The present invention relates generally to the field of medical devices intended for removing blockages from blood vessels. More particularly, the present invention relates to a thrombectomy device for the removal of Coronary/Peripheral vessel Thrombus.
BACKGROUND OF THE INVENTION
Cardiovascular disease (CVD) is a general term for conditions affecting the heart or blood vessels. It's usually associated with a build-up of fatty deposits inside the arteries and an increased risk of blood clots. It can also be associated with damage to arteries in organs such as the brain, heart, and eyes.
Cardiovascular diseases (CVDs) have become the prime germ of deaths in India which have started affecting the individuals at least a decade earlier and in their most productive midlife years. An attestation to the existence of cardiovascular disease (CVD) is the development of thrombus in the vascular system. When the blood vessels of the vascular system are blocked by thrombus, the procedure of angioplasty is executed to dilate occluded areas to maintain the normal blood flow in the peripheries of blood vessels.
The thrombus which blocks the blood vessel is usually comprised of fibrin. Various known techniques for the removal of thrombus include both chemical and mechanical method. Chemical method involves the injection of lysing agents into the systemic vessels or near the blood clots to dissolve and disperse the thrombus. The mechanical treatment involves the use of catheters which removes the thrombus from the blood vessel. In each of these cases, although the block is reduced in size or a passageway is created, the residual thrombus sometimes remains within the vessel.
Since the removal of these residues is very critical to ensure that it does not migrate to other parts of the vessel, as such migration could lead to serious complications, such as embolism, stroke, or a heart attack. The existing device fails to resist the migration of thrombus residue to other parts of the blood vessel. Therefore, there is a need to create a medical device in which the elements of the device are used to clear the blockage and effectively remove the residual thrombus fragments from the blood vessel.
OBJECTS OF THE INVENTION
An object of the invention is to provide a thrombectomy device for the removal of Coronary/Peripheral Artery Thrombus.
Another object of the invention is to provide a thrombectomy device which functions to deploy, scoop, collect, and remove the thrombus from the blood vessel walls without tearing the blood vessel.
Another object of the invention is to provide a thrombectomy device which effectively removes and collect the residual fragments of thrombus from the blood vessel.
Yet another object of the invention is to provide a thrombectomy device which does not allow the escaping of thrombus fragments into the other blood vessels
Still another object of the invention is to provide a thrombectomy device which is easy to use and cost effective.
SUMMARY OF THE INVENTION
The inventors of the present invention have invented a thrombectomy device for removing a thrombus from a blood vessel. The device includes a nitinol meshed collection bag and an inner balloon catheter within the collection bag. The guide wire is inserted through a lumen which places the device near to the thrombus after crossing through the thrombus. Then, the balloon is inflated, the inflation leads to the opening of meshed collection bag. Subsequently the balloon will be deflated. The meshed collection bag being of Nitinol/stainless steel or its alloys or any medical grade material) material retains its inflated shape. The meshed collection bag is then pulled outwards carrying the thrombus inside it. Then the complete device which includes the deflated balloon, the meshed collecting bag and thrombus is withdrawn with the thrombectomy device.
According to a first aspect of the invention, a thrombectomy device for the removal of Coronary/Peripheral Artery Thrombus is provided. The thrombectomy device comprises a guide wire, a catheter with a shaft running on the guide wire, a meshed collection bag coupled to the first end of the shaft, an inflatable balloon engulfed inside the meshed collection bag, the inflatable balloon capable of inflating the meshed collection bag along with the inflation of the balloon, four threads connected to an open end of the meshed collection bag on one side and to the shaft on the other side; the four threads being merging at a single point on to the shaft to form a single string. Further, the meshed collection bag is closed or deflated by pulling the four threads using the string which collects the thrombus inside the meshed collected bag without escaping the fragments of the thrombus.
In accordance with an embodiment of the present invention, the material of the meshed collected bag is medical-grade stainless steel or cobalt alloy metal.
In accordance with an embodiment of the present invention, the meshed collection bag is inflated using the balloon and the meshed collected bag retains its shape until closed or deflated by pulling the string.
In accordance with an embodiment of the present invention, the meshed collection bag is having a cup shaped appearance having the open end and a closed end.
In accordance with an embodiment of the present invention, the threads are connected at an equal distance on to the open end of the meshed collection bag.
In accordance with an embodiment of the present invention, the meshed collection bag is inflated using the balloon and the meshed collected bag retains its shape until closed or deflated by pulling the string.
BRIEF DESCRIPTION OF DRAWINGS
So that the manner in which the above recited features of the present invention can be understood in detail, a more particular description of the invention, briefly summarized above, may have been referred by embodiments, some of which are illustrated in the appended drawings. It is to be noted, however, that the appended drawing illustrate only typical embodiments of this invention and are therefore not to be considered limiting of its scope, for the invention may admit to other equally effective embodiments.
