Thrombectomy catheter and methods of use
11134967 ยท 2021-10-05
Inventors
- Eric Raul Guerra (Ooltewah, TN, US)
- Xochitl Brahms Guerra (Ooltewah, TN, US)
- Mayra Paulina Guerra (Ooltewah, TN, US)
Cpc classification
A61M2025/09175
HUMAN NECESSITIES
A61M25/0147
HUMAN NECESSITIES
A61B17/221
HUMAN NECESSITIES
A61M25/0074
HUMAN NECESSITIES
A61M2025/0037
HUMAN NECESSITIES
A61B17/3207
HUMAN NECESSITIES
A61M25/003
HUMAN NECESSITIES
International classification
A61B17/3207
HUMAN NECESSITIES
A61B17/221
HUMAN NECESSITIES
A61B17/22
HUMAN NECESSITIES
Abstract
A thrombectomy catheter with a catheter or delivery sheath having a dual lumen extending therethrough, the catheter having a proximal segment and a distal segment and a linear section coupled therebetween, the distal segment configured as a loop, a port or aperture formed therein said dual lumen of said catheter, the port positioned proximate the distal segment, and a guidewire configured to longitudinally traverse therethrough one of the dual lumen of the catheter, said guidewire having a first end affixed to a mesh strainer, the mesh strainer configured to longitudinally traverse therethrough the other of the dual lumen of the catheter and exit therethrough said port and follow said loop to form retractable mesh strainer.
Claims
1. A hand operated surgical device to traverse within a patient's vessel to a thrombus located therein, said surgical device comprising: a flexible positioning instrument having an elongated catheter with a dual lumen bore therein extending from a first catheter end to a second catheter end, said dual lumen bore having a first lumen and a second lumen, said first lumen extends therethrough said elongated catheter from said first catheter end to said second catheter end, and therethrough a flexible pigtail extending therefrom said second catheter end, said flexible pigtail configured as a loop having a pigtail end that loops back to a position proximate said second catheter end, said pigtail end having a guidewire exit aperture, said second lumen extends therethrough said elongated catheter from said first catheter end therethrough said second catheter end, to an instrument exit aperture proximate said second catheter end; a guidewire extendable therethrough said first lumen of said elongated catheter and said pigtail, and extendable therefrom said guidewire exit aperture, said guidewire configured to straighten said pigtail upon passage therethrough to enable said second catheter end and said pigtail to traverse within the patient's vessel to the thrombus and retraction of said guidewire returns said first lumen to said pigtail; and a retractable instrument having a proximal member and a distal member coupled to said proximal member, said distal member having a deformable circular rim and a barrier membrane affixed thereto, said deformable circular rim extendable therethrough said instrument exit aperture to expand said deformable circular rim to deploy said barrier membrane, wherein rotation of said first catheter end of said elongated catheter rotates said flexible pigtail, said flexible pigtail rotates said deformable circular rim and said barrier membrane by contact with said flexible pigtail to capture the thrombus therein said barrier membrane.
2. The surgical device of claim 1, further comprising a guidewire entrance aperture connected to said first lumen and positioned proximate said first catheter end.
3. The surgical device of claim 1, further comprising an instrument entrance aperture connected to said second lumen and positioned proximate said first catheter end.
4. The surgical device of claim 1, further comprising a hand grip affixed thereto said first catheter end.
5. The surgical device of claim 1, wherein said retractable instrument is configured to be withdrawn from said second lumen to remove the thrombus from the patient's vessel.
6. The surgical device of claim 1, wherein said flexible pigtail is configured with a single lumen bore.
7. The surgical device of claim 1, wherein said deformable circular rim is configured to collapse upon entry therein said instrument exit aperture and traverse within said second lumen with the thrombus trapped therein said barrier membrane.
8. The surgical device of claim 1, wherein said deformable circular rim and said barrier membrane are configured to deploy therefrom said instrument exit aperture proximate said flexible pigtail.
9. The surgical device of claim 1, wherein said deformable circular rim further comprises a first deformable section and second deformable section.
10. The surgical device of claim 9, wherein said deformable rim further comprises a pivot joint positioned therebetween said first deformable section and said second deformable section.
11. The surgical device of claim 10, wherein said pivot joint is configured to collapse upon entry therein said instrument exit aperture and said first deformable section and said second deformable section are configured to traverse within said second lumen with the thrombus trapped therein said barrier membrane.
12. The surgical device of claim 10, wherein said pivot joint and said first deformable section, said second deformable section, and said barrier membrane are configured to deploy therefrom said instrument exit aperture.
13. The surgical device of claim 12, wherein a rotation of said elongated catheter results in said rotation of said pigtail and further results in said rotation of said pivot joint, said first deformable section, said second deformable section to collect a biomaterial therein.
