Intracavity pressure attenuation and energy rebound device

Abstract

The present invention is a device for improving the resilience force of the aortic vessel, overcoming major arteriosclerosis to provide a therapy for improving cardiac function and reducing hypertension, referred to as' Intraluminal Pressure Attenuation and Energy Resilience Device (IPDERD) ', which is implantable within a tubular or capsular wall of a vessel of the human or animal body, said device comprising: a variable-volume component comprising a variable-volume material and a variable-volume material arranged between the variable-volume material and the variable-volume material; the container is suitable for interacting with a blood vessel to adjust the volume in the blood vessel; an energy storage mechanism that interacts with the variable volume component wherein a reduction in the volume of the variable volume component produces a pressure or energy store that can then be released to increase the volume of the variable volume component; also included is a fixation assembly, such as a stent for fixation, and a variable volume assembly, such as a balloon, for damping pressure waveforms and counterpulsation. The invention also provides a method for treating blood vessels of a human or animal body. The method comprises the following steps: preparing a patient; determining a to-be-treated part in the blood vessel; an intraluminal pressure attenuation and energy rebound device (IPDERD), i.e., an implantable device, is positioned at a location within a tubular or capsular wall of the blood vessel.

Description

Technical Field

[0001] The present invention relates to a method for deploying a tubular wall compliance and load-bearing device in a human or animal body, which is intended to change or adjust the compliance or load-bearing capacity of a tubular or saccular wall segment to a pulsatile pressure load. The present invention is composed of an intracavitary stent or fixation assembly, and one or more air bags, fluid storage chambers or chambers that are adjusted and monitored through a catheter or connecting pipeline; the device is deployed to a vascular treatment site in a compressed state, and then unfolded and attached to the inner wall of the blood vessel to play a role in the vascular cavity.

[0002] When applied to the cardiovascular system, the present invention enhances the secondary pumping function of the heart, reduces cardiac load and improves aortic and coronary blood flow by attenuating the time-varying blood pressure waveform during systole and enhancing the time-varying blood pressure waveform during diastole.

[0003] By adding balloons, fluid reservoirs or chambers, the device can treat more vascular segments from the ascending aorta, thoracic aorta to the abdominal aorta, and reduce the pulse pressure load by attenuating and reducing systolic blood pressure and increasing diastolic blood pressure, thereby improving coronary artery, carotid artery and renal artery blood flow. Background Art

[0004] Heart failure is the fastest growing cardiovascular disease, with its incidence increasing by about 2% to 5% per year in people over 65 and as high as 10% per year in people over 75.

[0005] Heart failure is the leading cause of hospitalization and readmission in the United States among people over 65 years of age.

[0006] Hypertension is a common precursor to heart failure. A recent study showed that 91% of heart failure patients had a history of hypertension, of which 42% had systolic dysfunction and 58% had diastolic dysfunction.

[0007] Aortic sclerosis caused by elastin degradation or atherosclerotic plaque formation is one of the causes of hypertension. With age, the aorta gradually hardens and dilates, leading to increased cardiac load, increased left ventricular pressure, increased aortic peak blood flow pressure, faster aortic pulse wave conduction velocity, and enhanced early wave reflection, which further aggravates late systolic pressure.

[0008] Data show that systolic blood pressure continues to rise with age, while diastolic blood pressure tends to stabilize after about 50 years of age, which leads to an increase in pulse pressure difference after 50 years of age.

[0009] As the aorta hardens, the arterial system loses compliance, which can lead to high blood pressure. Therefore, aortic stiffening appears to be a contributing factor to high blood pressure (hypertension), heart failure, stroke, and kidney disease.

[0010] Aortic compliance is crucial for effective cardiovascular dynamics. Insufficient aortic compliance leads to increased systolic cardiac load and poor coronary perfusion during diastole due to insufficient vascular recoil. Aortic compliance decreases with age, which is directly related to aortic wall sclerosis.

[0011] Approximately 80% of arterial compliance is concentrated in the ascending aorta and aortic arch segments. The expansion of the ascending aorta and arch during systole and the contraction / recoil during diastole are referred to as the secondary heart pump; this function declines with age and is directly related to the decrease in aortic compliance and increased sclerosis.

[0012] The stiffness of the aortic wall can be defined using various metrics and is typically represented by the pressure-strain elastic modulus (Ep): .

[0013] where and represent the vascular diameters during systole and diastole, respectively, and represent the intravascular pressures during systole and diastole, respectively.

