WO2008101244A2

WO2008101244A2 - Guiding catheter support devices and methods

Info

Publication number: WO2008101244A2
Application number: PCT/US2008/054287
Authority: WO
Inventors: Randall J. Beyeris; Fernando Di Caprio; Brady J. Hatcher
Original assignee: Via Biomedical, Inc.
Priority date: 2007-02-18
Filing date: 2008-02-19
Publication date: 2008-08-21
Also published as: WO2008101244A3; WO2008101244A8

Abstract

The invention involves devices and methods for supporting (or otherwise minimizing movement or translation of the distal end of) guiding catheters (or similar objects) in the vessel of a patient while advancing or attempting to advance interventional devices (or similar objects) that are being utilized within the guiding catheter.

Description

GUIDING CATHETER SUPPORT DEVICES AND METHODS

TECHNICAL FIELD

BACKGROUND

Many medical procedures involve the use of a guiding catheter (or similar device) through portions of vessels of a patient, such as those of the coronary, neurological, or other vasculatures; or those of similar vessel- like systems (e.g., the lymphatic, urinary, reproductive, respiratory, or digestive systems). In these cases, the guiding catheter is typically used by the attending physician as a passageway to deliver interventional devices (or similar objects) to the potential therapy site. Very often in these types of procedures the physician experiences a phenomenon that is often referred to as "guiding catheter back-out" (or other similar terms). "Back- out" of the guiding catheter may be defined by the action of the distal section of the guiding catheter moving or translating away from the original seated position in the vessel. This back-out is usually caused by the physician pushing an interventional device distally through the guiding catheter and possible tortuosity, which then causes the guidewire or interventional device to push back on the guiding catheter, resulting in loss of guiding catheter position within the vessel and degradation of guiding catheter support (due to bending or buckling of the distal section of the guiding catheter). The loss of guiding catheter position within the vessel results in increased procedure time and increased possibility of patient trauma. Degradation of guiding catheter support results in a reduction in pushability of the interventional device, contributing to the inability to achieve the desired therapy. Movement or back-out of the guiding catheter is visualized with fluoroscopy or some other type of real time imaging. Currently physicians combat guiding catheter back-out with techniques that contain increased patient risk, increased procedure time, and/or increased procedure cost. Some of the current techniques used to reduce the effects of guiding catheter back-out include: (A) torqueing the guiding catheter until it is wedged against the vessel wall to reduce its ability to bend or move proximally, (B) navigating the guiding catheter further into the vessel to help prevent further bending or back-out (this is commonly referred to as "deep seating"), (C) placing another device or guidewire into non-target vessels to help hold the guiding catheter in place while pushing distally on the interventional device, (D) replacing the guiding catheter with a stiffer or larger diameter guiding catheter or one that is specifically designed to anchor in the vessel, (E) pulling out the interventional device(s) and/or guidewire(s) and using alternative interventional device(s) or treatment to achieve the desired therapy. All of the aforementioned techniques have significant risks associated with them that do not make them ideal techniques to use in clinical procedures. While some guiding catheter support improvement can be realized, the techniques usually do not give the amount of desired guiding catheter support that the physician would like to experience. While skilled physicians attempt various techniques, it is apparent to those in the field that there is not an optimal solution for eliminating the phenomenon and effects of guiding catheter back-out.

In the commonly performed percutaneous transluminal coronary angioplasty (PTCA) procedure, guiding catheter back-out occurs in a significant proportion of procedures due to the need to deliver interventional devices to or through calcified lesions, tortuous anatomy, chronic total occlusions, and/or bifurcations.

SUMMARY OF THE INVENTION

The invention is an apparatus and method for increasing the support characteristics or minimizing movement of the distal section of a guiding catheter advanced into a vessel (while a physician attempts to advance interventional devices within the guiding catheter), comprising a long, stiff main body having proximal and distal ends; the apparatus having sufficient stiffness to minimize guiding catheter deflection (while a physician attempts to advance interventional devices within the guiding catheter), yet having sufficient flexibility to be advanced through the guiding catheter.

Another embodiment of the invention is very similar to the first embodiment, but is designed to incorporate active stiffening to minimize movement of the distal section of a guiding catheter advanced into a vessel, comprising of a selectively deformable outer body with an internal pull wire; having sufficient flexibility to be advanced through the guiding catheter, yet having sufficient stiffness when actuated to minimize guiding catheter movement (while a physician attempts to advance interventional devices within the guiding catheter).

Other embodiments of the invention are methods for using devices to minimize movement of the distal section of a guiding catheter advanced into a vessel (while a physician attempts to advance interventional devices within the guiding catheter); the guiding catheter having proximal and distal ends.

