DESC:VERSATILE ABSORBABLE FLOW REGULATING DEVICE AND METHOD TO DEVELOP BALLOON BASED STENT DELIVERY SYSTEM
TECHNICAL FIELD

[0001] Embodiments are generally related to medical implant devices and methods. Embodiments are also related to blood flow regulating devices and methods. Embodiments are further related to implantation devices for atrial septum in the heart of a mammalian. Embodiments are more particularly related to a versatile absorbable flow regulating device and method for developing balloon-based stent delivery systems.
BACKGROUND OF THE INVENTION
[0002] A healthy mammalian heart (human heart) comprises of four chambers namely atria (right atrium and left atrium) and ventricles (left ventricle and right ventricle). The atria collect the blood from the body and lungs whereas the ventricles pump the blood to the body and lungs. The oxygenated blood which is pumped by the left ventricles carries oxygen to the body. The deoxygenated blood is returned to the right heart via veins and pumped to the lungs via the pulmonary artery originating from the right heart.
[0003] The oxygenated blood in the lungs flows into the left atrium via pulmonary veins and then to the left ventricle where it is pumped to the body. Right and left chambers of the heart are separated by a wall to avoid the mixing of oxygenated and deoxygenated blood.
[0004] The congenital opening between the right and left atria of the heart is called an Atrial Septal Defect (ASD). In the presence of an ASD, oxygenated blood in the left atrium flows into the right atrium, and the amount of the blood to be received by the right atria increases. In time, this would lead to volume overload, pulmonary congestion, and heart failure; this in turn decreases life expectancy. Furthermore, the emboli passing through this hole may reach to the brain leading to strokes.
[0005] If the blood flowing through the left atrium to the right atrium is above a certain amount, ASD must be occluded. Otherwise, irreversible damage may occur in the pulmonary arteries. In the fetal heart, there is a hole (foramen ovale) between the atria, and this hole is partially covered by a membrane wherein the hole between the membranes allows the blood to pass from right to left atria, and it is vital for the baby. Following the birth, the membrane closes the hole, and in few months the hole is completely occluded in most cases.
[0006] A Versatile Flow Regulating Device (VFRD) device is generally intended to create a hole (small ASD) between the two collecting chambers in the heart (right and left atria), i.e., opposite to the purpose of an occluder to allow the flow of blood from a chamber that is under high pressure to a chamber that is less stiff and under lesser pressure. By creating such a hole, symptoms resulting from back flow of blood into the areas filling that chamber could be prevented. In an exemplary scenario, if the pressure in the left atria is high then the back pressure would be into the lungs from which the oxygenated blood is draining into the left atria which causes the patient to be breathless and may cause coughing out blood. Alternatively, if the blood flows from left atria to the right atria through the opening artificially created, then there is no problem with saturations but there may be a slight reduction in blood flow into the organs. However, such an arrangement would improve the exercise capacity making the patient able to do routine life activities without feeling breathless.
[0007] It is to be noted that the trans-catheter procedures discussed herein are associated with certain risks. For example, while attempting to make a hole to implant the FRD, laceration or bleeding may occur in the vessels which may require surgical invention or blood transfusion. Additionally, infection can be another risk which may require antibiotic treatment. Very rarely stroke and accordingly long-term function loss may also occur. Allergic reactions or loss of renal functions may develop due to contrast material. Furthermore, creating a hole may also predispose the patient to paradoxic embolism and stroke if the blood flow reverses to make the shunt from right to left.
[0008] Adding to it, urgent surgical intervention may be needed due to inappropriate location of the FRD or premature release of the device from the catheter. Also, the device can be dislocated after being released and may harm the adjacent heart valves where an operation is required to treat the condition. Rarely, the device may not be implantable, or clots can form around the device, leading to embolism.
