Source: https://patents.google.com/patent/US9889006B2/en
Timestamp: 2019-12-15 02:31:33
Document Index: 449210663

Matched Legal Cases: ['§ 371', 'art 100', 'art 100', 'art 100', 'Application No. 14829758', 'Application No. 14829758']

US9889006B2 - Device and methods for self-centering a guide catheter - Google Patents
Device and methods for self-centering a guide catheter Download PDF
US9889006B2
US9889006B2 US14/906,393 US201414906393A US9889006B2 US 9889006 B2 US9889006 B2 US 9889006B2 US 201414906393 A US201414906393 A US 201414906393A US 9889006 B2 US9889006 B2 US 9889006B2
US14/906,393
US20160158006A1 (en
2014-07-22 Priority to US14/906,393 priority patent/US9889006B2/en
2016-06-09 Publication of US20160158006A1 publication Critical patent/US20160158006A1/en
2016-08-19 Assigned to MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH reassignment MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: SANDHU, GURPREET S., SPOON, DANIEL B., TEFFT, Brandon J.
2018-02-13 Publication of US9889006B2 publication Critical patent/US9889006B2/en
210000001765 Aortic Valve Anatomy 0 claims description 42
210000003709 Heart Valves Anatomy 0 abstract description 12
This application is a National Stage application under 35 U.S.C. § 371 of International Application No. PCT/US2014/047541, having an International Filing Date of Jul. 22, 2014, which claims the benefit of U.S. Provisional Application Ser. No. 61/856,910, filed Jul. 22, 2013. The disclosure of the prior applications are considered part of (and are incorporated by reference in) the disclosure of this application.
In one general aspect, this document features a device for centering a medical instrument in a conduit within a patient. The device comprises a framework of a plurality of elongate metal frame members and a covering that is attached to the framework. The covering is a biocompatible membrane or film. The frame members are attached to each other to define a central lumen having an open proximal end and an open distal end. The distal end has a greater diameter than a diameter of the proximal end. The frame members are attached to each other to further define two or more side apertures that are nearer to the proximal end than to the distal end. In various implementations, the plurality of elongate metal frame members may be comprised of nitinol, wherein the device is collapsible to a low-profile configuration adapted for confinement within a delivery sheath, and wherein the device can self-expand to an expanded configuration when the device is not contained within the delivery sheath. The frame members may be attached to each other to further define four or more side apertures that are nearer to the proximal end than to the distal end. The side apertures may be symmetrically positioned about a longitudinal axis of the device. The side apertures may define open fluid flow paths that are not occluded by the covering. In some embodiments, the plurality of elongate metal frame members form a plurality of petals. In particular embodiments, adjacent petals of the plurality of petals overlap each other. The plurality of petals may be hinged to a proximal end collar of the device.
In another general aspect, this document features a device for centering a medical instrument in a conduit within a patient. The device comprises a flared body comprised of two or more polymeric portions. The two or more polymeric portions are coupleable to each other to define a central lumen having an open proximal end and an open distal end. The distal end has a greater diameter than a diameter of the proximal end. The two or more polymeric portions are attached to each other to further define two or more side apertures that are nearer to the proximal end than to the distal end, wherein the side apertures are symmetrically positioned about a longitudinal axis of the device, and wherein the side apertures define open fluid flow paths that are not occluded by the polymeric portion.
FIG. 1A is a schematic diagram of a human heart shown in partial cross-section undergoing a catheterization using a guide catheter that is intended to transmit a guidewire through an aortic valve orifice.
FIG. 1B is a schematic diagram of a human heart shown in partial cross-section undergoing a catheterization using a self-centering guide catheter to transmit a guidewire through an aortic valve orifice in accordance with some embodiments provided herein.
FIGS. 2A and 2B are perspective schematic illustrations of a guide catheter-mounted device for self-centering the guide catheter in accordance with some embodiments provided herein.
FIG. 3A is an example embodiment of a self-expanding guide catheter-mounted device for self-centering the guide catheter in accordance with some embodiments provided herein.
FIG. 3B is another example embodiment of a self-expanding guide catheter-mounted device for self-centering the guide catheter in accordance with some embodiments provided herein.
FIG. 4 is flowchart of a heart valve catheterization process in accordance with some embodiments provided herein.
FIG. 5A is a top view of another guide catheter-mounted device for self-centering a guide catheter in accordance with some embodiments provided herein.
FIG. 5B is a perspective side view of the device of FIG. 5A.
FIG. 5C is a bottom view of the device of FIG. 5A.
