WO2014191924A1

WO2014191924A1 - Mitral cerclage septal puncture device

Info

Publication number: WO2014191924A1
Application number: PCT/IB2014/061765
Authority: WO
Inventors: June-Hong Kim
Original assignee: June-Hong Kim
Priority date: 2013-05-29
Filing date: 2014-05-28
Publication date: 2014-12-04
Also published as: KR101611854B1; KR20140140483A

Abstract

This invention is related to a catheter body embedded with at least one balloon which is inflated for guiding a needle cannula through a side port. Once a distal end of the catheter body is near a puncture zone, the balloon is inflated against the coronary sinus wall, pushing the distal end of catheter body against the puncture zone and stabilizing it. Then, the needle cannula is advanced piercing the interventricular septum at the puncture zone.

Description

Mitral Cerclage Septal Puncture (MCSP) Device

CROSS REFERENCE TO RELATED APPLICATION

[0001 ] This application claims priority of U.S. Patent Application No.61 /828,532, filed on May 29, 2013, which is incorporated by reference in its entirety into this application.

BACKGROUND

[0002] In a Mitral Cerclage Annuloplasty (MCA) procedure, a suture is positioned to encircle the mitral valve (MV) annulus. Then tension is applied on the suture to close a leak or a defect of the MV.

[0003] Such MCA procedures require traversing basal interventricular septum via the proximal septal vein (PSV) to form a circumferential pathway around the mitral annulus. Although the coronary sinus approach of a MCA is generally known as the easiest way to perform the MCA procedure, interventricular septal traversal still presents as the biggest challenge and is limited by the anatomic suitability of the PSV.

[0004] The biggest challenge in the MCA procedure is passing the mitral cerclage wire through the basal interventricular septum. First, the basal interventricular septum must be pierced with the Mitral Cerclage Septal Puncture (MCSP) needle without damaging the nearby critical structures such as the Left Anterior Descending (LAD) artery.

[0005] Second, the mitral cerclage wire must properly exit through the MCSP needle cannula into the right ventricular outflow tract (RVOT) and not end up in the right ventricular inflow tract (RVIT). RVOT is the ideal exit for the mitral cerclage wire as shown in FIG. 1 .

[0006] In persons with a well developed PSV, it can be used relatively easily as the pathway for the mitral cerclage wire to transverse the basal interventricular septum and exit into the RVOT. During the pre-surgical evaluation, cardiac CT imaging can be used to visualize the development of PSV to determine wether it is anatomically well suited to be used as the pathway for the mitral cerclage wire.

[0007] However, if the PSV is not developed in a anatomically suitable way to serve as the pathway for the mitral cerclage wire, MCA procedure may become impossible to perform safely without damaging the near by critical structures.

[0008] Furthermore, even if the PSV is anatomically well suited, during the actual

MCA procedures, the mitral cerclage wire often exits via the PSV into the RVIT more frequently than the RVOT. Hence, the ideal exit for the mitral cerclage wire, the RVOT is often not accessed.

[0009] Therefore, a MCSP device is needed in persons in whom the PSV is not anatomically well suited to be used as a safe pathway for the mitral cerclage wire, and also in persons in whom the PSV guides the mitral cerclage wire into the RVIT instead of the RVOT.

[0010] Fig. 2 shows an example of a known MCSP device. The needle cannula exits the MCSP device proximal to the distal straight tip, and the distal straight tip extends beyond the exit point for the needle cannula. [0011 ] The distal tip of such device interferes with a safe positioning of the MCSP catheter. The interventricular septum is pierced at the junction of the great cardiac vein and the anterior interventricular vein (the puncture zone). Then the mitral cerclage wire is passed via the needle cannula through the myocardium of the basal septum. If such MCSP device is advanced further into the heart, the distal tip may puncture and damage the LAD artery.

[0012] In the current invention, the distal tip of MCSP device is removed and an inflatable balloon(s) is attached to the distal end of the catheter. Removal of the distal tip allows the MCSP device to be advanced further into the heart and positioned safely at the puncture zone without risking damage to the near by LAD artery. Once in position at the puncture zone, the balloon(s) can be inflated to change and guide the direction of the needle cannula as it exits the MCSP device so that it does not puncture and damage the adjacent structures.

