CN113423451B

CN113423451B - Thrombolysis catheter and use method thereof

Info

Publication number: CN113423451B
Application number: CN201980091500.1A
Authority: CN
Inventors: 埃里克·拉尔夫·古拉; 欧持特·布拉姆·古拉; 玛拉·波琳娜·古拉
Original assignee: Ma LaBolinnaGula; Ou ChiteBulamuGula; Ai LikeLaerfuGula
Current assignee: Ma LaBolinnaGula; Ou ChiteBulamuGula; Ai LikeLaerfuGula
Priority date: 2018-12-15
Filing date: 2019-05-01
Publication date: 2023-07-28
Anticipated expiration: 2039-05-01
Also published as: MX2021007034A; EP3893981A4; CA3122708A1; JP2022524892A; CN113423451A; WO2020122978A1; BR112021011486A2; KR20210118392A; EP3893981A1

Abstract

A embolectomy catheter having a catheter or delivery sheath with a dual lumen extension that includes a proximal section, a distal section, and a linear section sandwiched between the two sections. The distal section is provided as an annular ring with a port or opening formed in the dual lumen of the catheter. The port is positioned proximate to the distal section and a guidewire is positioned longitudinally through one of the two chambers of the catheter. A suction device is connected to one of the two chambers and is configured to create a vacuum in the catheter and the annular ring to remove biological material.

Description

Thrombolysis catheter and use method thereof

Cross Reference to Related Applications

To the maximum extent allowed by law, this U.S. partially-continuous patent application claims priority to U.S. patent application Ser. No. 15/964,593, application day 2018, month 4, 27, U.S. patent application entitled "thrombolytic catheter and method of use" and its full benefit, and U.S. patent application claims priority to U.S. provisional application Ser. No. 62/598,436, application day 2017, month 12, 13, entitled "X-shaped traction thrombolytic catheter and method of use", both of which are incorporated herein by reference in their entirety.

Technical Field

This disclosure relates to medical catheter devices, and more particularly to medical catheter devices having a deployable tool for removing thrombus (multiple thrombi).

Background

Catheters are medical devices or instruments manufactured in medical grade materials that serve a wide variety of functions, such as insertion into the human body to treat a disease or to perform a surgical procedure. In addition, catheters are often elongate with a steering tool at their distal end and are used for performing surgical procedures in confined or inaccessible locations within the human or animal body, etc. For example, catheters may be used for suturing, cutting with a knife or scissors, or through small arthroscopic, endoscopic incisions, skin or body openings as a capturing and retrieval device.

In addition, angioplasty, atherectomy, and deployment of stents and stent bypass, the step of treating vascular disease often involves peeling material or plaque from the vessel wall, potentially causing the formation of a plug or free plug into the blood stream, and its volume may be so large as to occlude smaller downstream vessels and potentially block blood flow to body tissue. If an obstruction occurs in an important organ such as the heart, lungs, or brain, the result may be a serious threat to the health or life of the patient.

One previous scheme included: the catheter apparatus has: a hose equipped with an axial bore, wherein a remote actuator means is provided at the proximal end to activate an annular ring elastically deformable by sliding to clear the restriction at the distal deployment opening. Thereby deploying the elastically deformable annular ring and the partition portion attached thereto and maintaining its deployment setting. A disadvantage of this solution is that the elastically deformable annular ring may be excessively or linearly stretched causing tearing of the tissue or vessel in the deployment area. Another disadvantage of this approach is that the slidably elastically deformable annular ring may scratch or puncture biopsy tissue, a plug, or puncture the vessel wall as the deployment opening is extended and/or retracted. Furthermore, this elastically deformable annular ring is generally unable to prevent the material from escaping from the filter (partition) during collapse and retraction.

In another previous version, the catheter device is equipped with a self-expanding vascular device, such as an expandable support cuff in the joint area to support a capsule or mesh filter to filter or remove material from the vasculature and capture the thrombus mass. A disadvantage of this approach is that the mesh filter may degrade and flow in the blood vessel, potentially damaging downstream cells and tissues that would normally be supplied by the blocked vessel. Therefore, it may be difficult or impossible to use in small diameter vessels.

Thus, there is clearly an unmet need for a thrombolytic catheter and method of use thereof that deploys from the vessel wall, digs up, collects and removes material, plaque, plug and embolism without tearing the tissue or vessel, without lacerating or puncturing the biopsy tissue, plug or puncturing the vessel wall. In addition, to prevent material from freeing up the filter (the blocking portion) during collapse and recovery of the catheter, degradable flow through the vessel is prevented and may result in damage to downstream cells and tissues normally supplied by the blocked vessel, and manipulation of the catheter in small diameter vessels is achieved.

Disclosure of Invention

Briefly described, in an exemplary embodiment, the apparatus overcomes the above-described deficiencies and meets the need for an embolectomy catheter and method of use by providing a catheter or delivery sheath having a body-extending dual lumen (channel). The catheter has a proximal section, a distal section, and a linear section sandwiched between the two sections, and a guide wire, the distal section being provided as an annular ring (pigtail) or ring, a port or opening being formed in the dual lumen of the catheter, the port being located proximal to the distal section, the guide wire being provided to longitudinally penetrate one of the dual lumens of the catheter, the guide wire being configured with a mesh filter belt (basket/mesh) provided to longitudinally penetrate the other lumen of the catheter dual lumen and to pass out of the port and form a recoverable mesh filter belt along the ring, and thus for deployment without tearing tissue or blood vessel from inside the blood vessel, without tearing or puncturing biopsy tissue, plug or puncturing the vessel wall, digging up, collecting, and removing material, plaque, plug, and embolism, while preventing material from being free from the filter (blocking portion) during collapse and retraction of the catheter, preventing undegradable flow through the blood vessel and possibly causing damage to cells and tissues normally supplied by the blocked blood vessel and cells and tissues downstream from the same, and achieving a small vessel operation in the blood vessel.

