44 of fastener 40 from distal connector 42 of control tube 14.
  • MIA 10 may be configured so that the force required to disengage distal connector 46 from female connector 52 is greater than the force required to disengage proximal connector 44 from distal connector 42. As a result, an operator of MIA 10 may apply an amount of force that may selectively disengage proximal connector 44 from distal connector 42 without disengaging distal connector 46 from female connector 52.
  • one or more of the connecting elements of distal connector 46 and female connector 52 may be configured to disengage upon providing a force along an axis other than the axis of guidewire 12.
  • distal connector 46 and female connector 52 may engage upon providing force on control tube 14 relative to guidewire 12, but may be configured to disengage only upon rotation of control tube 14 relative to guidewire 12.
  • pulling on control tube 14 relative to guidewire 12 may disengage proximal connector 44 from distal connector 42.
  • control tube 14 After disengaging proximal connector 44 from distal connector 42 by movement of control tube 14 proximally relative to guidewire 12, control tube 14 is free to slide proximally. As control tube 14 moves proximally relative to guidewire 12, thickening 15 contacts proximal end 20 of marker support. As control tube 14 continues to move proximally, since thickening 15 has a larger diameter than proximal end 20, thickening 15 moves proximal end 20 in the proximal direction, thereby changing the configuration of marker support 18 and straightening loops formed by filaments 22.
  • thickening 15 pulls proximal end 20 away from distal end 32 (which is connected to fastener 40, which is attached to guidewire 12 via distal connector 46 and female connector 52) thereby reverting marker support 18 to its straightened, collapsed configuration.
  • Configuration of marker support 18 in its straightened, collapsed configuration may be verified by using imaging to determine position or relative position of any of the markers on marker support 18.
  • guidewire 12 and control tube 14 may be removed together from the body, optionally through a catheter external to guidewire 12 and control tube 14.
  • Embodiments of the invention described in the figures show MIAs comprising marker supports comprising 3 filaments and 3 loop-like structures. Further embodiments of the invention comprise marker supports having 4, 5, 6, 7 or 8 filaments or 4, 5, 6, 7 or 8 loop-like structures which extend to abut a surface of an internal body tissue.
  • MIA may be removed from the body without reverting to collapsed position as described above.
  • MIA 10 as depicted in Fig. 1C may be removed from the body by introduction of a catheter (not shown in figures) external to MIA 10, having an internal diameter smaller than the diameter of deployed marker support 18.
  • MIA 10 may be removed by forcefully pulling guidewire 12 and control tube 14 simultaneously in the proximal direction relative to the catheter, or pushing the catheter.
  • the distal end of the catheter may force the loops formed by filaments 22 in the distal direction. Loops may bend upon compression during insertion into the catheter. Loops may bend at weakening 30 or at other locations along loops, as structural integrity of marker support 18 need not be maintained after removal from body, if marker support 18 is configured to be a single-use apparatus.
  • Fig. ID discloses an MIA 11 according to an embodiment of the invention.
  • MIA 11 comprises a marker support 19, a guidewire 12 and a control tube 14.
  • Fig. ID shows MIA 11 in its deployed configuration.
  • Marker support 19 may comprise a distal end 32 and a proximal end 20.
  • Marker support may comprise filaments 22, which are each connected to distal end 32 and a proximal end 20.
  • marker support 18 comprises 3 filaments 22.
  • Marker support may comprise tissue markers 24, weakenings 30, distal marker 28 and proximal marker 26.
  • distal end 32 may be fused to control tube 14 and proximal end 26 may be slidable on and external to control tube 14.
  • Marker support 19 may further comprise struts 80. Upon transition between various configurations, struts 80 keep the structural stability and ensure proper formation of loops formed by filaments 22. Struts 80 may be connected to each filament 22 at about one third of the length of each filament from the filament proximal and distal ends.
  • Marker support 19 at proximal end 20 comprises connector 70.
  • MIA 11 further comprises removal tube 68, comprising distal connector 72 at the distal end of removal tube 68.
  • Removal tube 68 is configured to be external to and slidable on control tube 14.
  • Distal connector 72 is configured to removably interconnect with connector 70.
  • one of distal connector 72 and connector 70 may have male configuration and the other may have a compatible interlocking female configuration.
  • MIA 11 Before introduction into a body of a patient, MIA 11 may be transformed from its collapsed configuration to a semi-deployed configuration (both not shown in figures) and inserted into a catheter. MIA 11 may enter the human body via a catheter in a semi-deployed configuration in which marker support 19 filaments 22 are bent at weakening 30, similar to the configuration of marker support 18 in Fig. IB.
  • marker support 19 may be positioned against aortic valve. Loops formed by filaments 22 are substantially are pointed in a substantially proximal direction. Marker support 19 may be positioned against aortic valve by moving control tube 14 proximally relative to guidewire 12. A medical practitioner may realize that marker support 18 is properly positioned, for example, through feeling increased resistance while moving control tube 14 proximally when abutment region of marker support 18 abuts against an aortic valve.
  • proper deployment of marker support 19 may be verified by an imaging modality to determine if distance between the proximal marker 26 and distal marker 28 corresponds to a predetermined distance associated between the markers in deployed state.
  • TAVI may be performed. After performance of TAVI or another procedure, MIA 11 may be removed from the body.
  • MIA 11 may be removed from the body with the assistance of removal tube 68 as follows: Distal connector 72 of removal tube 68 may engage and connect to connector 70 of marker support 19 by distal motion of removal tube 68 relative to control tube 14. After connection of connector 70 to distal connector 72, removal tube may be moved proximally relative to control tube 14, thereby sliding proximal end 20 in the proximal direction, thereby straightening loops formed by filaments 22 and reverting marker support 19 to its collapsed configuration. Upon collapsing marker support 19 to collapsed configuration, MIA 11 may be removed from the body, for example, by simultaneously moving control tube 14 and removal tube 68 in the proximal direction.
  • Fig. IE discloses an MIA 13 according to an embodiment of the invention.
  • MIA 13 comprises a marker support 21, a guide wire 12 and a control tube 14.
  • Fig. IE shows MIA 13 in its deployed configuration.
  • Marker support 21 may further comprise struts 81 and struts 83. Upon transition between various configurations, struts 81 and 83 keep the structural stability and ensure proper formation of loops formed by filaments 22. .
  • Struts 81 may be connected to each filament 22 at about one third of the length of each filament from the filament proximal and distal ends.
  • Struts 83 may be connected to each filament 22 at about two thirds of the length of each filament from the filament proximal and distal ends.
  • marker supports may comprise 2, 3, 4, or 5 struts to provide structural stability and ensure proper loop formation.
  • Figs. 2A-2F depict sections of marker supports of MIAs according to embodiments of the invention. These sections each comprise weakenings at which marker support filaments may bend or fold while MIA is in a semi-deployed configuration. Filaments, according to embodiments of the invention, may be ribbon-like in structure, having a larger width than thickness along the filament.
  • Fig. 2 A depicts a filament weakening 110 comprising a filament 112, an aperture 114 and folding region 118.
  • the figure depicts filament weakening 110 in a plan view, looking down upon the length and width of a section of the filament.
  • Fig. 2B depicts a plan view of a filament weakening 120 comprising a filament 112, an indentation 124 and a folding region 128.
  • Fig. 2C depicts a filament weakening 130 comprising a filament 132, an indentation 134 and a folding region 138.
  • Fig. 2C depicts a filament in an edge-on view, showing the thickness of the filament.
