This application is based on and claims priority under 35 U.S.C. § 119, with respect to Japanese Application No. 2003-172621 filed on Jun. 17, 2003, the entire content of which is incorporated herein by reference.
This invention generally relates to a device for removing substance from a lumen. More particularly, the present invention pertains to a living body lumen washing apparatus for removing lipid encapsulated in the lumen wall to clean the inside of the living body lumen such as, for example, the removal of plaque produced in a heart blood vessel (for example in a coronary artery) to wash the blood vessel lumen.
Various types of ischemic heart diseases are known, for example a stricture of the heart caused by a stricture of a coronary artery and advanced myocardial infarction. A stricture of a blood vessel is caused by lipid produced in the blood vessel wall and plaque is produced by an increase of the lipid and a succeeding tissue reaction. Arteriosclerosis (atheroma) is then formed by accumulation of the lipid to constrict the blood vessel lumen. Heretofore, it has been considered that ischemic heart diseases originate from a stricture or occlusion of a high degree by formation of atheroma in a coronary artery.
In recent years, a relatively novel doctrine has been reported by research workers. According to this theory, some acute strictures of the heart are caused by rupture of plaque. Although several views have been presented indicating that plaque rupture is caused by inflammation or by a physical stimulus during blood vessel intratreatment, no established theory has been developed.
Plaque which is easy to rupture as generally described above is called vulnerable plaque and accumulates in the blood vessel lumen. This is, therefore, different from incrassate atheroma in that it cannot be discriminated or detected even by an angiography inspection. It is considered, however, that when vulnerable plaque ruptures, the lipid infiltrates into the blood and forms a core to start coagulation of the blood to thereby form a thrombus which occludes the blood vessel lumen to cause acute myocardial infarction to develop.
As shown in
An article entitled “The Coming of Age of Vulnerable Plaque” in the November 2000 issue of START-UP (Volume 5, Number 10, pgs 19-23) discusses the possibility of developing acute myocardial infarction from vulnerable plaque and the need for a diagnosis and treatment method.
Removing plaque such as described above in advance, and washing or otherwise cleaning the blood vessel lumen, can help prevent development of acute myocardial infarction arising from a rupture of plaque.
Also, considering living body lumen walls other than blood vessel walls, if lipid encapsulated in the lumen wall can be removed to wash the lumen wall, it may be possible to help inhibit the development of symptoms and/or inhibit expansion of the symptoms.
Generally speaking, a living body lumen washing apparatus is provided which makes it possible to remove lipid encapsulated in the lumen wall to clean the living body lumen such as, for example, by removing plaque and washing a blood vessel lumen.
According to one aspect, a living body lumen washing apparatus includes a catheter body adapted to be inserted into a living body lumen and a removing device for generating a liquid pressure in the living body lumen to remove lipid encapsulated in the lumen wall.
Liquid pressure is generated in the living body lumen by the removing device provided on the catheter body and the lipid encapsulated in the lumen wall can be removed with the living body lumen being washed.
The removing device may be formed from an agitation device which applies liquid pressure to the lumen wall. The catheter body may also a device for applying vibrational energy to the lumen wall to further facilitate or enhance the cleaning effect. In addition, the catheter body may include a wash introducer for introducing wash into the living body lumen to also facilitate or enhance the cleaning effect.
Different types of wash can be used, including a solution containing a surface-active agent or a solution containing a radiopaque contrast agent. Also, a solution containing liposomes can be used.
The catheter body may be provided with an observation device for observing the state of the lumen wall and/or the dispersion state of removed lipid. It is also possible to provide an arrangement for blocking removed lipid that is of a size sufficient to occlude the living body lumen. This can be in the form of a capturing device for capturing removed lipid of the size sufficient to occlude the lumen. Alternatively, the apparatus may comprise a mechanism for pulverizing the lipid after removed.
The apparatus can be used in connection with a living body lumen in the form of a blood vessel, with the living body lumen washing apparatus being used to wash and remove lipid encapsulated in the blood vessel wall. The liquid pressure generated by the agitation device may be a liquid pressure generated by agitation of the wash introduced into the blood vessel or by agitation of the blood.
