WO2003097151A1 - Dispositif pour traiter des maladies cardio-vasculaires - Google Patents
Dispositif pour traiter des maladies cardio-vasculaires Download PDFInfo
- Publication number
- WO2003097151A1 WO2003097151A1 PCT/EP2003/005028 EP0305028W WO03097151A1 WO 2003097151 A1 WO2003097151 A1 WO 2003097151A1 EP 0305028 W EP0305028 W EP 0305028W WO 03097151 A1 WO03097151 A1 WO 03097151A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- balloon
- blood
- pressure
- blood flow
- blood vessel
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Ceased
Links
Classifications
-
- 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
- A61M25/10—Balloon catheters
- A61M25/1018—Balloon inflating or inflation-control devices
- A61M25/10181—Means for forcing inflation fluid into the balloon
-
- 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
- A61M25/10—Balloon 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
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1052—Balloon catheters with special features or adapted for special applications for temporarily occluding a vessel for isolating a sector
-
- 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
- A61M2230/00—Measuring parameters of the user
- A61M2230/04—Heartbeat characteristics, e.g. ECG, blood pressure modulation
-
- 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
- A61M2230/00—Measuring parameters of the user
- A61M2230/30—Blood pressure
-
- 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
- A61M25/10—Balloon catheters
- A61M25/1018—Balloon inflating or inflation-control devices
- A61M25/10184—Means for controlling or monitoring inflation or deflation
Definitions
- the invention relates to a device for interrupting the blood flow in blood vessels with a feed tube which can be inserted into the blood vessel and which is connected to one or more balloons which are expandable by supplying a liquid or a gas, and a pressure generating device which applies the pressure to expand the balloon generated via the liquid or the gas.
- the invention further relates to a method for inducing the growth and new formation of vessels.
- Cardiovascular diseases are one of the most common causes of death in the industrialized countries.
- the cause of cardiovascular morbidity and mortality is to a large extent the insufficient supply of organs with blood (ischemia).
- arteriosclerotic changes in the vessels The cause of the insufficient supply is usually arteriosclerotic changes in the vessels.
- Atherosclerosis is a systemic disease of the arteries with chronically progressive degeneration and changes in the vascular wall. The result is wall hardening and wall deformation with often constricting the vessel lumen.
- the cause of the formation of arteriosclerosis is considered to be the Gender and age, among other things, the way of life (e.g. blood lipid levels), toxic influences (e.g. smoking), high blood pressure and metabolic diseases (e.g. diabetes mellitus).
- Atherosclerosis usually progresses slowly. However, growth is not regular or strictly continuous. If there is a rapidly progressive increase in arteriosclerosis in a vascular segment, this can result in a displacement of the vascular lumen and thus an obstruction of the blood flow.
- a blood clot thrombus
- a blood clot can be formed by activating the coagulation cascade, which also impairs the blood flow within the vessel.
- a rapidly occurring low supply leads to an undersupply of the cells in the subsequent perfusion section. The result is often the destruction of tissue.
- Cardiac infarction myocardial infarction
- stroke apoplex
- tissue loss due to insufficient supply is often the destruction of tissue.
- other areas of the organism's current can also be damaged if there is insufficient supply as a result of a reduction in vascular lumen.
- the catheter or microsurgical instrument used is advanced to the place of use via blood-carrying vessels.
- a reversible relocation of the vessel and thus an interruption of the blood flow is accepted.
- Disabilities or relocations of the blood flow that exist for longer lead to a reduced supply of the subsequent tissue and can cause complications such as tissue death.
- collateral circuits are vessels that branch off from the main blood vessel in the direction of the same supply area. If the blood flow in the original vessel is restricted, these vessels can act as a bypass blood path and thus prevent a reduced supply of the dependent tissue sections.
- Preformed collaterals occur in most organ systems in a healthy organism. These generally narrow, pre-formed collaterals are not sufficient for a functionally effective collateral cycle. The expansion of the preformed collaterals to further lumen vessels, which allow an effective collateral circulation, often only takes place under pathological conditions.
