MANUAL CLOT ASPIRATION AND FILTRATION SYSTEM AND METHOD OF REMOVING A CLOT

Abstract

A manual clot aspiration and filtration system enables a method of removing a clot without general anesthesia and the expense of an operating room. An aspiration and filtration system for bodily fluid utilizes a syringe coupled with a filter unit to draw bodily fluid through the filter unit to collect debris on the filter. A flow valve may then be turned and the plunger depressed to force the filtered fluid back into the body. The filter may be configured to capture particles such as blood clots and plaque. The filter unit has a cover that can be removed for inspection and/or removal of the collected debris. When the cover is replaced, trapped air may be removed by turning the flow-valve to a purge direction and pressing the plunger into the syringe to force fluid back toward the filter unit to purge the trapped air through the purge valve.

Claims

1. An aspiration and filtration system for bodily fluid comprising: a) an inlet-sheath; b) an inlet one-way valve coupled to the inlet sheath; c) a return-sheath; d) a return one-way valve coupled to the return sheath; e) a filter unit comprising: i) a filter housing having an inlet and an outlet; ii) a filter configured in the filter housing between the inlet and outlet; iii) a cover that is detachably attachable to the filter housing; wherein the filter unit is configured to receive said bodily fluid into the inlet from a patient and wherein said bodily fluid is configured to flow through the filter to the outlet of the filter unit, wherein the filter filters particles from the bodily fluid between the inlet and the outlet within the filter housing; wherein the filter is separate from the filter housing and the cover; wherein the filter is removable from the filter housing by removing the cover; f) a purge valve coupled to the filter housing cover and having an outlet opening configured above the filter housing to enable purging trapped air from the filter unit with bodily fluid contained within the filter unit; g) a syringe comprising a plunger within a barrel, wherein the syringe is configured between the filter unit and the return-sheath; h) a flow-valve coupled with the syringe; wherein the flow-valve is configured between the filter unit and the return-sheath and is configured for turning from an inlet flow configuration to a purge flow configuration; wherein the flow-valve has said inlet flow configuration for drawing said bodily fluid through the inlet-sheath, through the filter housing and into the syringe, whereby debris from the bodily fluid is collected by the filter; wherein the flow-valve has said purge flow configuration for forcing said bodily fluid from the syringe into the filter unit and air out of the outlet opening of the purge valve; and wherein the flow-valve has a return flow configuration for forcing said bodily fluid from the syringe into the return-sheath; wherein the return sheath is a separate sheath from the inlet-sheath, and wherein the return sheath is configured between the outlet of the filter housing and said patient; and wherein the said particles are configured to be removed from the filter housing with the bodily fluid retained in the filter housing.

2. The aspiration and filtration system of claim 1, wherein the filter has a mean flow pore size of 100 microns or less.

3. The aspiration and filtration system of claim 1, wherein the filter has a mean flow pore size of 50 microns or less.

4. The aspiration and filtration system of claim 1, wherein the filter has a filter efficiency of 95% or more for particles of 50 microns or greater.

5. The aspiration and filtration system of claim 1, wherein the syringe is coupled to the flow-valve by a luer lock fitting.

6. The aspiration and filtration system of claim 1, wherein the purge valve is coupled to the cover of the filter unit.

7. The aspiration and filtration system of claim 1, wherein the syringe has a volume of at least 30 cc.

8. The aspiration and filtration system of claim 7, wherein the filter housing has a volume that is less than the volume of the syringe.

9. The aspiration and filtration system of claim 1, wherein the syringe has a volume of at least 50 cc

10. The aspiration and filtration system of claim 9, wherein the filter housing has a volume that is less than the volume of the syringe.

11. The aspiration and filtration system of claim 1, wherein the bodily fluid is blood and the debris comprises thrombus.