14. The surgical device of claim 10, wherein said rotation of said flexible pigtail rotates said first deformable section and said second deformable section by contact with said flexible pigtail to capture the thrombus therein said barrier membrane.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) The present thrombectomy catheter and methods of use will be better understood by reading the Detailed Description of the embodiments with reference to the accompanying drawing figures, in which like reference numerals denote similar structure and refer to like elements throughout, and in which:
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(13) It is to be noted that the drawings presented are intended solely for the purpose of illustration and that they are, therefore, neither desired nor intended to limit the disclosure to any or all of the exact details of construction shown, except insofar as they may be deemed essential to the claimed invention.
DETAILED DESCRIPTION
(14) In describing the exemplary embodiments of the present disclosure, as illustrated in
(15) Referring now to
(16) Furthermore, second catheter end 22 of surgical positioning instrument 10 may be configured as a loop, open ended loop, or enclosure, such as pigtail 50 formed thereon or attached thereto second catheter end 22. It is contemplated herein that pigtail 50 may be formed in a variety of sizes and configurations and include first pigtail section 51 and second pigtail section 52 with first pigtail section 51 affixed thereto second catheter end 22 of elongated catheter 20 and second pigtail section 52 forming an enclosure that loops around back to a position proximate second catheter end 22. It is contemplated herein that elongated catheter 20 and pigtail 50 may preferably be configured or constructed of plastic, polymeric material includes polytetrafluorethylene, polyurethane, polyethylene, Teflon, and the like as such materials offers a variety of forms, shapes, ease of manufacture, and flexibility; however, other suitable materials may be utilized provided such material has sufficient strength, flexibility, and/or durability as would meet the purpose described herein. The material of elongated catheter 20, second lumen 32 pigtail 50, second lumen or medical instrument exit aperture 25 may be reinforced with fibers, rings, or longitudinal ribs, for example, to enable it to withstand the forces exerted on it by retractable instrument 60 while it is constrained within second lumen 32 and deformed by elongated catheter 20.
(17) First lumen 31 may extend therethrough hand grip 36, elongated catheter 20, and pigtail 50, beginning with an entrance hole, such as first lumen or guidewire entrance aperture 24 and exit therefrom pigtail 50 proximate pigtail end 53 through an exit or deployment hole opening to the environment, such as first lumen or guidewire exit aperture 26.
(18) Second lumen 32 may extend therethrough hand grip 36 and elongated catheter 20 beginning with an entrance hole, such as first instrument aperture 23 and exit therefrom elongated catheter 20 proximate second catheter end 22 through an exit or deployment hole, such as second instrument aperture 25 proximate second catheter end 22.
(19) Referring now to
(20) Alternatively, first lumen 31 and pigtail lumen 31B may be utilized as an access for additional laparoscopic or endoscopic devices, and/or fluid access or withdrawal, lighting, video, and like medical instruments 40A. Such an endoscope can also provide surgical implements such as lasers, scalpels, irrigation and aspiration means, visualization means, and the like 40A. The specific configuration and dimensions of first lumen 31 and pigtail lumen 31B will vary with the intended use of surgical positioning instrument 10, and whether access for additional medical instruments 40A is provided. In general the axial bore of first lumen 31 may have an internal diameter of 6-12 F (French=1/3 mm), however other diameters are contemplated herein to accommodate a working channel of an endoscope.
(21) Referring now to
(22) Moreover, deformable rim 67 may be configured of one or two components, such as first deformable section 61 and second deformable section 62 and may alternatively include one or more pivot joint 68 therebetween first deformable section 61 and second deformable section 62. Deformable rim 67 is preferably made of a flexible, elastic, or shape memory material or alloy biocompatible material capable of flexing, bending, or collapsing to a configuration which may enter and exit first instrument aperture 23, traverse axial bore of second lumen 32, expanding to deployed net after passing therethrough second instrument aperture 26, and collapsing to re-enter second instrument aperture 26 to extract biomaterial therefrom a blood vessel or other vascular channel or conduit V.
(23) It is further contemplated herein that deformable rim 67 may include one or more joints or hinges, such as pivot point 68 positioned therearound deformable rim 67 or between first deformable section 61 and second deformable section 62 to enable deformable rim 67, first deformable section 61, and second deformable section 62 to linearly collapse or fold and traverse therethrough first instrument aperture 23, axial bore of second lumen 32, and second instrument aperture 25. It is still further contemplated herein that deformable rim 67 may form an opening, such as rim inlet 69.
(24) When expanded, deformable rim 67 may have a diameter of from about 1 cm or less to about 3 cm but other sizes are contemplated herein. Moreover, a barrier membrane or other sifting or filtering membrane, such as mesh strainer 63 preferably runs, spans, or is affixed thereto deformable rim 67 loosely, forming a rounded open end capture net across rim inlet 69. Mesh strainer 63 may be utilized to filter or capture clots, plaque, emboli, thrombi (blood clots), fatty deposit, or other undesirable material or debris from within human blood vessels V.