  • the loop Upon applying a compression force on a loop of a marker support in a deployed state comprising filament weakening 130, the loop tends to bend at filament weakening 130 rather than at a location of the loop without a weakening.
  • the loop Upon removal of the compression force, the loop reverts back to its shape prior to compression.
  • Fig. 2D depicts an edge-on view of a filament weakening 140 comprising a filament 142, an indentation 144 and a folding region 148.
  • Fig. 2E depicts a plan view of a filament weakening 150 comprising a filament 152, an aperture 154, an indentation 156 and a folding region 158.
  • the asymmetrical geometry allows the marker support to maintin its structural integrity after being folded inside a catheter with a small internal diameter, in its semi-deployed configuration
  • Fig. 2F depicts a plan view of a filament weakening 160 comprising a filament 162, an aperture 164, an aperture 166 and a folding region 168.
  • the geometry of 168 also provide high elasticity to tortion and to bending in the orthogonal direction.
  • filament weakenings are depicted as filaments comprising apertures, indentations or combinations thereof.
  • a filament weakening comprises a region in which filament material is substituted with an alternate material having a different level of flexibility than the filament material.
  • FIGs. 3 A and 3B shows a clipping mechanism 200.
  • Clipping mechanism 200 may be used in MIAs according to embodiments of the invention.
  • Clipping mechanism 200 comprises a sleeve 202 having a distal end 204 and an opening 206.
  • Clipping mechanism 200 may comprise a male connector 208, a female connector 210, a guidewire 212, marker support 214 and a distal lock 216.
  • Marker support 214 may be fused to male connector 208, and together may be slidable along guidewire 212.
  • Distal lock 216 may comprise a female connector 210.
  • Sleeve 202 may be fused at its distal end 204 to distal lock 216.
  • male connector 208 Upon operation of clipping mechanism 200, male connector 208 is moved towards female connector 210 by sliding on guidewire 212. Distal end then enters opening 206 of sleeve 202. Upon further motion of male connector 208 towards female connector 210, the connectors engage eachother as shown in Fig. 3B. Protective sleeve 202 prevents human tissue from preventing engagement by preventing human tissue from entering into clipping mechanism.
  • Figs. 4A and 4B show a clipping mechanism 220.
  • Clipping mechanism 220 may be used in MIAs according to embodiments of the invention.
  • Clipping mechanism 220 comprises a sleeve 222, a male connector 224, a guidewire 240 and a distal lock 250.
  • Sleeve 222 may comprise a band 230.
  • Male connector 224 may comprise a groove 226 and a head 228.
  • Male connector 224 may be slidable on guidewire 240.
  • male connector 224 may slide distally along guidewire 240, thereby causing head 228 to enter sleeve 222.
  • Band 230 is configured to encompass guidewire 240. Upon further motion of male connector 224 along guidewire 240, band 230 is moved radially away from guidewire 240 by tapered head 228. Upon further motion of male connector 224 along guidewire 240, band 230 reverts to prior position as it engages groove 226 as shown in figure 4B.
  • Band 230 may comprise an elastic material which reverts to its original position when slightly moved radially.
  • Figure 4B shows male connector 224 engaged with distal lock 250.
  • Figs. 5A and 5B show a packaged MIA 300 according to embodiments of the invention.
  • Packaged MIA 300 comprises a packaging tube 302 and a configuration tube 304.
  • Packaged MIA 300 further comprises a MIA 10 contained within packaging tube 302.
  • MIA 10 may be configured having elements as shown in Figs. 1 A-ID.
  • MIA 10 comprises a control tube 14, a protective covering 62 and a marker support 18.
  • MIA 10 may be assembled and configured in the deployed position, then subsequently contracted in the radial direction to present in the semi-deployed position. MIA 10 may then be introduced into configuration tube 304. Configuration tube 304 may be configured to encompass a distal section of MIA 10, the distal section comprising marker support 18, and optionally also comprising protective covering 62 and control tube 14. MIA 10, once partially enclosed by configuration tube 304 may be introduced into packaging tube 302 as shown in Fig. 5A. Packaging tube 302 may provide protection during shipping to ensure maintenance of structural integrity of MIA 10.
  • MIA 10 Prior to use, MIA 10 may be removed from packaging tube 302 while maintaining configuration tube 304 in place, enclosing distal end of MIA 10, as shown in fig. 5B.
  • Configuration tube 304 may be configured to have a diameter narrower than a catheter hub 310. Distal end of configuration tube 304 may be inserted into catheter hub 310.
  • MIA 10 may then be introduced to a catheter 312 via catheter hub 310 by pushing MIA 10 distally relative to catheter hub 310.
  • Catheter 312 may be introduced into a body cavity of a patient prior to introduction of MIA 10 into catheter 312.
  • MIA 10 can be maintained so that marker support 18 remains in the semi-deployed state during packaging and shipping using a configuration tube so that the MIA can be employed upon removal from packaging and inserted into a catheter hub, without first transforming MIA 10 to another state.
  • an apparatus for determining a location of a surface of an internal organ of a body comprising: a marker support having a proximal end, a distal end and an axis, the marker support having a collapsed state, a semi-deployed state and a deployed state, the marker support comprising: a plurality of filaments, each having at least one tissue marker and at least one weakening, in which in the collapsed state the filaments lie within a relatively small radial distance from the axis and which, upon transformation to the deployed state, each filament forms a loop, and which, upon compression of the loop in the direction of the axis to enter the semi-deployed state having a smaller radial diameter than in the deployed state, each loop folds at its weakening, and which, upon release of the compression of the loop, each loop moves radially outward from the axis to the deployed state.
  • each weakening is located approximately between 30% and 70% of the length between the proximal end and distal end of each filament.
  • the weakening comprises an aperture in the filament.
  • the weakening comprises an indentation in the filament.
  • the tissue markers define abutment regions configured to be located proximal to the distal and proximal ends of the marker support when the marker support is in a semi-deployed and deployed state.
  • the plurality of filaments comprises 3 filaments.
  • the apparatus further comprises a guidewire and a control tube.
  • the distal end of the marker support is attached to a connector element, the connector element being slidable on the guidewire.
  • the connector element can be removably linked to the guidewire.
  • connector element can be removably linked to the control tube.
  • the proximal end of the marker support is slidably attached to and external to the control tube.
  • the removable link can be formed between a male connector and a female connector.
  • the amount of force required to detach the connector element from the control tube is different than the amount of force required to detach the connector element from the guidewire.
  • the direction of force required to detach the connector element from the control tube is different than the direction of force required to detach the connector element from the guidewire.
  • the apparatus further comprises a thickening towards the distal end of the control tube.
  • the thickening upon movement in the proximal direction relative to the guidewire, engages the proximal end of the marker support and upon further movement in the proximal direction, transforms the marker support from a deployed state to a collapsed state.
  • the apparatus further comprises support struts connecting between filaments of the marker support.
  • the marker support distal end is attached to the distal end of the control tube and the marker support proximal end is slidably attached to the control tube.
  • the apparatus further comprises a removal tube, external to and slidable on the control tube.
  • the distal end of the removal tube is removably linked to the proximal end of the marker support.
  • the apparatus further comprises a sleeve having an opening through which a connector may enter to engage the other connector.
  • a system comprising: the aforementioned apparatus; and a first tube encompassing a distal section of the apparatus and maintaining the apparatus in a semi-deployed state.
  • the tube encompasses a distal section of the apparatus comprising the marker support.