According to its main aspects and broadly stated, the through-bolt catheter and method of use comprises a catheter or delivery sheath having a through-body extending dual lumen, the catheter having a proximal section, a distal section, and a linear section sandwiched therebetween, the distal section being configured as an annular ring, a port or opening being formed in the dual lumen of the catheter, the port being proximal to the distal section, a guidewire being configured to longitudinally extend through one of the dual lumens of the catheter, a mesh filter belt being secured at a first end of the guidewire, the mesh filter belt being configured to longitudinally extend through the other of the dual lumens of the catheter, and exiting through the port and forming a recyclable mesh filter belt along the annular ring.

The teleoperated surgical device in an exemplary embodiment includes a flexible positioning tool having a tensile catheter having a dual lumen bore (bore) extending from a first catheter end to a second catheter end, the dual lumen bore having a first lumen extending entirely within the tensile catheter and the pigtail, a second lumen extending entirely within the tensile catheter, a guidewire extending entirely within the tensile catheter and the first lumen of the pigtail, and extendable from the pigtail, the guidewire being configured to angle the pigtail, a retraction tool configured to have a proximal end portion and a distal end portion connected to the proximal end portion, the distal end portion having a deformable annular ring and a barrier membrane affixed to the deformable annular ring, the vent being extendable to the second lumen of the tensile catheter.

In a further exemplary embodiment of a method of removing biological material from a patient's blood vessel, there is included the step of providing a teleoperated surgical device having a flexible positioning tool having a dual-lumen bore extending from a first catheter end to a second catheter end, the dual-lumen bore having a first lumen extending entirely within the tensioning catheter and the pigtail, and a second lumen extending entirely within the tensioning catheter, the guide wire extending entirely within the tensioning catheter and the first lumen of the pigtail, and a retraction tool configured to have a proximal end portion and a distal end portion connected to the proximal end portion. The distal tip portion comprises a deformable annular ring and a barrier membrane attached to the deformable annular ring that is extendable through the second lumen of the tensioning catheter, maneuvering a surgical device in a patient's blood vessel, positioning the pigtail to access biological material, deploying the deformable annular ring and the barrier membrane from the second lumen, rotating the deformable annular ring and the barrier membrane adjacent the biological material, collecting biological material in the barrier membrane, and retrieving the deformable annular ring, the barrier membrane and the biological material through the second lumen.

In view of this, a feature of the catheter and method of use is that it is capable of multiple rotations of the pigtail or distal section of the annular ring to access unwanted material, allowing it to dig up plugs, plaque, emboli, thrombus (multiple thrombi), fat deposits, or other unwanted material or debris in the meshed blood filter strip and remove it from the body vessel.

Another feature of the embolectomy catheter and method of use is its ability to provide a mesh filter belt or basket-like permeabilizer (porius), i.e., blood cells are free to pass through when a embolic, plaque, embolism, thrombus (multiple thrombi), fat deposit, or other undesirable material or debris is captured therein.

Still another feature of the present invention is the ability to provide a dual-lumen catheter, one lumen of which forms a guide wire passageway and the other lumen of which forms a mesh filter belt passageway.

Yet another feature of the embolectomy catheter and method of use is its ability to provide a distally operated surgical device or guidewire.

Yet another feature of the embolectomy catheter and method of use is its ability to provide a flexible dual-lumen catheter.

Yet another feature of the embolectomy catheter and method of use is its ability to provide a flexible dual-lumen catheter with a flexible pigtail, with a guidewire channel and a deployment or exit port formed near or at the tail end.

Yet another feature of the embolectomy catheter and method of use is its ability to provide a retrievable mesh filter belt extending through the surrounding distal section, configured as an annular ring to form a basket or mesh, for use in lifting emboli, plaque, thrombus, or other exfoliated matter in the mesh filter belt.

Yet another feature of the embolectomy catheter and method of use is the ability to provide the catheter with a deployable mesh basket, mesh filter belt to surround the distal section of the catheter in an annular ring, pigtail.

Yet another feature of the embolectomy catheter and method of use is the ability to provide vascular devices that overcome the drawbacks of previously known vascular filter screens and embolectomy/thrombolysis devices, and use a smaller number of components.

Yet another feature of the embolectomy catheters and methods of use is the ability to provide vascular devices that can be scaled down to a small delivery architecture, thereby making the devices useful in small blood vessels.

Yet another feature of the embolectomy catheter and method of use is its ability to provide vascular devices without the need for a dedicated delivery catheter.

Yet another feature of the embolectomy catheter and method of use is its ability to provide vascular equipment to reduce the risk of thrombi, plaque, embolism, thrombus (thrombi), fat deposits, or other undesirable materials or fragments from the device when the device is recovered or removed.

Yet another feature of the embolectomy catheter and method of use is its ability to provide percutaneous puncture removal of thrombi, plaque, emboli, thrombi (blood clots), fat deposits, other undesirable materials or fragments from human blood vessels without surgery or the use of a crushed clot dissolving agent by vascular devices.

Yet another feature of the embolectomy catheter and method of use is its ability to provide vascular equipment to rotate the pigtail, annular ring, or distal section disposed as an annular ring multiple times to access the undesirable material, to capture thrombi, plaque, emboli, thrombi (blood clots), fat deposits, other undesirable materials or fragments from the human blood vessel.