- the induction of collateral circuits is induced, among other things, by hypoxia (undersupply of tissues with oxygen).
- Animal experiments have shown that the induction of collaterals can be induced by repeated two-minute hypoxia (Mohri M, Tomoike H, Noma M, Inoue T, Hisano K, Nakamura M. "Duration of ischemia is vital for collateral development: repeated brief coronary artery occlusions in conscious dogs ". Circulation Research 1989; 64: 287-96). In these experiments, an occlusion of the arteries was brought about by external pressure.
- the task is to develop a device that enables the induction of collateral circuits through the formation and growth of new vessels.
- a device according to the preamble of claim 1, in which the pressure generating device causes the balloon to expand for a certain period of time followed by a release of the pressure, and by a method according to the preamble of claim 22 which a device is at least partially inserted into a blood vessel and has means for repeated, temporary interruption of the blood flow by closing the blood vessel.
- the invention is based on the finding that recurrent ischemia
- the device according to the invention must be such that it expands the balloon for a certain, generally short period of several minutes, e.g. B. 2 min, which closes the blood vessel and then opens again by releasing the pressure.
- the device according to the invention is basically suitable for use in all vessel sections of the human or animal body.
- the pressure to inflate the balloon is adjusted so that the balloon rests against the vessel wall, but does not irreversibly expand it. In this way, an effective occlusion of the blood vessel is effected during the expansion of the balloon without causing damage to the vessel, particularly the intima.
- the interruption of the blood flow according to this invention is an essential part of the therapy. A side effect that is difficult to prevent is thus advantageously used.
- the device expediently has a control unit with a time-dependent circuit for initiating the generation of pressure.
- This control unit causes the repeated, periodically repeated expansion of the balloon to close the blood vessel over a period of time that lasts between several hours and several weeks, e.g. B. eight to twelve weeks. Such a period is usually necessary to ensure the effective formation of new vessels guarantee. It is important in therapy that the balloon is inflated frequently, but only for short periods of time, in order to induce the formation and growth of vessels without damaging tissue dependent on the blood supply. A typical program of the control unit therefore looks such that the vessel is closed for 2 minutes at intervals of 15 or 30 minutes.
- the blood flow is only partially interrupted by the device inserted into the blood vessel, in particular the balloon, in that the blood vessel is only partially closed.
- the balloon is not expanded to the wall of the vessel, but only to a certain percentage of the lumen of the vessel.
- the blood flow is severely restricted in this way to induce the formation of new vessels, but it is not completely interrupted.
- the expanded balloon should stop 50 to 90% of the blood flow.
- the blood flow according to this alternative embodiment is not completely interrupted, the risk of the loss of tissue supplied by the blood flow is reduced, so that the blood flow can be interrupted for longer periods or also continuously partially.
- the balloon is accordingly not expanded at defined intervals.
- the expansion of the balloon or the strength of the interruption of the blood flow in the course of the treatment can also be increased, preferably to the extent that collateral circuits have already formed through the formation and growth of vessels, which ensure the adequate blood supply.
- the ball or balloons are usually located at the distal end of the feed tube, where an easily deformable guide wire can also be provided for easier positioning of the device and stabilization of the position.
- a corresponding, easily deformable end is also used for conventional guidewires.
- the device can be positioned in the target vessel via the lumen of an already positioned catheter (guide catheter). Alternatively, however, positioning is also possible via a guide wire previously inserted into the blood vessel. For this purpose, it makes sense that a lumen with a distal opening for receiving the guide wire runs through the interior of the feed tube, it being possible here to use both the actual inner lumen of the feed tube and an additional lumen placed therein.
- wire-guided positioning by means of an eyelet located on the outside of the feed pipe is also possible.
- the positioning of the device in the vessel is further facilitated in that the supply pipe is designed to be separable from the control unit or the pressure generating device at the proximal end.
- radiopaque markings can be made in the area of the supply tube, particularly proximal and distal of the balloon, which makes positioning by means of X-ray radiation possible even without injuring contrast agents which are harmful to health.
