BR112021011486A2 - THROMBECTOMY CATHETER AND METHODS OF USE - Google Patents

Abstract

thrombectomy catheter and methods of use. a thrombectomy catheter with a dispensing catheter or 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 mesh, a port or opening formed in said dual lumen of said catheter, the port positioned proximate to the distal segment and a guidewire configured to cross longitudinally therethrough one of the dual lumens of the catheter, a suction device connected thereto to one of the dual lumens and configured to create a vacuum therein, the catheter and mesh to extract a biomaterial.

Description

1 / 28

THROMBECTOMY CATHETER AND METHODS OF USE CROSS REFERENCE WITH RELATED ORDERS

[001] To the fullest extent permitted by law, the present Part of the United States Continuing Patent Application hereby claims priority and all benefits of US Patent Application No. 15/964,593, filed April 27, 2018, which is titled “Thrombectomy Catheter and Methods of Use”, which claims priority to US Provisional Application No. in this document by reference in its entirety.

TECHNICAL FIELD

[002] The description generally refers to medical catheter devices and more specifically refers to medical catheter devices with an implantable instrument to remove thrombus (blood clots).

FUNDAMENTALS

[003] A catheter is a medical device or apparatus made of medical grade materials that serve a wide range of functions, such as insertion into the body to treat disease or perform a surgical procedure. In addition, catheters are often elongated in shape, having manipulation means at their distal end and used for surgical manipulation of matter in a confined or inaccessible space within a human or animal body. For example, catheters can be used to perform suturing, cutting with a knife or scissor action, or by capture and retrieval devices through a small arthroscopic, endoscopic, percutaneous incision or body opening.

[004] In addition, angioplasty, atherectomy, and stent implantation and stent grafts, procedures to treat vascular disease, often dislodge material or plaque from vessel walls, which can result in

2 / 28 clot formation or the release of emboli, which enter the bloodstream, and can be large enough to obstruct smaller downstream vessels and potentially block blood flow to the tissue. The result can pose a serious threat to a patient's health or life if the blockage occurs in critical tissues such as the heart, lungs or brain.

[005] An earlier approach includes a catheter device having a cannula with an axial orifice wherein a remote actuator means at a proximate end activates an elastically deformable sliding mesh to extend beyond the confines of the implantation opening at the distal end thereof to deploy the elastically deformable mesh and barrier member affixed thereto and achieves its deployed configuration. A disadvantage of this approach is that the elastically deformable mesh can expand excessively or expand linearly, causing a tear in tissue or a vessel in the area of implantation. Another disadvantage of this approach is that the deformable mesh can cut or puncture the biopsy, coagulate or impale the vessel wall when the sliding elastically deformable mesh is expanded and/or retracted back into the implantation opening. Furthermore, this elastically deformable mesh is generally unable to prevent material from escaping the filter (barrier member) during the collapse and shrinkage process.

[006] Another prior approach includes a catheter device having a self-expanding vascular device, such as an expandable support arch for an articulation region to support a bag or mesh filter to filter or remove matter and capture emboli from within a sling. vascular system. A disadvantage of this approach is that the mesh filter can degrade the flow through the vessel and can result in damage to downstream cells and tissue normally fed by the blocked vessel. Consequently, it may be difficult or impossible to use such devices in

3 / 28 small diameter pots.

[007] Therefore, it is readily apparent that there is a recognizable unmet need for a thrombectomy catheter and methods of using the same that work to implant, harvest, collect and remove material, plaque, clots and emboli from the vessel walls without causing a tear to tissue or a vessel, a cut or perforation of the biopsy, which clots or impales the vessel wall. Furthermore, to prevent material from escaping the filter (barrier member) during the collapse and retraction process, do not degrade flow through the vessel and could result in damage to downstream cells and tissue normally fed by the blocked vessel and to allow operation in small diameter vessels.

SUMMARY

[008] Briefly described, by way of example, the present apparatus overcomes the aforementioned disadvantage and meets the recognized need for a thrombectomy catheter and methods of use, by providing a dispensing catheter or sheath with a double lumen (passage) that extends therethrough, the catheter having a proximal segment and a distal segment and a linear section coupled therebetween, the distal segment configured as a mesh (pigtail wire) or rim, a port or opening formed in the said double lumen of said catheter, the port positioned proximate to the distal segment, and a guidewire configured to cross longitudinally through one of the dual lumens of the catheter, said guidewire configured with a mesh filter device (basket/net) configured to cross longitudinally therethrough the other dual lumen of the catheter and exit through said port and follow said mesh to form a tel. retractable and thus works to implant, harvest, collect and remove material, plaque, clots and emboli from inside the vessel without causing tissue or vessel rupture, cut or puncture the biopsy, clot or impale the vessel wall, to prevent that the

4 / 28 material escapes from the filter (barrier member) during the collapse and retraction process, does not degrade the flow through the vessel and could result in damage to downstream cells and tissues normally fed by the blocked vessel, and to allow operation in small diameter pots.

[009] In accordance with its main and widely stated aspects, the thrombectomy catheter and methods of use include a dispensing catheter or sheath having a double 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 mesh, a port or opening formed in said double lumen of said catheter, the port positioned proximate to the distal segment and a guidewire configured to traverse longitudinally therethrough of one of the dual lumen of the catheter, said guidewire having a first end affixed to a mesh filter device, the mesh filter device configured to longitudinally traverse the other dual lumen of the catheter and exit through said port and follow said mesh to form the filter device with retractable screen.