  • the system further comprises a second tube encompassing the first tube and the apparatus.
  • a method for the manufacture of a marker support for determining a location of a surface of an internal organ of a body comprising: forming a marker support having a proximal end, a distal end and an axis, the marker support having a collapsed state, a semi-deployed state and a deployed state, the marker support comprising: a plurality of filaments, each having at least one tissue marker; transforming the marker from a collapsed state, in which in the collapsed state the filaments lie within a relatively small radial distance from the axis to a to a deployed state in which each filament forms a loop, by moving the proximal and distal ends closer to each other; and further transforming the marker from a deployed state to a semi-deployed state by compression of the loop in the direction of the axis to enter the semi-deployed state having a smaller radial diameter than in the deployed state.
  • the filaments each having at least one tissue marker
  • each of the verbs, "comprise,” “include” and “have,” and conjugates thereof, are used to indicate that the object or objects of the verb are not necessarily a complete listing of components, elements or parts of the subject or subjects of the verb.

Abstract

Embodiments of the invention relate to a multi-stage imaging aid comprising a guidewire and a marker support configured to have three states: a collapsed state, a semi-deployed state and a deployed state. In the semi-deployed state, the MIA may be transferred from outside of the body of a patient to inside the body of the patient via the patient's vascular system. For example, a marker support may be transformed from a collapsed state to a semi-deployed state outside of the human body. The marker support in the semi-deployed state may then be introduced into a narrow catheter which may be introduced into a human heart, without destroying the structural integrity of the marker support. The marker support may then be transformed from the semi-deployed state to the deployed state inside the heart by removal of the narrow catheter.

Description

MULTI-STAGE IMAGING AID (MIA)
RELATED APPLICATIONS
[0001] The present application claims the benefit under 35 U.S.C. 119(e) of U.S. Provisional Application 62/036,124 filed on August 12, 2014, the disclosure of which is incorporated herein by reference.
TECHNICAL FIELD
[0002] Embodiments of the present invention relate to devices for imaging internal features of the body.
BACKGROUND
[0003] The aortic valve is located in the wall of the left ventricle at the entrance of the aorta and operates to prevent blood pumped by the left ventricle into the aorta from flowing back into the heart. The aortic valve may become leaky or blocked, causing a condition known as aortic insufficiency. In such patients, replacement of the aortic valve may be recommended. Transcatheter Aortic Valve Implantation (TAVI) is a procedure in which a patient's defective aortic valve is replaced with a prosthetic valve in a procedure using a catheter, rather than in a procedure involving sternotomy, opening the patient's chest cavity. Advantages of TAVI over sternotomy include reduced risk of medical complication and shorter recovery times.
[0004] A difficulty in performing TAVI is ensuring proper placement of the prosthetic valve, in the place of the defective valve. Improper placement of the prosthetic heart valve may not cure the patient's aortic valve complication, and may even cause harm to the patient by blocking proper blood flow and cause additional complications. This difficulty in performing TAVI stems from the fact that heart tissue is difficult to visualize using standard imaging procedures that are typically employed to guide a surgeon in performing the procedure.
SUMMARY
[0005] An aspect of an embodiment of the invention relates to providing apparatus, hereinafter referred to as a multistage imaging aid (MIA), for positioning markers that are readily imaged using a conventional medical imaging modality on a surface of an internal body tissue to aid in identifying the surface and making a location of the surface visible using the imaging modality. The markers may be referred to as tissue markers, and may be held in place by a marker support. An exemplary surface which may be identified using an MIA is the surface of the aortic valve and/or tissue surrounding the aortic valve.
[0006] Previous intracorporeal imaging aids have been described in WO 2013/153470, incorporated herein by reference. Previously disclosed intracorporeal imaging aids comprised marker supports which were configured to transform from a collapsed state to a deployed state within an orifice of the human body. In some instances, there was concern that structure of the human anatomy in some patients in which the intracorporeal imaging aid was being used would prevent transformation of the marker support from a collapsed to a deployed state. For example, after being introduced into a heart of a human patient, there was concern that the marker support would contact the inner wall of the heart while undergoing transformation and presenting a large radial diameter. Contacting the inner wall of the heart may prevent accurate transformation from the collapsed state to the deployed state, potentially rendering the marker support unusable. Transformation of the marker support from a collapsed state to the deployed state outside the human body and subsequent introduction into the heart would not be possible, because introduction of a deployed marker support into a catheter suitable (having a narrow diameter) for introduction into a human heart via a patient's vascular system would destroy the structural integrity of the marker support.
[0007] Accordingly, embodiments of the invention relate to MIA comprising a guidewire and a marker support configured to have three states: a collapsed state, a semi-deployed state and a deployed state. In the collapsed state, the marker support the filaments lie within a relatively small radial distance from the axis (relative to the semi-deployed state) and may lie along the axis of the MIA, substantially parallel to the MIA. In the semi-deployed state, the MIA may be transferred from outside of the body of a patient to inside the body of the patient via the patient' s vascular system. For example, a marker support may be transformed from a collapsed state to a semi-deployed state outside of the human body. The marker support in the semi-deployed state may then be introduced into a narrow catheter which may be introduced into a human heart, without destroying the structural integrity of the marker support. The marker support may then be transformed from the semi-deployed state to the deployed state inside the heart by removal of the narrow catheter.
[0008] According to an embodiment of the invention, a marker support comprises a distal collar at the marker support's distal end, a proximal collar at the marker support's proximal end, and a plurality of filaments connecting the proximal collar and the distal collar. The filaments may each comprise a tissue marker. The tissue marker may be situated on the marker support approximately mid- way along the length of the filament between the proximal and distal collars. The filaments may each further comprise a weakening. In a semi-deployed state, the marker support may be radially compressed to a relatively small radial diameter (relative to the deployed in a configuration in which each filament is reversibly "folded over" at its weakening. Upon decompressing the marker support, the weakening may open such that the marker support reverts to a deployed state. The weakening may be situated approximately mid-way along the length of the filament between the proximal and distal collars.
[0009] Further embodiments of the invention relate to an MIA having a marker support in which control of configuration of the marker support may be controlled by alternate movement of a proximal collar and of a distal collar relative to a guidewire using a control tube, while the marker support is located in the human body. According to an embodiment of the invention, MIA comprises a dual-clipping mechanism configured to enable multiple stages of engagement between a guidewire and a control tube. The dual-clipping mechanism is configured to allow for transformation of a marker support from a deployed state to a collapsed state after use of the marker support within an internal cavity of an organism. According to embodiments of the invention, the dual-clipping mechanism may assist a user in collapsing a marker support within a patient, for example, with the heart of a patient. Upon collapse of the marker support, the MIA may be easily and quickly removed from the body of the patient.
[0010] In an embodiment of the invention, each support filament is processed so that each filament may assume a loop- shape in which proximal and distal ends of the filament are located close to each other. Upon bringing the proximal and distal ends of the MIA within the deployment distance of each other, the filament naturally assumes a loop deployment shape. Optionally, processing the filament to assume the loop deployment shape comprises annealing the filament on a suitable jig, mandrel or die that maintains the filament in the loop deployment shape during annealing and/or shape setting by heat treatment. In some embodiments of the invention, the filament is formed from a suitable shape memory or superelastic alloy treated to remember the loop deployment shape.