Yet another feature of the embolectomy catheter and method of use is its ability to remove the mesh, basket, deployable mesh basket, or mesh filter belt from the dual lumen catheter multiple times without loss of pigtail, annular ring, or placement of the distal segment of the annular ring adjacent the working area.

Yet another feature of the embolectomy catheter and method of use is its ability to provide a vascular device with aspiration or suction by which the unwanted material is approximated in the distal end of the lumen and pulled through the lumen passageway, suction of unwanted material (suction-type embolectomy) to collect and remove thrombi, plaque, embolism, thrombus (multiple thrombi), fat deposits, or other unwanted material or debris from the human blood vessel.

These and other features of the described thrombolytic catheter and method of use will become more apparent to those of ordinary skill in the art from the following detailed description of the embodiments and claims when read in light of the accompanying drawings.

Drawings

This thrombolytic catheter and method of use will be more readily understood upon reading the detailed description of the embodiments and upon reference to the accompanying drawings, in which like reference numerals refer to like structures and may be considered like elements throughout, and in which:

FIG. 1A is a top perspective view of an exemplary embodiment of a through-bolt catheter;

FIG. 1B is a cross-sectional perspective view of an exemplary embodiment of a dual-lumen stretch catheter of the thrombolytic catheter of FIG. 1A;

FIG. 1C is a cross-sectional perspective view of an exemplary embodiment of a single-lumen pigtail of the thrombolytic catheter of FIG. 1A;

FIG. 2 is a top perspective view of an exemplary embodiment of the thrombolytic catheter of FIG. 1A; the display guide wire penetrates through the first chamber to extend the tail pipe;

FIG. 3 is a top perspective view of an exemplary embodiment of a vascular medical tool;

FIG. 4A is a top perspective view of an exemplary embodiment of the thrombolytic catheter of FIG. 1; displaying a guidewire extending therethrough in a first chamber, and a retractable tool extending therethrough in a second chamber;

FIG. 4B is a cross-sectional perspective view of a stretch catheter of the thrombolytic catheter of FIG. 1; a guide wire and a retractable tool are displayed therein;

FIG. 5A is a top perspective view of the exemplary transcatheter of FIG. 1 and a retractable tool deployed between the same and a pigtail;

FIG. 5B is a front perspective view of the transembolic catheter of FIG. 5A with the vascular medical tool, showing the unwanted material or fragments being recaptured by the netting;

FIG. 6 is a top perspective view of the transembolic catheter of FIG. 5A with the retractable tool deployed through the heart and in the pulmonary vessel wall, showing the net capture of the recovered unwanted material or fragments;

FIG. 7 is a flow chart of a method of deploying, using, and retrieving the transembolic catheter of FIGS. 1-6 to remove unwanted material or debris from the vessel wall vessel;

FIG. 8 is a top perspective view of an exemplary embodiment of a thrombolytic catheter with aspiration device;

FIG. 9 is a top perspective view of the exemplary transembolic catheter of FIG. 8 with unwanted material being pulled into the distal end of the lumen; and is also provided with

FIG. 10 is a flow chart of a method of deploying, using, and retrieving the transembolic catheter of FIGS. 1-6 and 8-9 to withdraw unwanted material or debris from a vessel wall vessel by aspiration;

it is noted that the figures shown are for illustrative purposes only and they are neither intended nor intended to limit the actual details of any or all of the illustrated constructions except insofar as they may be considered an important part of the claimed invention.

Detailed Description

In describing the exemplary embodiments of the present disclosure, i.e., as set forth in fig. 1A, 1B, 1C, 2, 3, 4A, 4B, 5A, 5B, 6, 7, 8, 9, 10, specific terms are used for clarity. However, the disclosure is not intended to be limited to the specific terminology so selected, and it is to be understood that each specific element includes all technical equivalents which operate in a similar manner to accomplish a similar function. The embodiments of the claims may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein. The examples set forth herein are non-limiting examples and are only a few of the other possible examples.

1A, 1B, 1C, by way of example and not limitation, illustrate an exemplary embodiment of a flexible surgical positioning tool 10. The surgical positioning tool 10 may include a base portion, such as a handle 36, having a first rotating lobe 37 and a second rotating lobe 38, coupled to a longitudinal linear portion, hose, housing, catheter, or sheath, as the elongate catheter 20 extends linearly from the handle 36. Preferably, the stretch catheter 20 may include two or biaxial tube bores or spaces therethrough or formed therein and extends from a first catheter end 21 to a second catheter end 22. In addition, two or more of the tube bores therethrough may include a first chamber 31 and a second chamber 32 separated by a divider 33.

In addition, the second catheter end 22 of the surgical positioning tool 10 may be provided as an annular ring, an open ring, or a closed ring, such as a pigtail 50 formed or mounted on the second catheter end 22. It is contemplated herein that the pigtail 50 may be formed of a variety of sizes or configurations and include a first pigtail portion 51 and a second pigtail portion 52, the first pigtail portion 51 being attached to the second conduit end 22 of the stretch conduit 20 and the second pigtail portion 52 forming a closed loop looped back to a position proximate the second conduit end 22. It is contemplated herein that the stretch tube 20 and pigtail 50 may preferably be constructed or constructed of a moldable plastic, polymeric material, including polytetrafluoroethylene, polyurethane, polyethylene, teflon, and the like, i.e., such materials provide a multi-type morphology, shape, ease of manufacture and flexibility; however, other suitable materials may be used, i.e., materials having sufficient strength, flexibility, and/or durability to meet this goal. The material of the stretch tube 20, the second chamber 32, the pigtail 50, the second chamber or the medical tool outlet opening 25 may be reinforced with fibers, rings, or longitudinal ribs, for example, so that the recyclable tool 60 may withstand the forces exerted on it when enclosed in the second chamber 32 and deformed by the stretch tube 20.