- Such radiopaque markings are known per se and are widely used in the field of catheter technology.
- the expansion of the balloon is effected by a liquid or a gas which is brought into the balloon via a pressure line by applying pressure.
- a liquid or a gas which is brought into the balloon via a pressure line by applying pressure.
- Both the supply pipe itself and another lumen located in the supply pipe can serve as the pressure line.
- the control unit which can be located intra- or extracorporeally during the treatment, advantageously not only controls the inflation and deflation of the balloon, but also serves to monitor various vital functions.
- an electrocardiogram EKG
- EKG electrocardiogram
- Monitoring the blood pressure is particularly useful for therapy because the pressure to inflate the balloon can be adjusted to the prevailing blood pressure in order to ensure an effective occlusion of the blood vessel by expanding the balloon to its wall, but without, on the other hand application too high a pressure to cause an irreversible expansion of the wall and thus damage.
- control unit can also be equipped with a telemetry function which forwards the measured data to other systems such as the central monitoring unit of a hospital. This forwarding can take place continuously or only if there are deviations from the setpoint in the form of an alarm system.
- one or more ultrasound crystals can also be attached to the flexible supply tube.
- the ultrasound crystals make it possible to measure the blood flow rate (Doppler shift). This results in a good control of the blood flow in the corresponding vessel.
- changes in post-ischemic hyperperfusion can be detected using the ultrasound crystals.
- the overall treatment usually takes a long period of time up to several weeks, it makes sense to leave the part of the device according to the invention inserted into the vascular system over the entire therapy period in the vascular system. In this way, the effort for positioning the feed pipe is kept low, which is all the more important since the individual treatment steps in the form of inflation of the balloon take place at comparatively short intervals.
- the parts of the device located intracorporeally during the treatment are advantageously provided with an antithrombotic coating.
- drug treatment with anticoagulant substances makes sense.
- Such coatings and substances for avoiding thrombosis are known to the person skilled in the field of medical technology.
- Another way to prevent thrombosis is to provide a mesh or cage distal to the balloon, the detached thrombus intercept and prevent further negative consequences.
- VEGF vascular endothelial growth factor
- FGF-2 fibroblast growth factor 2
- IGF insulin like growth factor
- NO nitrogen monoxide
- heparin heparin
- the supply pipe can be provided with additional lumens.
- the messenger substances can be applied via an opening in front of or after the balloon (or at both locations).
- the intravascular application of a messenger substance or another substance close to the tissue can be achieved by means of a mass which is attached to the supply tube or to the balloon and dissolves over time.
- the invention also extends to the new formation of parenchymatous cells of other organ systems, which are newly formed or differentiated by the illustrated invention.
- Figure 1 is a schematic representation of the device according to the invention in the form of a longitudinal section.
- the device according to the invention comprises a flexible feed tube 4 which is inserted into the vascular system from proximal 5 to distal 5 '.
- a balloon which is expanded Condition 1 extends to the vessel wall and in this way closes the blood vessel and interrupts the blood flow.
- the balloon 1 is expanded by supplying a liquid or a gas through the pressure line 2, which runs through the lumen of the supply pipe 4.
- a pressure generating device 3 At the opposite end of the pressure line there is a pressure generating device 3, which can generate a pressure for the expansion of the balloon 1 and can reduce this pressure after a certain period of time, so that the volume of the balloon 1 decreases accordingly.
- the considerably smaller volume of the balloon in the unexpanded state 1 ′ compared to the expanded state can be seen from the schematic illustration using the dashed line.