[0010] In an exemplary embodiment of the remotely operated surgical device, a flexible positioning instrument is included having an elongate catheter with a double lumen orifice therein extending from a first catheter end to a second catheter end, the orifice lumen having a first lumen and a second lumen, and a pigtail wire attached thereto to the second end of the catheter, the first lumen extends through the elongated catheter and the pigtail wire, the second lumen extends through the elongate catheter, a guidewire that can be extended through the first lumen of the elongate catheter and the pigtail wire, and be extended from the same pigtail wire, the guide wire configured to bend the wire in the form of a pig's tail and a

5/28 retraction instrument configured as having a proximal member and a distal member coupled to the proximal member, the distal member having a deformable rim and a barrier membrane affixed thereto to the deformable rim and extensible through the second lumen of the elongate catheter.

[0011] In another exemplary embodiment of the method for removing a biomaterial from a patient's vessel, including the steps of providing a remotely operated surgical device having a flexible positioning instrument, the flexible positioning instrument having an elongated catheter with an orifice of double lumen extending from a first end of the catheter to a second end of the catheter, the double lumen orifice having a first lumen and a second lumen and a pigtail wire attached to the second end of the catheter, the first lumen extends through the elongate catheter and the pigtail wire, the second lumen extends through the catheter, a guidewire extends through the first lumen of the elongated catheter and the pig, and a retraction instrument configured to have a proximal member and a distal member coupled to the proximal member, the distal member having a deformable rim and a membrane the barrier affixed to the same deformable and extensible hoop through the second lumen of the elongated catheter, maneuvering the operated surgical device through the patient's vessel, positioning the pigtail-shaped wire close to the biomaterial, implanting the deformable hoop and the barrier membrane from the second lumen, rotating the deformable the rim and the barrier membrane approach the biomaterial, collecting the biomaterial in it in the barrier membrane, retracting the deformable rim, the barrier membrane and the biomaterial through the second lumen.

[0012] Therefore, a feature of the thrombectomy catheter and methods of use is its ability to rotate the wire in a pigtail shape or distal segment configured as a mesh, several times

6 / 28 close to unwanted material, allowing you to collect clots, plaque, emboli, thrombi (blood clots), fat deposit, or other unwanted material or debris in the same mesh blood filter device and extract them from a blood vessel human.

[0013] Another feature of the thrombectomy catheter and methods of use is its ability to provide a filter device with a porous screen or basket so that blood cells can pass freely while clots, plaques, emboli, thrombi (blood clots), grease deposit or other undesirable material or debris is trapped in it.

[0014] Yet another feature of the thrombectomy catheter and methods of use is its ability to provide a double lumen catheter, where one lumen forms a passageway for the guidewire and the other lumen forms a passageway for the mesh filter device.

[0015] Yet another feature of the thrombectomy catheter and methods of use is the ability to provide a remotely operable surgical device or guidewire.

[0016] Yet another feature of the thrombectomy catheter and methods of use is the ability to provide a flexible double lumen catheter.

[0017] Yet another feature of the thrombectomy catheter and methods of use is the ability to provide a flexible dual-lumen catheter with a flexible pigtail-shaped wire lumen with a guidewire passage and an opening or port. outlet formed near or at the tip end.

[0018] Yet another feature of the thrombectomy catheter and methods of use is the ability to provide a filter device with a retractable mesh that traverses the distal segment configured as a mesh to form a basket or net to collect clots, plaque, emboli or other material. evicted in the same screen filter device.

[0019] Yet another feature of thrombectomy catheter and

7 / 28 methods of use is the ability to provide a catheter with an implantable mesh basket, mesh, screen filter device to track around a mesh, pigtail-shaped wire lumen in the distal segment of the catheter.

[0020] Yet another feature of the thrombectomy catheter and methods of use is the ability to provide a vascular device that overcomes the disadvantages of previously known vascular filter meshes and thrombectomy/embolectomy devices and employs few components.

[0021] Yet another feature of the thrombectomy catheter and methods of use is the ability to provide a vascular device that is capable of being contracted for a small dispensing profile, thus allowing the use of the device in small blood vessels.

[0022] Yet another feature of the thrombectomy catheter and methods of use is the ability to provide a vascular device without the need for specialized dispensing catheters.

[0023] Yet another feature of the thrombectomy catheter and methods of use is the ability to provide a vascular device to provide a vascular device that reduces the risk of clots, plaque, emboli, thrombus (blood clots), fat deposits or other unwanted material or debris escaping the device when the device is retracted and removed.

[0024] Yet another feature of the thrombectomy catheter and methods of use is the ability to provide a vascular device to remove clots, plaque, emboli, thrombus (blood clots), fatty deposits or other unwanted material or debris from human blood vessels. without performing surgery or without causing a clot-buster.

[0025] Yet another feature of the thrombectomy catheter and methods of use is the ability to provide a vascular device to capture clots, plaques, emboli, thrombus (blood clots), fatty deposits or other unwanted material or debris from blood vessels.

8 / 28 humans just rotating the wire in the form of a pigtail, mesh or distal segment configured as a mesh several times close to the undesirable material.

[0026] Yet another feature of the thrombectomy catheter and methods of use is the ability to remove the mesh, basket, implantable mesh basket or mesh filter device multiple times through the double lumen catheter without losing the lumen position of the wire in pigtail shape, mesh or distal segment configured as a mesh adjacent to the work area.

[0027] Yet another feature of the thrombectomy catheter and methods of use is the ability to provide a vascular device with aspiration or suction via an aspiration device to collect and remove clots, plaque, emboli, thrombi (blood clots), depositing fat or other unwanted material or human blood vessel debris by aspirating unwanted material (aspiration thrombectomy) into a distal end of a lumen close to the unwanted material and pulling it down the lumen channel.