With reference to FIG. 1, a schematic diagram is provided of human heart 100 shown in partial cross-section undergoing a catheterization using a guide catheter 120. Guide catheter 120 is depicted in aortic arch 102 for the purpose of transmitting a guidewire 130 through the orifice of an aortic valve 140. The blood flow in this region of heart 100 is from a left ventricle 104 to aortic arch 102. Therefore, guide catheter 120 is attempting to insert guidewire against the flow direction of the blood flowing from left ventricle 104 to aortic arch 102.
The process of crossing a heart valve using a guidewire is performed as a step in various heart treatment procedures. For example, TAVR procedures, valvuloplasties, hemodynamic studies on a stenotic valve, and other types of procedures involve the placement of a guidewire through the orifice of a heart valve. In addition to aortic valve procedures, other applications involving the placement of a guidewire through an orifice include perivalvular mitral valve 150 leak treatment procedures (or perivalvular aortic valve leak) and other treatment procedures involving fistulas at any site in the human heart or body.
Aortic valve 140 can be approached by guide catheter 120 via aortic arch 102. In some cases, guide catheter 120 can be percutaneously inserted in a femoral artery of a patient, and directed to the patient's aorta. From the aorta, guide catheter 120 can be directed to aortic arch 102. In other cases, aortic arch 102 can be accessed by guide catheter 120 via the patient's radial artery. Other aortic arch 102 access techniques are also envisioned. While in the depicted embodiment guide catheter 120 is generally linear at its distal end portion, in some embodiments the distal end portion of guide catheter 120 is angled (e.g., a terminal angle). In some embodiments, the terminal angle of guide catheter 120 is in a range of about 0 degrees to about 30 degrees, or about 30 degrees to about 60 degrees, or about 60 degrees to about 90 degrees.
With the distal tip of guide catheter 120 in a position superior to aortic valve 140, guidewire 130 can be ejected from guide catheter 120. The purpose of ejecting guidewire 130 from guide catheter 120 is to insert guidewire 130 through the orifice of aortic valve 140. As depicted in FIG. 1A, the longitudinal axis of guide catheter 120 may not be in alignment with the orifice of aortic valve 140. This can be the case particularly when aortic valve 140 is stenotic. Therefore, as guidewire 130 is ejected from guide catheter 120, the distal tip of guidewire 130 may often contact a leaflet of aortic valve 140 rather than passing through the orifice of aortic valve 140. The current practice for inserting guidewire 130 through aortic valve 140 involves random probing of aortic valve 140 with guidewire 130 until the orifice is penetrated. This practice can be inconvenient and time consuming. This can lead to strokes from dislodgement of calcium and atheroma from the valve leaflets. The devices and methods provided herein simplify and enhance the process of crossing an orifice with guidewire 130.
With reference to FIG. 1B, heart 100 is shown in partial cross-section undergoing a catheterization using guide catheter 120. Guide catheter 120 is in aortic arch 102 for the purpose of transmitting guidewire 130 through the orifice of aortic valve 140.
With reference to FIGS. 2A and 2B, a centering device 260 is schematically illustrated in upper and lower perspective viewing angles. These figures illustrate one example embodiment of the general shape and physical features of centering device 260. However, other shapes and physical features are also envisioned. For example, while centering device 260 is illustrated as bell shaped, in some embodiments the centering devices provided herein are cylindrical. In some embodiments, such cylindrically shaped centering devices may have a single central outlet opening.
In some embodiments, axial lumen 262 is in alignment with the longitudinal axis of the guide catheter (not shown) that is used to deploy centering device 260. Axial lumen 262 has a greater diameter at flared distal end 269 than at proximal end 261. The diameter of axial lumen 262 gradually decreases from flared distal end 269 to proximal end 261. Axial lumen 262 is configured to transmit a guidewire, catheter, or other elongate device therethrough. Axial lumen 262 is also configured to receive a fluid flow, such as a jet flow of blood from the orifice of a heart valve as described herein. The fluid flow enters axial lumen 262 at flared distal end 269. In that sense, centering device 260 acts like a funnel for catching and collecting fluid flow into axial lumen 262 via flared distal end 269.
A range of multiple different sizes of flared distal end 269 are envisioned, so as to suit different usage variations and body sizes. For example, in some embodiments flared distal end 269 is about 5 to 40 millimeters in diameter, about 10 to 35 millimeters in diameter, about 15 to 30 millimeters in diameter, or about 20 to 25 millimeters in diameter. Other centering device sizes are also contemplated.