(25) The specific configuration and dimensions of axial bore of second lumen 32 will vary with the use of surgical positioning instrument 10, the parameters of retractable instrument 60, such as insertion/retraction member 64 and sized to receive deformable rim 67 having first deformable section 61 and second deformable section 62 in a constrained configuration with mesh strainer 63 furled around first deformable section 61, second deformable section 62, and insertion/retraction member 64. In general, the axial bore of second lumen 32 may have an axial bore or internal diameter of 6-12 F (French=1/3 mm) to accommodate retractable instrument 60 in a constrained configuration, however other diameters are contemplated herein.
(26) Alternatively, second lumen 32 may be utilized as an access for additional laparoscopic or endoscopic devices, and/or fluid access or withdrawal, lighting, video, and like medical instruments 40A. Such an endoscope can also provide surgical implements such as lasers, scalpels, irrigation and aspiration means, visualization means, and the like 40A.
(27) Referring again to
(28) Referring now to
(29) In use, deformable rim 67 of first member end 65 may be preferably collapsed and mesh strainer 63 may be furled or wrapped therearound deformable rim 67 and/or first member end 65 of retractable instrument 60. Collapsed deformable rim 67 and furled mesh strainer 63 may be inserted therein first instrument aperture 23 of second lumen 32. Collapsed deformable rim 67 and furled mesh strainer 63 may be disposed within, extended, and traverse therethrough second lumen 32 of elongated catheter 20 and exit or deploy therethrough or extendable therefrom. Upon deformable rim 67 and furled mesh strainer 63 exit thereof second lumen 32, deformable rim 67 expands to deployed deformable rim 67 with mesh strainer 63 unfurled to an expanded collection state positioned proximate pigtail 50. When deployed first deformable section 61 and second deformable section 62 of deformable rim 67 expand back to a non-compressed position as shown in
(30) Referring now to
(31) It is contemplated herein that deformable rim 67 and pigtail 50 may be similar or matched in size and shape, such as circumference and/or diameter, to enable abutting or contact therebetween pigtail 50 and deformable rim 67 (deformable rim 67 abuts pigtail 50).
(32) Referring now to
(33) In use, push/pull P1 of guidewire 40 may be extended therethrough pigtail 50, causing pigtail 50 to straighten or elongate (as shown in
(34) Push/pull P1 of second member end 66 results in exit or deployment of deformable rim 67 having rim inlet 69 and mesh strainer 63 therethrough second instrument aperture 25 proximate a junction between second catheter end 22, and expanding to deployed deformable rim 67 with mesh strainer 63 after passing therethrough second instrument aperture 25 to a position proximate pigtail 50 therein blood vessel V.
(35) Moreover, rotation R3 of second member end 66 results in rotation R4 of deformable rim 67 within blood vessel V having rim inlet 69 and mesh strainer 63, which in turn causes deformable rim 67 having rim inlet 69 and mesh strainer 63 of retractable instrument 60 to scoop up or collect or capture clots, plaque, emboli, thrombi (blood clots), fatty deposit, biomaterial, or other undesirable material or debris M from blood vessel V.
(36) Furthermore, rotation R1 of elongated catheter 20 results in rotation R2 of pigtail 50 within blood vessel V which in turn results in rotation R4 of deformable rim 67 having rim inlet 69 and mesh strainer 63 due to abutting or contact therebetween pigtail 50 and deformable rim 67, which in turn causes deformable rim 67 having rim inlet 69 and mesh strainer 63 of retractable instrument 60 to scoop up or collect or capture clots, plaque, emboli, thrombi (blood clots), fatty deposit, biomaterial, or other undesirable material or debris M from blood vessel V.
(37) Push/pull P1 of second member end 66 results in collapsed deformable rim 67 having rim inlet 69 and mesh strainer 63 being retracted or entry therein second instrument aperture 25 and traversing therethrough second lumen 32 to first instrument aperture 23 to remove undesirable material or debris M captured therein mesh strainer 63 from blood vessel V. It is contemplated herein that such capture and retrieval of undesirable material or debris M may be accomplished multiple times with multiple passes, deployment, retract, and retrieval of retractable instrument 60 therethrough second lumen 32 of surgical positioning instrument 10.
(38) It is contemplated herein that second lumen 32 angioplasty, atherectomy, and deployment of stents and stent-grafts, procedures to treat vascular disease may be deployed therethrough second lumen 32. Such instruments often dislodge material or plaque from the vessel walls of blood vessel V, which may result in the formation of clots or the release of emboli, biomaterial, such as undesirable material or debris M, which enter the bloodstream, and may be large enough to occlude smaller downstream vessels and potentially blocking blood flow to tissue. The result may pose a serious threat to the health or life of a patient if the blockage occurs in critical tissue, such as the heart, lungs, or brain. Retractable instrument 60 may be utilized herein to traverse second lumen 32 to capture and remove undesirable material or debris M from blood vessel V.
