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Researchers Submit Patent Application, "Collapsible Medical Closing Device, a Method and a Medical System for Delivering an Object", for Approval

July 3, 2014



By a News Reporter-Staff News Editor at Politics & Government Week -- From Washington, D.C., VerticalNews journalists report that a patent application by the inventor Solem, Jan Otto (Bjarred, SE), filed on September 10, 2012, was made available online on June 19, 2014.

No assignee for this patent application has been made.

News editors obtained the following quote from the background information supplied by the inventors: "The present disclosure is related to the sealing of an opening in a body vessel or the wall of a heart cavity, e.g. a blood vessel or a human heart, and more precisely to a device, a system and a method for performing such sealing. Heart diseases, e.g. coronary artery disease, heart valve disease and congenital heart disease are responsible for a majority of mortality among humans. Previously, almost all patients underwent open heart surgery in order to correct such disorders. In an increasing number of cases, the disorder is nowadays corrected by means of percutaneous catheter minimal invasive based therapy. However, to get access to the body vasculature and the heart cavities, catheters, sometimes of large diameters are passed through the walls of such cavities or vessels, and thus making holes.

"Often such holes and channels dilated to considerably diameters, sometimes up to 7 to 9 mm, e.g. when inserting a heart valve by means of catheter techniques. While withdrawing such catheters, defects or holes remain open, threatening the patient to suffer from serious bleedings, sometimes life threatening. The largest channels have to be closed by surgical interventions, while the smallest in smaller vessels are left to close by nature. The latter means that a clot has to be formed in the channels by blood platelets and coagulation factors from the blood itself. To allow this process, compression from the outside is mandatory, sometimes for hours. Most used sealing methods involve some type of suturing to close the defect.

"A device and a method for sealing punctures and incisions without the use of suturing are described in U.S. Pat. No. 5,413,571. A biodegradable, fluid filled balloon that is positioned in the puncture seals the puncture. The device includes a shaft member that is left to be resorbed inside the body. The shaft member may be sutured to the skin or slightly below the outer surface of the skin.

"Yet another device for sealing a puncture is described in U.S. Pat. No. 5,916,236. The device comprises a retaining element having a distal occlusion element. The retaining element and thereby the occlusion element is fixed in the puncture by a fixing element positioned outside the vessel, and the three elements are left in the body to be resorbed.

"A sealing device and method is described in SE2990827. Here the sealing member is an elongated flexible thin walled tubing. This tubing has an elastic reinforcement at its distal end, which is adapted to form a funnel-shaped sealing against the inner wall of a body vessel when the tubing is circumferentially pursed outside the body vessel.

"From EP 1982 655 A1, an atrial appendage occlusion device is known. The occlusion device comprises a mesh or a braiding of at least one wire or thread. The occlusion device has been given a shape using a reshaping and/or heat-treatment process, and is self-expandable, as well as configured for safe anchoring in an atrial appendage of the left or right atrium of a heart, comprising proximal retention region at a proximal end of the occlusion device; a distal retention region; and a central region between the proximal retention region and the distal retention region. Disclosed is also an atrial appendage occlusion device comprising mesh or braiding of at least one wire or thread, where the occlusion device has been given a shape using a reshaping and/or heat-treatment process, and is self-expandable, as well as configured for safe anchoring in an atrial appendage of the left or right atrium of a heart, comprising proximal retention region at proximal end of the occlusion device; a distal retention region; and a central region between the proximal retention region and the distal retention region; where the occlusion device has a closed distal end without a hub for the wire or thread, and where the proximal retention region is of elongate spherical shape and at least partly hollow, and where the distal retention region comprises a distal anchoring element integrally made of the same mesh or braiding as the hollow elongate spherical proximal retention region. The document also discloses production of an atrial appendage occlusion device, where a spherical hollow mesh or braiding is produced in such a way that thin wires or threads which constitute the finished mesh or braiding are interwoven in the formation of the spherical hollow mesh or braiding at the distal end of the mesh or braiding, so that a distal retention region has a closed shape to the distal end.