[0009] Sivaprakasam M, et al., reported new technique for fenestration of the interatrial septum which is created by improvised use or a stent not intended for this use. However, it is important to ensure that the defect created in the heart is a precise diameter to a calibrated size to allow appropriate amount or blood flow, just enough to maintain the necessary cardiac output without causing other complications including severe decrease in oxygenation, device dislodgement, decrease in the size of hole in the device etc. It is equally important that such devices are precisely positioned to avoid damage or dysfunction or healthy heart tissues or structures. Alternatively, certain prior art solutions propose a modification to the device such as for example the IASD, V Wave device and the AFR device that are well known in the art.
[00010] The prior art devices for creating a shunt or an opening in the heart typically comprises a middle section (con-joined ring) which is circular and provides most of the support to the right and left disc-shaped end sections to keep its circular shape and calibrated diameter, and to keep its shape memory. Such prior art devices can be placed between two cardiac chambers to allow pressure reduction between the two cardiac chambers, a manual hole is further made by the wires or the device. However, the prior art devices lack stability and thereby are unable to attain a well-defined calibrated opening. Moreover, with conventional devices, due to the hole being in the ring that latches on to the wall or septum (partition between the two chambers), the hole may get covered in the process of endothelialization, i.e., the natural process of the body. All the existing devices for this purpose need creating a hole in the heart with a balloon prior to placing the device. In this invention the balloon and the device are combined making the procedure simple and less time consuming with less instrumentation and radiation to the patient.
[00011] Alternative embodiments of prior arts such as, the AFR and IASD teaches modifications to address the above-mentioned problems but has the drawback of having a metallic structure permanently placed in the heart. An ideal device to create a shunt in the atrial septum should be leaving no artificial structure in the heart and have the capacity to leave a permanent hole. A further problem with prior art devices is the disruption of the endothelialization process, which can cause formation of emboli travelling in the blood stream. Also, with the prior art devices there is a challenge to achieve sufficient stability, a sufficiently well-defined shunt, and reduced risk of formation of emboli.
[00012] Based on the foregoing a need therefore exists for an improved blood flow regulating device with easier deployment, improved stability, allowing for improved support, and the ability to retain the calibrated size, and improved properties with respect to endothelialization, as well as a method of manufacturing the device, as discussed in greater detail herein.
SUMMARY OF THE INVENTION
[00013] The following summary is provided to facilitate a clear understanding of the new features in the disclosed embodiment, and it is not intended to be a full, detailed description. A detailed description of all the aspects of the disclosed invention can be understood by reviewing the full specification, the drawing and the claims and the abstract, as a whole.
[00014] One objective of the present invention is to provide an improved versatile absorbable and easily deployable flow regulating device (VFRD) for creating a shunt in the heart.
[00015] Another objective of the present invention is to provide an improved method for developing versatile absorbable flow regulating device (VFRD) for creating a shunt in the heart.
[00016] Further objective of the present invention is to provide a versatile absorbable flow regulating device (VFRD) and method for developing balloon-based stent delivery systems.
[00017] The aforementioned aspects along with the objectives and the advantages can be achieved as described herein. A versatile absorbable flow regulating device (VFRD) and method for developing balloon-based stent delivery systems, is disclosed herein.
[00018] The versatile absorbable flow regulating (VFRD) device (100) comprises a double balloon unit (150) comprising of an inner balloon (110) and an outer balloon (120) wherein the double balloon unit (150) can be operatively configured with a deployable stent unit (130) of oval shape which is made of a biodegradable implantable material (e.g., a magnesium-based alloy) and is absorbed into the body (heart portion) of a mammalian. The diameter of the inner balloon can of 4-12 mm diameter and the diameter of the outer balloon can be of 8-24 mm.
[00019] In one embodiment of the proposed invention the deployable stent unit (130) of the versatile absorbable flow regulating device (VFRD) (100) comprises a central covered element (210) and at least two distal flared elements (220 and 230) wherein the central covered element (210) and the distal flared elements (220 and 230) are made of magnesium alloy which can be absorbed into the mammalian organ (body). Further, the central tubular element is covered with a polylactate. It is to be noted that the polylactate material discussed herein should not be considered in any limited sense, alternatively a person skilled in the art can use any other degradable polymer (e.g., PLGA, PGA, PCL) without limiting the scope of the present invention. The distal flared elements (220 and 230) prevent endothelialization and stability to the device.
