SYSTEMS, METHODS AND DEVICES FOR PROGRESSIVELY SOFTENING MULTI-COMPOSITIONAL INTRAVASCULAR TISSUE
Various embodiments of the systems, methods and devices are provided comprising angioplasty to break up calcification or other tissue in occlusive areas within a blood vessel. The various embodiments disclosed comprise pressure pulse periods designed to break up calcified occlusive material through a cyclically stretching of the vessel walls without damaging the vessel wall tissue.
1 . A system for treating a blood vessel, comprising:
an inflatable balloon operatively connected to a catheter;
a fluid reservoir in operative fluid communication with the inflatable balloon;
a pressure controller in operative communication with the fluid reservoir and adapted to deliver fluid from the fluid reservoir with a plurality of pressure pulse periods, each pressure pulse period comprising at least one balloon inflation comprising at least one pressure magnitude, the pressure controller further adapted to provide a relaxation period between successive pressure pulse periods, each relaxation period comprising a balloon pressure that is greater than zero; and
a processor in operative communication with the pressure controller, the processor comprising programmed instructions that, when executed, results in programmed execution of the plurality of pulse periods and the relaxation period between successive pulse periods.
2 . The system of claim 1 , wherein the programmed instructions further comprise at least one of the predetermined variables in the group consisting of: initial pressure magnitude, maximum pressure magnitude, final pressure magnitude, time of pressure application, time of relaxation period, pressure of relaxation period, and velocity of pressure application.
3 . The system of claim 1 , wherein the programmed instructions are adapted to ensure that the at least one pressure magnitude increases within each successive pressure pulse period in the plurality of pulse periods over time.
4 . The system of claim 1 , wherein the programmed instructions are adapted to ensure that the plurality of pulse periods each comprise a predetermined initial minimum pressure magnitude.
5 . The system of claim 4 , wherein the programmed instructions are adapted to ensure that the predetermined initial minimum pressure magnitudes are not the same for any of the pressure pulse periods in the plurality of pressure pulse periods.
6 . The system of claim 4 , wherein the programmed instructions are adapted to ensure the predetermined initial minimum pressure magnitudes increase across the plurality of pulse periods over time.
7 . The system of claim 1 , wherein the programmed instructions are adapted to ensure that the plurality of pulse periods each comprise a predetermined maximum pressure magnitude.
8 . The system of claim 7 , wherein the programmed instructions are adapted to ensure that the predetermined maximum pressure magnitudes are not the same for any of the pressure pulse periods in the plurality of pressure pulse periods.
9 . The system of claim 7 , wherein the programmed instructions are adapted to ensure that the predetermined maximum pressure magnitudes increase across the plurality of pulse periods over time.
10 . The system of claim 1 , wherein the programmed instructions are adapted to ensure that the pressure pulse period for each successive pressure pulse period within the plurality of pressure pulse periods comprises a constant time period.
11 . The system of claim 1 , wherein the programmed instructions are adapted to ensure that each successive pressure pulse period within the plurality of pressure pulse periods comprise unequal time periods.
12 . The system of claim 1 , wherein the programmed instructions are adapted to ensure that the each successive pressure pulse period within the plurality of pressure pulse periods increases in time.
13 . The system of claim 1 , wherein wherein the programmed instructions are adapted to ensure that the relaxation period between successive pressure pulse periods comprises a time period that is constant.
14 . The system of claim 1 , wherein the programmed instructions are adapted to ensure that the decompression period between successive pressure pulse periods comprises a time period that is variable.
15 . The system of claim 1 , wherein the programmed instructions are adapted to ensure that the decompression period between successive pressure pulse periods comprises a time period that increases.
16 . The system of claim 1 , wherein each of the at least one balloon inflations comprise a predetermined waveform type.
17 . The system of claim 16 , wherein the predetermined waveform type does not change within each pressure pulse period or across the series of pressure pulse periods.
18 . The system of claim 16 , wherein the at least one waveform type does change within at least one of the pressure pulse periods within the series of pressure pulse periods.
19 . The system of claim 1 , wherein the wherein the programmed instructions are adapted to ensure that the pressure velocity at the initiation of each of the pressure pulse periods within the series of pressure pulse periods is constant and does not vary between pressure pulse periods.
20 . The system of claim 1 , wherein the wherein the programmed instructions are adapted to ensure that the pressure velocity at the initiation of each of the pressure pulse periods within the series of pressure pulse periods is not the same for all of the pressure pulse periods.
21 . The system of claim 1 , wherein the wherein the programmed instructions are adapted to ensure that the pressure velocity at the initiation of each of the pressure pulse periods within the series of pressure pulse periods increases with each successive pressure pulse period.
22 . A method for treating a blood vessel with an inflatable balloon catheter, comprising:
providing the inflatable balloon catheter in operative and fluid communication with a pressure controller;
inserting the inflatable balloon catheter within the blood vessel to a location of interest;
using the pressure controller to execute a series of inflations, with relaxation periods between each inflation, wherein each relaxation period comprises a balloon pressure magnitude greater than zero.
23 . The method of claim 22 , further comprising ensuring that each inflation in the series of inflations comprises successively greater pressure magnitudes within the balloon.