"Finally there are holes and openings not created by interventional treatment activity, acquired as a result of disease or congenital. Some products for closing acquired or congenital defects are devices having umbrella shaped discs with spikes and a covering cloth. One disc is placed on each side of the defect and then pressed against each other and locked, StarFlex.RTM. (NMT Medical Inc.RTM., Boston Mass.) and CARDIA Patent Foramen Ovale Closure Device.RTM. (Cardia Inc.RTM., Burnsville, Minn.) are such devices. Other devices are made of Nitinol threads, e.g. having a double disc shape with a waist between the discs. They are inserted in openings that are to be closed, one disc on each side of the hole that are to be closed and the waist in the center of the hole, the discs being larger than the hole. There are two examples of such devices. The first, made by Occlutech.RTM., having one fixation point at the end of the device and the second, made by AGA medical.RTM. having two fixation points, one at each end of the device. In these devices, the Nitinol threads are joined in the centre of one or both of the discs.

"Some of the fixation points have a screw with windings to be attached to a rod. By means of that rod, the devices may be pulled into and pushed out of a catheter when being positioned in the opening to be closed. When in position, the device is detached from the rod by unscrewing the connection. Such fixation points provide a massive aggregation of material preventing access to the interior of the device at the position of the fixation point(s).

"A major disadvantage of the prior known devices is that they may not be delivered by a standard over-the-wire technique, also known as the Seldinger technique.

"Thus, there is a need for an improved medical system for delivering an object through a body opening to a target site in a body.

"There is also a need for an improved collapsible medical closing device for closing a body opening.

"Furthermore, a method of assembling a medical system for delivering an object, performed outside of a body and before using the assembly in any medical procedure would be advantageous.

"There is also a need for a simplified method of manufacturing a collapsible medical closing device and enabling delivery of a further device through a hollow sheath and/or enabling delivery of a collapsible medical closing device over a guide wire to remote target sites.

"An object of the present disclosure is to provide an improved device and a method for sealing of an opening in a body vessel or the wall of a heart cavity, e.g. a blood vessel or a human heart that is simple to use and that do not involve suturing. Another object of the invention is that all its parts are single use articles.

"Furthermore, an improved medical system, which makes medical intervention safer, more reliable, shorter, which system has less risk for infections and less invasive procedures would be advantageous."

As a supplement to the background information on this patent application, VerticalNews correspondents also obtained the inventor's summary information for this patent application: "Accordingly, embodiments of the present disclosure preferably seek to mitigate, alleviate or eliminate one or more deficiencies, disadvantages or issues in the art, such as the above-identified, singly or in any combination by providing a closing device, a medical system or a method of assembling a medical system, according to the appended patent claims.

"A major disadvantage of the prior known devices is that they may not be delivered by a standard over-the-wire technique, also known as the Seldinger technique. The present disclosure overcomes this disadvantage, amongst others, by providing a closing device that is capable of travelling over a catheter or a guide wire. The disclosed devices are provided with a hole or channel allowing for access into and through the device. Secondly, the disclosed devices have the capacity for a radial retraction.

"Embodiments of the present disclosure may be well suited for the selective occlusion of a vessel, lumen, channel, hole, cavity, or the like. Examples, without limitations, are a vessel, lumen, channel, or hole through which blood flows from one vessel to another vessel such as an Atrial Septal Defect (herein after ASD) or a Ventricular Septal Defect (herein after VSD). Other examples could be an Arterial Venous Fistula (AVF), Arterial Venous Malformation (AVM), a Patent Foramen Ovale (PFO), Para-Valvular Leak (PVL), or Patent Ductus Arteriosus (PDA), also called Ductus Botalli.

"According to one aspect of the disclosure, a collapsible medical closing device for closing a body opening is provided, which comprises a network of at least one thread, wire or fiber, and a closeable through channel in said network having an opening for receiving an elongated unit therein for delivery of said collapsible medical closing device over said elongated unit, wherein said network is irregular; and/or said elongated unit is a sheath.

"According to another aspect of the disclosure, a medical system for delivering an object through a body opening to a target site in a body is provided, which comprises a collapsible medical closing device for substantially closing said body opening, and comprising an elongated unit mounted inside said through channel.

"According to yet another aspect of the disclosure, a method of assembling a medical system for delivering an object is provided, which comprises positioning a treatment catheter and/or a guide wire through an opening of a collapsible medical closing device, positioning said collapsible medical closing device and said treatment catheter inside a restraining catheter, and positioning a pushing catheter inside said restraining catheter adjacent to the collapsible medical closing device. The method is in preferred embodiments performed outside of a body and before using said assembly in any medical procedure.

"Further embodiments of the disclosure are defined in the dependent claims, wherein features for the second and subsequent aspects of the disclosure are as for the first aspect mutatis mutandis.