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Biomedical Technology (AREA)
- Biophysics (AREA)
- Pulmonology (AREA)
- Engineering & Computer Science (AREA)
- Anesthesiology (AREA)
- Child & Adolescent Psychology (AREA)
- Hematology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Media Introduction/Drainage Providing Device (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Abstract
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| AU2003269562A AU2003269562A1 (en) | 2002-05-15 | 2003-05-14 | Device for treating cardiovascular diseases |
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE10222776A DE10222776A1 (de) | 2002-05-15 | 2002-05-15 | System zur wiederholten, aktiven Unterbrechung des Blutstroms |
| DE10222776.4 | 2002-05-15 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2003097151A1 true WO2003097151A1 (fr) | 2003-11-27 |
Family
ID=29432224
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/EP2003/005028 Ceased WO2003097151A1 (fr) | 2002-05-15 | 2003-05-14 | Dispositif pour traiter des maladies cardio-vasculaires |
Country Status (3)
| Country | Link |
|---|---|
| AU (1) | AU2003269562A1 (fr) |
| DE (1) | DE10222776A1 (fr) |
| WO (1) | WO2003097151A1 (fr) |
Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FR2500756A1 (fr) * | 1981-02-27 | 1982-09-03 | Ruesch Gmbh & Co Kg Willy | Instrument medical pour introduction dans les canaux physiologiques |
| US4644936A (en) * | 1982-11-19 | 1987-02-24 | Iabp | Percutaneous intra-aortic balloon and method for using same |
| EP0286359A2 (fr) * | 1987-04-10 | 1988-10-12 | Cardiometrics, Inc. | Appareil, système et méthode de mesure du flux sanguin volumétrique dans un vaisseau |
| US5084060A (en) * | 1989-02-15 | 1992-01-28 | Freund Precision, Inc. | Apparatus for enlarging a vessel or clearing obstructive tissue from a vessel according to vessel compliance |
| EP0609914A2 (fr) * | 1986-01-31 | 1994-08-10 | Werner Mohl, M.D. | Occlusion par pression intermittente du sinus coronaire |
| US5460609A (en) * | 1993-11-22 | 1995-10-24 | Advanced Cardiovascular Systems, Inc. | Electromechanical inflation/deflation system |
| WO1995028974A1 (fr) * | 1994-04-22 | 1995-11-02 | Bruno Maugeri | Dispositif de contrepulsion a ballonnet intra-aortique pour la mesure en continu du volume systolique du ventricule gauche |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE69204990T2 (de) * | 1991-01-03 | 1996-05-15 | Salk Inst For Biological Studi | Mitotoxin zur behandlung von gefässbeschädigung. |
-
2002
- 2002-05-15 DE DE10222776A patent/DE10222776A1/de not_active Ceased
-
2003
- 2003-05-14 AU AU2003269562A patent/AU2003269562A1/en not_active Abandoned
- 2003-05-14 WO PCT/EP2003/005028 patent/WO2003097151A1/fr not_active Ceased
Patent Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FR2500756A1 (fr) * | 1981-02-27 | 1982-09-03 | Ruesch Gmbh & Co Kg Willy | Instrument medical pour introduction dans les canaux physiologiques |
| US4644936A (en) * | 1982-11-19 | 1987-02-24 | Iabp | Percutaneous intra-aortic balloon and method for using same |
| EP0609914A2 (fr) * | 1986-01-31 | 1994-08-10 | Werner Mohl, M.D. | Occlusion par pression intermittente du sinus coronaire |
| EP0286359A2 (fr) * | 1987-04-10 | 1988-10-12 | Cardiometrics, Inc. | Appareil, système et méthode de mesure du flux sanguin volumétrique dans un vaisseau |
| US5084060A (en) * | 1989-02-15 | 1992-01-28 | Freund Precision, Inc. | Apparatus for enlarging a vessel or clearing obstructive tissue from a vessel according to vessel compliance |
| US5460609A (en) * | 1993-11-22 | 1995-10-24 | Advanced Cardiovascular Systems, Inc. | Electromechanical inflation/deflation system |
| WO1995028974A1 (fr) * | 1994-04-22 | 1995-11-02 | Bruno Maugeri | Dispositif de contrepulsion a ballonnet intra-aortique pour la mesure en continu du volume systolique du ventricule gauche |
Also Published As
| Publication number | Publication date |
|---|---|
| AU2003269562A1 (en) | 2003-12-02 |
| DE10222776A1 (de) | 2003-12-11 |
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