As fluid flows into axial lumen 262 at flared distal end 269, fluid flow that is out of alignment with the central longitudinal axis of axial lumen 262 (off-center flow) may impact inner surface 266. Such impact may cause centering device 260 to move laterally in response to the impact forces. Such lateral movement will take place so as to balance the lateral impact forces being imparted from the fluid flow to inner surface 266. In other words, centering device 260 will tend to self-center itself with the fluid flowing into axial lumen 262 such that the impact forces imparted by fluid flow are balanced around the central longitudinal axis of axial lumen 262. Hence, when centering device 260 is coupled to a guide catheter 120 (refer to FIG. 1B), centering device 260 can self-center the catheter 120 in relation to a fluid flow, such as a fluid flow through the orifice of aortic valve 140. When catheter 120 is centered in relation to aortic valve 140, guidewire 130 can be ejected from guide catheter 120 and successfully passed through the orifice of aortic valve 140.
With reference to FIGS. 3A and 3B, example centering devices 300 and 350 are depicted so as to illustrate some example manners of constructing the catheter-based centering devices provided herein. In the depicted embodiment, centering device 300 is constructed from a plurality of frame members 310 and a covering 320. Similarly, centering device 350 is constructed from a plurality of frame members 360 and a covering 370. Centering device 300 has a majority of frame members 310 configured in a longitudinal direction. In contrast, centering device 350 has a majority of frame members 360 configured in a circumferential pattern (or spiral pattern).
Still referring to FIGS. 3A and 3B, frame members 310 and 360 are a compilation of elongate structural members that are attached together to form a framework that creates the bell-shape of centering devices 300 and 350. Frame members 310 and 360 can be metallic, for example, constructed of nitinol, stainless steel, titanium, or a combination of materials. Frame members 310 and 360 can be wires that are wound and attached together (e.g., welded or glued) to create the bell-shape configuration. Alternatively, frame members 310 and 360 can originally be a tube that is laser cut and expanded into to the desired bell-shape configuration, and heat-set to make the bell-shape the natural configuration of frame members 310 and 360. In some embodiments, frame members 310 and 360 can have a polymeric covering or powder coating over or on the metallic frame members 310 and 360.
In some embodiments, a bell shaped centering device (e.g., a funnel shape) is constructed of two, three, four, five, six, or more than six petal shaped segments that can collapse for containment within a delivery sheath or guide catheter. Upon emergence from the delivery sheath or guide catheter, the petal shaped segments can open up to create a funnel shape (e.g., in a manner like the blooming of a flower). In some embodiments, the petal shaped segments overlap with each other, particularly when the structure is collapsed and to a lesser extent when the structure is expanded. In some embodiments, the petals are hinged to a central collar. In some embodiments, the petals are constructed of a super-elastic material (e.g., nitinol) that facilitates the collapsibility and expandability of the petals. In some embodiments, one or more of the petals includes apertures (e.g., like apertures 264 described above). In some embodiments, the petals are constructed of a framework of elongate elements (e.g., struts or wires made or nitinol or stainless steel) and a covering material is disposed on the framework. In some embodiments, the covering material can be ePTFE and the like.
Centering devices 300 and 350 also includes coverings 320 and 370 respectively. Coverings 320 and 350 may be made of any flexible, biocompatible material capable of acting as a barrier to fluid jet flow, such as that from the orifice of a heart valve. Such materials can include, but are not limited to, Dacron, polyester fabrics, Teflon-based materials, Polytetrafluoroethylene (PTFE), expanded Polytetrafluoroethylene (ePTFE), polyurethanes, metallic film or foil materials, or combinations of the foregoing materials.
With reference to FIG. 4, an example process 400 for using the devices and systems provided herein is illustrated by a flowchart. In general, process 400 is a method of advancing a guidewire from a catheter through an orifice (such as a heart valve) where a fluid is flowing in a counter direction to the direction the guidewire is being advanced.
At operation 410, a guide catheter is inserted into a patient by a clinician. In some cases, the insertion may be percutaneous. In some cases, the insertion may be through a natural body orifice or channel. The guide catheter can include a guidewire and a self-expanding centering device contained within a lumen of the catheter. The self-expanding centering device (such as wire-framed centering device embodiments 300 and 350 described in reference to FIGS. 3A and 3B) can be in a low-profile collapsed configuration within the lumen of the catheter.
With reference to FIGS. 5A, 5B, and 5C a centering device 560 is schematically illustrated in top, side perspective, and bottom viewing angles respectively. These figures illustrate one example embodiment of the general shape and physical features of centering device 560. However, other shapes and physical features are also envisioned. For example, while centering device 560 is illustrated as bell shaped, in some embodiments the centering devices provided herein are cylindrical. In some embodiments, such cylindrically shaped centering devices may have a single central outlet opening.