One method employs an apparatus that comprises a long, stiff main body having proximal and distal ends. Another method may be practiced with the embodiment of the apparatus comprising a selectively deformable outer body with an internal pull wire, whereas the apparatus is inserted into the guiding catheter lumen such that the selectively deformable portion of apparatus is in distal portion of the guiding catheter.

Any of the methods for use have the apparatus inserted into the guiding catheter lumen such that the stiff (passively or actively controlled) portion of apparatus is in the distal section of the guiding catheter. The apparatus position can be secured relative to the guiding catheter. Once the interventional device(s) has/have reached the desired target location and guiding catheter support is no longer necessary, the apparatus can then be removed (though some embodiments of the invention may not allow removal until after other interventional devices are removed). However, the apparatus may stay in the guiding catheter (secured or unsecured) for the duration of the procedure. Furthermore, the apparatus could be inserted into the guiding catheter prior to, or after interventional device(s) insertion (though some embodiments of the invention require insertion prior to insertion of other interventional devices). The guiding catheter may be any insertion sheath conventionally used in an interventional procedure, and can be used for treatments in vessels of one of lymphatic, urinary, reproductive, respiratory, or digestive systems.

DESCRIPTION OF THE FIGURES

The accompanying drawings schematically illustrate a particular embodiment of the invention, and are not intended to limit the scope of the invention.

Figure 1 is a schematic full-length top view of one embodiment of the invention.

Figure 2 is a schematic top view of the distal end of the embodiment of

Figure 1.

Figure 3 is a schematic full-length top view of another embodiment of the invention.

Figures 4 and 5 are schematic end or cross-sectional views of portions of embodiments generally corresponding to the embodiments in Figures 1 and 3. The embodiments are shown inside of a guiding catheter working adjacent to a double lumen stent delivery catheter.

Figure 6 is a schematic full-length top view (corresponding to the embodiments in Figures 1 through 5) of the invention inside of a guiding catheter.

Figure 7 is a schematic full-length top view of another embodiment of the invention.

Figure 8 is a schematic full-length top view (corresponding to the embodiment in Figure 7) of the invention inside of a guiding catheter.

Figure 9 is a schematic end or cross-sectional view of a portion of an embodiment generally corresponding to the embodiment in Figure 8. The embodiment is shown inside of a guiding catheter working around a double lumen stent delivery catheter. Figure 10 is a schematic full-length top view of another embodiment of the invention.

Figure 11 is a schematic full-length top view (corresponding to the embodiment in Figure 10) of the invention inside of a guiding catheter.

Figure 12 is a schematic full-length top view of another embodiment of the invention.

Figure 13 is a schematic full-length top view (corresponding to the embodiment in Figure 12) of the invention inside of a guiding catheter.

Figure 14 is a schematic end or cross- sectional view of a portion of an embodiment generally corresponding to the embodiments in Figures 10 and 12. The embodiment is shown inside of a guiding catheter working adjacent to a double lumen stent delivery catheter.

Figure 15 is a schematic full-length top view (corresponding to the embodiments in Figures 1 through 6 and 10 through 14) of the invention inside of an introducer sheath/guiding catheter with a "Proximal Clip." When enabled, the Proximal Clip maintains the apparatus position relative to the guiding catheter.

Figure 16 is a schematic end or cross-sectional view of a portion of an embodiment generally corresponding to the embodiment in Figure 15.

DETAILED DESCRIPTION

The following discussion accompanies the drawings, which schematically illustrate a particular embodiment of the invention, and are not intended to limit the scope of the invention. Thus, any reading of this discussion as limiting the scope of the invention is contrary to the intent of the inventors, who intend this discussion to describe and enable the full scope of their invention as limited only by the language of the accompanying claims.

Figures 1 and 2 are schematic full-length and distal-section top views of one embodiment of the invention, whereas the apparatus only has a stiff portion of shaft 17 in the select area where the shaft coincides with the distal section of a guiding catheter. This stiff portion of the shaft may be joined to the less stiff proximal and distal portions using various design or construction methods. The embodiment illustrated in Figures 1 and 2 (apparatus 100) shows the stiff portion of the shaft 17 inserted into the distal and proximal portions 13 as a coupler. This embodiment of the apparatus generally comprises a main body 14/16, whose cross- section is preferably round as illustrated, but in general could be oval or some other closed shape. In this embodiment, the proximal portion on the main body (proximal to the stiff region) comprises a tube on top of a solid rod 14/16, or it could be constructed out of a shaft that utilizes only a tube, or only a solid rod. The different shaft designs dictate various shaft performance characteristics and allow for diverse manufacturing methods.