According to another aspect, a living body lumen washing apparatus comprises a catheter body adapted to be inserted into a living body lumen having a lumen wall, with the catheter body possessing a lumen, at least one opening provided in the catheter body communicating the lumen to outside the catheter body, a rotatable shaft positioned in the lumen and extending along at least a portion of the catheter body, and a member provided on the shaft and extending outwardly from the shaft so that the member rotates together with the shaft. A motor is connected to the shaft to rotate the shaft and the member to generate liquid pressure sufficient to remove lipid encapsulated in the lumen wall.
Another aspect involves a method of removing lipid in a lumen wall of a living body lumen comprises introducing a catheter body having a lumen into the living body lumen, and generating at least one of liquid pressure and vibrational pressure in the living body lumen which acts on the lumen wall and is sufficient to rupture the lumen wall and remove lipid from the lumen wall.
The foregoing and additional features and characteristics of the present invention will become more apparent from the following detailed description considered with reference to the accompanying drawing figures in which like reference numerals designate like elements.
Generally speaking, the living body lumen washing apparatus 1 includes a catheter 2 (washing catheter) integrally provided with liquid pressure generating means or removing means for generating a liquid pressure in a blood vessel (for example in a coronary artery) to remove lipid encapsulated or located in the blood vessel wall and washing the blood vessel lumen, and a control apparatus 41 for controlling the liquid pressure generating means or removing means of the catheter 2.
More specifically, the catheter 2 includes a catheter body 3 adapted to be inserted into a blood vessel and, by way of example, an agitation device 7 serving as the removing means, with the agitating device being provided in the catheter body 3. The agitation device 7 agitates liquid, for example wash introduced into the blood vessel, to generate a liquid flow which may flow adversely or in opposition to the blood flow direction so that a liquid pressure generated by the adverse flow is applied to the blood vessel wall in order to raise the washing effect. Also, it is possible for the agitation device 7 to agitate the blood by itself, without introduction of a wash or other liquid, so that part of the blood flows adversely to or in opposition to the blood flow direction, thereby applying a liquid pressure generated by the adverse flow to the blood vessel wall. In this disclosed embodiment, a wash introducer 6 is provided for introducing wash 5 into the blood vessel to raise the washing effect.
As shown in
The rotary shaft 8 on which the screw 9 is integrally provided to form a single unit is positioned in a central lumen of the catheter body 3. Further, the wash 5 is supplied through a working lumen. In this instance, a wash introducer 6 serves as the working lumen through which the wash is supplied. One or more openings 10 are provided along the portion of the catheter body 3 corresponding to the location of the screw 9 so that the screw 9 and the open end of the working lumen are exposed through the opening(s) 10. By way of example, the catheter body 3 can be provided with two openings 10 positioned in a mutually opposing relationship to each other in a circumferential direction of the catheter body 3. That is, the two openings are located diametrically opposite one another on the catheter body.
The screw 9 is configured such that it introduces the wash 5 into a blood vessel and generates during rotation a liquid flow of the wash 5 directed in the opposite direction to the direction of blood flow. Plaque in the blood vessel wall, particularly the fibrous cap 44 (shown in
The catheter body 3 can also be provided with an observation device 13 to permit observation of the state of the blood vessel wall or a dispersion state of lipid removed from the blood vessel wall in the blood vessel, or both. The observation device 13 can be located at the distal end portion of the catheter body 3 and may be in the form of, for example, an endoscope, an ultrasonic transducer for ultrasonic image diagnosis, or the like. The observation device 13 can be connected to a monitor through the working lumen. Also it is possible to provide, based on observation information of the observation device 13, a control section for feeding back the information to the agitation device 7 serving as the removing means or liquid pressure generating means.
