Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/34—Trocars; Puncturing needles
  • A61B17/3478—Endoscopic needles, e.g. for infusion
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/02—Prostheses implantable into the body
  • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
  • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
  • A61F2/2451—Inserts in the coronary sinus for correcting the valve shape
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/02—Prostheses implantable into the body
  • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
  • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
  • A61F2/2466—Delivery devices therefor
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
  • A61M25/09—Guide wires
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M29/00—Dilators with or without means for introducing media, e.g. remedies
  • A61M29/02—Dilators made of swellable material
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
  • A61B2017/00238—Type of minimally invasive operation
  • A61B2017/00243—Type of minimally invasive operation cardiac
  • A61B2017/00247—Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
  • A61B2017/22051—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
  • A61B2017/22065—Functions of balloons
  • A61B2017/22071—Steering

Definitions

• MV mitral valve
• Such MCA procedures require traversing basal interventricular septum via the proximal septal vein (PSV) to form a circumferential pathway around the mitral annulus.
• PSV proximal septal vein
• the biggest challenge in the MCA procedure is passing the mitral cerclage wire through the basal interventricular septum.
• 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.
• MCSP Mitral Cerclage Septal Puncture
• 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 .
• 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.
• 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.
• 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.
• 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.
• 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.
• 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
• FIG. 1 shows proximal septal vein and basal interventricular septum.
• FIG. 2 shows a prior art.
• FIG. 3 shows the MCSP device without the distal tip.
• FIG. 7 A shows the relationship of the LAD artery, the MCSP device and the MCSP needle cannula.
• FIG. 7B shows a new ideal pathway being created for the passage of the mitral cerclage wire
• FIG. 8A shows the safe placement of the distal end of the MCSP device catheter near the LAD
• FIG. 8B shows the relationship of the needle cannula and the proximal septal vein.
• 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.
• FIG. 10 shows the MSCP device 1 comprising a hub 50 and a catheter body 10.
• FIG. 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.
• FIG. 12A shows the distal end of the catheter body 10 having an opening
• FIG. 12B shows the balloon 34 inflated guiding the needle cannula 20 through the side port 16.
• FIG. 13A shows the distal end of the catheter body 10 having a front end opening 12 and a lumen 14.
• 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.
• FIG. 14A shows the catheter body 10 having the guide wire GW and the needle cannula 20 within the catheter lumen 14.
• 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.
• FIG. 14C shows the needle cannula 20 is advanced through the side port
• 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.
• 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.
• FIG. 15C shows the needle cannula 20 is advanced through the side port
• FIG. 15D shows another embodiment of the catheter body 10 with a different configurations of the balloon member 30.
• 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).
• 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.
• 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.
• 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.
• 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.
• Figure 8B shows the relationship of the needle cannula and the proximal septal vein.
• mitral cerclage wire can often exits into the RVIT instead of the RVOT
• mitral cerclage wire can pass through the new pathway and properly exit into the RVOT.
• 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.
• FIG. 10 shows MSCP device 1 comprising a hub 50 and a catheter body
• 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.
• Figure 11 A shows an inflated balloon 34 at the end of the catheter body
• 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.
• 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.
• 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.
• 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.
• 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.
• GW guide wire
• the needle cannula 20 having a sharpened end 22 and a needle cannula lumen 24.
• 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.
• 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.
• 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.
• Figure 14B shows the balloon 34 inflated against the Coronary Sinus wall
• the needle cannula 20 exits through the catheter opening 12 at the puncture zone as shown in Fig. 13A & 13B.
• 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.
• Figure 15B shows the balloon 34 inflated against the Coronary Sinus wall
• Figure 15D shows another embodiment of the catheter body 10 with a different configurations of the balloon member 30.
• multiple balloons 34a, 34b and 34c can be utilized to fine tune the direction of the catheter body 10 and the needle cannula 20.

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Cited By (7)

Citations (5)

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• 2014
  • 2014-04-30 KR KR1020140052651A patent/KR101611854B1/ko active IP Right Grant
  • 2014-05-28 WO PCT/IB2014/061765 patent/WO2014191924A1/en active Application Filing

Patent Citations (5)

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