[0014] The pulse pressure (PP) is the difference between and , i.e., the pressure difference in the blood vessel between systole and diastole.

[0015] Systolic and diastolic blood pressures continue to rise with age until approximately 50 years old, after which the systolic blood pressure continues to rise while the diastolic blood pressure stabilizes, resulting in an increased pulse pressure, which exacerbates the cardiac load, raises the mean blood pressure, and reduces blood flow supply to adjacent blood vessels such as the coronary arteries during diastole.

[0016] Previous solutions for heart failure have included: (a) Drug therapy, which has limited effectiveness and is usually costly; (b) Intra-aortic balloon pump (IABP), which empties during systole to reduce pressure and counterpulsates during diastole to enhance pressure, but since the patient needs to be bedridden and connected to a large external console, this is only a temporary solution; (c) Ventricular assist devices, intra / extra-corporeal compression devices, and pumps, which require an external power source, leading to increased implantation complexity, high costs, and high patient risks; (d) Heart transplantation, which is limited by the scarcity of donors, high costs, and high risks.

[0017] For the treatment of vascular sclerosis, fixing a compliant chamber inside or outside the blood vessel can provide an aortic rebound repair therapy, thereby reducing blood pressure, alleviating the heart load, increasing the stroke volume and cardiac output. The aortic rebound repair device developed by the applicant has been verified in pig and human trials, with a 30% increase in pig cardiac output and a 25% to 29% increase in humans.

[0018] The applicant states that the prior art described in this specification does not constitute common general knowledge of a person of ordinary skill in the art at the priority date of this patent application. Summary of the Invention

[0019] The present invention is a device for improving the elasticity of the aortic blood vessel, overcoming aortic sclerosis to provide a therapy for improving cardiac function and reducing hypertension, called the "Intraluminal Pressure Decay and Energy Rebound Device (IPDERD)". The device can be implanted into the tubular or sac-like wall of a blood vessel in a human or animal body. The device includes: a variable volume component adapted to interact with the blood vessel to adjust the volume inside the blood vessel; an energy storage mechanism that cooperates with the variable volume component. When the volume of the variable volume component decreases, the device can generate pressure or energy storage in the energy storage mechanism, and the stored pressure or energy is then released to expand the variable volume component; a fixing component, such as a stent for fixing, and a variable volume component, such as an airbag, for attenuating the pressure waveform and counterpulsation.

[0020] The device may include an intraluminal component that is compressed and crimped into a deployment sheath. The device is implanted by sliding the device from the access blood vessel to the target blood vessel treatment site via an adjacent blood vessel through an interventional procedure. At the target blood vessel site, the device unfolds in the deployment guide sheath and conforms to the inner diameter of the blood vessel, thereby engaging and fixing it in the target blood vessel position. The device has a filling line that is connected to an intraluminal adjustment port or a transvascular line, and the transvascular line is connected to a housing containing an additional airbag, reservoir or chamber. The housing allows monitoring and adjustment to enhance the attenuation volume of the device.

[0021] The variable volume component is an airbag.

[0022] The energy storage mechanism can be a pressure storage device (such as an elastic chamber, a deformable reservoir) or an airbag.

[0023] The variable volume component can be partially or entirely made of an elastic material, and the elastic material itself serves as the energy storage mechanism.

[0024] The deformable reservoir, airbag or stent may have multiple elements in series or parallel to improve the overall performance.

[0025] The variable volume component and the energy storage mechanism can be preset with thresholds or reference pressures and / or volumes. After implantation, the volume and energy of the device can be adjusted through a subcutaneous port, which is connected to the variable volume component and the energy storage mechanism by a connecting tube. A subcutaneous needle is used to insert through the skin into the subcutaneous port to increase or remove volume.

[0026] The variable volume component can be filled with one or more of the following media: biocompatible fluid; liquid silicone; liquid saline; X-ray visible liquid containing contrast agent; temperature-sensitive gel that expands to the working volume at 37°C; elastin; collagen; combination of elastin and collagen; air; carbon dioxide; helium; or gas, water or other incompressible media.

[0027] The energy storage mechanism includes a compressible fluid chamber.

[0028] The medium filled in the energy storage mechanism can be one or more of the following compressible media: nitrogen, air, carbon dioxide, helium, or other gas or compressible media.