12. The aspiration and filtration system of claim 1, wherein the cover makes an air-tight seal with the filter housing.

13. A method of aspiration and filtration of particles from blood comprising: a) providing the aspiration and filtration system of claim 1; b) coupling the inlet-sheath to a patient's artery; c) setting the flow-valve to the inlet flow configuration; d) drawing the plunger from the barrel to pull blood from the artery, through the inlet-sheath, through the inlet one-way valve, into the filter housing, through the filter and into the syringe; e) filtering particles on the filter and producing a volume of filtered blood; f) turning the flow-valve to the return flow configuration; g) depressing the plunger into the barrel to force the filtered blood out of the syringe, through the flow-valve, through the return one-way valve and into the return-sheath; h) turning the flow-valve back to the inlet flow configuration; i) detaching the cover after drawing the plunger from the barrel; j) subsequently removing the particles from the filter housing while retaining bodily fluid within the filter housing; k) subsequently re-attaching the cover to the filter housing, wherein air is trap in the filter housing; l) subsequently depressing the plunger into the syringe to force the filtered blood back into the filter housing and the air that is trapped in the filter housing out of the outlet opening of the purge valve; and m) subsequently drawing the plunger from the syringe to pull the filtered blood from the filter housing with the trapped air now removed into the syringe

14. The method of claim 13, further comprising coupling the return-sheath to said patient's artery downstream of the inlet-sheath.

15. The method of claim 14, wherein depressing the plunger forces the filtered blood back into the patient's artery.

16. (canceled)

17. (canceled)

18. (canceled)

19. (canceled)

20. (canceled)

21. (canceled)

22. The method of claim 13, subsequently comprising setting the flow-valve to the return flow configuration; and depressing the plunger into the syringe to force the filtered blood out of the syringe, through the flow-valve, through the return one-way valve and into the return-sheath.

23. The method of claim 22, further comprising coupling the return-sheath to said patient's artery downstream of the inlet-sheath, wherein depressing the plunger forces the filtered blood back into the patient's artery.

24. The method of claim 22, wherein a volume of the filter housing is less than a volume of the syringe.

25. The method of claim 22, wherein the filter has a mean flow pore size of 100 microns or less.

26. The method of claim 22, wherein the filter has a mean flow pore size of 50 microns or less.

27. The method of claim 22, wherein the filter has a filter efficiency of 95% or more for particles of 50 microns or greater.

28. The method of claim 22, wherein the syringe is coupled to the flow-valve by a luer lock fitting.

29. The method of claim 22, wherein the purge valve is coupled to the cover of the filter unit.

30. The method of claim 22, wherein the syringe has a volume of at least 30 cc.

31. The method of claim 30, wherein the filter housing has a volume that is less than the volume of the syringe.

32. The aspiration and filtration system of claim 1, wherein the cover makes an air-tight seal with the filter housing.

Description

BRIEF DESCRIPTION OF SEVERAL VIEWS OF THE DRAWINGS

[0014] The accompanying drawings are included to provide a further understanding of the invention and are incorporated in and constitute a part of this specification, illustrate embodiments of the invention, and together with the description serve to explain the principles of the invention.

[0015] FIG. 1 shows a perspective view of an exemplary aspiration and filtration system with the inlet-sheath and return-sheath being coupled with the vascular system of a patient.

[0016] FIG. 2 shows a top view of an exemplary aspiration and filtration system having a filtration unit and a syringe coupled with a flow-valve to control the direction of flow of blood through the system.

[0017] FIG. 3 shows a front view of an exemplary aspiration and filtration system having a filtration unit and a syringe coupled with a flow-valve to control the direction of flow of blood through the system.

[0018] FIG. 4 shows a cross sectional front view of an exemplary aspiration and filtration system having a one-way valve coupled with the inlet-sheath prior to the filtration unit and an purge valve configured on the top of the filtration unit to remove any air after inspection of any debris, such as clot particles, within the filter unit.

[0019] FIG. 5 shows a cross sectional view of the exemplary aspiration and filtration system shown in FIG. 4, drawing blood into the filter unit by the syringe, wherein the plunger of the syringe is being pulled out of the syringe to create suction; debris is being collected on the filter.

[0020] FIG. 6 shows a cross sectional view of the exemplary aspiration and filtration system shown in FIG. 5, having the filter unit cover removed to enable inspection and removal of the debris.