[0028] These and other features of the thrombectomy catheter and methods of use will become more apparent to one skilled in the art from the following Detailed Description of Embodiments and Claims, when read in light of the Figures of the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0029] The present thrombectomy catheter and methods of use will be better understood by reading the Detailed Description of the modalities with reference to the figures of the accompanying drawings, where similar reference numerals denote similar structure and refer to similar elements throughout, and wherein: FIG. 1A is a top perspective view of an exemplary embodiment of a thrombectomy catheter;

9 / 28 to FIG. 1B is a perspective cross-sectional view of an exemplary embodiment of a double-lumen elongated catheter of the thrombectomy catheter of FIG. 1A; FIG. 1C is a perspective cross-sectional view of an exemplary embodiment of a single-lumen pigtail wire from the thrombectomy catheter of FIG. 1A; FIG. 2 is a top perspective view of an exemplary embodiment of the thrombectomy catheter of FIG. 1A , shown with a guidewire passing a first lumen therein which elongates the lumen of the pigtail wire; FIG. 3 is a top perspective view of an exemplary embodiment of vascular medical instrument; FIG. 4A is a top perspective view of an exemplary embodiment of the thrombectomy catheter of FIG. 1, shown with a guidewire passing through the first lumen and the retractable instrument passing through the second lumen; FIG. 4B is a perspective cross-sectional view of the elongated catheter of a thrombectomy catheter of FIG. 1, shown with a guidewire and a retractable instrument passing through it; FIG. 5A is a top perspective view of an exemplary thrombectomy catheter of FIG. 1 with a retractable instrument implanted between the same wires in the shape of a pig's tail; FIG. 5B is a front perspective view of the thrombectomy catheter of FIG. 5A with vascular medical instrument, shown retaining unwanted material or debris for recovery; FIG. 6 is a top view of the thrombectomy catheter of FIG. 5A passing through the heart and implanted into a vascular vessel of the lung with the retractable instrument shown retaining unwanted material or debris for recovery;

10 / 28 to FIG. 7 is a flowchart of a method of implantation using and retrieving the thrombectomy catheter of FIGs. 1-6 for removing unwanted material or debris from a vascular vessel; FIG. 8 is a top perspective view of an exemplary embodiment of a thrombectomy catheter with aspiration device; FIG. 9 is a top perspective view of an exemplary thrombectomy catheter of FIG. 8 with undesirable material being pulled into the distal end of the lumen; and FIG. 10 is a flowchart of a method of implantation using and retrieving the thrombectomy catheter of FIGs. 1-6 and 8-9 to remove unwanted material or debris from a vascular vessel by means of aspiration.

[0030] It should be noted that the drawings shown are intended solely for purposes of illustration and that they are therefore neither desired nor intended to limit the description to any or all of the exact construction details shown, except to the extent that may be considered essential to the claimed invention.

DETAILED DESCRIPTION

[0031] In describing exemplary embodiments of the present description, as illustrated in FIGS. 1A, 1B, 1C, 2, 3, 4A, 4B, 5A, 5B, 6 7, 8, 9 and 10, specific terminology is employed for the sake of clarity. The present description, however, is not intended to be limited to the specific terminology so selected and it should be understood that each specific element includes all technical equivalents that operate in a similar manner to perform similar functions. The embodiments of the claims may, however, be realized in many different ways and should not be construed as being limited to the embodiments set forth herein. The examples presented here are non-limiting examples and

11 / 28 are merely examples among other possible examples.

[0032] Referring now to FIGs. 1A, 1B, 1C, by way of example and not limitation, an example embodiment of a flexible surgical positioning instrument 10 is illustrated. The surgical positioning instrument 10 may include a base section, such as handle 36, having first pivot tab 37 and second pivot tab 38, as coupled to a longitudinal linear member, cannula, housing, catheter or sheath, such as elongate catheter 20 extending linearly from handle 36. Preferably, the catheter elongate 20 may include two or double axial holes therethrough or space created within the elongate catheter 20 and extending from the first end of the catheter 21 to the second end of the catheter 22. In addition, two or double axial holes therethrough may include the first lumen 31 and second lumen 32 separated by divider 33.

[0033] In addition, the second end of the catheter 22 of the surgical positioning instrument 10 may be configured as a mesh, open-ended mesh or enclosure, such as pigtail wire 50 formed therein or affixed to the second end. of the catheter 22. It is contemplated herein that the pigtail wire 50 may be formed in a variety of sizes and configurations and includes the first section of the pigtail wire 51 and the second section of the wire shaped pigtail 52 with the first pigtail-shaped wire section 51 affixed to the same second end of the catheter 22 of the elongate catheter 20 and the second pigtail-shaped wire section 52 forming an enclosure that circulates back to a position proximate the second end of the catheter 22. It is contemplated herein that the elongate catheter 20 and the pigtail wire 50 may preferably be configured or constructed of plastic, the polymeric material unique includes polytetrafluoroethylene, polyurethane, polyethylene, Teflon and the like,

12 / 28 as such materials offer a variety of shapes, shapes, ease of fabrication and flexibility; however, other suitable materials may be used, provided such material has sufficient strength, flexibility and/or durability to serve the purpose described herein. The material of the elongate catheter 20, second pigtail wire 50 of lumen 32, second lumen or medical instrument outlet port 25 may be reinforced with fibers, rings or longitudinal ribs, for example, to allow it to support the forces exerted on it by the retractable instrument 60 while being restricted within the second lumen 32 and deformed by the elongated catheter 20.

[0034] The first lumen 31 may extend through the handle 36, elongate catheter 20 and pigtail wire 50, starting with an entry hole, such as the first lumen or guidewire entry opening 24 and exiting the pigtail wire 50 near the end of the pigtail wire 53 through an exit or opening of the implantation hole to the environment, such as the first lumen or the guidewire exit opening 26 .