[0029] The device can be implanted into the ascending aorta, thoracic aorta and abdominal aorta through femoral artery or subclavian artery interventional surgery, and the operating pressure or filling volume can be adjusted by using an intravascular adjustment port connected to the intravascular port through an intravascular access line, or connected to an implant module through a transvascular line, and the module has a subcutaneous adjustment port and a wireless monitoring system.

[0030] The device can be used to repair the compliance of a blood vessel segment.

[0031] The device can be used to adjust the systolic and diastolic characteristics of blood vessels, thereby improving cardiovascular performance.

[0032] The variable volume component can integrate an electronic dynamic attenuation control and energy collection and release device.

[0033] The device can be applied to the ascending aorta by isolating the ascending aorta from the pulmonary artery.

[0034] The device can be applied to the ascending aorta and the pulmonary artery simultaneously.

[0035] The device can be applied to multiple blood vessels, including the ascending aorta and the descending aorta connected to the left and right sides of the heart.

[0036] The pressure or energy storage can be generated at least in part by gas compression in the device balloon.

[0037] The pressure or energy storage can be generated at least in part by elastic deformation of the device.

[0038] After the device operates, the system containing the blood vessel will perform better than an untreated blood vessel segment in terms of lower stiffness and / or higher compliance.

[0039] The energy storage mechanism releases the pressure or energy storage to assist the blood vessel pressure when the device acts on the load on the blood vessel wall.

[0040] The device may include at least one elastic component, and the elastic component is adapted to release energy to assist the blood vessel.

[0041] The device or the energy storage mechanism releases the pressure or energy storage when the blood vessel unloads.

[0042] The present invention also provides a method for treating blood vessels in a human or animal body, including the following steps: preparing a patient; determining a site in the blood vessel that needs treatment; positioning an implant device at a site within the tubular or sac-like wall of the blood vessel so that the load applied to the blood vessel is jointly borne by the blood vessel wall and the device, and when the wall and the device jointly act on the load, the blood vessel is assisted by the device; the device includes an energy storage mechanism, and the energy storage mechanism is charged with pressure or energy by the load applied to the device; the device includes a stent for fixation and an airbag for attenuation and counterpulsation; the device is implanted by loading a compressed and crimped deployment sheath into the blood vessel and removing the sheath to deploy the stent within the blood vessel. The device has a filling pipeline, and the filling pipeline is connected to a cavity adjustment port or a transvascular line to a housing, and the transvascular line is connected to a housing having an additional airbag, a reservoir or a chamber, and the housing allows monitoring and adjustment to enhance the attenuation volume of the device.

[0043] The method includes positioning a stent as part of the device within the blood vessel.

[0044] The energy storage mechanism can be an elastic cavity or a deformable reservoir.

[0045] The energy storage mechanism may include a chamber of compressible medium that stores the pressure or energy when compressed.

[0046] The energy storage mechanism may include an electronic energy harvesting device.

[0047] The compliance of the device can be adjusted by filling at the time of implantation or after implantation.

[0048] The compliance of the device can be adjusted after implantation through a subcutaneous port, and the port is connected to the variable volume part through a transvascular access port and is connected to the energy storage mechanism through a connecting catheter. A subcutaneous needle is inserted through the skin into the implantation port to increase or remove the volume.

[0049] The performance of the device can be monitored by electronic sensors installed in the subcutaneous port and / or variable volume components and energy storage mechanisms.

[0050] The sensors can be powered by implanted batteries, implanted induction coils powered by external coil induction, or by an electrically connected subcutaneous port and power needle.

[0051] The sensors can be connected to an electronic communication circuit through analog-to-digital conversion or digital connection. The electronic communication circuit can electronically send data to an external receiver via radio frequency, wireless network (Wi-Fi), or Bluetooth for recording and storing data.

[0052] Compliance can be adjusted by filling with a combination of one or more of the following media: biocompatible liquids; liquid silicone; saline; liquid containing contrast agent visible under X-ray; temperature-sensitive gel solution that expands to its final working volume at 37°C; uncured or liquid polymer that thermally cures at 37°C, or is activated by light or heat; thermally activated gel; elastin; collagen; combination of elastin and collagen; air; polymer that cures or thermosets after injection; gas, carbon dioxide, helium, air, or other compressible media; water.

[0053] The lumen can be a blood vessel.

[0054] The load applied to the blood vessel jointly borne by the blood vessel wall and the device can be the systolic phase of the cardiovascular system.