[0011] In the deployed state inside the body the MIA may be moved proximally toward a tissue surface inside the body to be located so that regions of loops containing tissue markers, the regions known as abutment regions, and their respective markers abut the tissue. An image of at least three markers acquired using a suitable medical imaging modality may be used to locate and determine orientation of the markers, and thereby determine orientation of a plane along which the surface of the abutted tissue substantially lies.
[0012] In an embodiment of the invention an MIA may be used to determine orientation of a planar region of tissue in which the aortic valve of a patient undergoing TAVI is located. Location of the planar region may be determined with relatively small risk of a support loop lodging in a commissure of the aortic valve because the support loops of a deployed MIA lie in general, transverse to the valve commissures.
[0013] According to an embodiment of the invention, the marker support may further comprise a proximal deployment marker at its proximal end (either on a filament portion or on a collar) and a distal deployment marker at its distal end (either on a filament portion or on a collar.) The distance between the proximal marker and distal marker may be identified using an imaging modality to determine if the marker support is in a deployed state or in a collapsed state.
[0014] According to an embodiment of the invention, relative motion between proximal marker and distal marker may be identified using an imaging modality to determine if the marker support is properly placed against a surface of an internal body tissue.
[0015] According to an embodiment of the invention, a packaged MIA is provided. The MIA can be maintained in the semi-deployed state during packaging and shipping using a configuration tube so that the MIA can be employed upon removal from packaging and inserted into a catheter hub, without first transforming the MIA to another state.
[0016] In the discussion unless otherwise stated, adjectives such as "substantially" and "about" modifying a condition or relationship characteristic of a feature or features of an embodiment of the invention, are understood to mean that the condition or characteristic is defined to within tolerances that are acceptable for operation of the embodiment for an application for which it is intended. Unless otherwise indicated, the word "or" in the specification and claims is considered to be the inclusive "or" rather than the exclusive or, and indicates at least one of, or any combination of items it conjoins.
[0017] This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter.
BRIEF DESCRIPTION OF FIGURES
[0018] Non-limiting examples of embodiments of the invention are described below with reference to figures attached hereto that are listed following this paragraph. Identical structures, elements or parts that appear in more than one figure are generally labeled with a same numeral in all the figures in which they appear. Dimensions of components and features shown in the figures are chosen for convenience and clarity of presentation and are not necessarily shown to scale.
[0019] Fig. 1A depicts an exploded view of an MIA in a collapsed, dissembled configuration according to embodiments of the invention;
[0020] Fig. IB depicts an MIA in a semi-deployed configuration according to embodiments of the invention;
[0021] Fig. 1C depicts an MIA in a deployed configuration according to embodiments of the invention;
[0022] Fig. ID depicts an MIA in a deployed configuration according to embodiments of the invention;
[0023] Fig. IE depicts an MIA in a deployed configuration according to embodiments of the invention;
[0024] Figs. 2A-2F depict geometries of weakening segments of marker supports according to embodiments of the invention;
[0025] Figs. 3A-3B depict clipping mechanisms in open (3A) and closed (3B) configurations according to embodiments of the invention;
[0026] Figs. 4A-4B depict clipping mechanisms in open (4 A) and closed (4B) configurations according to embodiments of the invention; and
[0027] Figs. 5A-5B depict a packaged MIA according to embodiments of the invention.
DETAILED DESCRIPTION
[0028] As mentioned above, MIAs according to embodiments of the invention are useful in imaging a patient's aortic valve and in aiding in replacement thereof. MIAs according to embodiments of the invention may be used to aid in medical procedures performed in a minimally invasive manner, obviating the need for large incisions.
[0029] In addition to imaging the aortic valve, various other imaging procedures may be performed using MIAs according to embodiments of the invention. For example, cardiovascular structures such as vessels, arteries, veins, branches, occlusions, blockages, chambers and valves may be visualized. Gastrointestinal structures such as the throat, esophagus, stomach, duodenum, intestines, colon and blockages therein may also be visualized. Pulmonary structures such as trachea, bronchi and thorax may also be visualized. Uro-gynecological structures such as the ureter, bladder, cervix, uterus, fallopian tubes and blockages may also be visualized. [0030] In addition to prosthetic valves, other medical devices may be positioned with devices according to embodiments of the invention including but not limited to, stents, catheters, balloon catheters, pace makers, radioactive medicines, therapeutics, cameras, laparoscopes and endoscopes.
[0031] MIAs according to embodiments of the invention may be used to direct laparoscopic or endoscopic surgery or to visualize target anatomical structures with directed energy therapies such as radiation therapy.
[0032] The term distal refers to a direction away from the opening in the body along the axis of a guidewire or catheter used to insert the MIA. The term proximal refers to a direction towards the opening in the body along the axis of a guidewire or catheter.
[0033] Reference is now made to the figures which illustrate various embodiments of an MIA according to embodiments of the invention, adapted for the performance of TAVI.
[0034] Fig. 1A depicts an MIA 10 in a collapsed, partially dissembled configuration. MIA 10 comprises a guidewire 12, a control tube 14, a marker support 18 and a fastener 40.
[0035] Marker support 18 may comprise a distal end 32 and a proximal end 20. Marker support may comprise filaments 22, which are each connected to distal end 32 and a proximal end 20.
According to an embodiment of the invention, and as shown in Figs 1A-1D, marker support 18 comprises 3 filaments 22. Marker support may comprise tissue markers 24, weakenings 30, distal marker 28 and proximal marker 26.
[0036] Guidewire 12 may have a protective covering 62 near its distal end and is shaped to form a loop 60 at its distal end. Guidewire 12 may comprise a distal lock 50 having a female connector
52.
[0037] Fastener 40 is configured to be slidably attached to guidewire 12. Fastener 40 comprises a distal connector 46 at its distal end and a proximal connector 44 at its proximal end.
[0038] Control tube 14 is configured to be slidably attached to guidewire 12, external to guidewire 12. Control tube 14 may comprise a thickening 15 near its distal end and a distal connector 42 at its distal end.
[0039] Marker support 18 may be configured to be external to guidewire 12 and fused at its distal end 32 to fastener 40. Marker support 18, at its proximal end 20 may be external to control tube 14. Marker support 18 may be slidably attached at its proximal end 20 to control tube 14 at a section of control tube 14 proximal relative to thickening 15.
[0040] Distal connector 46 and female connector 52 may be a male/ female clipping system which may, upon application of force, be engaged or disengaged. Although distal connector 46 is pictured as having a male configuration and female connector 52 is pictured as having a female configuration, these configurations may be reversed.
[0041] Distal connector 42 and proximal connector 44 may be a male/ female clipping system which may, upon application of force, be engaged or disengaged. Although distal connector 42 is pictured as having a female configuration and proximal connector 44 is pictured as having a male configuration, this configuration may be reversed.
[0042] Marker support 18 may be formed from metals such as stainless steel, shape memory alloys, superelastic alloys, titanium alloys, surgical steel, zirconium alloys, niobium alloys, tantalum alloys, polymers or other flexible and medically safe materials. According to an embodiment of the invention, marker support 18 is made from a nickel-titanium alloy. Marker support 18 may be formed, for example by cutting filaments using laser cutting techniques or by using wires or filaments optionally attached to collars. Marker support 18 may be shaped in its deployed position (shown in figure 1C) by shape setting in its deployed position. After being collapsed, marker support 18 may revert to its deployed position upon release of tension between distal and proximal ends of marker support 18 or by pushing proximal end and distal end towards each other.
[0043] According to an embodiment of the invention, marker support 18 is shaped, for example by annealing, in a manner that each filament comprises a single strand deformed to a position capable of forming a loop comprising an abutment region, which may be located at the proximal end of marker support 18 when it is in deployed configuration.