The wash 5 is provided for promoting the washing effect. A variety of washes can be used including, for example, a solution containing surface-active agent, a solution containing radiopaque contrast agent, a solution containing liposomes, a solution containing liposomes in which such agent is encapsulated, a saline, and a solution of two or more of the surface-active agent, radiopaque contrast agent, liposomes, micelles, liposomes encapsulating agent and saline. As preferable examples, a liquid wherein, for example, surface-active agent is contained as an agent for promoting solubilization of the thin wall section in saline or solution of contrast agent or liquid wherein, for example, a substance which forms micelles or liposomes is contained as an agent for dispersing removed lipid can be used. The surface-active agent, micelles and liposomes are agents having the oleophilic property. Representative examples of surface-active agents which are used for solubilization of the thin wall section and which can be applied here are listed in Table 1 below.
Representative Surface-Active Agents used for Solubilization of Thin Wall Section
Set forth below is a description of one example of a use in which the living body lumen washing apparatus 1 according to the embodiment described above can be applied. In this example described with reference to
The catheter body 3 is inserted into a coronary artery until the screw 9 (agitation device 7) on the distal end side of the catheter body 3 is positioned at a position generally corresponding to the location of plaque to be removed. The control apparatus 41 is activated to introduce solution containing, for example, liposomes (vesicle membranes similar to cells of a diameter from 10 nm to 10 μm made of phospholipid which forms biomembranes) 20 into the coronary artery through the working lumen forming the wash introducer 6 and to rotate the screw 9 through operation of the motor. By virtue of rotation of the screw 9, the wash 5 (i.e., the solution containing liposomes) is agitated so that it flows along a flow direction (hereinafter referred to as agitation flow) 22 by the rotation of the screw 9, with this flow direction or agitation flow being opposite to or against the direction of blood flow 21. Although the screw 9 does not contact the blood vessel wall, the fibrous cap forming plaque in the blood vessel wall is ruptured and lipid is scraped out or removed by the liquid pressure associated with the agitation flow 22 of the liposomes 20 and the wash 5. Further, because the apparatus 1 is preferably constructed and operated so that the agitation flow 22 is counter or opposite to the blood flow 21, the agitation effect of the wash is further raised or increased, thus facilitating or promoting the lipid scraping out/removing effect. The scraped out or removed lipid is taken into so-called microliposomes and granulated. After the control apparatus 41 is deactivated and the catheter body 3 is removed from the coronary artery, lipid granulated by the microliposomes 20 flows together with the blood and is processed and naturally metabolized by the hepar. In this manner, plaque produced in or present in the blood vessel wall of the coronary artery can be removed to wash the coronary artery.
The state of the blood vessel wall before the washing process can be observed using the observation device 13 (e.g., an endoscope or an ultrasonic transducer) provided at the distal end portion of the catheter body 3 to confirm the location of plaque, with the washing process being performed based on the observation information. Alternatively, or in addition, the state of the blood vessel wall during washing and the dispersion state of lipid scraped out or released into the blood vessel can be observed, with the washing process being performed based on the observation information. The washing effect can be further raised by the washing process based on the observation information.
In the above-described embodiment, the agitation device 7 in the form of the screw 9 made of a relatively soft material which generally does not have a bad influence on the living body is used as the removing means for performing removal of plaque and washing of the blood vessel wall. However, other alternatives may be employed.
Using this agitation device 7, the brush-like members 25 are rotated through operation of a motor 4 to agitate wash 5 injected into a blood vessel by way of the wash introducer 6 so that the wash 5 may flow adverse to or in opposition to the blood flow direction 21 to remove plaque. Since the brush-like members 25 are formed from bio-absorbable material, they can be absorbed by the living body in the event they fall off, thus not causing harm to the living body.
The vibrational energy application means 26 can be in the form of a vibration member 26 formed from, for example, a piezoelectric vibrator, an ultrasonic vibrator or the like. The vibration member 26 is disposed on the front side of the screw 9 (i.e., proximally of the screw) within the catheter body 3. In addition, an opening or widow 37 is provided in the portion of the catheter body 3 corresponding to the location of the vibration member 26.