[0035] The second lumen 32 can extend through the handle 36 and the elongate catheter 20 starting with an inlet hole, such as the first opening of the instrument 23 and exiting the same elongated catheter 20 near the second end of the catheter 22 through an exit or implantation orifice, such as the second opening of the instrument 25 near the second end of the catheter 22.

[0036] Referring now to FIG. 2, by way of example and not by way of limitation, an example embodiment of guidewire 40 for implantation and use of retraction in the first lumen 31 of the elongate catheter 20 and the pigtail wire lumen 31B of the wire is illustrated. pigtail shaped 50. Guidewire 40 may include the first end of the guidewire 41 and the second end of the guidewire 42. In use, a path or device for

13 / 28 vessel guide, such as guidewire 40 may be extended through the first lumen 31 of the elongate catheter 20 and lumen of the pigtail wire 31B of the pigtail wire 50 starting with a hole of inlet, such as the inlet opening of the first lumen 24 and exiting the pigtail wire 50 near the end of the pigtail wire 53 through an outlet or implantation hole opening to the environment, such as such as opening the first lumen 26 to a position beyond or extending and extending from the pig tail 50 to assist or guide the second end of the catheter 22 and the pig tail 50 through a blood vessel V, rotate, perform the fork or other vascular maneuverability.

The first end of the guidewire 41 extends through the implantation opening like the guidewire opening 26 and is remotely controlled from the second end of the guidewire 42. Furthermore, as the guidewire 40 passes through of the pigtail yarn 50, the pigtail yarn 50 can be angled or straightened (as shown in FIG. 2) or angled, such as the angle of the pigtail yarn A (from approximately 0-270 degrees relative to the perpendicular to the same elongated catheter 20, 9 hours counterclockwise to 12 hours). depending on the flexibility or rigidity of the first end of the guide wire 41 passing therethrough.

Furthermore, the first rotation R1 of the elongated catheter 20 causes or results in similar rotation as rotation R2 of the pigtail wire 50. Both angle A of the pigtail wire A and rotation R2 allow for a variety of positions of the first end of the guidewire 41 to assist or guide or position the guidewire 40, the pigtail wire 50 and the second end of the catheter 22 through a blood vessel V, curve, fork or other vascular maneuverability.

In addition, movement or movement of the guidewire 40, such as pushing/pulling PI the second end of the guidewire 42, causes the first end of the guidewire 41 to move in and out of the

14 / 28 opening guide wire 26 to assist or guide or position guide wire 40, pigtail wire 50 and second end 22 of catheter through a blood vessel, bend, fork or other vascular maneuverability v.

[0037] Alternatively, the first lumen 31 and the pigtail wire lumen 31B may be used as an access for additional laparoscopic or endoscopic devices and/or access or withdrawal of fluid, lighting, video and similar 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 configuration and specific dimensions of the first lumen 31 and the pigtail wire lumen 31B will vary with the intended use of the surgical positioning instrument 10, and whether access for additional medical instruments 40A is provided. In general, the axial orifice of the 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.

[0038] Referring now to FIG. 3, by way of example and not limitation, an example embodiment of a retractable instrument 60 for use with surgical positioning instrument 10 is illustrated. Retractable instrument 60 may include a proximal or elongated limb or operator, such as proximal member 64 having a first member end 65 and a second member end 66. The first member end 65 may be configured having a mesh, enclosure or basket, pigtail-shaped wire lumen, such as the collapsible collar. 67 configured therein and the proximal end of the second member 66. It is contemplated herein that the collapsible collar 67 may be configured in a variety of sizes and shapes, preferably combining the lumen of the pigtail-shaped wire 50 in size and shape.

[0039] In addition, the collapsible rim 67 can be configured in a

15 / 28 or two components such as the first collapsible section 61 and the second collapsible section 62 and may alternatively include one or more pivot joints 68 therebetween the first collapsible section 61 and the second collapsible section 62. The collapsible rim 67 is preferably made of a flexible, elastic or shape memory material or biocompatible alloy material capable of flexing, bending or collapsing into a configuration that can enter and exit the first instrument opening 23, traverse the axial hole of the instrument. second lumen 32, expanding to unfold the mesh after passing through the second instrument opening 26, and collapsing to reenter the second instrument opening 26 to extract biomaterial from a blood vessel or other vascular channel or conduit V.

[0040] It is further contemplated in this document that deformable rim 67 may include one or more joints or hinges, such as pivot point 68 positioned around deformable rim 67 or between first deformable section 61 and second deformable section 62 to allow the collapsible rim 67, first collapsible section 61, and second collapsible section 62 to retract or fold linearly and pass through first instrument opening 23, second lumen axial hole 32 and second instrument opening 25. It is further contemplated herein that the collapsible rim 67 can form an opening, like the rim inlet 69.

[0041] When expanded, the collapsible rim 67 may have a diameter of about 1 cm or less to about 3 cm, but other sizes are contemplated herein. In addition, a barrier membrane or other sieving or filtering membrane, such as screen filter device 63, preferably runs, extends, or is affixed to deformable rim 67 loosely, forming an open-ended capture net. rounded through rim inlet 69. Screen filter device 63 can be used to filter or capture clots, plaque, emboli, thrombus (blood clots), fat deposits or other material

16 / 28 unwanted debris from inside human blood vessels.

[0042] The configuration and specific dimensions of the axial hole of the second lumen 32 will vary with the use of the surgical positioning instrument 10, the parameters of the retractable instrument 60, such as the insertion/retraction element 64 and sized to receive the rim deformable 67 having first deformable section 61 and second deformable section 62 in a constrained configuration with screen filter device 63 wrapped around first deformable section 61, second deformable section 62 and insertion/retraction member 64. In general, the axial hole of the second lumen 32 may have an axial orifice or inside diameter of 6-12 F (French = 1/3 mm) to accommodate the retractable instrument 60 in a restricted configuration, however other diameters are contemplated herein.