The shaft of apparatus 100 as shown in Figures 1 and 2 is preferably jacketed or coated on at least a portion of its surface(s) with various polymers to ensure protection for shaft fractures and to provide smooth and/or lubricious surface transitions.

Figures 1 and 2 also illustrate the preference for the apparatus 100 to have radiopaque features 18 to identify the distal portion of the main body, such as single or multiple optional markers (e.g., radiopaque material wrapped around the apparatus, or filling a portion of the material forming the apparatus). As is known in the art, such features are not clinically required but are very useful to enable the apparatus position in the guiding catheter to be visualized. The preferred arrangement is illustrated in Figures 1 and 2, but the scope of the invention is not determined by the number, type, and location of radiopaque features. A similar and also optional use, of markings is at proximal locations along the length of main body 11 that indicate to the physician the total distance that the apparatus has been advanced into the body.

Referring to Figures 1 and 2, it may be seen that the distal section of this embodiment of apparatus 100 utilizes a tapered tip section 15 that is surrounded by a flexible coil component 19 (that may be radiopaque). This distal tip section could be constructed in a variety of ways known in the art to achieve the desired output of a tip that smoothly transitions from "floppy" 19 into the stiff distal section on the apparatus shaft 17.

Also, as illustrated, it is preferred (but not required) that the apparatus 100 is constructed with a proximal handle 12. The proximal handle will aid in the ability to control the position of the apparatus with respect to the guiding catheter. This embodiment of the invention may have an ergonomic handle constructed out of a molded polymer, but generally could be created to be of any durable material.

Figure 3 illustrates an embodiment of the invention in the form of apparatus

200 that is generally similar to apparatus 100 of Figures 1 and 2, with the notable difference being that the proximal portion of the main body is also a continuous component that comprises the stiff distal section. This embodiment utilizes a stiff shaft all the way proximal (to the proximal handle) to give increased pushability.

Figures 4 and 5 are cross-sectional end views that illustrate portions of embodiments generally corresponding to the embodiments in Figures 1 and 3. The embodiments 100 and 200 are shown inside of a guiding catheter 20 working adjacent to a double lumen stent delivery catheter 21. The shape of the embodiments shown in figures 4 and 5 are round and crescent, respectively, but could be any closed shape.

Figure 6 is a schematic full-length top view (corresponding to the embodiments in Figures 1 through 5) of the invention inside of a guiding catheter. This illustration is showing the relative position the apparatus 100 or 200 within a guiding catheter when fully inserted to the preferred location. The apparatus could be placed into the guiding catheter before or after the interventional device has been inserted.

Figure 7 schematically illustrates a full-length top view of another embodiment of the invention 300. This embodiment (illustrated in Figure 7) performs the same basic functions as embodiments 100 and 200, but utilizes a design that allows interventional devices to pass through it.

Figure 7 also illustrates the preference for the apparatus 300 to have radiopaque features 26 to identify the distal portion of the main body 25, such as single or multiple optional markers (e.g., radiopaque material wrapped around the apparatus, or filling a portion of the material forming the apparatus). As is known in the art, such features are not clinically required but are very useful to enable the apparatus position in the guiding catheter to be visualized. The preferred arrangement is illustrated in Figure 7, but the scope of the invention is not determined by the number, type, and location of radiopaque features. A similar, and also optional, use of markings is at proximal locations along the length of main body 24 that indicate to the physician the total distance that the apparatus has been advanced into the body.

Referring to Figure 7, it may be seen that the distal section of this embodiment of apparatus 300 utilizes a distinct soft tip section 27.

Also, as illustrated, it is preferred (but not required) that the apparatus 300 is constructed with a proximal handle 23. The proximal handle will aid in the ability to control the position of the apparatus with respect to the guiding catheter. This embodiment of the invention may have an ergonomic handle constructed out of a molded polymer, but generally could be created to be of any durable material.

The main body or shaft of the apparatus 300 is preferably constructed of a polymer combined with a metallic reinforcement. Examples of this construction include (but not be limited to) polymer encapsulated braided tubes, or stainless steel hollow stranded core tubing with a polymer sheathing. The inside wall of the main body tube may be lined, in whole or in part, with a lubricous material to aid in the deliverability of subsequent devices through the lumen. Within the main body tube, a "core wire" 28 is used as a push rod to aid in delivering the apparatus 300 distally to the desired location with respect to the guiding catheter. The core wire 28 may be removed once the physician achieves proper positioning of apparatus 300.

