SYSTEM AND METHOD FOR TREATMENT OF THE CLAUDIFICATION OF THE SUPERFICIAL FEMORAL AND PROXIMAL POPLITEAL ARTERY

Abstract

A system and accompanying methods for treating a blockage of the superior femoral artery including utilization of a puncture insertion mechanism, an introducer sheath, a guide catheter and an expandable device. Entry into the body is established through the popliteal and advancing retrograde through the popliteal artery toward the lower superior femoral artery region and in some embodiments utilizing an introducer sheath, a guide catheter and a balloon are featured.

Claims

1. A method of treating a blockage of the superior femoral artery (SFA) comprising the steps of: selecting an area behind a knee of the affected limb; creating a puncture site behind the knee; entering the puncture site through the popliteal; advancing retrograde through the popliteal toward a lower SFA region; utilizing an introducer sheath having a proximal end, a distal end, an opening at the distal end, and a passage in communication with the opening at the distal end, the one or more prostheses being movably disposed in the passage; utilizing a guide catheter; utilizing an expandable member positioning the distal end of the introducer sheath and the expandable member at the treatment site; and proximally retracting the introducer sheath relative to the expandable member and thereby cause the one or more prostheses to pass through the opening of the introducer sheath for expansion at the treatment site via the expandable member.

2. The method of treating a blockage of the superior femoral artery of claim 1 further comprising utilizing a guide wire.

3. The method of treating a blockage of the superior femoral artery of claim 1 wherein the introducer sheath comprises a three (3) French introducer sheath.

4. The method of treating a blockage of the superior femoral artery of claim 1 wherein the guide catheter is advanced in stages.

5. The method of treating a blockage of the superior femoral artery of claim 1 further comprising the step of advancing the guidewire independently to access the most proximal location in a vessel.

6. The method of treating a blockage of the superior femoral artery of claim 1 further comprising the step of introducing a balloon.

7. The method of treating a blockage of the superior femoral artery of claim 4 further comprising the step of advancing the guide catheter and paving proximal to distal in the direction of the puncture site.

8. The method of treating a blockage of the superior femoral artery of claim 1 further comprising the step of advancing distal to proximal in order to reduce a shower of emboli below the knee into the territory of the foot.

9. The method of treating a blockage of the superior femoral artery of claim 1 further comprising the step of positioning an embolic protection device in the region proximal to the puncture site to permit safe removal of dislodged plaque or emboli generated during the access and angioplasty procedure.

10. The method of treating a blockage of the superior femoral artery of claim 1 further comprising the step of removing dislodged plaque or emboli generated during the access and angioplasty procedure.

11. The method of treating a blockage of the superior femoral artery of claim 1 further comprising the step of advancing directly from the popliteal to the SFA and access not dealing with branch vessels allowing for navigation without wire.

12. The method of treating a blockage of the superior femoral artery of claim 1 further comprising the step of utilizing a system which does not include the guide wire for navigation of the popliteal and SFA.

13. The method of treating a blockage of the superior femoral artery of claim 1 further comprising the step of selecting or calibrating a measure of column strength of the guide catheter can break through heavily calcified lesion.

14. The method of treating a blockage of the superior femoral artery of claim 1 further comprising the step of operating in combination with a low-profile balloon catheter to advance proximally through the SFA.

15. The method of treating a blockage of the superior femoral artery of claim 1 further comprising the step of advancing the guide catheter in a method selected from the group consisting of in stages with a balloon and independently.

16. The method of treating a blockage of the superior femoral artery of claim 1 further comprising the steps of: advancing the guide catheter independently; accessing the most proximal location in the vessel prior to introduction of the balloon catheter; and paving proximally to distally in the direction of the puncture site to reduce shower of emboli below the knee into the territory of the foot.

17. The method of treating a blockage of the superior femoral artery of claim 1 further comprising the step of positioning an embolic protection device at or near the puncture site will permit safe removal of dislodged plaque or emboli generated during an access and angioplasty procedure.

18. The method of treating a blockage of the superior femoral artery of claim 1 further comprising the step of utilizing a retrograde paving technique to open the calcified lesion.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0065] Advantages of the present system will be apparent from the following detailed description of exemplary embodiments thereof, which description should be considered in conjunction with the accompanying drawings, in which having thus described the system in general terms, reference will now be made to the accompanying drawings, which are not necessarily drawn to scale, and wherein:

[0066] FIG. 1 illustrates cross sectional view of a human limb further illustrating the anatomy of the limb with the arteries highlighted and further illustrating an access point for a retrograde approach to treating blockages of the lower portion of the superficial femoral artery or lower SFA.