[0013] Furthermore, the attached balloon(s) can direct and guide the needle cannula as it pierces the basal interventricular septum creating a new ideal pathway for the mitral cerclage wire. Then the mitral cerclage wire can pass through the newly created path and exits the needle cannula into the RVOT

BRIEF DESCRIPTION OF THE DRAWING

[0014] FIG. 1 shows proximal septal vein and basal interventricular septum.

[0015] FIG. 2 shows a prior art.

[0016] FIG. 3 shows the MCSP device without the distal tip. [0017] FIG. 7 A shows the relationship of the LAD artery, the MCSP device and the MCSP needle cannula.

[0018] FIG. 7B shows a new ideal pathway being created for the passage of the mitral cerclage wire,

[0019] FIG. 8A shows the safe placement of the distal end of the MCSP device catheter near the LAD,

[0020] FIG. 8B shows the relationship of the needle cannula and the proximal septal vein.

[0021 ] FIG. 9 shows a drawing of pathway of the catheter as it passes through the superior vena cava, coronary sinus opening and into the coronary sinus.

[0022] FIG. 10 shows the MSCP device 1 comprising a hub 50 and a catheter body 10.

[0023] FIG. 11 A shows an inflated balloon 34 at the end of the catheter body 10.

[0024] FIG. 11 B shows a needle cannula 20 protruding from the distal end of the catheter body 10.

[0025] FIG. 11 C shows the needle cannula 20.

[0026] FIG. 11 D shows the close up view of the balloon 34.

[0027] FIG. 12A shows the distal end of the catheter body 10 having an opening

12, a lumen 14 and a side port 16.

[0028] FIG. 12B shows the balloon 34 inflated guiding the needle cannula 20 through the side port 16. [0029] FIG. 13A shows the distal end of the catheter body 10 having a front end opening 12 and a lumen 14.

[0030] FIG. 13B shows the balloon 34 inflated pushing the catheter body 10 against the coronary sinus wall 5 and the needle cannula 20 exiting through the opening 12.

[0031 ] FIG. 14A shows the catheter body 10 having the guide wire GW and the needle cannula 20 within the catheter lumen 14.

[0032] FIG. 14B shows the balloon 34 inflated against the Coronary Sinus wall 5 pushing the distal end of the catheter body 10 against the puncture zone 7.

[0033] FIG. 14C shows the needle cannula 20 is advanced through the side port

16, and it pierces the interventricular septum at the puncture zone 7.

[0034] FIG. 15A shows he a cross-sectional view of the distal end of the catheter body 10 having the catheter lumen 14 and the balloon member 30.

[0035] FIG. 15B shows the balloon 34 inflated against the Coronary Sinus wall 5 pushing the catheter body 10 against the puncture zone 7 and the needle cannula 20 against the side port 16.

[0036] FIG. 15C shows the needle cannula 20 is advanced through the side port

16 piercing the interventricular septum at the puncture zone 7.

[0037] FIG. 15D shows another embodiment of the catheter body 10 with a different configurations of the balloon member 30.

DETAILED DESCRIPTION [0038] As discussed above, Fig. 3 shows the MCSP device without the distal tip. Since there is no distal tip to interfere with safe positioning of the MCSP device, the distal end of the catheter can be place near the puncture zone without the risk of damaging the LAD artery. MCSP device shows an ideal passage of the MCSP needle cannula through the basal interventricular septum (FIG. 3).

[0039] Attached balloon is then inflated to change the direction of catheter. Then the inflated balloon(s) pushes the distal end of the catheter against the puncture zone and stabilizes it. Once the distal end of the catheter is firmly pushed against the puncture zone, the needle cannula pierces the interventricular septum at the puncture zone. The inflated balloon(s) guides the needle cannula as it exist the MCSP device further preventing damage to the LAD artery.

[0040] Once the balloon(s) is inflated and the radioactive dye fills the balloon(s), coronary angiogram can help visualize the structures and guide the needle cannula. As the needle cannula punctures the interventricular septum, the inflated balloon(s) can direct the needle cannula under the LAD artery creating a new pathway for the mitral cerclage wire safely.

[0041 ] Since a new pathway is created for the mitral cerclage wire and the PSV does not need to be used, the MCA procedure becomes independent of the anatomical suitability of the PSV. Further, since the balloon(s) can guide the needle cannula creating a new ideal pathway for the mitral cerclage wire, the wire can pass through the interventricular septum and exit into the RVOT and not the RVIT [0042] These figures show the MCSP device being used in a pig's heart. Figure 7 A shows the relationship of the LAD artery, the MCSP device and the MCSP needle cannula. As shown, it is possible to place the distal end of catheter close to the LAD artery without damaging it because it no longer has the distal straight tip.