These and other features, benefits, and advantages of the present invention will become apparent by reference to the following text figure, with like reference numbers referring to like structures across the views, wherein:
Figure 1 illustrates a thrombectomy device, in accordance with an embodiment of the invention;
Figure 2 illustrates the meshed collection bag, in accordance with an embodiment of the invention;
Figure 3A illustrates the meshed collection bag with an inflated balloon, in accordance with an embodiment of the present invention;
Figure 3B illustrates the meshed collection bag with a deflated balloon, in accordance with an embodiment of the present invention;
Figure 4 illustrates a magnified view of the meshed collection bag with threads, in accordance with an embodiment of the invention; and
Figure 5 illustrates an exemplary steps wise representation of functioning of the thrombectomy device, in accordance with an embodiment of the present invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
While the present invention is described herein by way of example using embodiments and illustrative drawings, those skilled in the art will recognize that the invention is not limited to the embodiments of drawing or drawings described and are not intended to represent the scale of the various components. Further, some components that may form a part of the invention may not be illustrated in certain figures, for ease of illustration, and such omissions do not limit the embodiments outlined in any way. It should be understood that the drawings and detailed description thereto are not intended to limit the invention to the particular form disclosed, button the contrary, the invention is to cover all modifications, equivalents, and alternatives falling within the scope of the present invention as defined by the appended claim. As used throughout this description, the word “may” issue in a permissive sense (i.e. meaning having the potential to), rather than the mandatory sense, (i.e. meaning must).
Further, the words “a” or “an” mean “at least one” and the word “plurality” means “one or more” unless otherwise mentioned. Furthermore, the terminology and phraseology used herein is solely used for descriptive purposes and should not be construed as limiting in scope. Language such as “including”, “comprising”, “having,” “containing,” or “involving,” and variations thereof, is intended to be broad and encompass the subject matter listed thereafter, equivalents, and additional subject matter not recited, and is not intended to exclude other additives, components, integers or steps. Likewise, the term “comprising” is considered synonymous with the terms “including” or “containing” for applicable legal purposes. Any discussion of documents, acts, materials, devices, articles and the like is included in the specification solely for the purpose of providing a context for the present invention. It is not suggested or represented that any or all of these matters form part of the prior art base or were common general knowledge in the field relevant to the present invention.
In this disclosure, whenever a composition or an element or a group of elements is preceded with the transitional phrase “comprising”, it is understood that we also contemplate the same composition, element or group of elements with transitional phrases “consisting of”, “consisting”, selected from the group of consisting of, “including”, or “is” preceding the recitation of the composition, element or group of elements and vice versa.
The present invention is described hereinafter by various embodiments with reference to the accompanying drawing, wherein reference numerals used in the accompanying drawing correspond to the like elements throughout the description. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiment set forth herein. Rather, the embodiment is provided so that this disclosure will be thorough and complete and will fully convey the scope of the invention to those skilled in the art. In the following detailed description, numeric values and ranges are provided for various aspects of the implementations described. These values and ranges are to be treated as examples only and are not intended to limit the scope of the claims. In addition, a number of materials are identified as suitable for various facets of the implementations. These materials are to be treated as exemplary and are not intended to limit the scope of the invention.
Referring to drawings the invention will be describe in detail. Figure 1 illustrates a thrombectomy device (100), in accordance with an embodiment of the invention. As shown in figure 1, the thrombectomy device (100) is used for the removal of Coronary/Peripheral Artery Thrombus. The thrombectomy device (100) comprises a guide wire (not shown in figures) and a catheter (102). The catheter (102) includes a shaft (104) which is hollow from inside. The shaft (104) and the catheter (102) along moves on the guide wire which is pre-inserted into the blood vessel. Further, the thrombectomy device (100) comprises a meshed collection bag (106). The meshed collection bag (106) is provided on the first end (108) of the shaft (104).
Figure 2 illustrates the meshed collection bag (106), in accordance with an embodiment of the invention. The material of the meshed collection bag (106) is medical-grade stainless steel or cobalt alloy metal. In accordance with an embodiment of the invention, the material of meshed collection bag (106) may be selected from, but not limited to, Nickel Titanium shape memory alloys and Nitinol. The material of meshed collection bag (106) may include properties such as but not limited to, biocompatibility, super elasticity and fatigue resistance and kink resistance. It may be obvious for the person skilled in the art to use similar material or material having properties similar instead of the materials mentioned above. Thus, the invention must not be seen in limiting the scope of the invention.