Figure 8 is a schematic full-length top view (corresponding to the embodiment in Figure 7) of apparatus 300 inside of a guiding catheter. As illustrated in Figure 8, the apparatus can be positioned so that the distal end actually protrudes out of the distal end of the guiding catheter. This distal positioning of the apparatus can actually add another element for the purpose of helping keep the guiding catheter in position. This is achieved because the distal section of apparatus 300 helps retain the guiding catheter position in the treatment site

(ostium, chamber, etc.), even if the guiding catheter has "backed-out." This embodiment of apparatus 300 is designed to be utilized completely inside of the guiding catheter or in the protruded state.

Figure 9 illustrates an end or cross-sectional view of a portion of an embodiment 31 of apparatus 300 generally corresponding to the embodiment in Figure 8. The embodiment is shown inside of a guiding catheter 29 working around a double lumen stent delivery catheter 30.

Figure 10 is a schematic full-length top view of another embodiment of the invention. Figure 10 illustrates an embodiment of the invention in the form of apparatus 400 that is generally similar to the apparatus 100 or 200 of Figures 1 through 3, with the notable difference being that the apparatus utilizes an articulating distal shaft design. The embodiment shown in Figure 10 employs a pull-wire design that has slots 34 of material removed from the outer wall to encourage articulation in one direction or another when the pull wire 33 is activated by the proximal handle 36. The intention of the embodiment illustrated as apparatus 400 is to provide resistance against the guiding catheter when it is getting deflected by an attempted delivery of an interventional device, and is going to "back-out".

Figure 11 is an illustration demonstrating the means used to provide the above mentioned resistance of apparatus 400 against the guiding catheter. The apparatus utilizes a design that when articulated, will "squeeze" the guiding catheter curves and will resist straightening that might occur to the guiding catheter by an attempted delivery of an interventional device.

Figure 12 is a schematic full-length top view of another embodiment 500 of the invention that is similar to apparatus 400, with the notable difference being that the apparatus utilizes an articulating distal shaft design on only one side. Figure 13 shows how apparatus 500 appears when utilized inside of a guiding catheter.

Figure 14 illustrates an end or cross-sectional view of a portion of an embodiment 31 generally corresponding to the embodiments in Figures 10 and 12. The embodiment is shown inside of a guiding catheter 29 working adjacent to a double lumen stent delivery catheter 30.

Figure 15 is a schematic full-length top view (corresponding to the embodiments in Figures 1 through 6 and 10 through 14) of the invention 44 inside of an introducer sheath/guiding catheter 42 with a "Proximal Clip" 43. When enabled, the Proximal Clip maintains the apparatus position relative to the guiding catheter.

Figure 16 is a schematic cross-sectional end view of a portion of an embodiment generally corresponding to the embodiment in Figure 15. The illustration shows the apparatus 44 in an introducer sheath/guiding catheter 42 with

"Proximal Clip" 43 to maintain apparatus position relative to the guiding catheter and also stays clear from obstructing the entrance of the introducer sheath.

Claims

We claim:

1. An apparatus for increasing the support characteristics or minimizing movement of the distal section of a guiding catheter advanced into a vessel (while a physician attempts to advance interventional devices within the guiding catheter), comprising of a long, stiff main body having proximal end distal ends; the apparatus having sufficient stiffness to minimize guiding catheter deflection, yet having sufficient flexibility to be advanced through the guiding catheter.

2. The apparatus of claim 1 , wherein the main body is a metal or metal alloy.

3. The apparatus of claim 1, wherein the main body is a metal or metal alloy comprising a material selected from the group consisting of tungsten, molybdenum, rhenium, L605, CoCr, MP-35, and alloys thereof.

4. The apparatus of claim 1 , wherein the main body cross section is round.

5. The apparatus of claim 1, wherein the main body cross section is any geometric shape.

6. The apparatus of claim 1, wherein the main body cross section is any geometric shape and further defines an internal lumen.

7. The apparatus of claim 6, wherein the internal lumen facilitates the use of a removable mandrel that is used to support the apparatus walls while it is pushed distally into position.

8. The apparatus of claim 1, wherein the main body is jacketed or embedded with a polymer.

9. The apparatus of claim 1, further comprising a lubricious coating on at least a portion of one surface of the apparatus.

10. The apparatus of claim 1, wherein the apparatus has gradient flexibility from proximal to distal ends.

11. The apparatus of claim 1 , further comprising at least one radiopaque marker at the distal end to indicate position of the apparatus relative to the distal end of the guiding catheter.