(39) It is further contemplated herein that pigtail 50 encircling of deformable rim 67 may protect blood vessel V when deformable rim 67 expands preventing contact therewith blood vessel V preventing a tear in tissue or a vessel in the deployment area.
(40) It is still further contemplated herein that pigtail 50 encircling of deformable rim 67 may protect blood vessel V when deformable rim 67 expands or retracts preventing contact therewith blood vessel V preventing slice or puncture the biopsy, clot, or impaling the vessel wall of blood vessel V.
(41) It is yet further contemplated herein that second lumen 32 may be utilized for delivery of other medical instrument(s), such as a suture to conduct a biopsy or other medical instrument to meet the needs of the medical application being performed with surgical positioning instrument 10.
(42) It is yet further contemplated herein that second lumen 32 may be sized or configured adjustable to accommodate different diameter or sized medical instruments 60.
(43) Referring now to
(44) In block or step 715, manipulating or moving guidewire 40 (push/pull P1 of guidewire 40 or rotate R1 elongated member 20) to alter the position of pigtail 50 for a path or vessel guiding device to maneuver or advance surgical positioning instrument 10 therethrough blood vessel V, turn, fork or other vascular maneuverability and positioning pigtail 50 proximate material or debris M.
(45) In block or step 720, deploying retractable instrument 60 via expanding deployed deformable rim 67 with mesh strainer 63 after passing therethrough second instrument aperture 25 to a position proximate pigtail 50 (deploying deformable rim 67 and mesh strainer 63 therefrom second lumen 32). When deployed first deformable section 61 and second deformable section 62 of deformable rim 67 expands back to a non-compressed position.
(46) In block or step 730, rotating deformable rim 67 and mesh strainer 63 proximate material or debris M via rotating second member end 66 of retractable instrument 60, rotation R3, results in rotation R4 of deformable rim 67 having rim inlet 69 and mesh strainer 63, which in turn causes expanded deformable rim 67 having rim inlet 69 and mesh strainer 63 of retractable instrument 60 to scoop up or collect or capture clots, plaque, emboli, thrombi (blood clots), fatty deposit, biomaterial, or other undesirable material or debris M from blood vessel V.
(47) In block or step 730, rotating deformable rim 67 and mesh strainer 63 proximate material or debris M via rotating elongated catheter 20, rotation R1, results in rotation R2 of pigtail 50 which in turn results in rotation R4 of deformable rim 67 having rim inlet 69 and mesh strainer 63 due to abutting or contact therebetween pigtail 50 and deformable rim 67, which in turn causes deformable rim 67 having rim inlet 69 and mesh strainer 63 of retractable instrument 60 to scoop up or collect or capture clots, plaque, emboli, thrombi (blood clots), fatty deposit, biomaterial, or other undesirable material or debris M from blood vessel V.
(48) In block or step 735, collecting material or debris M therein mesh strainer 63 via scooping up or collecting or capturing clots, plaque, emboli, thrombi (blood clots), fatty deposit, biomaterial, or other undesirable material or debris M from blood vessel V therein mesh strainer 63.
(49) In block or step 740, retracting deformable rim 67, mesh strainer 63, and material or debris M therethrough second instrument aperture 25 of second lumen 32 via collapsing deformable rim 67 by push/pull P1 of second member end 66 to retrieve collapsing deformable rim 67 and mesh strainer 63 may be furled or wrapped therearound deformable rim 67 and/or first member end 65, and retractable instrument 60 with undesirable material or debris M may be pulled therethrough or entry therein second instrument aperture 25 and exit out first instrument aperture 23.
(50) In block or step 745, repeating steps 715-740.
(51) The foregoing description and drawings comprise illustrative embodiments of the present disclosure. Having thus described exemplary embodiments, it should be noted by those ordinarily skilled in the art that the within disclosures are exemplary only, and that various other alternatives, adaptations, and modifications may be made within the scope of the present disclosure. Merely listing or numbering the steps of a method in a certain order does not constitute any limitation on the order of the steps of that method. Many modifications and other embodiments of the disclosure will come to mind to one ordinarily skilled in the art to which this disclosure pertains having the benefit of the teachings presented in the foregoing descriptions and the associated drawings. Although specific terms may be employed herein, they are used in a generic and descriptive sense only and not for purposes of limitation. Moreover, the present disclosure has been described in detail, it should be understood that various changes, substitutions and alterations can be made thereto without departing from the spirit and scope of the disclosure as defined by the appended claims. Accordingly, the present disclosure is not limited to the specific embodiments illustrated herein, but is limited only by the following claims.