[0044] Tissue marker 24, distal marker 28 and proximal marker 26 may all be formed from a radio-opaque material, preferably material which is easily discernible from native human tissue when using imaging techniques such as fluoroscopy, computed tomography (CT), ultrasound, magnetic resonance imaging (MRI), positron emission tomography (PET). In an embodiment of the invention, a marker may be formed from stainless steel, ceramic, titanium alloy, tungsten, zirconium, silver, platinum, tantalum or gold.
[0045] Marker 24 may be located, as in Fig. 1 A collapsed configuration, midway between distal end 32 and proximal end 20 of marker support 18. Weakening 30 may be located, as in Fig. 1A slightly proximal to marker 24 on each filament 22. According to an embodiment of the invention, weakening 20 may be located slightly distal relative to marker 24 on each filament 22.
[0046] According to an embodiment, in a collapsed configuration, marker 24 may be located at between about 40% and 60% of the length between proximal end 20 and distal end 32 of marker support. According to an embodiment, in a collapsed configuration, weakening 30 may be located at between about 30% and 70% of the length between proximal end 20 and distal end 32 of marker support.
[0047] Guide wire 12 and control tube 14 may be formed using guide wires and control tubes known in the art.
[0048] In an embodiment of the invention, loop 60 may have a curved tip to allow for positioning in the left ventricle without puncturing heart tissue. In an embodiment of the invention, loop 60 may be coated with a protective coating 62, for example, a coated wire, to prevent puncturing of heart tissue. Positioning of loop 60 in the left ventricle limits further movement of guidewire 12 in the distal direction.
[0049] Reference is now made to Fig. IB. Figure IB depicts MIA 10 in an assembled semi-deployed state, inside a catheter 16. After assembly of MIA 10, transition of marker support 18 from a collapsed position in which marker support filaments are parallel to axis of MIA 10, as shown in Fig. 1A to a semi-deployed state as shown in Fig. IB can be made by moving distal end 32 and proximal end 20 of marker support 18 closer to each other. This movement causes loops to be formed by filaments 22. Each filament folds at weakening 30. Marker support 18, along with guidewire 12 and control tube 14 may be introduced into catheter 16.
[0050] MIA 10 may be introduced into a human body through catheter 16 in a position as shown in Fig. IB.
[0051] In Fig. IB, MIA 10 is shown in a position in which proximal connector 44 of fastener 40 is engaged with distal connector 42 of control tube 14. Distal end 32 of marker support 18 is shown fused to fastener 40. Movement of control tube 14 in either the proximal or the distal direction relative to guidewire 12 within catheter 16 will move semi-deployed marker support 18 in the same direction as control tube 14.
[0052] MIA 10 may be advanced from outside the body to a relevant organ within the body such as the left ventricle for performance of a procedure involving visualization techniques, by introduction into a catheter 16 and by simultaneously advancing control tube 14 and guidewire 12 in the distal direction through the catheter.
[0053] Once MIA 10 has been advanced to the relevant organ, catheter 16 may be removed while maintaining control tube 14 and guidewire 12 in the same position while pulling proximally on catheter 16. Upon removal of catheter 16, MIA 10 may revert to a deployed state, as shown in Fig. 1C. [0054] Fig. 1C depicts MIA 10 in a deployed state. Once catheter 16 is removed, or after advancing the control tube, if needed, loops formed by filaments 22 of marker support 18 move in the radial direction away from the guidewire, as marker support 18 has been shaped to assume deployment shape as described above. In the deployed state, marker support 18 is ready for operation in a visualization technique.
[0055] According to an embodiment of the invention, MIA 10 is used in TAVI. Guidewire 12 may be advanced to the point that loop 60 is lodged in the left ventricle of the heart and can no longer move in the distal direction. Upon removal of catheter 16, for example by pulling catheter in the proximal direction relative to guidewire 12 and control tube 14, marker support 18 transforms from the semi-deployed state to the deployed state in the orifice of the left ventricle, so that each loop is pointed generally in the proximal direction. The tissue markers 24 are in a position in which they may be moved in the proximal direction to abut the aortic valve.
[0056] Although loops of marker support 18 have been formed outside of the body and compressed into a relatively narrow catheter having an internal diameter of about 0.5-12mm, preferably between about 0.9 and about 3mm, the loops maintain their structural integrity and revert to their position in the loop deployment shape as shown in Fig. 1C upon removal from catheter 16. Maintaining structural integrity of the loops assists the loops in proper positioning of tissue markers 24 and proper functioning of marker support 24. Maintaining structural integrity of the loops can be attributed to weakening 30. If a marker support similar to marker support 18 were to be introduced into a narrow catheter in a semi-deployed state, without a weakening 30, loops of the marker support may become permanently crimped and/or improperly folded in a manner that would prevent functioning of the marker support upon removal from the catheter.
[0057] Once marker support 18 has been deployed as in Fig. 1C, it may be positioned against aortic valve. Loops formed by filaments are substantially pointed in a substantially proximal direction. Marker support 18 may be positioned against aortic valve by moving control tube 14 proximally relative to guidewire 12. A medical practitioner may realize that marker support 18 is properly positioned, for example, through feeling increased resistance while moving control tube 14 proximally when abutment region of marker support 18 abuts against aortic valve.
[0058] In an embodiment of the invention, proper placement of marker support 18 may be verified by an imaging modality to determine if distance between the proximal marker 26 and distal marker 28 corresponds to a predetermined distance associated between the markers in deployed state. Proper placement of marker support 18 may be verified by imaging relative motion of proximal marker 26 in the direction of distal marker 28 upon gentle pulling of control tube 14 in the proximal direction, thereby slightly compressing marker support 18. Upon distal motion, for example, by release of control tube 14, and allowing marker support 18 to spring back in the distal direction, proximal marker 26 moves away from distal marker 28.
[0059] Upon verification of proper positioning of marker support using imaging techniques such as fluoroscopy, CT, ultrasound, MRI and/or PET, TAVI may be performed. After performance of TAVI or another procedure, MIA 10 may be removed from the body.
[0060] According to an embodiment of the invention, marker support 18 is straightened to a collapsed configuration before MIA 10 is removed from the body. Marker support may be straightened by pushing control tube 14 in the distal direction relative to guide wire 12, thereby sliding fastener 40 in the distal direction on guidewire 12 and thereby bringing distal connector 46 of fastener 40 closer to female connector 52 of distal lock 50. Distal connector 46 may engage female connector 52 by application of force in the distal direction on control tube 14 (or alternatively, application of force by pulling guidewire 12 in the proximal direction.)
[0061] The engagement may be done in a protecting sleeve in order to prevent entrapment of biological tissue between the male and female conectors thereby preventing engagement. Further detail of protecting sleeves according to embodiments of the invention is provided below in connection to figs 3 A, 3B, 4A and 4B.