"Some embodiments of the disclosure provide for an improved and simplified method of manufacturing a collapsible medical closing device.

"Some embodiments of the disclosure also provide for delivery of further devices through hollow sheath and/or delivery of a collapsible medical closing device over at least one guide wire to remote target sites.

"Some embodiments of the disclosure also provide for enabling a collapsible medical closing device to travel over a sheath, such as a catheter inside a body, such as a mammal body, and thus providing a way of positioning an object and sealing a gap of a hole or an opening in a body, such as a mammal body, with one single piece of equipment, i.e. one single system comprising catheters and at least one collapsible medical closing device, which system can be used for both placing an object and sealing a gap.

"Some embodiments of the disclosure also provide for enabling an easier procedure of positioning an object inside a body, such as a mammal body and avoiding regular surgery.

"Some embodiments of the disclosure also provide for enabling an improved and simplified method of manufacturing a collapsible medical closing device and enabling putting an opening in the center of disc-shaped sections, by making sure that there is no need for joining points in the center of any of the disc-shaped sections.

"In one embodiment the thread's two ends are joined by means of welding, however other means of joining the ends may be used, like pinching the ends together, or hooking them together.

"Some embodiments of the disclosure also enables a collapsible medical closing device to be fitted to various catheters with different sizes, and thus provides for compact coaxial aggregates without substantially increasing the cross section or diameter of the collapsible medical closing device.

"Some embodiments of the disclosure also provide for an easier way of placing an object, like an artificial valve in the aortic valve position and avoiding invasive open heart surgery.

"Some embodiments of the disclosure also provide for an alternative of providing a collapsible medical closing device with an opening by the use of fasteners, which device can be customized to fit a catheter of a particular size. Such fasteners can be provided in different sizes so that a collapsible medical closing device can be used for a wide variety of catheters with different sizes. Furthermore, the fasteners can be automatically closable/sealable or self-closing/self-sealing, depending on pressure. The fasteners can also be provided with a through bore.

"Some embodiments of the disclosure also provide for enabling a gap of an opening in a body, such as a mammal body, to be sealed with a collapsible medical closing device from both sides of the opening and thus providing a more reliable sealing of an opening in a body.

"In some embodiments the collapsible medical closing device has two disc-formed or cylinder-formed sections with an intermediate shaft section. However, the collapsible medical closing device could have any number of disc-formed or cylinder-formed sections with intermediate shaft sections in-between.

"Some embodiments of the disclosure also provide for a more reliable sealing of a gap of an opening, such as an opening in a cardiac wall, an opening to a coronary vessel, an opening in a percutaneous delivery channel, an opening in the abdominal wall or an opening to an aneurysm.

"Some embodiments of the disclosure also provide for a way of decreasing the size and diameter of the tubular, cylindrical or disc-shaped collapsible medical closing device during delivery of it to a target site in a body, such as a mammal body.

"Some embodiments of the disclosure also provide a means of releasing the collapsible medical closing device from its delivery position inside the restraining catheter into its target position at the target site. Releasing may be done in a safe way, allowing for retracting a closing device prior to fully releasing it into the body.

"Some embodiments of the disclosure also provide for delivering a medical closing device, such as a collapsible medical closing device by the use of a compact unit or an integrated unit. This compact design may even be provided in combination with delivery of another object passing through the closing device and a tissue opening to a target site before closing off the opening with the closing device.

"Some embodiments of the disclosure also provide for a collapsible medical closing device, which is easily deployed.

"Some embodiments of the disclosure also make medical intervention safer, more reliable, shorter, and/or lower the risk for infections and decreases the number of invasive procedures.

"Some embodiments of the disclosure also provide for cost effective health care.

"In one embodiment, the device may be filled with sealing material like polytetrafluorethylen (PTFE). The sealing material may be polyurethane. The sealing material may be polyvinyl or other polymers. The sealing material may be a biological degradable material. The degradable material may be polydioxanone (PDS). The degradable material may be polyglactin (Vicryl). The degradable material may be polyglycolic acid (Dexon). The sealing material may be a resorbable material that will be resorbed by the body. The sealing material may be provided as a filling of the closing device. The sealing material may be arranged inside the closing device. The sealing material may be integrated with the closing device. Integration may be provided as a monolithic unit. The sealing material may be interweaved into threads of the closing device. The sealing material may be provided as a coating covering at least a portion of a surface of the closing device. The sealing material may also comprise nonresorbable cloths or Dacron.