As fluid flows into axial lumen 562 at flared distal end 569, fluid flow that is out of alignment with the central longitudinal axis of axial lumen 562 (off-center flow) may impact inner surface 566. Such impact may cause centering device 560 to move laterally in response to the impact forces. Such lateral movement will take place so as to balance the lateral impact forces being imparted from the fluid flow to inner surface 566. In other words, centering device 560 will tend to self-center itself with the fluid flowing into axial lumen 562 such that the impact forces imparted by fluid flow are balanced around the central longitudinal axis of axial lumen 562. Hence, when centering device 560 is coupled to a guide catheter 120 (refer to FIG. 1B), centering device 560 can self-center the catheter 120 in relation to a fluid flow, such as a fluid flow through the orifice of aortic valve 140. When catheter 120 is centered in relation to aortic valve 140, guidewire 130 can be ejected from guide catheter 120 and successfully passed through the orifice of aortic valve 140.
1. A device for centering a medical instrument in a conduit within a patient, the device comprising:
a framework comprised of a plurality of elongate metal frame members, wherein the frame members are attached to each other to define a central lumen having an open proximal end and an open distal end, wherein the distal end has a diameter that is larger than a diameter of the proximal end, and wherein the frame members are attached to each other to further define two or more side apertures that are nearer to the proximal end than to the distal end; and
a covering, wherein the covering is attached to the framework and the covering is a biocompatible membrane or film, wherein the side apertures define open fluid flow paths that are not occluded by the covering.
2. The device of claim 1, wherein the plurality of elongate metal frame members are comprised of nitinol, wherein the device is collapsible to a low-profile configuration adapted for confinement within a delivery sheath, and wherein the device can self-expand to an expanded configuration when the device is not contained within the delivery sheath.
3. The device of claim 1, wherein the frame members are attached to each other to further define four or more side apertures that are nearer to the proximal end than to the distal end.
5. The device of claim 1, wherein the plurality of elongate metal frame members form a plurality of petals.
6. The device of claim 5, wherein adjacent petals of the plurality of petals overlap each other.
7. The device of claim 6, wherein the plurality of petals are hinged to a proximal end collar of the device.
8. The device of claim 1, wherein the framework is bell-shaped.
9. The device of claim 8, wherein the framework is shape-set into the bell-shape.
10. The device of claim 9, wherein the plurality of elongate metal frame members comprise nitinol.
11. The device of claim 10, wherein the plurality of elongate metal frame members are made from a tube of nitinol that is cut and expanded into the bell-shape.
12. The device of claim 8, wherein a diameter of the central lumen gradually decreases in a direction from the distal end to the proximal end.
13. The device of claim 1, further comprising one or more radiopaque markers.
14. The device of claim 1, wherein the framework is funnel-shaped.
15. A system for treating a human patient, the system comprising:
a self-centering device comprising:
a covering, wherein the covering is attached to the framework and the covering is a biocompatible membrane or film, wherein the side apertures define open fluid flow paths that are not occluded by the covering;
a guidewire comprising an elongate metal wire; and
a guide catheter with a lumen, wherein the self-centering device and the guidewire are arranged to be contained within the lumen, wherein the self-centering device is in a low-profile configuration when the self-centering device is contained within the lumen, and wherein the self-centering device can self-expand to an expanded configuration when the self-centering device is not contained within the lumen.
16. A method for treating a human patient, the method comprising:
providing a medical device system comprising:
a guide catheter with a lumen, wherein the self-centering device and the guidewire are arranged to be contained within the lumen, wherein the self-centering device is in a low-profile configuration when the self-centering device is contained within the lumen, and wherein the self-centering device can self-expand to an expanded configuration when the self-centering device is not contained within the lumen;
inserting the guide catheter containing the self-centering device and the guidewire into the patient;
causing the self-centering device to emerge from a distal end of the guide catheter, wherein the self-centering device reconfigures from the low-profile configuration to the expanded configuration when the self-centering device emerges from the guide catheter; and
causing the guidewire to emerge from a distal end of the guide catheter.
17. The method of claim 16, wherein the method is used to treat a stenotic aortic valve of the patient.
18. The method of claim 16, wherein the method is used to treat perivalvular aortic or mitral valve leaks, or a vascular fistula in the patient.
US14/906,393 2013-07-22 2014-07-22 Device and methods for self-centering a guide catheter Active 2034-10-16 US9889006B2 (en)
US14/906,393 US9889006B2 (en) 2013-07-22 2014-07-22 Device and methods for self-centering a guide catheter
US20160158006A1 US20160158006A1 (en) 2016-06-09
US9889006B2 true US9889006B2 (en) 2018-02-13
US14/906,393 Active 2034-10-16 US9889006B2 (en) 2013-07-22 2014-07-22 Device and methods for self-centering a guide catheter
US15/872,510 Pending US20180140418A1 (en) 2013-07-22 2018-01-16 Device and methods for self-centering a guide catheter
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Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:SANDHU, GURPREET S.;SPOON, DANIEL B.;TEFFT, BRANDON J.;SIGNING DATES FROM 20141201 TO 20141202;REEL/FRAME:039480/0505