Figure 3A illustrates the meshed collection bag (106) with an inflated balloon (302), in accordance with an embodiment of the present invention. As shown in figure 3A, the meshed collection bag (106) comprises an inflatable balloon (302). The inflatable balloon (302) is engulfed inside the meshed collection bag (106). The mouth of the inflatable balloon (302) is connected to the shaft (104). Thus, the balloon (302) is inflated by in-deflater filled with saline contrast attached to the proximal hub of the shaft (104). The pressure required to inflate the balloon (302) is transferred through the shaft (104) into the mouth of the balloon. In accordance with an embodiment of the present invention, as the inflatable balloon is engulfed inside the meshed collection bag (106), in that manner, the inflatable balloon (302) inflates the meshed collection bag (106) along with the inflation of the balloon (302).
Figure 3B illustrates the meshed collection bag (106) with a deflated balloon (302), in accordance with an embodiment of the present invention. As shown in figure 3B, the meshed collection bag (106) retains its shape after the deflation of the balloon (302). As the material of the meshed collected bag (106) is stainless steel or cobalt alloy metal or nitinol which are all hard and malleable materials. Thus, when the meshed collection bag (106) is inflated using the balloon (302), the meshed collected bag (106) retains its inflated shape (as shown in figure 3B) until closed or deflated. In accordance with an embodiment of the invention, the meshed collection bag (106) when inflated is having a cup shaped appearance and includes an open end (304) and a closed end (306).
Figure 4 illustrates a magnified view of the meshed collection bag (106) with threads (402), in accordance with an embodiment of the invention. As shown in figure 4, the meshed collection bag (106) is connected to four threads (402). The four threads (402) are connected to the open end (304) of the meshed collection bag (106) on one side and to the shaft (104) on the other side. Further, the threads (402) are connected at an equal distance on to the open end (304) of the meshed collection bag (106). Precisely, the open end (304) of cup shape appearance of the meshed collecting bag (106) contains four equidistant hooks supporting the connecting threads (402) to merge at one single point as a single string (404). The single string (404) facilitates the closure of the meshed collecting bag (106), when the string (404) is pulled. That is, the meshed collection bag (106) is closed or deflated by pulling the four threads (402) through the string (404) which collects the thrombus inside the meshed collected bag (106) without escaping the fragments of the thrombus or clot. In accordance with an embodiment of the invention, the material of the threads is one of but not limited to, Nitinol or any adaptable material. Moreover, the density of the mesh size of meshed collected bag (106) in the range of 80-100 micrometers (0.08 to 0.1 mm) that does not allow the thrombus particles to escape through the meshed collected bag (106).
Figure 5 illustrates an exemplary steps wise representation of functioning of the thrombectomy device (100), in accordance with an embodiment of the present invention. As shown in figure 5, the catheter (102) along with the shaft (104) is guided on the guide wire (not shown in figures) near the thrombus inside the blood vessel (502). The shaft (104) is advanced further penetrating the thrombus, that is the meshed collection bag (106) along with the balloon (302) passes through the thrombus/clot by dislodging the thrombus.
Once, the meshed collection bag (106) with the balloon (302) passes the thrombus. The balloon (302) is inflated which in turn inflates the meshed collecting bag (106). The balloon is then deflated while the meshed collecting bag retains its shape of the blood vessel (502). Further, the open end (304) of the cup shape appearance of the meshed collecting bag (106) includes four equidistant hooks supporting the connecting threads (402) to merge at one single point as a single string (404) facilitating the closure of the meshed collecting bag, when pulled. The advantage provided by the cup shaped meshed collecting bag (106) is being that the meshed collecting bag (106) completely engulfs the thrombus which negates the possibility of escaping the thrombus and its fragments.
At the last, the malleable meshed collection bag (106) is closed by manually pulling the string (404) which further pulls the connecting threads (402) leading to closure/deflation of the meshed collection bag (106). The overall apparatus is then retracted and then the meshed collection bag (106) containing thrombus mass is taken out.
The present invention includes many advantages. One of the major advantages is that the thrombus or clot is completely removed from the blood vessel and no thrombus fragments are transferred into other blood vessels. Further, the mesh collection bag (106) is reusable. That is, the mesh collecting bag (106) would be sterilized and can last up to few intervention procedures. Further, hydrophilic Coating can be done on the mesh collecting bag (106) to increase the trackability. Lastly, the device is cost effective the balloon catheter can be reused.
Various modifications to these embodiments are apparent to those skilled in the art from the description and the accompanying drawings. The principles associated with the various embodiments described herein may be applied to other embodiments. Therefore, the description is not intended to be limited to the embodiments shown along with the accompanying drawings but is to be providing broadest scope of consistent with the principles and the novel and inventive features disclosed or suggested herein. Accordingly, the invention is anticipated to hold on to all other such alternatives, modifications, and variations that fall within the scope of the present invention and appended claims.