[0043] Alternatively, the second lumen 32 may be used as an access for additional laparoscopic or endoscopic devices and/or access or withdrawal of fluid, lighting, video and similar 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.

[0044] Referring again to FIG. 1A, the outer diameter of the catheter 20 may vary with application, the size of the first lumen 31 and second lumen 32, the size of the collapsible rim 67 of the retractable instrument 60 having the first collapsible section 61 and the second collapsible section 62, either access for additional laparoscopic or endoscopic devices and/or access or withdrawal of fluid, lighting, video and the like 40A and whether additional lumens are included in the surgical positioning instrument 10.

[0045] Referring now to FIGs. 4A and 4B, by way of example and not limitation, an example embodiment of the retractable instrument 60 for implantation and use of retraction in the second lumen 32 of the surgical positioning instrument 10 is illustrated.

17 / 28 the end of the guidewire 42 can be pulled and as the guidewire 40 retracts through the pigtail wire 50, the pigtail wire 50 can return to the tail wire configuration. pork or mesh as shown in FIGs. 1 and 4A.

[0046] In use, the deformable rim 67 of the end of the first member 65 can preferably be collapsed and the screen filter device 63 can be wrapped or wound around the deformable rim 67 and/or the end of the first member 65 of the retractable instrument 60. The collapsible collapsible rim 67 and the creased screen filter device 63 can be inserted into the first instrument opening 23 of the second lumen 32. The collapsed collapsible collar 67 and the creased screen filter device 63 can be arranged inside, extending and passing through the second lumen 32 of the elongate catheter 20 and exiting or extending therethrough or extending therefrom. After the collapsible collar 67 and the creased mesh filter device 63 exit the second lumen 32, the collapsible collar 67 expands into the collapsible collar 67 implanted with the mesh filter device 63 unrolled to an expanded collection state positioned near the wire in pigtail shape 50. When deployed, the first collapsible section 61 and second collapsible section 62 of the collapsible rim 67 expand back to an uncompressed position, as shown in FIG. 5 to create the expanded collapsible rim 67 with rim inlet 69 and screen filter device 63, wherein the expanded collapsible rim 67 preferably matches or can be positioned near or within the pigtail wire 50, as shown in FIG. 5

[0047] Referring now to FIG. 5A and 5B, by way of example and not limitation, an example embodiment of the retractable instrument 60 shown implanted from the same second lumen 32 of the surgical positioning instrument 103 is illustrated In use, push/pull PI to

18/28 end of second member 66 may implant or extend collapsible collar 67 into pigtail wire 50 or beyond the confines of second instrument opening 25 at distal end of second catheter end 22 to implant collapsible collar 67 and the mesh filter device 63 affixed thereto and reach its implanted configuration.

Rotation R3 of the end of second member 66 causes or results in similar rotation, as does rotation R4 of deformable rim 67 with rim inlet 69 and screen filter device 63, which in turn causes deformable rim 67 having inlet 69 and filter device with screen 63 of retractable instrument 60 to collect or collect or capture clots, plaque, emboli, thrombus (blood clots), fat deposit, biomaterial or other undesirable material or debris M from blood vessel V.

Furthermore, rotation R1 of elongated catheter 20 results in rotation R2 of pigtail 50 which in turn results in rotation R4 of deformable rim 67 with rim inlet 69 and mesh filter device 63 due to abutting or to contact between the same pigtail wires 50 and deformable hoop 67 (deformable hoop 67 abuts the hogtail wire 50), which in turn causes deformable hoop 67 to have hoop entry 69 and screen filter device 63 of retractable instrument 60 collects or collects or captures clots, plaque, emboli, thrombus (blood clots), fat deposit, biomaterial or other undesirable material or debris M from blood vessel V.

Undesirable material or debris M can be removed from blood vessel V by extracting retractable instrument 60 and collapsible rim 67 with rim inlet 69 and screen filter device 63 containing unwanted material or debris M back into the same second instrument opening 25 collapsible collar 67 and pulling retractable instrument 60 under second lumen 32 of surgical positioning instrument 10 and out of first instrument opening 23, as shown in FIGs. 4A and 4B.

Push/pull PI end of

19 / 28 second member 66 may recover deformable rim 67 by collapsing deformable rim 67 and screen filter device 63 may be wrapped or wound around deformable rim 67 and/or end of first member 65 and retractable instrument 60 with undesirable material or debris M can be pulled through the second instrument opening 25 and out of the first instrument opening 23.

[0048] It is contemplated in this document that the deformable ring 67 and the pigtail wire 50 may be similar or combined in size and shape, such as circumference and/or diameter, to allow for containment or contact between them between the pigtail yarn 50 and deformable ring 67 (deformable ring 67 confines pigtail yarn 50).

[0049] Referring now to FIG. 6, by way of example and not by way of limitation, an example surgical device modality, the combination of retractable instrument 60 and surgical positioning instrument 10, is illustrated. In use, the surgical positioning instrument 10, shown with wire in the form tail 50 inserted into a patient and serpentinely implanted through blood vessel V, heart H, lung L and into the blood vessel of lung V. It is contemplated herein that the surgical positioning instrument 10 may be implanted therein in any transport container of fluid where debris needs to be removed.

[0050] In use, push/pull PI the guide wire 40 can be extended through the pigtail wire 50, causing the pigtail wire 50 to straighten or elongate (as shown in Fig. 2) or the angle, such as the angle of pigtail wire A, in the same blood vessel V depending on the flexibility or rigidity of the first end of the guide wire 41 passing therethrough. Furthermore, the first rotation R1 of the elongated catheter 20 causes the wire to form a tail of

20 / 28 pig 50 rotate similarly, rotation R2 in blood vessel V. Both the angle of the pigtail wire A and rotation R2 allow a variety of positions of the first end of the guide wire 41 to assist or guide or position guidewire 40, pigtail wire 50, and second end of catheter 22 through the same or the same blood vessel V, heart H, lung L to snake, turn, maneuver a fork or other vascular maneuverability to precisely maneuver and position the pigtail wire 50 in blood vessel V. The purpose of the surgical positioning instrument 10 is to preferentially position the lumen of the pigtail wire 50 at a specific location within a patient's vessel.