[0055] When the blood vessel wall and the device act on the load, it can be the diastolic phase of the cardiovascular system. BRIEF DESCRIPTION OF THE DRAWINGS

[0056] Now, an embodiment of the present invention will be described by way of example with reference to the accompanying drawings, wherein: Figure 1 shows a multi-balloon multi-stent intracavitary pressure decay and energy rebound device (IPDERD), which includes a connected implantable housing (including a subcutaneous port, additional balloons or decay chambers, and a wireless monitoring system), and the drawings show that the wireless signal is received by a computer, mobile phone, or watch device.

[0057] Figure 2 shows an IPDERD with a transvascular catheter for monitoring and adjusting the device, where the adjustment port on the implant module is adjusted by a syringe inserted into the subcutaneous port (multi-lumen tubing connection can be used).

[0058] Figure 3 Shown is an IPDERD with an intracavitary port after removing the filling and adjustment lines.

[0059] Figure 4 shows an IPDERD that reconnects the line to the in-vessel port of the IPDERD through a femoral artery access procedure and is adjusted using an attached syringe and an external pressure gauge.

[0060] Figure 5 Shown is an IPDERD deployed via the left subclavian artery, where the first balloon is located in the ascending aorta, the second balloon is located in the thoracic aorta, and the third balloon is located in the abdominal aorta.

[0061] Figure 6 Shown is an IPDERD deployed via the femoral artery, where the first balloon is located in the thoracic aorta, and the second and third balloons are located in the abdominal aorta and the lower abdominal aorta.

[0062] Figure 7 shows the deployment process of the crimped IPDERD in the target blood vessel: after removing the sheath, the stent unfolds and engages with the blood vessel wall, and then the balloon is inflated.

[0063] Figure 8 shows the state where the balloon and the stent are crimped and loaded into the deployment sheath. Detailed implementation mode

[0064] Multi-balloon multi-stent in-vessel pressure attenuation and energy rebound device (IPDERD) 1000 Figure 1 shows the multi-balloon multi-stent in-vessel pressure attenuation and energy rebound device (IPDERD) 1000.

[0065] The IPDERD 1000 is composed of axially arranged balloons 1010 and 1020, which are connected and fixed to the aorta 100 through a catheter line 1100, located in the thoracic aorta 300 distal to the left subclavian artery 200 to the abdominal aorta 500 near the kidney 400, and the balloons are fixed by stents 1011, 1012, 1021, 1022 and 1031.

[0066] Transvascular line connected to the implantable housing for monitoring and adjusting the IPDERD 3000 The IPDERD 1000 is connected to the implantable housing 3000 through a catheter line 2000. The catheter line 2000 uses a transvascular access port 900 to connect the sensor 2200 and the catheter line 2000 to the implantable housing 3000. As shown in Figure 2, the housing includes: a subcutaneous inflation adjustment port 3500, an additional balloon or attenuation chamber 3030, and a wireless monitoring system 3300. The catheter line 2000 (as shown in the second inset of Figure 2) can have a multi-lumen structure, allowing simultaneous media inflation 2100 and electrical connection 2020 to connect to the housing 3000 or other required connection lines.

[0067] The inset 4000 of Figure 1 shows that the wireless signal can be received by a computer 4100, a mobile phone 4200, or a watch device 4300.

[0068] The IPDERD is implanted through an interventional procedure. For the specific method, refer to the subsequent description in Figure 7.

[0069] Using port 3500, a subcutaneous needle, and syringe 5000, the balloon is inflated to the mean aortic pressure or other pressure levels set by the doctor. The wireless pressure monitor can record the balloon pressure. An external pressure monitor 5300 as shown in Figure 4 can also be used. After removing the needle, the IPDERD is activated and operational. The implant housing can be placed in a skin pocket in the lower abdomen, and the patient can resume activities.

[0070] Working Principle of the Intracavitary Pressure Decay and Energy Rebound Device (IPDERD) 1000 When balloons 1010, 1020, and 3200 are set to the working pressure, the systolic pressure decay and diastolic energy rebound effects begin. As the systolic pressure rises and propagates along the aorta, balloon 1011 reduces its volume by compressing the internal medium, while the high pressure causes the medium to transfer downstream to balloon 1020 and / or chamber 3200, thereby reducing the systolic blood pressure of the entire left arterial system and alleviating the left heart load. When the arterial pressure wave propagates into the diastolic phase, the pressure drops, and balloon 1010 causes the attenuated energy to rebound or be released through the expansion of the medium and the volume expansion from the connected balloons or chambers, thereby increasing the arterial diastolic blood pressure and enhancing blood flow to the carotid, coronary, and renal arteries.

