DELIVERY SYSTEM FOR IMPLANTS USED IN STRUCTURAL HEART DISEASES BY A MINIMALLY INVASIVE METHOD

Abstract

A delivery system for implants used in structural heart diseases by a minimally invasive method comprises a catheter (2) which is connected with the distal section of the balloon (1) and on the other side with the straight cap with the lateral canal (10) to which a pressure syringe for pumping the balloon is attached. The catheter is covered from the outside with a special shield (8). The balloon (1) has a necking in the middle section and inside the balloon and in the catheter (8) there is a canal (6) led outside the balloon formed at the end in the shape of a coil (3). Inside the balloon (1) or outside it at its distal and proximal ends the system is equipped with at least one anchoring mechanism shapely formed crimped on the balloon surface of the implant preventing its uncontrolled moving.

Claims

1. A delivery system for implants used in structural heart diseases by a minimally invasive method comprising a catheter (2) connected with the distal section of the balloon (1) and on the other side with the straight cap with the lateral canal (10) to which a pressure syringe for pumping the balloon is attached, and the catheter is covered from the outside with a special shield (8), and the balloon (1) has a necking in the middle section and inside the balloon and in the catheter (8) there is a canal (6) led outside the balloon formed at the end in the shape of a coil (3) characterised by the fact that inside the balloon (1) or outside it at its distal and proximal ends the system is equipped with at least one anchoring mechanism shapely formed crimped on the balloon surface of the implant preventing its uncontrolled moving.

2. The system of claim 1 characterised by the fact that the anchoring system is placed on the straight section of the canal (3) at the intersection with the proximal part of the balloon (1) and it is formed in the shape of a cone (4) whose widened part is aimed at the balloon.

3. The system of claim 1 characterised by the fact that the anchoring mechanisms are made inside the balloon in its distal and proximal sections in the form of a protrusion (5,5′) of the canal inside the balloon (6).

4. The system of claim 1 characterised by the fact that the anchoring system is made at the proximal end of the shield (8) of the catheter (2) in the form of a sheath getting bigger in the direction of the diameter outlet.

5. The system of claim 1, characterised by the fact that the anchoring mechanisms in the form of markers (8) placed on the outside surface of the canal (6) whose diameter is bigger than the diameter of the canal.

6. The system of claim 1 characterised by the fact that the anchoring systems in the form of a sheath at the end of the shield (8) formed like a cone dilation in the direction of the distal end of the balloon.

Description

[0011] The invention is presented in the example of realisation in the drawing in which FIG. 1 shows the system from the side, and. FIG. 2 shows the example of realisation with exposed dimensions.

[0012] The said system consists of a delivering balloon 1 made of polyamide, where its shape after expansion and filling with contrast reagent resembles the shape of a roller of a “dog-bone” type , whose middle section has a necking in reference to broader sections at both bases of the roller. The characteristic necking after expansion of the balloon in its middle section allows to locate an implant in this place, particularly a metal frame of the prosthetic heart valve and its immobilization, which prevents and precludes sliding of the implant from the balloon surface. The guiding balloon 1 can also be devoid of the necking in the middle section. However, it constitutes one of the elements of good positioning of the prosthetic heart valve. In its distal part there is a supply line—a catheter 2 made of polyamide with the diameter of 7 Fr (where the abbreviation Fr applied in the field of technology is a unit of length and it is equal to 0.3 mm). In the proximal section of the balloon there is the end of the pipe 3 formed in the shape of a coil called “pig tail”, made of polyamide. The said end is preceded by a special cone (nozzle) whose widened part is aimed at the balloon. Inside the balloon the cone 4 has a necking 5 led out axially from its base, and the said necking is bigger than the diameter of the inner guiding canal 5 and it is connected with canal 6. A similar protrusion 5′ of the canal 6 is made on the other side of the balloon. The said elements 5,5′ additionally prevent sliding of the implant located on the balloon after crimping the said implant in the necking of the balloon. One “pig end” of the pipe 3 is straight and in the final section it is characteristically curled up as a coil. The diameter of the circle from which the said end curled up in a characteristic and unique way is formed is usually 26 mm. However, this diameter fluctuates in the range from 21 to 31 mm. The distance of the outer part of the said curled up end to the straight part is 24.5 mm.The diameter of the pipe 3 is from 4Fr to 6Fr and its whole length from 40 to 60 mm (in FIG. 2 the example of the length 50 mm ad the diameter of 4Fr is presented). The end of the pipe 3 as an atraumatic element protects the left heart ventricle against damage. The length of the balloon between the pipe 3 and the line 2, supplying the contrast reagent is 90 mm and its diameter in the necking is 23 mm. However, it is permissible to change the size in the range from 60 to 110 mm in case of its length and 13 to 33 mm in case of the diameter. The balloon diameter outside the necking is bigger by 2 mm in comparison to the diameter of the necking. The said necking can be made of a thickened material, which lowers the risk of perforation, of the balloon bursting during crimping, and thereafter during expansion of the valve. The proximal and distal sections widen in comparison to the middle section forming an angle of the value in the range of 100-130°. Inside the middle part of the balloon there are 7 platinum—iridium markers located on the special line connecting both ends of the balloon. Their aim is to expose the balloon in the X-rays while maneuvering it during the delivery and implantation process. Moreover, the said markers after tightening the implant on the crimped balloon-constitute an additional anchoring mechanism of the crimped prosthetic heart valve on its surface preventing sliding of the said valve. A special tube-shaped shield 8 with the diameter slightly bigger than the diameter of the catheter 2 is placed on the proximal end of the line 2 (catheter) supplying the contrast reagent to the balloon, which enables maneuvering the system inside the vessel. At the proximal end in the contact point with the distal end of the balloon the shield 8 has a sheath (extension of the tube) which additionally protects a placed implant, particularly a crimped prosthetic heart valve against sliding and against damage. At the other end of the line 8 there is a cap 9 for supplying contrast in the direction of the balloon. At the end of the catheter 2 there is a straight cap with a lateral canal 10 to which a pressure syringe for pumping the balloon is attached. The outer shield 8 with the sheath is removed after delivering the system into the final destination.

[0013] The order of expansion of the balloon and filling it with the contrast reagent is characteristic for the system. In the first place the fluid fills the distal section, thereafter the proximal section is filled and finally the middle section, where the crimped prosthetic heart valve, the implant or another device for treating the valve system defects is placed.

[0014] Facilitation of the process of the prosthetic heart valve positioning is characteristic and unique for the system. Additionally, there is a possibility of repeat locating and positioning (refixing) the prosthetic heart valve with use of the delivery system inside the vessel as well as of the refixing the prosthetic heart valve which is dislocated.