[0051] Pushing/pulling PI on the end of the second limb 66 results in the exit or implantation of the deformable rim 67 with rim inlet 69 and mesh filter device 63 through the second instrument opening 25 near a junction between the second end of the catheter 22 and expanding into the implanted deformable rim 67 with mesh filter device 63 after passing through the second instrument opening 25 to a position proximate the pigtail wire 50 in blood vessel V.

[0052] In addition, rotation R3 of the end of second member 66 results in rotation R4 of deformable rim 67 within blood vessel V with rim inlet 69 and mesh filter device 63, which in turn causes the rim to deformable 67 having rim inlet 69 and filter device with screen 63 of retractable instrument 60 to collect or collect or capture clots, plaque, emboli, thrombus (blood clots), fat deposit, biomaterial or other undesirable material or debris M from the vessel blood v.

[0053] In addition, rotation R1 of the elongated catheter 20 results in rotation R2 of the pigtail wire 50 within the blood vessel V,

21 / 28 which in turn results in the rotation R4 of the deformable ring 67 having the inlet of the ring 69 and the screen filter device 63 due to the abutment or contact between the pigtail wire 50 and the deformable ring 67 , which in turn makes the deformable rim 67 having rim inlet 69 and filter device with screen 63 of the retractable instrument 60 to collect or collect or capture clots, plaque, emboli, thrombus (blood clots), fat deposit, biomaterial or other undesirable material or debris M from the blood vessel V.

[0054] Pushing/pulling PI on the end of the second member 66 results in a collapsed deformable rim 67 having rim inlet 69 and screen filter device 63 being retracted or entering the second instrument opening 25 and traversing through the second lumen 32 into the first instrument opening 23 to remove unwanted material or debris M captured in mesh filter device 63 from blood vessel V. It is contemplated herein that such capture and recovery of unwanted material or debris M may be performed multiple times with multiple passes, implantation, retraction and retrieval of the retractable instrument 60 through the second lumen 32 of the surgery positioning instrument 10.

[0055] It is contemplated herein that second lumen angioplasty 32, atherectomy and implantation of stents and stent grafts, procedures to treat vascular diseases, may be implanted through the second lumen

32. These instruments often dislodge material or plaque from the vessel walls of blood vessel V, which can result in clot formation or the release of emboli, biomaterials such as unwanted material or M debris, which enter the bloodstream and can be large enough to occlude smaller vessels downstream and potentially blocking blood flow to the tissue. The result can pose a serious threat to a patient's health or life if the blockage occurs in critical tissues such as the heart, lungs or brain. The retractable instrument 60 can be

22/28 used in this document to traverse the second lumen 32 to capture and remove unwanted material or debris M from the blood vessel V.

[0056] It is further contemplated in this document that the pigtail wire 50 surrounding the deformable ring 67 can protect the blood vessel V when the deformable ring 67 expands preventing contact with the same blood vessel V preventing a tissue rupture or a vase in the implantation area.

[0057] It is further contemplated in this document that the pigtail wire 50 encircling the deformable edge 67 can protect the blood vessel V when the deformable edge 67 expands or retracts, avoiding contact with the blood vessel V, avoiding cutting or puncture the biopsy, clot or impale the blood vessel wall V.

[0058] It is further contemplated in this document that the second lumen 32 can be used for dispensing other medical instrument(s), such as a suture to conduct a biopsy or other medical instrument to meet application needs medical examination being performed with the surgical positioning instrument 10.

[0059] It is further contemplated herein that the second lumen 32 may be sized or adjustable to accommodate medical instruments 60 of different diameters or sizes.

[0060] Referring now to FIG. 7, a flowchart 700 of using surgical positioning instrument 10 and retractable instrument 60 to remove clots or release emboli, biomaterials such as unwanted material or debris M from blood vessel V is illustrated. positioning 10 having elongate member 20 with two or double axial holes therethrough, such as first lumen 31 and second lumen 32 and pigtail wire 50 at one end and integral retractable instrument 60 having collapsible rim 67 and filter device with screen 63 as described above in FIGS. 1-6

23/28 including (folding the deformable collar 67 and wrapping the mesh filter device 63 around the end of the first member 65 and inserting into the first instrument opening 23 of the second lumen 32) and (crossing the first instrument opening 23 (push /pull PI the end of the second member 66) to the second instrument port 25 of the second lumen 32).

[0061] In block or step 715, manipulate or move guidewire 40 (push/pull guidewire PI 40 or rotate elongated member R1 20) to change the position of pigtail wire 50 to a vessel guide path or device for maneuvering or advancing the surgical positioning instrument 10 through blood vessel V, bend, fork or other vascular maneuverability and positioning the pigtail wire 50 close to material or debris M.

[0062] In block or step 720, implant retractable instrument 60 via implanted deformable rim expansion 67 with mesh filter device 63 after passing through second instrument opening 25 to a position close to the lumen of the pigtail wire 50 (implanting the deformable ring 67 and the mesh filter device 63 of the same second lumen 32). When deployed, the first deformable section 61 and second deformable section 62 of the deformable rim 67 expands back to an uncompressed position.