[0071] This principle has been verified in a bench model, showing a 25% to 35% reduction in pulse pressure, comparable to the inventor's previous intracavitary technology, a 30% to 100% improvement in left coronary artery blood flow, and a 30% increase in stroke volume and cardiac output.

[0072] Adjusting the Intracavitary Port 1001 of the IPDERD via Femoral Artery Access Figure 3 Shows the IPDERD 1001, which consists of axially arranged balloons 1010 and 1020, connected and fixed within the aorta 100 through catheter tubing 1100, located in the thoracic aorta 300 distal to the left subclavian artery 200 to the abdominal aorta 500 near the kidney 400. The balloons are fixed by stents 1011, 1012, 1021, 1022. The distal end of the catheter tubing 1100 (below stent 1022) is connected to the intracavitary port 1500, and the sensor 2200 is located within balloon 1020.

[0073] As shown in Figure 4, the intracavity line 5100 attached to the external pressure gauge 5300 and the syringe 5001 is connected to the IPDERD intracavity port 1500 via the femoral artery 900 through interventional transvascular access, such that the port 2500 and the line 2000 can move along the aorta 500 to connect to the IPDERD port 1500, thereby enabling the inflation and adjustment of the IPDERD balloon. Subsequently, inflation and pressure adjustment can be performed. The pressure state within the IPDERD can also be measured. If the lumen of the access line 5100 contains an electrical connection as described for the catheter 2000, the sensor 2200 can also be used.

[0074] It should be noted that Figure 3 Figure 5 shows the IPDERD 1001 (still with the intracavity port 1500) after the removal of the inflation and adjustment lines 2000 and 5100, while Figure 4 shows the process of reconnecting the lines 2000 and 5100 to the IPDERD intracavity port 1500 through femoral artery access and performing adjustments using the attached syringe 5001 and the external pressure gauge 5300. During the initial deployment phase of the IPDERD, the port 2500 and the line 2500 may have been pre-connected to simplify the deployment process, and subsequent adjustments can be completed during the patient's scheduled follow-up visit.

[0075] Intracavity Pressure Decay and Energy Rebound Device (IPDERD) 1001 The function of the device 1001 is the same as that of the above-mentioned device 1000. However, the performance of a fully intracavity device is limited by the available volume of the intravascular balloon. By increasing the balloon diameter and length, the volume can be increased to enhance the effect of reducing pulse pressure.

[0076] Deployment of IPDERD 1002 via the left subclavian artery Figure 5 Figure 6 shows a three-balloon IPDERD deployed via the left subclavian artery, where the first balloon 1030 is located in the ascending aorta 100, the second balloon 1010 is located in the thoracic aorta 300, and the third balloon 1020 is located in the abdominal aorta 500. The catheter tubing is located in the left subclavian artery (LSA) 200 and is connected to the implantable housing 3000 that can be placed subcutaneously in the left chest region.

[0077] Deployment of IPDERD 1003 via the femoral artery Figure 6 Figure 7 shows a three-balloon IPDERD deployed via the femoral artery (FA), where the first balloon 1010 is located in the thoracic aorta 300, and the second balloon 1020 and the third balloon 1030 are located in the abdominal aorta and the lower abdominal aorta 500.

[0078] Release of the crimped IPDERD within the blood vessel lumen Figure 7 shows the deployment process of the crimped IPDERD in the target blood vessel (illustrated as the LSA 200). That is, after removing the sheath 800, the stent 1012 is deployed and engaged with the blood vessel wall 300, and then the balloon 1010 is released and inflated through the catheter inflation line 2000.

[0079] Compress the IPDERD and load it into the deployment sheath Figure 8 shows the balloon and stent loaded into the deployment sheath.

[0080] Performance comparison Measurements were made using a custom-made mock circulation loop (MCL, a device that mechanically mimics the heart and circulatory system). The working fluid was water at 37 °C. Pressures at the proximal, distal, and inside the balloon of the device were recorded using calibrated pressure sensors (Honeywell, Charlotte, North Carolina, USA) and an NI data acquisition system (NI USB-6229, National Instruments, Austin, Texas, USA), and the data was analyzed using LabVIEW software (LabVIEW 2017, National Instruments, Austin, Texas, USA). Intra-aortic balloon (IAB) devices with effective volumes of 20 ml, 30 ml, and 40 ml were placed inside a rigid simplified aortic model and fixed with the prototype stent. Before inflating the balloon of the IAB device, a sinusoidal pulsatile flow waveform of 70 beats per minute was generated using a gear pump (BVP-Z, Ismatec, Glattbrugg, Switzerland) as the baseline. The pulsation amplitude of the pump and the MCL resistance were adjusted until a pulse pressure of 60 mmHg (systolic pressure 160 mmHg, diastolic pressure 100 mmHg) was reached. In each experiment, the IAB device was inflated to an average pressure of 130 mmHg inside the balloon. Before data collection, the pressure and flow data inside the MCL were allowed to stabilize for 120 seconds, and the pulse pressure was recorded. The percentage reduction in pulse pressure compared to the baseline was calculated. Each balloon volume experiment was repeated 3 times (n = 3).