The first chamber 31 may extend entirely within the handle 36, the tensioning catheter 20, and the pigtail 50, beginning at an inlet aperture, such as the first chamber or guide wire inlet opening 24, and exiting from the proximal end 53 of the pigtail 50 from an outlet or deployment aperture open to the environment, such as the first chamber or guide wire outlet opening 26.

The second chamber 32 may extend entirely within the handle 36, the tensioning catheter 20, beginning at an inlet opening, such as the first tool opening 23, and exiting from the tensioning catheter 20 at the second catheter proximal end 22 from an outlet or deployment hole, such as the second tool opening 25 at the second catheter proximal end 22.

Referring now to fig. 2, by way of example and not limitation, an exemplary embodiment of deployment and retrieval of the guidewire 40 in the first lumen 31 of the tensioning catheter 20 and the liner lumen 31B of the liner 50 is illustrated. The guidewire 40 may include a first guidewire end 41 and a second guidewire end 42. In use, a path or vessel guiding device, such as guide wire 40, may extend entirely within the first lumen 31 of the tensioning catheter 20 and the liner lumen 31B of the liner 50, beginning at the inlet aperture, such as the first lumen inlet opening 24, and exiting the environment through the outlet or deployment hole opening from the proximal end 53 of the liner 50, such as from the first lumen outlet opening 26 to an overrun or overrun position, or may extend from the liner 50 to assist or guide movement of the second catheter end 22 and liner 50 through the vessel V, turn, branch, or other vessel. The first guidewire tip 41 extends through the deployment opening, such as guidewire opening 26, and is remotely controlled from the second guidewire tip 42. In addition, the guidewire 40 is threaded through the pigtail 50, which pigtail 50 may be angled or vertical (as shown in FIG. 2), or an angle such as pigtail angle A (from about 0-270 degrees from perpendicular to the stretch catheter 20, 9 o 'clock counterclockwise to 12 o' clock), depending on the flexibility and rigidity of the first guidewire tip 41 threaded therethrough. In addition, the first rotation R1 of the stretch tube 20 causes or results in a similar rotation, such as rotation R2 of the pigtail 50. The two pigtail angles a and rotation R2 allow for various positioning of the first guidewire tip 41 to assist or guide or position the guidewire 40, the pigtail 50, and the second catheter tip 22 for precise movement through the vessel V, steering, bifurcation, or other vessel. Further, movement of the guidewire 40 or movement of the guidewire 40, such as pushing/pulling on the P1 of the second guidewire tip 42, causes the first guidewire tip 41 to move into and out of the guidewire opening 26 to assist or guide or position the guidewire 40, pigtail 50, and second catheter tip 22 through the vessel, turn, bifurcation, or other movement within the vessel V.

As an alternative, the first chamber 31 and the pigtail chamber 31B may be used for the inlet of additional laparoscopic or endoscopic devices and/or fluid inlet or retrieval, illumination, video recording, and inlet of medical tools such as class 40A. Such endoscopes may also provide surgical instruments such as lasers, scalpels, irrigation and aspiration tools, visualization tools, and class 40A tools. The particular configuration and dimensions of the first chamber 31 and the pigtail chamber 31B will vary depending on the intended use of the surgical positioning tool 10, as well as whether additional surgical tools 40A are provided. Generally, this axial bore of the first chamber 31 may have an inner diameter of 6-12F (French, unit equal to 1/3 mm), although other diameters may be considered herein to fit the working channel of the endoscope.

Referring now to fig. 3, by way of example and not limitation, an exemplary embodiment of a recyclable tool 60 is illustrated for use with the surgical positioning tool 10. The recyclable tool 60 may include a proximal or stretching portion or operator, such as a proximal end portion 64 having a first portion end 65 and a second portion end 66. The first portion end 65 may be configured with an annular ring, closed ring, or basket, pigtail (e.g., a deformable ring 67 disposed thereon proximate the second portion end 66). It is contemplated that the deformable ring 67 may be provided in a variety of sizes and shapes to match the size and shape of the pigtail 50.

In addition, the deformable ring 67 may be provided to be constructed of one or two components, such as a first deformable portion 61 and a second deformable portion 62 and optionally include one or more pivot joints 68 between the first deformable portion 61 and the second deformable portion 62. The deformable ring 67 is preferably made of a flexible, resilient, or shape memory material or alloy, a biocompatible material that can be bent, curved, or collapsed to be configured to enter and exit the first tool opening 23, extend through the axial lumen of the second chamber 32, after passing through the second tool opening 26 to deploy the mesh, and collapse to re-enter the second tool opening 26 to remove the biomaterial from the blood vessel or other vascular passageway or catheter (tube) V.

It is additionally contemplated herein that the deformable ring 67 may include one or more joints or hinges, such as a knuckle 68 located near the deformable ring 67 or between the first and second deformable portions 61, 62, to effect linear collapse or folding of the deformable ring 67, the first deformable portion 61, and the second deformable portion 62 through the first tool opening 23, the axial bore of the second chamber 32, and the second tool opening 25. It is further contemplated herein that the deformable ring 67 may define an opening, such as an annular inlet 69.