[0063] In block or step 730, rotating deformable rim 67 and screen filter device 63 approach material or debris M through second end of rotating member 66 of retractable instrument 60, rotation R3, results in rim rotation R4 deformable 67 having rim inlet 69 and screen filter device 63, which in turn causes expanded deformable rim 67 having rim inlet 69 and screen filter device 63 of retractable instrument 60 to collect or collect or capture clots, plate , emboli, thrombi (blood clots), fat deposits,

24 / 28 biomaterial or other undesirable material or debris M from the blood vessel V.

[0064] In block or step 730, rotating deformable collar 67 and screen filter device 63 approach material or debris M via rotating elongated catheter 20, rotation R1, results in rotation R2 of pigtail wire 50 which in turn results in rotation R4 of the deformable rim 67 having rim inlet 69 and the screen filter device 63 due to abutment or contact between the pigtail wire 50 and the deformable rim 67, which in turn causes the collapsible rim 67 with rim inlet 69 and the mesh filter device 63 of the retractable instrument 60 to collect or collect or capture clots, plaque, emboli, thrombus (blood clots), fat deposit, biomaterial or other undesirable material or Debris M from blood vessel V.

[0065] In the block or step 735, collection of material or debris M in the filter device with mesh 63 by means of excavation or collection or capture of clots, plaque, emboli, thrombi (blood clots), fat deposit, biomaterial or other unwanted material or debris M from blood vessel V in the same 63 mesh filter device.

[0066] In the block or step 740, retraction of the deformable rim 67, filter device with screen 63 and material or debris M through the second instrument opening 25 of the second lumen 32 through the collapse of the deformable rim 67 through push/pull PI a end of the second member 66 to recover the collapse of the collapsible rim 67 and the screen filter device 63 may be wrapped or wrapped around the collapsible rim 67 and/or the end of the first member 65, and the retractable instrument 60 with undesirable material or Debris M can be pulled through it or enter the second instrument opening 25 and exit the first instrument opening 23.

[0067] In block or step 745, repeat steps 715-740.

[0068] Referring now to FIG. 8, by way of example, and not

25 / 28 as a limitation, an example embodiment of a flexible surgical positioning instrument 10 is illustrated. The surgical positioning instrument 10 may include hub or access port such as suction port 90 positioned close to handle 36 or catheter first end 21. Suction port 90 may provide access, may be connected, in communication with first lumen 31 by passing the length of elongate catheter 20, lumen of pigtail wire 31B, pigtail wire 50 and the pigtail-shaped end of the wire 53. In addition, the surgical positioning instrument 10 may include a side arm or conduit, such as the suction tube 80, which may include a distal end, such as the first end of the tube 81 and a proximal end, or second end, of tube 82. The second end of tube 82 may be affixed or detachably affixed to suction port 90. Suction tube 80 may include ir three-way regulating valve 84 with regulating bar 85. The regulating bar 85 can be rotated (rotationally) between the open position for passage therethrough and for suction, bypass position for diverting debris M to the threaded port and cover 83 and the closed position to seal the second end of the tube 82. In addition, the surgical positioning instrument 10 may include a suction, vacuum or negative pressure device, such as the suction device 70. The suction device 70 may include a syringe with a housing or body, such as the syringe barrel 72, the plunger 71 positioned therein and pulled or moved, such as the M movement on the syringe barrel 72, and the adapter port 73 provides an outlet or inlet on the syringe barrel 72. The suction device 70 or more specifically the adapter port 73 can be connected, in communication or detachably connected to the same first end of the tube 81, preferably to perform suction, vacuum, or suction S through suction tube 80, suction port 90, catheter lumen 31

26 / 28 elongated 20, lumen of the pigtail wire 31B of the pigtail wire 50 and through the end of the pigtail wire 53.

[0069] Referring now to FIG. 9, by way of example, and not by way of limitation, an example of a pigtail wire embodiment 50 shown next to clots, plaque, emboli, thrombus (blood clots), fat deposit, biomaterial or other unwanted material or debris M within the blood vessel V. Further, aspiration or suction, thereby, suction device 70 preferably results in debris M being aspirated or pulled or pulled (pulls/sucks) or collected or captured at the end of the lumen of the pigtail-shaped wire 53. In addition, with continuous suction or suction (aspiration thrombectomy), thus, the suction device 70 debris M can be pulled or passed through the lumen of the tail-shaped wire. 31B of pigtail wire 50, lumen 31 of elongate catheter 20, suction port 90 and suction tube 80, into the same suction device 70 by which debris M was removed from blood vessel y.

[0070] It is contemplated in this document that the pigtail wire 50 may be in an extended configuration, as shown in FIG. 2, rather than a rolled configuration as shown in FIGs. 5 during aspiration or suction (aspiration thrombectomy) of debris M.

[0071] Referring now to FIG. 10, a flowchart 1000 of using surgical positioning instrument 10 and retractable instrument 60 to remove clots or release emboli, biomaterials such as unwanted material or debris M from blood vessel V by means of aspiration or suction is illustrated. In block or step 1010, provide surgical positioning instrument 10 with elongated limb 20 with two or double axial holes therethrough, such as first lumen 31 and second lumen 32 and pigtail wire 50 at one end and

27 / 28 suction port 90, suction tube 80 and suction device 70, as described above in FIGS. 8-9.

[0072] In block or step 1015, manipulate or move the first end of the catheter 21 to change the lumen position of the pigtail wire 50 to a vessel guide path or device to maneuver or advance the positioning instrument surgical 10 through blood vessel V, routed, performs the fork or other vascular maneuverability and pigtail-shaped wire lumen positioning 50 of nearby material or debris M, block or step 1020.

[0073] In the block or step 1030, operate the suction device 70 (aspiration or suction) to collect, capture, debris M at the end of the pigtail wire 53. Also, with continuous suction or suction step 1040 (aspiration thrombectomy), thus, the debris suction device 70 M can be pulled through or through the lumen of the pigtail wire 31B of the pigtail wire 50, lumen 31 of the elongated catheter 20, port suction tube 90 and suction tube 80, suction device 70 step 1050, whereby debris M was removed from blood vessel V.