[0043] Figure 7B shows a new ideal pathway being created for the passage of the mitral cerclage wire rendering the MCA procedure independent of the anatomical suitability of the PSV. De novo septal vein is also seen in this picture. The path of needle puncture is different than the de novo septal vein.

[0044] Figure 8A shows the safe placement of the distal end of the MCSP device catheter near the LAD. It also shows the MCSP needle cannula exiting the MCSP device.

[0045] Figure 8B shows the relationship of the needle cannula and the proximal septal vein. Once the needle cannula creates its own ideal pathway for the mitral cerclage wire, the proximal septal vein is no longer needed as the pathway for the cerclage wire.

[0046] Furthermore, when the PSV is used as a pathway, the mitral cerclage wire can often exits into the RVIT instead of the RVOT However, when the new ideal pathway is created, mitral cerclage wire can pass through the new pathway and properly exit into the RVOT.

[0047] Figure 9 shows a drawing of pathway of the catheter as it passes through the superior vena cava, coronary sinus opening and into the coronary sinus. Once the distal end of the catheter is near the puncture zone, the balloon(s) is inflated pushing the catheter against the puncture zone and stabilizing it. Then the needle cannula is advanced piercing the interventricular septum at the puncture zone.

[0048] Figure 10 shows MSCP device 1 comprising a hub 50 and a catheter body

10. The hub 50 is located at the proximal end of the device 1 . The hub 50 is equipped with a needle controller 52 and a balloon controller 54.

[0049] Figure 11 A shows an inflated balloon 34 at the end of the catheter body

10. Fig. 11 B shows a needle cannula 20 protruding from the distal end of the catheter body 10. Fig. 11 C shows the needle cannula 20. Fig. 11 D shows the close up view of the balloon 34.

[0050] Figure 12A shows the distal end of the catheter body 10 having an opening 12, a lumen 14 and a side port 16. Within the lumen 14 of the catheter body 10 are the guide wire (GW) and the needle cannula 20. The needle cannula 20 has a sharpened end 22 and needle cannula lumen 24.

[0051 ] Figure 12A also shows the balloon member 30 attached to the catheter body 10 on opposite side of the side port 16. The balloon member 30 includes a balloon house 32 and a balloon 34. The distal end portion of the catheter body having balloon member 30 and port 16 can be deflectable.

[0052] Figure 12B shows the balloon 34 inflated guiding the needle cannula 20 through the side port 16. Once the distal end of the catheter body 10 is near the puncture zone 7, balloon 34 is inflated against the coronary sinus wall 5, pushing the distal end of catheter body 10 against the puncture zone 7 and stabilizing it. Then the needle cannula 20 is advanced piercing the interventricular septum at the puncture zone 7.

[0053] Figure 13A shows the distal end of the catheter body 10 having a front end opening 12 and a lumen 14. Within the lumen 14 of the catheter body 10 are the guide wire (GW) and the needle cannula 20 having a sharpened end 22 and a needle cannula lumen 24.

[0054] Figure 13A also shows the balloon member 30 attached to the catheter body 10. The balloon member 30 includes a balloon house 32 and a balloon 34.

[0055] Figure 13B shows the balloon 34 inflated pushing the catheter body 10 against the coronary sinus wall 5 and the needle cannula 20 exiting through the opening 12.

[0056] Figure 14 A shows the catheter body 10 having the guide wire GW and the needle cannula 20 within the catheter lumen 14. The distal end of the catheter body 10 is near the puncture zone 7.

[0057] Figure 14B shows the balloon 34 inflated against the Coronary Sinus wall

5 pushing the distal end of the catheter body 10 against the puncture zone 7.

[0058] As shown in Figure 14C, once the balloon 34 is inflated and the distal end of the catheter body 10 is stabilized firmly against the puncture zone 7, the needle cannula 20 is advanced through the side port 16, and it pierces the interventricular septum at the puncture zone 7.

[0059] In another embodiment without a side port, the needle cannula 20 exits through the catheter opening 12 at the puncture zone as shown in Fig. 13A & 13B. [0060] Figure 15A shows the a cross-sectional view of the distal end of the catheter body 10 having the catheter lumen 14 and the balloon member 30. The side port 16 is located on the opposite side of the balloon member 30. Within the catheter lumen 14 are the guide wire GW and the needle cannula 20.