When extended, the deformable ring 67 may have a diameter of from about 1 centimeter or less to about 3 centimeters, although other dimensions are contemplated herein. In addition, a barrier film or other impurity removing (or filtering) film, such as a mesh filter belt 63, is preferably loosely worked, stretched over, or otherwise attached to the deformable ring 67 to form a circular open end capture mesh that spans the annular inlet 69. The mesh filter belt 63 may be used to filter or capture emboli, plaque, emboli, thrombus (multiple thrombi), fat deposits, or other undesirable materials or fragments from the human blood vessel V.

The particular arrangement and size of the axial bore of the second chamber 32 will vary depending upon the application of the surgical positioning tool 10, the circumference of the retrievable tool 60, such as the insertion/retrieval portion 64 and sized to receive the constrained deformable ring 67 having the first and second deformation portions 61, 62, i.e., the mesh filter belt is wrapped around the first and second deformable portions 61, 62 and the insertion/retrieval portion 64. Generally, the axial bore of the second chamber 32 may have an axial bore or inner diameter of 6-12F (French, units equal to 1/3 mm) to accommodate the restrained retractable tool 60, although other diameters are contemplated herein.

As an alternative, the second chamber 32 may be used as an additional laparoscope or endoscope, and/or fluid inlet or retrieval, illumination, video recording, and inlet of medical tools such as class 40A. Such endoscopes may also provide surgical instruments such as lasers, scalpels, irrigation and aspiration tools, visualization tools, and class 40A tools.

Referring again to fig. 1A, the outer diameter of the catheter 20 may vary depending on the application, the size of the first and second chambers 31, 32, the size of the deformable ring 67 of the retrievable tool 60 having the first and second deformed portions 61, 62, whether to be used as an additional laparoscope or endoscope, and/or fluid inlet or retrieval, illumination, video recording, and inlet of medical tools such as class 40A, and whether to include additional chambers in the surgical positioning tool 10.

Referring now to fig. 4A and 4B, by way of example and not limitation, an illustrative embodiment of a retractable tool 60 for deployment and retraction in the second chamber 32 of the surgical positioning tool 10 is illustrated. In addition, the second guidewire tip 42 may be pulled and the guidewire 40 withdrawn through the pigtail 50, and the pigtail 50 may be restored to the pigtail or annular ring arrangement shown in fig. 1 and 4A.

In use, the deformable ring 67 of the first portion end 65 may be prone to collapse and the mesh filter belt 63 may be rolled or wrapped around the deformable ring 67 and/or the first portion end 65 of the recyclable tool 60. The collapsed deformable ring 67 and rolled mesh filter belt 63 may be inserted into the first tool opening 23 of the second chamber 32. The collapsed deformation ring 67 and rolled mesh filter belt 63 may be placed, stretched, and run through the second lumen 32 of the stretch catheter 20 and out, or deployed entirely, or stretched therefrom. When the deformable ring 67 and rolled mesh filter belt 63 leave the second chamber 32, the deformable ring 67 is stretched with the stretched mesh filter belt 63 positioned proximal to the pigtail 50, the deployed deformable tube 67 in the stretched collection state. When the first and second deformable portions 61, 62 of the deformable ring 67 are extended in opposite directions to the non-compressed position shown in fig. 5 to become an extended deformable ring 67 having an annular inlet 69 and a mesh filter belt 63, the extended deformable ring 67 tends to cater for or be positioned adjacent to or in the pigtail 50 as shown in fig. 5.

Referring now to fig. 5A and 5B, by way of example and not limitation, an exemplary embodiment of the illustrated retrievable tool 60 deployed from the second chamber 32 of the surgical positioning tool 103, in use, the pushing/pulling P1 of the second portion end 66 may deploy or extend the deformable ring 67 in the pigtail 50 or beyond the limits of the second tool opening 25 distal to the second catheter end 22 to deploy the deformable ring 67 and the mesh filter belt 63 mounted thereon and maintain its deployed setting. Rotation R3 of the second portion end 66 causes or causes a similar rotation, such as rotation R4 of the deformable ring 67 with the annular inlet 69 and mesh filter belt 63, thereby causing the deformable ring 67 with the annular inlet 69 and mesh filter belt 63 of the recyclable tool 60 to dig or collect or capture a plug, plaque, embolism, thrombus (multiple thrombi), fat deposit, or other undesirable material or debris M from the vessel V. In addition, rotation R1 on the tensioning catheter 20 causes rotation R2 on the pigtail 50, which in turn causes rotation R4 on the deformable ring 67 with the annular inlet 69 and mesh filter belt 63 due to abutment or contact of the pigtail and deformable ring 67 (the deformable ring 67 abutting against the pigtail 50), which in turn causes the deformable ring 67 with the annular inlet 69 and mesh filter belt 63 of the retrievable tool 60 to dig or collect or capture a plug, plaque, embolism, thrombus (multiple thrombus), fat deposit, or other undesirable material or debris M from the vessel V. The unwanted material or debris M may be removed from the vessel V via the second tool opening 25 by the retrievable tool 60 containing the unwanted material or debris M and the deformable ring 67 having the annular inlet 69 and mesh filter belt 63, collapsing the deformable ring 67 and pulling the retrievable tool 60 downwardly from the second chamber 32 of the surgical positioning tool 10 and out of the first tool opening 23, as shown in fig. 4A and 4B. The deformable ring 67 is retrieved by pushing/pulling the P1 of the second portion end 66 to collapse the deformable ring 67 and the mesh filter belt 63 may be rolled up or wrapped around the deformable ring 67 and/or the first portion end 65, while the retractable tool 60 with the unwanted material or debris M may be pulled into the second tool opening 25 and out of the first tool opening 23.

It is contemplated herein that the deformable ring 67 and the pigtail 50 may be similar or matched in size and shape, such as circumference and/or diameter, to achieve abutment or contact between the pigtail 50 and the deformable ring 67 (the deformable ring 67 abutting the pigtail 50).