[0067] FIG. 2 illustrates a cross sectional view of the procedural tract illustrating the access point for retrograde approach to treating blockages of the lower SFA. Further illustrated is the puncture site for sheath access through Popliteal behind the knee. Herein, the system being utilized introduces a 3F introducer sheath, a guide catheter for advancing toward an area of dense plaque within the lower SFA and a balloon in a deflated orientation. The blood flow direction is illustrated and thus retrograde access is being performed herein.

[0068] FIG. 3 illustrates cross sectional view of the access point for retrograde approach to treating blockages of the lower SFA. Further illustrated is the puncture site for sheath access through Popliteal behind the knee. Herein, the system being utilized introduces a 3F introducer sheath, a guide catheter for advancing toward an area of dense plaque within the lower SFA and a balloon in an inflated orientation in order to free up the blockage in a retrograde paving technique which opens up the calcified lesion.

[0069] FIG. 4. illustrates a right side view, detailed cutaway of the anatomy of limb showing access point for retrograde approach to treating lower SFA, illustrating the full path for entry and delivery from the popliteal entry to superficial femoral artery.

[0070] FIG. 5. illustrates a left side view, detailed cutaway of the anatomy of the limb showing access point for retrograde approach to treating lower SFA, illustrating the entirety of the entry and delivery path from the popliteal entry to superficial femoral artery in the color green. In this figure, the pathway is illuminated from the puncture site through popliteal behind the knee to the blockage are in the lower SFA.

DETAILED DESCRIPTION OF THE SEVERAL EMBODIMENTS

[0071] The detailed description set forth below in connection with the appended drawings is intended as a description of presently preferred embodiments of the system and does not represent the only forms in which the present system may be constructed and/or utilized. The description sets forth the functions and the sequence of steps for constructing and operating the system in connection with the illustrated embodiments.

[0072] FIG. 1 illustrates a cross sectional view of a human limb further illustrating the anatomy of the limb with the arteries highlighted and further illustrating an access point 10 for a retrograde approach to treating blockages of the lower superficial femoral artery (SFA).

[0073] FIG. 2 illustrates a cross sectional view of the procedural tract 5 illustrating the access point 10 for retrograde approach to treating blockages of the lower SFA, further illustrating the instrumentation utilized at the access point 10 or the puncture site and for sheath access through the Popliteal and popliteal artery 15 behind the knee. Herein, the system being utilized introduces an introducer sheath 20, a guide catheter 30 for advancing toward an area of dense plaque 40 within the lower SFA 50 and a balloon 60 in a deflated orientation.

[0074] In one embodiment, the introducer sheath 20 utilized may be a three French or 3F introducer sheath 20. The blood flow direction indicator 70 is illustrated, thus denoting that retrograde access is being performed herein. Again, a guide wire 80 may also be utilized in conjunction with the currently described system.

[0075] FIG. 3 illustrates a further cross-sectional view of the procedural tract 5 illustrating the access point 10 and the system deployed further illustrating the access point 10 through the Popliteal and popliteal artery 15 behind the knee for retrograde approach to treating blockages of the lower SFA 50. Further illustrated is the puncture site for sheath access through Popliteal behind the knee. Herein, the system being utilized introduces a 3F introducer sheath 20, a guide catheter 30 for advancing toward an area of dense plaque 40 within the lower SFA 50 and the balloon 60, now in the inflated orientation in order to free up the blockage in a retrograde paving technique which opens up the calcified lesion.

[0076] Once again, the blood flow direction indicator 70 is illustrated, thus denoting that retrograde access is being performed herein. Additionally illustrated herein is a guidewire 80, which may also be utilized.

[0077] Further, as the direction of the blood flow is opposed to direction of operation of the system and thus the initial the paving as illustrated constitutes retrograde access being performed. In an alternative methodology, the guide catheter may be advanced in stages with the balloon.

[0078] In an additional embodiment, the guidewire may be advanced independently to access the most proximal location in the vessel prior to introduction of the balloon catheter and paving can advance proximal to distal (i.e in the direction of the puncture site).

[0079] FIG. 4. illustrates a right-side view of a more detailed cutaway of the anatomy of the limb 100 illustrating the entirety of the entry and delivery tract 5 from the popliteal artery 15 entry to superficial femoral artery in the color green. In this figure, the pathway is illuminated from the puncture site through popliteal behind the knee to the blockage are in the lower SFA.

[0080] FIG. 5. illustrates a left side view, detailed cutaway of the anatomy of the limb 105 showing access point for retrograde approach to treating lower SFA, illustrating the entirety of the entry and delivery path 5 from the popliteal artery 15 entry to superficial femoral artery in the color green. In this figure, the pathway is illuminated from the puncture site through popliteal behind the knee to the blockage are in the lower SFA.