[0021] FIG. 7 shows a cross sectional view of the exemplary aspiration and filtration system shown in FIG. 6, having the filter unit cover replaced and the flow-valve turned to or configured in an purge direction to force blood from the syringe back into the filter unit to remove any gas, such as air through the purge valve configured above the filter housing.

[0022] FIG. 8 shows a front cross sectional view of an exemplary aspiration and filtration system having the flow-valve turned in a return direction to return filtered blood back to the patient.

[0023] FIG. 9 shows a front cross sectional view of an exemplary aspiration and filtration system with the syringe removed from the flow-valve.

[0024] FIG. 10 shows a front view of an exemplary flow-valve coupled with a return-sheath and the flow-valve turned in a filter direction for producing an inlet flow of blood into the filter unit.

[0025] FIG. 11 shows a front view of an exemplary flow-valve coupled with a return-sheath and the flow-valve turned in a return direction for directing a flow of blood to the patient.

[0026] Corresponding reference characters indicate corresponding parts throughout the several views of the figures. The figures represent an illustration of some of the embodiments of the present invention and are not to be construed as limiting the scope of the invention in any manner. Further, the figures are not necessarily to scale, some features may be exaggerated to show details of particular components. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a representative basis for teaching one skilled in the art to variously employ the present invention.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS

[0027] As used herein, the terms “comprises,” “comprising,” “includes,” “including,” “has,” “having” or any other variation thereof, are intended to cover a non-exclusive inclusion. For example, a process, method, article, or apparatus that comprises a list of elements is not necessarily limited to only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. Also, use of “a” or “an” are employed to describe elements and components described herein. This is done merely for convenience and to give a general sense of the scope of the invention. This description should be read to include one or at least one and the singular also includes the plural unless it is obvious that it is meant otherwise.

[0028] Certain exemplary embodiments of the present invention are described herein and are illustrated in the accompanying figures. The embodiments described are only for purposes of illustrating the present invention and should not be interpreted as limiting the scope of the invention. Other embodiments of the invention, and certain modifications, combinations and improvements of the described embodiments, will occur to those skilled in the art and all such alternate embodiments, combinations, modifications, improvements are within the scope of the present invention.

[0029] Referring to FIGS. 1 and 2, an exemplary aspiration and filtration system 10 is configured to draw bodily fluid 16, such as blood, from a patient 12 through an inlet-sheath 20 and return the flow of bodily fluid to the patient through a return-sheath 22. Blood may be drawn by the syringe 30 into a filter unit 40 where any debris, such as clot particles are collected. The syringe has a syringe barrel 31 that the plunger 32 moves within to draw fluid in and force fluid out. The flow-valve 60 can then be turned to a return direction to direct the filtered blood back into the patient through the return-sheath. An inlet one-way valve 21 is configured between the patient and the filter unit and a return one-way valve 23 is configured between the flow-valve 60 and the patient. The filter unit has a cover 50 that can be removed to inspect and/or remove any debris collect by the filter, therein. This inspection process introduces air into the system, and specifically into the filter housing, that will have to be removed before the flow of bodily fluid in resumed by the system. The flow-valve can be turned to purge direction to direct fluid flow back into the filter unit and force any air through the outlet opening 49 of the purge valve 48. The inlet one-way valve 21 will stop flow back into the inlet sheath 20 and thereby force it out of the purge valve. Note that the outlet opening is above the filter housing to ensure that the trapped air is purged from the filter housing. Also, the purge valve is configured with or coupled to the cover 50 of the filter unit.

[0030] As shown in FIG. 3, an exemplary aspiration and filtration system 10 has a filtration unit 40 and a syringe 30 coupled with a flow-valve 60 to control the direction of flow of bodily fluid through the system. The plunger 32 of the syringe can be drawn from the syringe barrel 31 to pull blood into the syringe. Blood flows through the inlet one-way valve 21, through the filter 45 in the filter unit 40, through the filter sheath 25 and into the syringe. The filter sheath, such as a conduit extends from the filter unit 40 and the syringe 30 and may be coupled with the flow valve 60. The flow-valve 60 can then be turned to a return direction to force the fluid from the syringe into the return-sheath. The blood will flow through the flow-valve, through the return one-way valve 23, through the return sheath 22 and back into the patient, or be expelled.