Referring now to fig. 6, by way of example and not limitation, an illustrative embodiment of a surgical device is illustrated that is composed of a retractable tool 60 and a surgical positioning tool 10. In use, the surgical positioning tool 10, shown with the pigtail 50, is inserted into a patient and deployed in a serpentine fashion into a blood vessel V, heart H, lung L, and pulmonary blood vessel V. It is contemplated herein that the surgical positioning tool 10 may be deployed in any fluid carrying vessel where debris needs to be removed.

In use, the push/pull P1 of the guidewire 40 may be extended in the pigtail 50, resulting in the pigtail 50 being either vertical or extended (shown in FIG. 2) or bent into the vessel V, such as the pigtail angle A, depending on the flexibility or rigidity of the first guidewire tip 41 threaded therethrough. In addition, stretching the first rotation R1 of the catheter 20 causes the pigtail 50 to similarly rotate R2 in the vessel V. Both the pigtail angle a and the rotation R2 enable extensive positioning of the first guidewire tip 41 to assist or guide or position the guidewire 40, the pigtail 50, and the second catheter tip 22 to pass through or at the vessel V, heart H, lung L, meander, turn, bifurcate or other vessel movement to precisely move and deploy the pigtail 50 in the vessel V. The goal of the surgical positioning tool 10 is to preferably position the pigtail 50 at a specific location in the patient's blood vessel.

The pushing/pulling P1 of the second portion end 66 causes the exit or deployment of the deformable ring 67 having the annular inlet 69 and mesh filter belt 63 from within the second tool opening 25 proximate the junction between the second catheter ends 22 and deployment to deploy the deformable ring 67 with mesh filter belt through the second tool opening 25 to a position proximate the pigtail 50 in the blood vessel V.

Further rotation R3 of the second portion end 66 causes rotation R4 of the deformable ring 67 with the annular inlet 69 and the mesh filter belt 63 in the vessel V, thereby causing the deformable ring 67 with the annular inlet 69 and the mesh filter belt 63 of the retrievable tool 60 to dig or collect or catch a plug, plaque, embolism, thrombus (plural thrombi), fat deposit, or other undesirable material or debris M from the vessel V.

In addition, rotation R1 of the tensioning catheter 20 causes rotation R2 of the pigtail 50 in the blood vessel V, resulting in rotation R4 of the deformable ring 67 with the annular inlet 69 and the mesh filter belt 63 due to abutment or contact between the pigtail 50 and the deformable ring 67, which in turn causes the deformable tube 67 with the annular inlet 69 and the mesh filter belt 63 of the recyclable tool 60 to dig up or collect or catch a plug, plaque, embolism, thrombus (plural thrombi), fat deposit, or other undesirable material or debris M in the blood vessel V.

The pushing/pulling P1 of the second portion end 66 causes the collapsed deformable ring 67 with the annular inlet 69 and mesh filter belt 63 to retract or enter the second tool opening 25 and pass through the second chamber 32 to the first tool opening 23 to remove unwanted material or debris M trapped in the mesh filter belt 63 from the blood vessel V. It is contemplated herein that such capturing and retrieving of unwanted material or debris M may be accomplished in multiple passes through multiple back and forth paths, i.e., deployment, retrieval in the second chamber 32 of the surgical positioning tool 10, and retrieval of the retrievable tool 60.

It is contemplated herein that in the second chamber 32, the steps of deployment of angioplasty, atherectomy, and stent bypass, treatment of vascular disease, may be performed through the second chamber 32. Such tools often peel material or plaque from the vessel wall, potentially causing plug formation or embolism free into the blood stream, and may be so large as to occlude smaller downstream vessels and potentially block blood flow to body tissue. If an obstruction occurs in an important organ such as the heart, lungs, or brain, the result may be a serious threat to the health or life of the patient. A retractable tool 60 may be used herein to penetrate the second chamber 32 to capture and remove unwanted material or debris M from the vessel V.

It is further contemplated herein that the pigtail 50 surrounding the deformable ring 67 may protect the blood vessel V from contact with the blood vessel V as the deformable ring 67 is extended within the blood vessel V, preventing tearing of tissue or blood vessel at the deployment site.

It is further contemplated herein that the pigtail 50 surrounding the deformable ring 67 may protect the blood vessel V from lacerations or punctures of biopsy tissue, a plug, or punctures the vessel wall of the blood vessel V as the deformable ring 67 is extended or retracted within the blood vessel V.

It is further contemplated herein that second chamber 32 may be used to transport other medical tools, such as sutures, to guide biopsy tissue or other medical tools to meet the medical application requirements of surgical positioning tool 10.

It is further contemplated herein that the second chamber 32 may be sized or configured to accommodate medical tools 60 of different diameters or sizes.

Referring now to fig. 7, a flowchart 700 is illustrated for using the surgical positioning tool 10 and the retrievable tool 60 to remove a plug or free plug, biological material, such as a non-desired material or fragment M, from a blood vessel V. In block or step 710, a surgical positioning tool 10 having a tensile portion 20 extending therethrough, such as a first chamber 31 and a second chamber 32, and a pigtail 50 at one end and an integral retrievable tool 60 having a deformable ring 67 and a mesh filter belt 63 as described above in fig. 1-6, is provided, including (collapsing the deformable ring 67 and the mesh filter belt 63 wrapped around the first portion end 65 and inserted into the second chamber 32 of the first tool opening 23) and (pushing/pulling P1 through the first tool opening 23 (second portion end 66) to the second tool opening 25 of the second chamber 32).