"In some embodiments, the Nitinol thread may have the mentioned sealing materials attached to the thread instead, and not freely floating in the disc-shaped sections.

"In some embodiments the thread is made of a Magnesium alloy.

"In further embodiments, the thread or the wire comprises at least one micro coil. The use of one or several micro coils improves the flexibility of the thread or wire. Furthermore, the use of one or several micro coils has the advantage of making the collapsible medical closing device more dense, since the structure is made more micro-porous and thereby enabling a faster biological closing with thrombocytes, fibrin and cells.

"In yet another embodiment an expanding or swelling synthetic material is used, which may expand and thereby contribute to filling the gap in the hole or puncture site.

"The swelling material may be a swelling polymer, such as disclosed in WO2009049677, which is incorporated herein in its entirety for all purposes.

"An important feature of the collapsible medical closing device here described is that the whole device may change in diameter, one diameter when placed outside a catheter or a rod, and both disc-shaped sections opened, and another smaller diameter when the catheter or rod is retracted from the device. Thus the device will close the opening with a disc on each side of the hole and then retract in the radial direction in the order of pulling tissue towards the device center.

"In one embodiment the side of disc-shaped sections facing tissue after deployment may have hooks or barbs in order to increase friction against tissue. Importantly, the device has no central opening in its natural shape, when not being mounted on a catheter or a rod.

"It should be emphasized that the term 'comprises/comprising' when used in this specification is taken to specify the presence of stated features, integers, steps or components but does not preclude the presence or addition of one or more other features, integers, steps, components or groups thereof.

BRIEF DESCRIPTION OF THE DRAWINGS

"These and other aspects, features and advantages of which embodiments of the disclosure are capable of will be apparent and elucidated from the following description of embodiments of the present disclosure, reference being made to the accompanying drawings, in which:

"FIG. 1 is a lateral view in which a collapsible medical closing device is schematically shown before temperature memory fixation;

"FIG. 2 is a lateral view of a collapsible medical closing device after temperature memory fixation;

"FIG. 3a is a lateral view, which illustrates a guide wire passing through the collapsible medical closing device;

"FIG. 3b is a lateral view, which illustrates a catheter passing through the collapsible medical closing device;

"FIG. 4a shows a lateral view of a closing device and illustrates a catheter passing through the closing device;

"FIG. 4b shows a front view of a closing device and illustrates a catheter passing through the closing device;

"FIG. 5 is a lateral view of the collapsible medical closing device inserted into another catheter;

"FIG. 6 is a lateral view of a pushing catheter behind the collapsible medical closing device positioned in a catheter, the collapsible medical closing device being pushed halfway out;

"FIG. 7 is a lateral view of the medical system inside the left ventricle of a heart;

"FIG. 8 shows another lateral view of the medical system inside the left ventricle of a heart;

"FIG. 9 is yet another lateral view of the medical system inside the left ventricle of a heart;

"FIG. 10 is a further lateral view of the medical system inside the left ventricle of a heart;

"FIG. 11a is an anatomic sketch of the central structures in a human thorax used for description of a Ductus Botalli.

"FIG. 11b: is an anatomic sketch of the central structures in a human thorax used for description of a closure of a Ductus Botalli by means of a collapsible medical closing device;

"FIG. 12a is an anatomic sketch of the central structures in a human thorax used for description of a fistula between a left coronary artery and the pulmonary artery;

"FIG. 12b is an anatomic sketch of the central structures in a human thorax used for description of a closure of a fistula between a left coronary artery and the pulmonary artery by means of a closing device;

"FIG. 13a shows a section of a human body surface;

"FIG. 13b depicts how a treatment hole is closed by means of a collapsible medical closing device;

"FIG. 14 is another front view of a collapsible medical closing device;

"FIG. 15 is a lateral view of a collapsible medical closing device after temperature memory fixation; and

"FIG. 16 is a lateral view of a collapsible medical closing device."

For additional information on this patent application, see: Solem, Jan Otto. Collapsible Medical Closing Device, a Method and a Medical System for Delivering an Object. Filed September 10, 2012 and posted June 19, 2014. Patent URL: http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&u=%2Fnetahtml%2FPTO%2Fsearch-adv.html&r=1642&p=33&f=G&l=50&d=PG01&S1=20140612.PD.&OS=PD/20140612&RS=PD/20140612

Keywords for this news article include: Patents.

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