[0031] As shown in FIG. 4, a filter unit 40 has a filter 45 configured therein to produce a pre-filter portion 44 upstream of the filter, and filtered portion 46 downstream of the filter, when bodily fluid is flowing into the syringe. A cover 50 is configured over the filter housing 42 and a purge valve 48 is configured above the top 47 of the filter unit or filter housing to enable gas, such as air be expelled from the system. The outlet opening 49 of the purge valve is above the enclosed space of the filter unit, or the volume of space within the filter unit from the inlet one-way valve 21 and the outlet 43 of the filter unit or housing. There is a volume for the flow of bodily fluid from the inlet one-way valve to the inlet 41 of the filter unit, or housing. It may be desirable for the inlet one-way valve to be configure proximal to the filter housing or be configured between the filter housing and the inlet sheath. The inlet one-way valve may be coupled to and between the filter housing and the inlet sheath, for example.

[0032] As shown in FIG. 5, the exemplary aspiration and filtration system shown in FIG. 4, is drawing fluid 16, such as blood, into the filter unit 40 by the syringe 30, wherein the plunger 32 of the syringe is being pulled out of the syringe barrel 31 to create suction. Debris 70, such as clot debris and plaque, is being collected on the filter 45. The filtered fluid 17, 17′ is drawn into the syringe. The flow-valve 60 is configured in a filter direction to allow inlet flow of bodily fluid into the filter unit 40 in this process step of the aspiration and filtration method.

[0033] As shown in FIG. 6, the exemplary aspiration and filtration system shown in FIG. 5 has the filter unit cover 50 removed to enable inspection and removal of the debris 70. As described herein, this will introduce air into the system.

[0034] As shown in FIG. 7, the exemplary aspiration and filtration system 10 shown in FIG. 6 has the filter unit cover 50 replaced and the flow-valve 60 is still in the filter direction, or a purge direction now as pushing the plunger 32 back into the syringe barrel 31 causes the filtered fluid 17 to flow from the syringe back into the filter unit 40 to purge trapped air from the filer housing 42. Gas in the filter unit will flow through the outlet opening 49 of the purge valve 48 as the plunger is depressed. Note that the inlet one-way valve 21 prevents flow of fluid back into the inlet-sheath.

[0035] As shown in FIG. 8, an exemplary aspiration and filtration system 10 has the flow-valve 60 turned in a return direction to return filtered fluid 17 back to the patient through the return one-way valve 23 and the return-sheath 22.

[0036] As shown in FIG. 9 an exemplary aspiration and filtration system 10 has the syringe 30 removed from the flow-valve 60. The syringe has a coupled end 34, or end that couples with the flow-valve, such as through a luer lock, an example of a valve syringe coupling 62. A Luer lock has threads 63 that couple with the threads 33 of the coupled end 34 of the syringe.

[0037] As shown in FIG. 10, an exemplary flow-valve 60 is coupled with a return-sheath 22 and the flow-valve is configured in an inlet flow configuration, or filter direction, to allow a flow of filtered fluid into the syringe or a flow of filtered fluid back into the filter unit to purge any air.

[0038] As shown in FIG. 11, an exemplary flow-valve 60 is coupled with a return-sheath 22 and the flow-valve 60 is configured in a return flow configuration, or return direction, to force fluid from the syringe through the return sheath 22 to the patient or to expel the fluid.

[0039] It will be apparent to those skilled in the art that various modifications, combinations and variations can be made in the present invention without departing from the scope of the invention. Specific embodiments, features and elements described herein may be modified, and/or combined in any suitable manner. Thus, it is intended that the present invention cover the modifications, combinations and variations of this invention provided they come within the scope of the appended claims and their equivalents.