At block or step 715, the steering or moving guidewire 40 (push/pull P1 of guidewire 40 or rotation R1 of stretch portion 20) changes the position of the pigtail 50 for a path or vascular guiding device to move or advance the surgical positioning tool 10 through the vessel V, steer, branch or make other movement in the vessel and deploy the pigtail 50 proximate the material or fragment M.

In block or step 720, after passing through the second tool opening 25 to a position proximate the pigtail 50 (deployment of the deformable ring 67 and mesh filter belt 63 from the second chamber 32), the retrievable tool 60 is deployed by extending the deployed deformable ring 67 with mesh filter belt 63. When the first deformable portion 61 and the second deformable portion 62 of the deployed deformable ring 67 are extended in opposite directions to the incompressible position.

In block or step 730, rotating R3 causes rotation R4 of the deformable ring 67 with the annular inlet 69 and the mesh filter belt 63 by rotating the second portion end 66 of the retractable tool 60 to rotate the deformable ring 67 and the mesh filter belt 63 toward the material or debris M, thereby causing the deformable ring 67 with the annular inlet 69 and the mesh filter belt 63 of the retractable tool 60 to dig or collect or capture a plug, plaque, embolism, thrombus (multiple thrombi), fat deposit, or other undesirable material or debris M from the vessel V.

In block or step 730, rotation R1 causes rotation R2 of the pigtail 50 by stretching the catheter 20 to rotate the deformable ring 67 and mesh filter belt 63 toward the material or debris M, thereby causing rotation R4 of the deformable ring 67 with annular inlet 69 and mesh filter belt 63 due to abutment or contact between the pigtail 50 and deformable ring 67, thereby causing the deformable ring 67 with annular inlet 69 and mesh filter belt 63 of the retrievable tool 60 to dig or collect or capture a plug, plaque, embolism, thrombus (plural thrombi), fat deposit, or other undesirable material or debris M from the vessel V.

In block or step 735, material or debris M is collected in the mesh filter belt 63 by scooping or collecting or capturing a plug, plaque, embolism, thrombus (multiple thrombi), fat deposit, or other undesirable material or debris M from the vessel V in the mesh filter belt 63.

In block or step 740, the deformable ring 67, the mesh filter belt 63, and the material or debris M are retracted in the second tool opening 25 of the second chamber 32 in a manner to collapse the deformable ring 67. By pushing/pulling P1 of the second part end 66 to retrieve the deformable ring 67 in collapse, the mesh filter belt 63 may be wrapped around or around the deformable ring 67 and/or the first part end 65, and the retrievable tool 60 with unwanted material or debris M may be pushed into or into the second tool opening 25 and out of the first tool opening 23.

In block or step 745, steps 715-740 are repeated.

Referring now to fig. 8, by way of example and not limitation, an exemplary embodiment of a flexible surgical positioning tool 10 is illustrated. Surgical positioning tool 10 may include an access hub or port, such as aspiration port 90 positioned proximate handle 36 or first catheter end 21. The suction port 90 may provide access to, and may be connected to, the first chamber 31 having the length of the stretch tube 20, the liner chamber 31B of the liner 50, to the liner end 53. Additionally, the surgical positioning tool 10 can include a side arm or tube, such as a suction tube 80, which can have a distal end, such as a first tube end 81 and a proximal end, or a second tube end 82. The second tube end 82 may be secured or removably secured to the suction port 90. The suction tube 80 may include a three-way stopcock 84 that includes a stopcock strip 85. The plug strip 85 can be rotated (rotatable) in an open position for access path and suction for redirecting debris M to a diverted position of the threaded interface and cap 83, and a closed position for closing the second tube end 82. Further, the surgical positioning tool 10 may include a suction, vacuum or negative pressure device, such as the aspiration device 70. The aspiration device 70 may comprise a syringe having a housing or body of the syringe barrel 72 in which the plunger 71 is pulled or moved, such as movement M within the syringe barrel 72 and an adapter port 73 that provides an outlet or inlet for the syringe barrel 72. The suction device 70, or more specifically the fitting port 73, may be connected to, in communication with, or removably connected to the first tube end 81, preferably through the suction tube 80, the suction port 90, the chamber 31 of the tensioning catheter 20, the liner chamber 31B of the liner 50, and through the liner end 53 for suction, evacuation, or suction S.

Referring now to fig. 9, by way of example and not limitation, the illustrated exemplary embodiment of a pigtail 50 shows a proximal plug, plaque, embolism, thrombus (plural thrombi), fat deposit, or other undesirable material or debris M in a blood vessel V. In addition, suction or suction through the suction device 70 tends to cause the debris M to be sucked or pulled (multiple pulls/suction) or collected or caught into the tail pipe end 53. Furthermore, by continuous suction or suction (suction through-bolt) of the suction device 70, the debris M may be pulled or penetrated through the liner chamber 31B of the liner 50, the chamber 31 of the stretching catheter 20, the suction port 90, and the suction tube 80 to the suction device 70, thereby removing the debris M from the blood vessel V.

It is contemplated herein that in suction or suction (suction through bolt) of the debris M, the pigtail 50 may be in an extended configuration as shown in fig. 2, rather than in a surrounding configuration as shown in fig. 5.

Referring now to fig. 10, a flowchart 1000 is illustrated for using the surgical positioning tool 10 and the retrievable tool 60 to remove a plug or free plug, biological material such as unwanted material or debris M from a blood vessel V by aspiration or suction. In block or step 1010, a surgical positioning tool 10 is provided having a tensile portion 20 generally comprising two or more axial bores. Such as described above in fig. 8-9, the first chamber 31 and the second chamber 32, and one end of the pigtail 50 and the suction port 90, suction tube 80, and suction apparatus 70.