[0062] Upon engagement of distal connector 46 with female connector 52, control tube 14 may be pulled in the proximal direction relative to guidewire 12. This motion may disengage proximal connector 44 of fastener 40 from distal connector 42 of control tube 14. MIA 10 may be configured so that the force required to disengage distal connector 46 from female connector 52 is greater than the force required to disengage proximal connector 44 from distal connector 42. As a result, an operator of MIA 10 may apply an amount of force that may selectively disengage proximal connector 44 from distal connector 42 without disengaging distal connector 46 from female connector 52. Alternatively, one or more of the connecting elements of distal connector 46 and female connector 52 may be configured to disengage upon providing a force along an axis other than the axis of guidewire 12. For example, distal connector 46 and female connector 52 may engage upon providing force on control tube 14 relative to guidewire 12, but may be configured to disengage only upon rotation of control tube 14 relative to guidewire 12. As a result, once both distal connector 46 and female connector 52, as well as proximal connector 44 and distal connector 42 are engaged, pulling on control tube 14 relative to guidewire 12 may disengage proximal connector 44 from distal connector 42. [0063] After disengaging proximal connector 44 from distal connector 42 by movement of control tube 14 proximally relative to guidewire 12, control tube 14 is free to slide proximally. As control tube 14 moves proximally relative to guidewire 12, thickening 15 contacts proximal end 20 of marker support. As control tube 14 continues to move proximally, since thickening 15 has a larger diameter than proximal end 20, thickening 15 moves proximal end 20 in the proximal direction, thereby changing the configuration of marker support 18 and straightening loops formed by filaments 22. Upon continued movement of control tube 14 proximally relative to guidewire 12, thickening 15 pulls proximal end 20 away from distal end 32 (which is connected to fastener 40, which is attached to guidewire 12 via distal connector 46 and female connector 52) thereby reverting marker support 18 to its straightened, collapsed configuration.
[0064] Configuration of marker support 18 in its straightened, collapsed configuration may be verified by using imaging to determine position or relative position of any of the markers on marker support 18. Upon straightening of marker support 18 to its collapsed position, guidewire 12 and control tube 14 may be removed together from the body, optionally through a catheter external to guidewire 12 and control tube 14.
[0065] Embodiments of the invention described in the figures show MIAs comprising marker supports comprising 3 filaments and 3 loop-like structures. Further embodiments of the invention comprise marker supports having 4, 5, 6, 7 or 8 filaments or 4, 5, 6, 7 or 8 loop-like structures which extend to abut a surface of an internal body tissue.
[0066] According to an embodiment of the invention, MIA may be removed from the body without reverting to collapsed position as described above. For example, MIA 10 as depicted in Fig. 1C may be removed from the body by introduction of a catheter (not shown in figures) external to MIA 10, having an internal diameter smaller than the diameter of deployed marker support 18. MIA 10 may be removed by forcefully pulling guidewire 12 and control tube 14 simultaneously in the proximal direction relative to the catheter, or pushing the catheter. The distal end of the catheter may force the loops formed by filaments 22 in the distal direction. Loops may bend upon compression during insertion into the catheter. Loops may bend at weakening 30 or at other locations along loops, as structural integrity of marker support 18 need not be maintained after removal from body, if marker support 18 is configured to be a single-use apparatus.
[0067] Reference is now made to Fig. ID. Fig. ID discloses an MIA 11 according to an embodiment of the invention. MIA 11 comprises a marker support 19, a guidewire 12 and a control tube 14. Fig. ID shows MIA 11 in its deployed configuration. [0068] Marker support 19 may comprise a distal end 32 and a proximal end 20. Marker support may comprise filaments 22, which are each connected to distal end 32 and a proximal end 20. According to an embodiment of the invention, marker support 18 comprises 3 filaments 22. Marker support may comprise tissue markers 24, weakenings 30, distal marker 28 and proximal marker 26.
[0069] Referring again to Fig. ID, distal end 32 may be fused to control tube 14 and proximal end 26 may be slidable on and external to control tube 14.
[0070] Marker support 19 may further comprise struts 80. Upon transition between various configurations, struts 80 keep the structural stability and ensure proper formation of loops formed by filaments 22. Struts 80 may be connected to each filament 22 at about one third of the length of each filament from the filament proximal and distal ends.
[0071] Marker support 19 at proximal end 20 comprises connector 70.
[0072] MIA 11 further comprises removal tube 68, comprising distal connector 72 at the distal end of removal tube 68. Removal tube 68 is configured to be external to and slidable on control tube 14. Distal connector 72 is configured to removably interconnect with connector 70. For example, one of distal connector 72 and connector 70 may have male configuration and the other may have a compatible interlocking female configuration.
[0073] Before introduction into a body of a patient, MIA 11 may be transformed from its collapsed configuration to a semi-deployed configuration (both not shown in figures) and inserted into a catheter. MIA 11 may enter the human body via a catheter in a semi-deployed configuration in which marker support 19 filaments 22 are bent at weakening 30, similar to the configuration of marker support 18 in Fig. IB.
[0074] Once marker support 19 has been deployed as in Fig. ID, it may be positioned against aortic valve. Loops formed by filaments 22 are substantially are pointed in a substantially proximal direction. Marker support 19 may be positioned against aortic valve by moving control tube 14 proximally relative to guidewire 12. A medical practitioner may realize that marker support 18 is properly positioned, for example, through feeling increased resistance while moving control tube 14 proximally when abutment region of marker support 18 abuts against an aortic valve.
[0075] In an embodiment of the invention, proper deployment of marker support 19 may be verified by an imaging modality to determine if distance between the proximal marker 26 and distal marker 28 corresponds to a predetermined distance associated between the markers in deployed state. [0076] Upon verification of proper positioning of marker support using imaging techniques such as fluoroscopy, CT, ultrasound, MRI and/or PET, TAVI may be performed. After performance of TAVI or another procedure, MIA 11 may be removed from the body.
[0077] MIA 11 may be removed from the body with the assistance of removal tube 68 as follows: Distal connector 72 of removal tube 68 may engage and connect to connector 70 of marker support 19 by distal motion of removal tube 68 relative to control tube 14. After connection of connector 70 to distal connector 72, removal tube may be moved proximally relative to control tube 14, thereby sliding proximal end 20 in the proximal direction, thereby straightening loops formed by filaments 22 and reverting marker support 19 to its collapsed configuration. Upon collapsing marker support 19 to collapsed configuration, MIA 11 may be removed from the body, for example, by simultaneously moving control tube 14 and removal tube 68 in the proximal direction.
[0078] Reference is now made to Fig. IE. Fig. IE discloses an MIA 13 according to an embodiment of the invention. MIA 13 comprises a marker support 21, a guide wire 12 and a control tube 14. Fig. IE shows MIA 13 in its deployed configuration.
[0079] Marker support 21 may further comprise struts 81 and struts 83. Upon transition between various configurations, struts 81 and 83 keep the structural stability and ensure proper formation of loops formed by filaments 22. . Struts 81 may be connected to each filament 22 at about one third of the length of each filament from the filament proximal and distal ends. Struts 83 may be connected to each filament 22 at about two thirds of the length of each filament from the filament proximal and distal ends.
[0080] According to embodiments of the invention, marker supports may comprise 2, 3, 4, or 5 struts to provide structural stability and ensure proper loop formation.
[0081] Reference is now made to Figs. 2A-2F, which depict sections of marker supports of MIAs according to embodiments of the invention. These sections each comprise weakenings at which marker support filaments may bend or fold while MIA is in a semi-deployed configuration. Filaments, according to embodiments of the invention, may be ribbon-like in structure, having a larger width than thickness along the filament.
[0082] Fig. 2 A depicts a filament weakening 110 comprising a filament 112, an aperture 114 and folding region 118. The figure depicts filament weakening 110 in a plan view, looking down upon the length and width of a section of the filament. Upon applying a compression force on a loop of a marker support in a deployed state comprising filament weakening 110, for example, introduction of a marker support into a catheter or tube narrower than the diameter of the deployed marker support, the loop tends to bend at filament weakening 110 rather than at a location of the loop without a weakening. Upon removal of the compression force, the loop reverts back to its shape prior to compression. The geometry of of folding region is configured to provide resistance to tortion and bending in the orthogonal direction.