[0074] The above description and drawings comprise illustrative embodiments of the present description. Having thus described exemplary embodiments, it should be noted by those skilled in the art that the descriptions within are exemplary only and that various other alternatives, adaptations and modifications may be made within the scope of the present description. The mere listing or numbering of 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 description will come to the mind of one skilled in the art to which this description pertains, having the benefit of the teachings presented in the foregoing descriptions and the associated drawings. Although specific terms may be used

28 / 28 here, they are used in a generic and descriptive sense only and not for purposes of limitation.

Furthermore, the present description has been described in detail, it is to be understood that various changes, substitutions and alterations may be made therein, without departing from the spirit and scope of the description as defined by the appended claims.

Therefore, the present description is not limited to the specific embodiments illustrated herein, but is limited only by the following claims.

Claims (21)

1. Remotely operated surgical device, said surgical device characterized in that it comprises: a flexible positioning instrument having an elongate catheter with a double lumen orifice therein extending from a first end of the catheter to a second end of the catheter, said double lumen orifice having a first lumen and a second lumen, and a pigtail wire attached to said second end of the catheter, said first lumen extending through said elongated catheter and said tail wire of pig, said second lumen extends through said elongate catheter; a guidewire extensible through said first lumen of said elongated catheter and said pigtail wire, and extensible from said pigtail wire, said guidewire configured to skew said wire in the form of a pig's tail; and a suction device connected to said first lumen and configured to create a vacuum in said first lumen of said elongate catheter and said pigtail wire. 2. Remotely operated surgical device according to claim 1, characterized in that it additionally comprises a guidewire inlet opening positioned close to said first catheter end and a guidewire outlet opening positioned close to one end. of the pigtail yarn of said pigtail yarn. A remotely operated surgical device according to claim 1, characterized in that a rotation of said elongated catheter results in said rotation of said pigtail wire. 4. Remotely operated surgical device according to claim 1, characterized in that it additionally comprises a handle affixed to said first end of the catheter. 5. Remotely operated surgical device according to claim 3, characterized in that said pigtail-shaped wire is arranged in a location within the patient's vessel. A remotely operated surgical device according to claim 1, characterized in that it further comprises a first instrument opening positioned close to said first catheter end and a second instrument opening positioned close to said second catheter end. A remotely operated surgical device according to claim 1, characterized in that said pigtail wire additionally comprises a lumen of the pigtail wire in communication with said first lumen. A remotely operated surgical device according to claim 7, characterized in that it additionally comprises an aspiration port positioned proximate to said first catheter end, said aspiration port in communication with said first lumen. A remotely operated surgical device according to claim 8, characterized in that it further comprises a suction tube having a first tube end and a second tube end, said second tube end in communication with said delivery port. aspiration. 10. Remotely operated surgical device according to claim 9, characterized in that it additionally comprises a suction device in communication with said first tube end. A remotely operated surgical device according to claim 10, characterized in that said suction device further comprises a syringe having a syringe barrel, a plunger positioned in said syringe barrel and the adapter port exiting said syringe barrel. syringe cylinder. 12. Remotely operated surgical device according to claim 9, characterized in that said suction tube includes a regulating valve with a regulating bar rotating between an open position, a bypass position and a closed position. A remotely operated surgical device according to claim 10, characterized in that rotation of said first catheter end results in said rotation of a pigtail wire end adjacent to a biomaterial therein. A remotely operated surgical device according to claim 13, characterized in that a suction in said suction device creates an suction in said suction tube, in said suction port, in said first lumen and in said lumen of the wire. in the form of a pig's tail to collect said biomaterial therein. 15. The remotely operated surgical device according to claim 14, characterized in that the additional suction in said suction device suctions said biomaterial through said lumen of pigtail-shaped wire, from said first lumen, from said suction port, of said suction tube and to said suction device. 16. A method for removing a biomaterial from a patient vessel, characterized in that it comprises the steps of: providing a remotely operated surgical device having a flexible positioning instrument, said flexible positioning instrument having an elongate catheter with an orifice of dual lumen therein extending from a first end of the catheter to a second end of the catheter, said dual lumen orifice having a first lumen and a second lumen, and a pigtail wire attached to said second end of the catheter , said first lumen extends through said elongate catheter and said pigtail wire, said second lumen extends through said elongate catheter, a guidewire extendable through said first lumen of said elongate catheter, and of said pig's tail wire, and a suction device connected to said first lumen and configured to to create a vacuum in said first lumen of said elongated catheter and said pigtail wire; maneuvering said operated surgical device through the patient's vessel; positioning said pigtail wire close to the biomaterial; suctioning said suction device; and collecting the biomaterial in said first lumen. The method of claim 16, further comprising the step of moving said guidewire in said first lumen to straighten said pigtail-shaped wire at an angle. 18. Method according to claim 16, characterized in that it additionally comprises the step of rotating said first catheter end that rotates said pigtail-shaped wire close to the biomaterial. A method according to claim 16, characterized in that it further comprises the step of moving said guidewire in said first lumen to abut said pigtail-shaped wire close to the biomaterial. Method according to claim 18, characterized in that it additionally comprises the step of rotating said first catheter end and rotating said pigtail wire close to the biomaterial. 21. Method according to claim 20, characterized in that it additionally comprises the step of further aspirating the biomaterial through said first lumen to collect the biomaterial in said aspiration device. 1 / 11 2 / 11 3 / 11 4 / 11 5 / 11 6 / 11 7 / 11 8 / 11 9 / 11 10 / 11 11 / 11