12. The apparatus of claim 1, further comprising a flexible distal end.

13. The apparatus of claim 1, further comprising a flexible coil on the distal end.

14. The apparatus of claim 1, further comprising a handle connected to the proximal end of the device.

15. The apparatus of claim 1, further comprising at least one marking at a proximal location along the length of the main body to indicate a total distance that the apparatus has been advanced into the body vessel.

16. The apparatus of claim 1, further comprising a feature for fixing the location of the apparatus relative to the guiding catheter.

17. The apparatus of claim 1, wherein the main body is comprised of an inner body and an outer body.

18. An apparatus for minimizing movement of the distal section of a guiding catheter advanced into a vessel (while a physician attempts to advance interventional devices within the guiding catheter), comprising a selectively deformable and stiffening outer body with an internal pull wire; having sufficient flexibility to be advanced through the guiding catheter, yet having sufficient stiffness when actuated to minimize guiding catheter deflection.

19. The apparatus of claim 18, wherein the main body is a metal or metal alloy.

20. The apparatus of claim 18, wherein the main body is a metal or metal alloy comprising a material selected from the group consisting of tungsten, molybdenum, rhenium, L605, CoCr, MP-35, and alloys thereof.

21. The apparatus of claim 18, wherein the inner body is a metal or metal alloy.

22. The apparatus of claim 18, wherein the inner body is a metal or metal alloy comprising a material selected from the group consisting of tungsten, molybdenum, rhenium, L605, CoCr, MP-35, and alloys thereof.

23. The apparatus of claim 18, wherein the apparatus cross section is round.

24. The apparatus of claim 18, wherein the apparatus cross section is any geometric shape.

25. The apparatus of claim 18, wherein the outer body is jacketed or embedded with a polymer.

26. The apparatus of claim 18, further comprising a lubricious coating on at least a portion of one surface of the apparatus.

27. The apparatus of claim 18, wherein the apparatus has gradient flexibility from proximal to distal ends.

28. The apparatus of claim 18, further comprising at least one radiopaque marker at the distal end to indicate position of the apparatus relative to the distal end of the guiding catheter.

29. The apparatus of claim 18, further comprising a flexible distal end.

30. The apparatus of claim 18, further comprising a flexible coil on the distal end.

31. The apparatus of claim 18, further comprising a handle connected to the proximal end of the device for actuating the pull wire.

32. The apparatus of claim 18, further comprising at least one marking at a proximal location along the length of the main body to indicate a total distance that the apparatus has been advanced into the body vessel.

33. The apparatus of claim 18, further comprising a feature for fixing the location of the apparatus relative to the guiding catheter.

34. A method for minimizing movement of the distal section of a guiding catheter advanced into a vessel (while a physician attempts to advance interventional devices within the guiding catheter), the guiding catheter having proximal and distal ends, comprising:

a) providing an apparatus comprising a long, stiff main body having proximal end distal ends,

b) inserting the apparatus into the guiding catheter lumen such that the stiff portion of apparatus is in distal section of the guiding catheter.

35. The method of claim 34, further comprising:

c) securing the position of the apparatus relative to the guiding catheter.

36. The method of claim 34, further comprising:

d) removing the device after guide support is no longer necessary.

37. The method of claim 34, in which the guiding catheter is any insertion sheath used in an interventional procedure.

38. The method of claim 34, in which the vessel is of one of lymphatic, urinary, reproductive, respiratory, or digestive systems.

39. The method of claim 34, in which the apparatus is inserted prior to interventional device(s).

40. The method of claim 34, in which the apparatus is inserted after interventional device(s).

41. A method for minimizing movement of the distal section of a guiding catheter advanced into a vessel (while a physician attempts to advance interventional devices within the guiding catheter), the guiding catheter having proximal and distal ends, comprising:

a) providing an apparatus comprising a selectively deformable outer body with an internal pull wire,

b) inserting the apparatus into the guiding catheter lumen such that the selectively deformable portion of apparatus is in distal portion of the guiding catheter.

42. The method of claim 41 , further comprising :

e) securing the position of the apparatus relative to the guiding catheter.

43. The method of claim 41 , further comprising:

f) removing the device after guide support is no longer necessary.

44. The method of claim 41, in which the guiding catheter is any insertion sheath used in an interventional procedure.

45. The method of claim 41 , in which the vessel is of one of lymphatic, urinary, reproductive, respiratory, or digestive systems.

46. The method of claim 41, in which the apparatus is inserted prior to interventional device(s).

47. The method of claim 41, in which the apparatus is inserted after interventional device(s).