[00020] Note that the stent unit (130) discused herein is an exemplary embodiment of stent unit (130) that can be configured and deployed using the double balloon unit (110). Alternatively, a person skilled in the art can adapt the double balloon unit (110) to deploy any type of stent unit (130) without limiting the scope of the proposed invention.
[00021] The stent unit (130) for creating a shunt in the heart of a mammalian (human) can be coated with an antibiotic or any other drug. The stent unit (130) can be expanded for further requirements to adjust the physiology changes in the body.
[00022] The stent unit (130) can be incorporated with a plurality of pressure sensors on the right atrial side and left atrial side. The balloon-based stent unit (130) can be configured with varying size and shape depending on the physiological parameters of the mammalian. The size of the central hole of the stent unit (130) can be reduced through deployment of further devices and a partial central membrane can be incorporated to allow the change in calibre as the membrane is absorbed. The membrane is configured by using a partially biodegradable material or a filament or an elastic polymeric material or natural fabrics. Further, the membrane comprises an elastic polymeric material selected from a group including, but not limited to nylon, polyester, polypropylene, polytetrafluoroethylene, and expanded polytetrafluoroethylene etc. Also, the proximal and distal elements are expandable, and the proximal element has lower expansion strength than the distal element.
[00023] Another embodiment of the present invention teaches a method of manufacturing the stent unit (130) comprising steps of: braiding a tubular braid of wires where opposite ends of each wire are arranged at a proximal portion of the tubular braid, and loops of the wires are arranged at a distal end of the tubular braiding; forming a distal disc of the distal end of the tubular braiding; forming a proximal disk of the proximal end of the tubular braiding; forming a central aperture in each of the distal and proximal discs such that the apertures are joined by a central channel of the tubular braiding; extending between the discs and fixating the opposite ends of each wire of the tubular braid in a single connecting element located at the proximal disk wherein the single connecting element being set at a distance from a central axis extending through the channel. In this instance such a stent will be made of self-expansile memory alloys like Nitinol.
[00024] The proximal and distal elements having a general stent shape defined by a tube of open cells molded at the right angle to the central tube. The central element is composed of the same structure as the two ends but retains the tubular structure which in turn is covered with an absorbable material (e.g., poly lactate).
[00025] In one embodiment of the present invention, a blood flow regulating device (the stent unit (130)) that can be configured between the chambers of the atrium through septum is disclosed. The device (130) can effectively relive the left atrial pressure by allowing the blood flow through interatrial shunt of pre shaped and pre-determined diameter. The blood flow regulating device (130) proposed herein can be advantageous in providing an improved blood flow regulating device with improved stability, allowing the improved support, and the ability to retain the calibrated size, and improved properties with respect to endothelialization.
BRIEF DESCRIPTION OF DRAWINGS
[00026] The accompanying figures, in which like reference numerals refer to identical or functionally similar elements throughout the separate views and which are incorporated in and form a part of the specification, further illustrate the present invention and, together with the detailed description of the invention, serve to explain the principles of the present invention.
[00027] FIG. 1 illustrates a perspective view of the versatile absorbable flow regulating device (VFRD) (100) comprising of a double balloon unit (150) operatively configured with a stent unit (130), in accordance with the disclosed embodiments;
[00028] FIG. 2 illustrates a perspective view of the stent unit (130) [mounted], in accordance with the disclosed embodiment;
[00029] FIG. 3 illustrates a perspective view of the stent unit (130) deployed in position, in accordance with the disclosed embodiments;
[00030] FIG. 4 illustrates an on-face view of the stent unit (130) with struts across the atrial septum of the mammalian, in accordance with the disclosed embodiments;
[00031] FIG. 5 illustrates a perspective view of the double balloon unit (150) showing the inner balloon (110) and outer balloon (120), in accordance with the disclosed embodiments;
[00032] FIG. 6 illustrates a perspective view of the double balloon unit (150) wherein the inner balloon (110) inflated, in accordance with the disclosed embodiments;
[00033] FIG. 7 illustrates a perspective view of the double balloon unit (150) wherein both the inner balloon (110) and outer balloon (120) inflated, in accordance with the disclosed embodiments;
[00034] FIG. 8 illustrates a perspective view of the double balloon unit (150) mounted with the stent unit (130), in accordance with the disclosed embodiments; and
[00035] FIG. 9 illustrates a perspective of the stent unit (130) inside the atrial septum of the mammalian, in accordance with the disclosed embodiments.