[0081] In one embodiment, a method of treating a blockage of the superior femoral artery (SFA) is disclosed, which involves the steps of:

[0082] selecting an area behind a knee of the affected limb;

[0083] creating a puncture site behind the knee;

[0084] entering the puncture site through the popliteal;

[0085] advancing retrograde through the popliteal toward a lower SFA region;

[0086] utilizing an introducer sheath having a proximal end, a distal end, an opening at the distal end, and a passage in communication with the opening at the distal end, the one or more prostheses being movably disposed in the passage;

[0087] utilizing a guide catheter;

[0088] utilizing an expandable member;

[0089] positioning the distal end of the introducer sheath and the expandable member at the treatment site; and

[0090] proximally retracting the introducer sheath relative to the expandable member and thereby cause the one or more prostheses to pass through the opening of the introducer sheath for expansion at the treatment site via the expandable member.

[0091] Additionally, the method includes the use of a guide wire and where it is advanced in stages. In another embodiment, the introducer sheath comprises a three (3) French introducer sheath.

[0092] In yet another embodiment, the method includes additional steps of advancing the guidewire independently to access the most proximal location in a vessel and introducing a balloon. In another embodiment, the method involves the steps of advancing the guide catheter and paving proximal to distal in the direction of the puncture site and advancing distal to proximal in order to reduce a shower of emboli below the knee into the territory of the foot.

[0093] In an alternate embodiment, the method of treating a blockage of the superior femoral artery comprises the step of positioning an embolic protection device in the region proximal to the puncture site to permit safe removal of dislodged plaque or emboli generated during the access and angioplasty procedure and comprises the step of removing dislodged plaque or emboli generated during the access and angioplasty procedure.

[0094] Another aspect of the method of treating a blockage of the superior femoral artery of claim 1 includes the step of advancing directly from the popliteal to the SFA and access not dealing with branch vessels allowing for navigation without wire and optionally utilizing a system which does not include the guide wire for navigation of the popliteal and SFA.

[0095] Furthermore, the method of treating a blockage of the superior femoral artery of further comprises the step of selecting or calibrating a measure of column strength of the guide catheter can break through heavily calcified lesion and the step of operating in combination with a low-profile balloon catheter to advance proximally through the SFA.

[0096] In yet another embodiment, the method of treating a blockage of the superior femoral artery of further comprises the step of advancing the guide catheter in a method selected from the group consisting of in stages with a balloon and independently, and may also include the steps of:

[0097] advancing the guide catheter independently;

[0098] accessing the most proximal location in the vessel prior to introduction of the balloon catheter; and

[0099] paving proximally to distally in the direction of the puncture site to reduce shower of emboli below the knee into the territory of the foot.

[0100] Finally, in yet another embodiment, the method of treating a blockage of the superior femoral artery comprises the step of positioning an embolic protection device at or near the puncture site will permit safe removal of dislodged plaque or emboli generated during an access and angioplasty procedure and the step of utilizing a retrograde paving technique to open the calcified lesion.

[0101] In yet another embodiment, a system for treating a blockage of the superior femoral artery is disclosed, which includes:

[0102] a puncture mechanism;

[0103] selecting an area behind a knee of the affected limb;

[0104] creating a puncture site behind the knee;

[0105] entering the puncture site through the popliteal;

[0106] advancing retrograde through the popliteal toward a lower SFA region;

[0107] an introducer sheath;

[0108] a guide catheter; and

[0109] a balloon.

[0110] Additionally, the system for treating a blockage of the superior femoral artery may utilize a low profile balloon catheter to pave proximal through the SFA, while maximizing the column strength of the guide catheter to break through heavily calcified lesion.

[0111] In yet another embodiment, a method of delivering one or more prostheses to a treatment site is disclosed, involving the steps of providing a catheter, and using a sheath having a proximal end, a distal end, an opening at the distal end, and a passage in communication with the opening, the one or more prostheses being movably disposed in the passage with an expandable member near the distal end of the sheath, the one or more prostheses being positionable over the expandable member, and a valve member near the distal end of the sheath adapted for selectively retaining a first set of prostheses within the passage and to engage the one or more prostheses whereby the one or more prostheses may be moved relative to the expandable member by moving the sheath; positioning the distal end of the sheath and the expandable member at the treatment site; and proximally retracting the sheath relative to the expandable member to move the valve member and thereby cause a first set of prostheses to pass through the opening of the sheath for expansion at the treatment site via the expandable member while retaining a second set of prostheses within the passage.