[0081] The IAB device reduced the average pulse pressure of 60.6 ± 1.4 mmHg to 49.4 ± 0.7 mmHg, 44.6 ± 1.9 mmHg, and 38.6 ± 0.8 mmHg, corresponding to effective balloon volumes of 20 ml, 30 ml, and 40 ml, respectively. This corresponds to an average reduction in pulse pressure of 18% (20 ml balloon volume), 29% (30 ml balloon volume), and 34% (40 ml balloon volume).

[0082] When using two IAB devices, each with a volume of 9 ml and a total volume of 18 ml, the average reduction in pulse pressure was 16%, which was equivalent to the effect of a single 20 ml balloon.

[0083] When two IAB devices are connected to an additional 9 ml external balloon, with a total volume reaching 27 ml, the average reduction in pulse pressure increases to 24%. This indicates that even with a smaller length or diameter of the intravascular balloon, performance can be improved by increasing the chamber, reservoir, or balloon volume in the implantable housing.

[0084] It is thus concluded that the IPDERD prototype can use the maximum effective balloon volume tested to reduce the average pulse pressure of 60.6 mmHg to 38.6 mmHg, a reduction of 34%. This result indicates that the device has the potential to become a non-surgical solution for the treatment of aortic rebound repair in hypertension and heart failure.

Claims

1. An apparatus implantable within the wall of a tubular or sac-like vessel of a human or animal body, comprising: A variable volume component for interacting with a blood vessel to adjust the volume within the blood vessel; An energy storage mechanism that cooperates with the variable volume component, such that when the volume of the variable volume component decreases, the device is capable of generating pressure or energy storage in the energy storage mechanism, and the pressure or energy storage is subsequently released to expand the variable volume component; further comprising a fixation component such as a stent, and a variable volume component such as a balloon for attenuating a pressure waveform and for counterpulsation.

2. The apparatus according to claim 1, wherein the apparatus has an intraluminal component that is compressed and crimped into a deployment sheath and is deployed via an interventional procedure to a treatment site in a target vessel adjacent to a blood vessel, and the apparatus unfolds in the deployment sheath and conforms to the inner diameter of the blood vessel so as to engage and fix it in the target vessel position.

3. The apparatus according to claim 2, wherein the apparatus has an infusion line that is connected to an intraluminal adjustment port or a transvascular line, and the transvascular line is connected to a housing that includes an additional balloon, a reservoir, or a chamber, and the housing allows monitoring and adjustment to enhance the attenuation volume of the apparatus.

4. The apparatus according to claim 2, wherein the apparatus has an intraluminal port to which an intraluminal connection line is attached, and the connection line is connected to the intraluminal port via an interventional catheter inserted into an adjacent blood vessel, such as the femoral artery.

5. A method for treating a blood vessel in a human or animal body, the method comprising the following steps: Prepare the patient; determine the site of treatment desired in the blood vessel; position the implantable device within a section of the tubular or sac-like wall of the blood vessel at the site, whereby the load applied to the blood vessel is shared by the wall and the device, and the blood vessel is assisted by the device when the wall and the device act together on the load; the device includes an energy storage mechanism that is charged with pressure or energy by the load applied to the device.

6. The method according to claim 5, wherein the apparatus includes a stent for fixation and a balloon for attenuation and counterpulsation, and the apparatus is implanted by loading a compressed and crimped deployment sheath into the blood vessel and removing the sheath to unfold the stent within the blood vessel.

7. The method according to claim 6, wherein the apparatus has an infusion line that is connected to an intraluminal adjustment port or a transvascular line, and the transvascular line is connected to a housing having an additional balloon, a reservoir, or a chamber, and the housing allows monitoring and adjustment to enhance the attenuation volume of the apparatus and allows the apparatus to be infused during deployment and use.

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