DETAILED DESCRIPTION
[00036] The principles of operation, design configurations and evaluation values in these non-limiting examples can be varied and are merely cited to illustrate at least one embodiment of the invention, without limiting the scope thereof.
[0001] The present invention teaches a versatile absorbable flow regulating device (VFRD) (100) that can be implanted between the chambers of the atrium through septum. This implantable device (100) is suitable for relieving the left atrial pressure by allowing the blood flow through interatrial shunt by pre-shaped and predetermined diameter.
[0002] The versatile absorbable flow regulating (VFRD) device (100) comprises a double balloon unit (150) comprising of an inner balloon (110) and an outer balloon (120) wherein the double balloon unit (150) can be operatively configured with a deployable stent unit (130) of oval shape which is made of a biodegradable implantable material (e.g., a magnesium-based alloy) and is absorbed into the body (heart portion) of a mammalian. The diameter of the inner balloon can of 4-12 mm diameter and the diameter of the outer balloon can be of 8-24 mm.
[0003] In one embodiment of the proposed invention the deployable stent unit (130) of the versatile absorbable flow regulating (VFRD) device (100) comprises a central covered element (210) and at least two distal flared elements (220 and 230) wherein the central covered element (210) and the distal flared elements (220 and 230) are made of magnesium alloy which can be absorbed into the mammalian organ (body). Further, the central tubular element is covered with a polylactide. It is to be noted that the polylactide material discussed herein should not be considered in any limited sense, alternatively a person skilled in the art can use any other degradable polymer (e.g., PLGA, PGA, PCL) without limiting the scope of the present invention. The distal flared elements (220 and 230) prevent endothelialization.
[0004] Note that the stent unit (130) disused herein is an exemplary embodiment of stent unit (130) that can be configured and deployed using the double balloon unit (110). Alternatively, a person skilled in the art can adapt the double balloon unit (110) to deploy any type of stent unit (130) without limiting the scope of the proposed invention.
[0005] The stent unit (130) for creating a shunt in the heart of a mammalian (human) can be coated with an antibiotic or any other drug. The stent unit (130) can be expanded for further requirements to adjust the physiology changes in the body.
[0006] The stent unit (130) can be incorporated with a plurality of pressure sensors on the right atrial side and left atrial side. The balloon-based stent unit (130) can be configured with varying size and shape depending on the physiological parameters of the mammalian. The size of the central hole of the stent unit (130) can be reduced through deployment of further devices and a partial central membrane can be incorporated to allow the change in calibre as the membrane is absorbed. The membrane is configured by using a partially biodegradable material or a filament or an elastic polymeric material or natural fabrics. Further, the membrane comprises an elastic polymeric material selected from a group including, but not limited to nylon, polyester, polypropylene, polytetrafluoroethylene, and expanded polytetrafluoroethylene etc. Also, the proximal and distal elements are expandable, and the proximal element has lower expansion strength than the distal element.
[0007] Another embodiment of the present invention teaches a method of manufacturing the stent unit (130) comprising steps of: braiding a tubular braid of wires where opposite ends of each wire are arranged at a proximal portion of the tubular braid, and loops of the wires are arranged at a distal end of the tubular braiding; forming a distal disc of the distal end of the tubular braiding; forming a proximal disk of the proximal end of the tubular braiding; forming a central aperture in each of the distal and proximal discs such that the apertures are joined by a central channel of the tubular braiding; extending between the discs and fixating the opposite ends of each wire of the tubular braid in a single connecting element located at the proximal disk wherein the single connecting element being set at a distance from a central axis extending through the channel.