[0083] Fig. 2B depicts a plan view of a filament weakening 120 comprising a filament 112, an indentation 124 and a folding region 128. Upon applying a compression force on a loop of a marker support in a deployed state comprising filament weakening 120, the loop tends to bend at filament weakening 120 rather than at a location of the loop without a weakening. Upon removal of the compression force, the loop reverts back to its shape prior to compression.
[0084] Fig. 2C depicts a filament weakening 130 comprising a filament 132, an indentation 134 and a folding region 138. Fig. 2C depicts a filament in an edge-on view, showing the thickness of the filament. Upon applying a compression force on a loop of a marker support in a deployed state comprising filament weakening 130, the loop tends to bend at filament weakening 130 rather than at a location of the loop without a weakening. Upon removal of the compression force, the loop reverts back to its shape prior to compression. Similarly, Fig. 2D depicts an edge-on view of a filament weakening 140 comprising a filament 142, an indentation 144 and a folding region 148.
[0085] Fig. 2E depicts a plan view of a filament weakening 150 comprising a filament 152, an aperture 154, an indentation 156 and a folding region 158. The asymmetrical geometry allows the marker support to maintin its structural integrity after being folded inside a catheter with a small internal diameter, in its semi-deployed configuration
[0086] Fig. 2F depicts a plan view of a filament weakening 160 comprising a filament 162, an aperture 164, an aperture 166 and a folding region 168. The geometry of 168 also provide high elasticity to tortion and to bending in the orthogonal direction.
[0087] In Figs. 2A-2F, filament weakenings are depicted as filaments comprising apertures, indentations or combinations thereof. In an embodiment of the invention, a filament weakening comprises a region in which filament material is substituted with an alternate material having a different level of flexibility than the filament material.
[0088] With regard to previously described protective sleeve, reference is now made to Figs. 3A and 3B. Figs. 3 A and 3B shows a clipping mechanism 200. Clipping mechanism 200 may be used in MIAs according to embodiments of the invention. Clipping mechanism 200 comprises a sleeve 202 having a distal end 204 and an opening 206. Clipping mechanism 200 may comprise a male connector 208, a female connector 210, a guidewire 212, marker support 214 and a distal lock 216.
[0089] Marker support 214 may be fused to male connector 208, and together may be slidable along guidewire 212. Distal lock 216 may comprise a female connector 210. Sleeve 202 may be fused at its distal end 204 to distal lock 216.
[0090] Upon operation of clipping mechanism 200, male connector 208 is moved towards female connector 210 by sliding on guidewire 212. Distal end then enters opening 206 of sleeve 202. Upon further motion of male connector 208 towards female connector 210, the connectors engage eachother as shown in Fig. 3B. Protective sleeve 202 prevents human tissue from preventing engagement by preventing human tissue from entering into clipping mechanism.
[0091] Reference is now made to Figs. 4A and 4B. Figs. 4A and 4B show a clipping mechanism 220. Clipping mechanism 220 may be used in MIAs according to embodiments of the invention. Clipping mechanism 220 comprises a sleeve 222, a male connector 224, a guidewire 240 and a distal lock 250. Sleeve 222 may comprise a band 230. Male connector 224 may comprise a groove 226 and a head 228. Male connector 224 may be slidable on guidewire 240.
[0092] During the operation of clipping mechanism 220, male connector 224 may slide distally along guidewire 240, thereby causing head 228 to enter sleeve 222. Band 230 is configured to encompass guidewire 240. Upon further motion of male connector 224 along guidewire 240, band 230 is moved radially away from guidewire 240 by tapered head 228. Upon further motion of male connector 224 along guidewire 240, band 230 reverts to prior position as it engages groove 226 as shown in figure 4B. Band 230 may comprise an elastic material which reverts to its original position when slightly moved radially. Figure 4B shows male connector 224 engaged with distal lock 250.
[0093] Reference is now made to Figs. 5A and 5B, which show a packaged MIA 300 according to embodiments of the invention. Packaged MIA 300 comprises a packaging tube 302 and a configuration tube 304. Packaged MIA 300 further comprises a MIA 10 contained within packaging tube 302. MIA 10 may be configured having elements as shown in Figs. 1 A-ID. MIA 10 comprises a control tube 14, a protective covering 62 and a marker support 18.
[0094] MIA 10 may be assembled and configured in the deployed position, then subsequently contracted in the radial direction to present in the semi-deployed position. MIA 10 may then be introduced into configuration tube 304. Configuration tube 304 may be configured to encompass a distal section of MIA 10, the distal section comprising marker support 18, and optionally also comprising protective covering 62 and control tube 14. MIA 10, once partially enclosed by configuration tube 304 may be introduced into packaging tube 302 as shown in Fig. 5A. Packaging tube 302 may provide protection during shipping to ensure maintenance of structural integrity of MIA 10.
[0095] Prior to use, MIA 10 may be removed from packaging tube 302 while maintaining configuration tube 304 in place, enclosing distal end of MIA 10, as shown in fig. 5B. Configuration tube 304 may be configured to have a diameter narrower than a catheter hub 310. Distal end of configuration tube 304 may be inserted into catheter hub 310. MIA 10 may then be introduced to a catheter 312 via catheter hub 310 by pushing MIA 10 distally relative to catheter hub 310. Catheter 312 may be introduced into a body cavity of a patient prior to introduction of MIA 10 into catheter 312.
[0096] MIA 10 can be maintained so that marker support 18 remains in the semi-deployed state during packaging and shipping using a configuration tube so that the MIA can be employed upon removal from packaging and inserted into a catheter hub, without first transforming MIA 10 to another state.
[0097] There is further provided in accordance with an embodiment of the invention an apparatus for determining a location of a surface of an internal organ of a body, the apparatus comprising:a marker support having a proximal end, a distal end and an axis, the marker support having a collapsed state, a semi-deployed state and a deployed state, the marker support comprising: a plurality of filaments, each having at least one tissue marker and at least one weakening, in which in the collapsed state the filaments lie within a relatively small radial distance from the axis and which, upon transformation to the deployed state, each filament forms a loop, and which, upon compression of the loop in the direction of the axis to enter the semi-deployed state having a smaller radial diameter than in the deployed state, each loop folds at its weakening, and which, upon release of the compression of the loop, each loop moves radially outward from the axis to the deployed state. Optionally, each weakening is located approximately between 30% and 70% of the length between the proximal end and distal end of each filament. Optionally, the weakening comprises an aperture in the filament. Optionally, the weakening comprises an indentation in the filament. Optionally, the tissue markers define abutment regions configured to be located proximal to the distal and proximal ends of the marker support when the marker support is in a semi-deployed and deployed state. Optionally, the plurality of filaments comprises 3 filaments. Optionally, the apparatus further comprises a guidewire and a control tube. Optionally, the distal end of the marker support is attached to a connector element, the connector element being slidable on the guidewire. Optionally, the connector element can be removably linked to the guidewire. Optionally, connector element can be removably linked to the control tube. Optionally, the proximal end of the marker support is slidably attached to and external to the control tube. Optionally, the removable link can be formed between a male connector and a female connector. Optionally, the amount of force required to detach the connector element from the control tube is different than the amount of force required to detach the connector element from the guidewire. Optionally, the direction of force required to detach the connector element from the control tube is different than the direction of force required to detach the connector element from the guidewire. Optionally, the apparatus further comprises a thickening towards the distal end of the control tube. Optionally, the thickening, upon movement in the proximal direction relative to the guidewire, engages the proximal end of the marker support and upon further movement in the proximal direction, transforms the marker support from a deployed state to a collapsed state. Optionally, the apparatus further comprises support struts connecting between filaments of the marker support. Optionally, the marker support distal end is attached to the distal end of the control tube and the marker support proximal end is slidably attached to the control tube. Optionally, the apparatus further comprises a removal tube, external to and slidable on the control tube. Optionally, the distal end of the removal tube is removably linked to the proximal end of the marker support. Optionally, the apparatus further comprises a sleeve having an opening through which a connector may enter to engage the other connector.