CLAIMS

We claim:

1. A thrombectomy device (100) for the removal of Coronary/Peripheral artery thrombus, comprises
? a guide wire;
? a catheter (102) with a shaft (104) running on the guide wire;
characterized in that
? a meshed collection bag (106) coupled to the first end (108) of the shaft (104);
? an inflatable balloon (302) engulfed inside the meshed collection bag (106), the inflatable balloon (302) capable of inflating the meshed collection bag (106) along with the inflation of the balloon (302);
? four threads (402) connected to an open end (304) of the meshed collection bag (106) on one side and to the shaft (104) on the other side; the four threads (402) being merging at a single point on to the shaft (104) to form a single string (404);
wherein the meshed collection bag (106) is closed or deflated by pulling the four threads (402) using the string (403) which collects the thrombus inside the meshed collection bag (106) without escaping the fragments of the thrombus.

2. The device (100) as claimed in claim 1, wherein material of the meshed collection bag is Nitinol.

3. The device (100) as claimed in claim 1, wherein the meshed collection bag (106) is inflated using the balloon (302) and the meshed collected bag (106) retains its shape until closed or deflated by pulling the string (404).

4. The device (100) as claimed in claim 1, wherein the meshed collection bag (106) is having a cup shaped appearance having the open end (304) and a closed end (306).

5. The device (100) as claimed in claim 1, wherein the threads (402) are connected at an equal distance on to the open end (304) of the meshed collection bag (106).