[0008] The proximal and distal elements having a general stent shape defined by a tube of open cells molded at the right angle to the central tube. The central element is composed of the same structure as the two ends but retains the tubular structure which in turn is covered with an absorbable material (e.g., poly lactate).
[0009] In one embodiment of the present invention, a blood flow regulating device (the stent unit (130)) that can be configured between the chambers of the atrium through septum is disclosed. The device (130) can effectively relive the left atrial pressure by allowing the blood flow through interatrial shunt of pre shaped and pre-determined diameter. The blood flow regulating device (130) proposed herein can be advantageous in providing an improved blood flow regulating device with improved stability, allowing the improved support, and the ability to retain the calibrated size, and improved properties with respect to endothelialization.
[0010] It will be appreciated that variations of the above-disclosed and other features and functions, or alternatives thereof, may be desirably combined into many other different systems or applications. Also, that various presently unforeseen or unanticipated alternatives, modifications, variations or improvements therein may be subsequently made by those skilled in the field.
,CLAIMS:I/WE CLAIM
1. A versatile absorbable flow regulating device and method to develop balloon based stent delivery system, comprising:
a double balloon unit (150) comprising of an inner balloon (110) and an outer balloon (120) wherein the double balloon unit (150) can be operatively configured with a deployable stent unit (130) of oval shape which is made of a biodegradable implantable material (e.g., a magnesium-based alloy) and is absorbed into the body (heart portion) of a mammalian wherein the diameter of the inner balloon can of 4-12 mm diameter and the diameter of the outer balloon can be of 8-24 mm.
2. The device as claimed in claim 1 wherein the deployable stent unit (130) of the versatile absorbable flow regulating device (VFRD) (100) comprises a central covered tubular element (210) and at least two distal flared elements (220 and 230) wherein the central covered tubular element (210) and the distal flared elements (220 and 230) are made of magnesium alloy which can be absorbed into the mammalian organ (body) wherein the central tubular element is covered with a polylactate.
3. The device as claimed in claim 1 wherein the stent unit (130) for creating a shunt in the heart of a mammalian (human) can be coated with an antibiotic or any other drug wherein the stent unit (130) can be expanded for further requirements to adjust the physiology changes in the body.
4. The device as claimed in claim 1 wherein the stent unit (130) can be incorporated with a plurality of pressure sensors on the right atrial side and left atrial side wherein the balloon-based stent unit (130) can be configured with varying size and shape depending on the physiological parameters of the mammalian.
5. The device as claimed in claim 4 wherein the size of the central hole of the stent unit (130) can be reduced through deployment of further devices and a partial central membrane can be incorporated to allow the change in calibre as the membrane is absorbed.
6. The device as claimed in claim 4 wherein the membrane is configured by using a partially biodegradable material or a filament or an elastic polymeric material or natural fabrics.
7. A method for manufacturing the stent unit, comprising:
braiding a tubular braid of wires where opposite ends of each wire are arranged at a proximal portion of the tubular braid, and loops of the wires are arranged at a distal end of the tubular braiding; forming a distal disc of the distal end of the tubular braiding;
forming a proximal disk of the proximal end of the tubular braiding; forming a central aperture in each of the distal and proximal discs such that the apertures are joined by a central channel of the tubular braiding;
extending between the discs and fixating the opposite ends of each wire of the tubular braid in a single connecting element located at the proximal disk wherein the single connecting element being set at a distance from a central axis extending through the channel.
8. The device as claimed in claim 1 wherein the proximal and distal elements having a general stent shape defined by a tube of open cells molded at the right angle to the central tube wherein the central element is composed of the same structure as the two ends but retains the tubular structure which in turn is covered with an absorbable material (e.g., poly lactate).
9. The device as claimed in claim 1 wherein the stent unit (130) [a blood flow regulating device] can be configured between the chambers of the atrium through septum.
10. The device as claimed in claim 1 wherein the stent unit (130) can effectively relive the left atrial pressure by allowing the blood flow through interatrial shunt of pre shaped and pre-determined diameter.