[0098] There is further provided in accordance with an embodiment of the invention a system comprising: the aforementioned apparatus; and a first tube encompassing a distal section of the apparatus and maintaining the apparatus in a semi-deployed state. Optionally, the tube encompasses a distal section of the apparatus comprising the marker support. Optionally, the system further comprises a second tube encompassing the first tube and the apparatus.
[0099] There is further provided according to an embodiment of the invention, a method for the manufacture of a marker support for determining a location of a surface of an internal organ of a body, the method comprising: forming a marker support having a proximal end, a distal end and an axis, the marker support having a collapsed state, a semi-deployed state and a deployed state, the marker support comprising: a plurality of filaments, each having at least one tissue marker; transforming the marker from a collapsed state, in which in the collapsed state the filaments lie within a relatively small radial distance from the axis to a to a deployed state in which each filament forms a loop, by moving the proximal and distal ends closer to each other; and further transforming the marker from a deployed state to a semi-deployed state by compression of the loop in the direction of the axis to enter the semi-deployed state having a smaller radial diameter than in the deployed state. Optionally, the filaments each further comprise a weakening, and wherein upon transforming the marker from a deployed state to a semi-deployed state, each loop is folded at its weakening.
[00100] In the description and claims of the present application, each of the verbs, "comprise," "include" and "have," and conjugates thereof, are used to indicate that the object or objects of the verb are not necessarily a complete listing of components, elements or parts of the subject or subjects of the verb.
[00101] Descriptions of embodiments of the invention in the present application are provided by way of example and are not intended to limit the scope of the invention. The described embodiments comprise different features, not all of which are required in all embodiments of the invention. Some embodiments utilize only some of the features or possible combinations of the features. Variations of embodiments of the invention that are described, and embodiments of the invention comprising different combinations of features noted in the described embodiments, will occur to persons of the art. The scope of the invention is limited only by the claims.

Claims

1. An apparatus for determining a location of a surface of an internal organ of a body, the apparatus comprising:
a marker support having a proximal end, a distal end and an axis, the marker support having a collapsed state, a semi-deployed state and a deployed state, the marker support comprising:
a plurality of filaments, each having at least one tissue marker and at least one weakening, in which in the collapsed state the filaments lie within a relatively small radial distance from the axis and which, upon transformation to the deployed state, each filament forms a loop, and which, upon compression of the loop in the direction of the axis to enter the semi-deployed state having a smaller radial diameter than in the deployed state, each loop folds at its weakening, and which, upon release of the compression of the loop, each loop moves radially outward from the axis to the deployed state.
2. The apparatus according to claim 1 wherein each weakening is located approximately between 30% and 70% of the length between the proximal end and distal end of each filament.
3. The apparatus according to any one of the previous claims wherein the weakening comprises an aperture in the filament.
4. The apparatus according to any one of the previous claims wherein the weakening comprises an indentation in the filament.
5. The apparatus according to any one of the previous claims, wherein the tissue markers define abutment regions configured to be located proximal to the distal and proximal ends of the marker support when the marker support is in a semi-deployed and deployed state.
6. The apparatus according to any one of the previous claims wherein the plurality of filaments comprises 3 filaments.
7. The apparatus according to any one of the previous claims further comprising a guidewire and a control tube.
8. The apparatus according to claim 7 wherein the distal end of the marker support is attached to a connector element, the connector element being slidable on the guidewire.
9. The apparatus according to claim 8 wherein the connector element can be removably linked to the guidewire.
10. The apparatus according to claim 8 wherein the connector element can be removably linked to the control tube.
11. The apparatus according to claim 7 wherein the proximal end of the marker support is slidably attached to and external to the control tube.
12. The apparatus according to claim 9 or 10 wherein the removable link can be formed between a male connector and a female connector.
13. The apparatus according to claim 9 or 10 wherein the amount of force required to detach the connector element from the control tube is different than the amount of force required to detach the connector element from the guidewire.
14. The apparatus according to claim 9 or 10 wherein the direction of force required to detach the connector element from the control tube is different than the direction of force required to detach the connector element from the guidewire.
15. The apparatus according to any one of claims 7 to 14 further comprising a thickening towards the distal end of the control tube.
16. The apparatus according to claim 15 wherein the thickening, upon movement in the proximal direction relative to the guidewire, engages the proximal end of the marker support and upon further movement in the proximal direction, transforms the marker support from a deployed state to a collapsed state.
17. The apparatus according to any one of the previous claims further comprising support struts connecting between filaments of the marker support.
18. The apparatus according to claim 7 wherein the marker support distal end is attached to the distal end of the control tube and the marker support proximal end is slidably attached to the control tube.
19. The apparatus according to claim 18 further comprising a removal tube, external to and slidable on the control tube.
20. The apparatus according to claim 19 wherein the distal end of the removal tube is removably linked to the proximal end of the marker support.
21. The apparatus according to claim 12, further comprising a sleeve having an opening through which a connector may enter to engage the other connector.
22. A system comprising:
the apparatus according to claim 1 ; and a first tube encompassing a distal section of the apparatus and maintaining the apparatus in a semi-deployed state.
23. The system according to claim 22 in which the tube encompasses a distal section of the apparatus comprising the marker support.
24. The system according to claim 22 or 23 further comprising a second tube encompassing the first tube and the apparatus.
25. A method for the manufacture of a marker support for determining a location of a surface of an internal organ of a body, the method comprising:
forming a marker support having a proximal end, a distal end and an axis, the marker support having a collapsed state, a semi-deployed state and a deployed state, the marker support comprising: a plurality of filaments, each having at least one tissue marker; transforming the marker from a collapsed state, in which in the collapsed state the filaments lie within a relatively small radial distance from the axis to a to a deployed state in which each filament forms a loop, by moving the proximal and distal ends closer to each other; and
further transforming the marker from a deployed state to a semi-deployed state by compression of the loop in the direction of the axis to enter the semi-deployed state having a smaller radial diameter than in the deployed state.
26. The method according to claim 25 wherein the filaments each further comprise a weakening, and wherein upon transforming the marker from a deployed state to a semi-deployed state, each loop is folded at its weakening.
PCT/IB2015/056138 2014-08-12 2015-08-12 Multi-stage imaging aid (mia) WO2016024235A1 (en)

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IT201800000671A1 (en) * 2018-01-10 2019-07-10 Matteo Montorfano DEVICE FOR INSERTING A GUIDE WIRE INTO A BLOOD VESSEL
WO2019138334A1 (en) * 2018-01-10 2019-07-18 Montorfano Matteo A device for inserting a guide wire in a blood vessel

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