[0061 ] Figure 15B shows the balloon 34 inflated against the Coronary Sinus wall

5 pushing the catheter body 10 against the puncture zone 7 and the needle cannula 20 against the side port 16.

[0062] As shown in Figure 15C, once the balloon 34 is inflated and the catheter body 10 is stabilized against the puncture zone 7, the needle cannula 20 is advanced through the side port 16 piercing the interventricular septum at the puncture zone 7.

[0063] Figure 15D shows another embodiment of the catheter body 10 with a different configurations of the balloon member 30. For example, multiple balloons 34a, 34b and 34c can be utilized to fine tune the direction of the catheter body 10 and the needle cannula 20.

[0064] It will be appreciated that those skilled in the art will be able to devise numerous alternative arrangement that, while not shown or described herein, embody the principles of the invention and thus are within its spirit and scope.

Claims

What is claimed is:

1 . A puncture device, adapted to induce a cerclage wire reached in the coronary sinus into the right ventricular outflow tract (RVOT) in a mitral cerclage annuloplasty procedure, comprising: a tubular body, characterized in that the tubular body moves through the superior vena cava and the coronary sinus, punctures the inter ventricular septum between the coronary sinus and the right ventricle, makes a passage for communicating between the coronary sinus and the RVOT, and induces the cerclage wire into the right ventricle.

2. The puncture device according to claim 1 , further comprising:

a hole arranged at the frontal side of the body;

a needle member having a pointed shape at the front portion, the needle being insertable into the body, the needle being movable back and forth through the hole; and a support member being arranged in the opposite side of the hole, the support preventing the body from being pushed back when the device punctures the inter ventricular septum.

3. The puncture device according to claim 2, further comprising:

a control member configured to move and control the needle member in order for the needle member to move back and forth, and puncture the inter ventricular septum.

4. The puncture device according to claim 2, wherein the support member is configured to have a balloon member inflatable by an air.

5. The puncture device according to claim 4, wherein the balloon member is configured to have a pump to supply air for inflation.

6. The puncture device according to claim 4, wherein the balloon is configured to have an injection member to inject a dye into the balloon in order to visually identify a puncturing point.

7. A puncture device, adapted to induce a cerclage wire reached in the coronary sinus into the right ventricular outflow tract (RVOT) in a mitral cerclage annuloplasty procedure, comprising: a tubular body having

a hole arranged at the frontal side of the body, and

a needle member having a pointed shape at the front portion, the needle being insertable into the device, the needle being movable back and forth through the hole, characterized in that the tubular body moves through the superior vena cava and the coronary sinus, punctures the inter ventricular septum between the coronary sinus and the right ventricle, makes a passage for communicating between the coronary sinus and the RVOT, and induces the cerclage wire into the right ventricle.

8. The puncture device according to claim 7, further comprising:

9. The puncture device according to claim 7, further comprising:

a support member arranged in the opposite side of the hole, the support preventing the tubular body from being pushed back when the device punctures the inter ventricular septum.

10. The puncture device according to claim 9, wherein the support member is configured to have a balloon member inflatable by an air.

11 . The puncture device according to claim 10, wherein the balloon member is configured to have a pump to supply air for inflation.

12. The puncture device according to claim 10, wherein the balloon is configured to have an injection member to inject a dye into the balloon in order to visually identify a puncturing point.

13. A puncture method in a mitral cerclage annuloplasty procedure for inducing a cerclage wire reached in the coronary sinus into the right ventricular outflow tract (RVOT), the method comprising the steps of:

positioning a puncture device near the inter ventricular septum in order the device face toward the right ventricular outflow tract (RVOT) moving through the coronary sinus;

puncturing the inter ventricular septum using the puncture device and making a hole for communicating between the coronary sinus and the RVOT; and

inserting the cerclage wire through the hole from the coronary sinus and passing the cerclage wire into the right ventricle.

14. The method according to claim 13, wherein the puncturing step is configured to use a support member being arranged in the rear side of the puncture device for preventing the puncture device from being pushed back when the device punctures the inter ventricular septum.

15. The method according to claim 14, wherein the support member is configured to have a balloon member inflatable by an air from the outside.

16. The method according to claim 14, wherein the balloon member is configured to have an injection member to inject a dye into the balloon in order to visually identify a puncturing point.