In block or step 1015, the first catheter tip 21 is maneuvered or moved to alter the position of the pigtail 50, the surgical positioning tool 10 is moved or advanced in the vessel V for a path or vessel guiding device, turned around, bifurcated or otherwise moved in the vessel and the pigtail 50 is positioned adjacent to the material or fragment M, block or step 1020.

In block or step 1030, the suction device 70 is operated (suction or suction) to collect, catch, the debris M in the tail end 53. Further through the suction device 70, a continuous suction or suction-free step 1040 (suction through-plug) is performed, and the debris M may be pushed or penetrated through the lumen 31B of the pigtail 50, the lumen 31 of the tensioning catheter 20, the suction port 90, and the suction tube 80 to the suction device 70 at step 1050 to remove the debris M from the blood vessel V.

The foregoing description and drawings contain illustrative embodiments of this disclosure. With this exemplary embodiment, it should be noted by those of ordinary skill in the art that the disclosure is merely exemplary, and that various alternatives, adaptations, and modifications may be made in the present disclosure. The mere listing of steps in a particular order or counting method is not to be taken as a limitation of the order of the steps of the method. Those of ordinary skill in the art will envision numerous adaptations and other embodiments in the disclosure that retain the teaching benefit of the foregoing description and related figures. Although specific terms may be employed herein, they are used in a generic and descriptive sense only and not for purposes of limitation. Further, while this disclosure has been described in detail, it should be understood that various changes, substitutions and alterations can be made hereto without departing from the spirit and scope of the disclosure as defined by the appended claims. According to this, this disclosure is not limited to the specific embodiments set forth herein, but is limited only by the following claims.

Claims

1. A teleoperated surgical device for penetration into a patient's blood vessel to reach a thrombus therein, the surgical device comprising:

a flexible positioning tool having a stretch conduit with a dual chamber bore extending from a first conduit end to a second conduit end, the dual chamber bore having a first chamber and a second chamber, a flexible pigtail extending from the second conduit end, the first chamber extending generally in the stretch conduit and the flexible pigtail, the flexible pigtail being configured to have a pigtail end looped back to a position proximate the second conduit end, the pigtail end having a guidewire outlet opening, the second chamber extending generally in the stretch conduit, passing from the first conduit end to the second conduit end to a tool outlet opening proximate the second conduit end;

a guidewire threaded in the first lumen of the tensioning catheter and the flexible pigtail, the guidewire extending through the flexible pigtail to erect the flexible pigtail, the second catheter tip and the flexible pigtail being threaded into a patient's blood vessel to thrombus;

A retrievable tool having a proximal end portion and a distal end portion connected to the proximal end portion, the distal end portion containing a deformable annular ring and a barrier membrane affixed to the deformable annular ring, the deformable annular ring being extendable entirely through the tool outlet opening to extend the deformable annular ring to deploy the barrier membrane, wherein rotation of the first catheter end of the tensioning catheter rotates the flexible pigtail which rotates the deformable annular ring and the barrier membrane to capture thrombus in the barrier membrane; and

a suction device connected to the first chamber and arranged to create a vacuum in the first chamber of the tensioning catheter and the flexible pigtail.

2. The teleoperated surgical device of claim 1, further comprising a guidewire inlet opening located proximate to the first conduit end and a guidewire outlet opening located proximate to the pigtail end of the flexible pigtail.

3. The teleoperated surgical device of claim 1, rotation of the tensioning catheter resulting in the rotation of the flexible pigtail.

4. The teleoperated surgical device of claim 1, further comprising a handle secured to the first catheter tip.

5. The teleoperated surgical device of claim 3, the flexible pigtail configured to be disposed at a location within a patient's blood vessel.

6. The teleoperated surgical device of claim 1, further comprising a first tool opening located proximate the first conduit end and a second tool opening located proximate the second conduit end.

7. The teleoperated surgical device of claim 1, the flexible pigtail further comprising a pigtail chamber in communication with the first chamber.

8. The teleoperated surgical device of claim 7, further comprising an aspiration port located proximate the first conduit end, the aspiration port in communication with the first chamber.

9. The teleoperated surgical device of claim 8, further comprising a suction tube having a first tube end and a second tube end, the second tube end in communication with the suction port.

10. The teleoperated surgical device of claim 9, wherein the aspiration device is in communication with the first tube end.

11. The teleoperated surgical device of claim 10, wherein the aspiration device further comprises a syringe having a syringe barrel, a plunger in the syringe barrel, and an adapter port forming an outlet of the syringe barrel.

12. The teleoperated surgical device of claim 9, wherein the suction tube comprises a tap valve having a tap rotatable between an open position, a steering position, and a closed position.

13. The teleoperated surgical device of claim 10, wherein rotation of the first catheter tip is configured to cause the rotation of a tail tube tip adjacent the thrombus.

14. The teleoperated surgical device of claim 13, wherein suction in the suction device creates suction in the suction tube, in the suction port, in the first chamber, and in the pigtail chamber to collect the thrombus therein.

15. The teleoperated surgical device of claim 14, wherein further aspiration in the aspiration device empties the thrombus from the pigtail chamber, the first chamber, the aspiration port, the aspiration tube into the aspiration device.

16. The teleoperated surgical device of claim 1, further comprising a tool inlet opening connected to the second chamber and located proximate the first conduit end.

17. The teleoperated surgical device of claim 1, wherein the retractable tool is configured to be retracted in the second chamber to remove the thrombus from the patient's blood vessel.