In this disclosed embodiment, the vibration member 26 is brought to a position corresponding to the location of plaque 42 to be removed, and the blood and the injected wash 5 are vibrated by vibrations generated by the vibration member 26. Vibrational pressure generated by the vibrations is applied to the fibrous cap 44 of plaque 42 to be removed. The fibrous cap 44 is placed into a more readily rupturable state by the vibrational pressure and the liquid pressure generated by the agitation of the screw 9 so that lipid 43 can be scraped out or removed to thus remove plaque 42.
After plaque is removed by the agitation device as described in the various embodiments discussed above, when a comparatively large lipid mass flows together with the blood flow, the lipid mass can be introduced into the net-like member or filter 32 through the opening 33 and caught by the net-like member 32, thus blocking the lipid mass from flowing to a peripheral blood vessel.
Also, although not specifically shown together, it is possible to include as the removing means a jet injection port and a suction port in the catheter body 3 so that wash is jet-injected from the jet injection port 28, plaque is removed by the jet pressure, and removed plaque is sucked into the catheter body 3 from the suction port(s) 29.
Additionally, though not specifically shown, it is possible to use a soft sponge-like member attached to the catheter body 3 to remove plaque in a generally scraping manner to perform a washing process for the blood vessel wall. Also it is possible to otherwise use a soft fibrous member to remove plaque in a scraping manner to perform a washing process for the blood vessel wall.
In the embodiments described above, the embodiments of the living body lumen washing apparatus are applied to remove plaque in a coronary artery and wash the blood vessel wall. However, the apparatus can be applied also to the removal of lipid encapsulated in the lumen wall in any other living body lumen than the blood vessels and washing of the inside of the lumen.
By inserting the catheter body 3 into a living body lumen and generating a liquid pressure by the removing means provided in the catheter body 3, lipid encapsulated in the lumen wall can be removed to wash the inside of the lumen. In other words, a new treatment method can be employed by which the development and prevention of expansion of the symptom can be realized by the living body lumen washing apparatus
Using the removing means in the form of the agitating device, liquid pressure sufficient to rupture or more easily rupture the thin wall portion covering the lipid can be applied to the lumen wall without substantially damaging the lumen wall.
Using the vibrational energy application means for applying vibrational energy to the lumen wall together with the removing means or agitation device, the washing effect is further raised or facilitated by the vibrational pressure associated with the vibrational energy, and the treatment involving removal of lipid and washing can be performed without substantially damaging the lumen wall.
When the wash introducer for introducing wash into the living body lumen is provided in addition to the removing means or agitation device, the washing effect is further raised or enhanced by the wash, and the treatment involving removal of lipid and washing can be performed without substantially damaging the lumen wall.
The washing effect can also be increased by using the solution containing a surface-active agent therein, a solution containing a radiopaque contrast agent therein or a solution containing liposomes therein.
Providing the observation means on the catheter body makes it possible to observe or assess the state of the lumen wall and/or the state of dispersion of the removed lipid. Thus, a portion of the lumen wall to be treated can be observed, or while the portion is observed, a lipid removing and washing process can be performed with a higher degree of certainty and the treatment can be performed better.
Using the device for blocking a piece of removed lipid that is of a size sufficient to occlude or inhibit flow through the living body lumen, a piece of lipid which has been removed but is not in a pulverized state can be blocked from moving to some other portion and occluding the lumen. Also, using the capturing means, it is possible to capture a piece(s) of lipid which has been removed but is not in a pulverized state and is generally of a size that might to occlude the lumen. Accordingly, the piece of lipid can be blocked from moving to some other portion and occluding the lumen.
Where apparatus is provided with the pulverizing means for pulverizing removed lipid, lipid of a size generally sufficient to occlude a lumen is blocked from moving to some other portion and occluding the lumen.
Finally, using the living body lumen washing apparatus to remove vulnerable plaque produced or present in the blood vessel wall and perform a washing process for the blood vessel lumen, it is possible to reduce the possibility of an acute stricture of the heart.
The principles, preferred embodiments and modes of operation of the present invention have been described in the foregoing specification. However, the invention which is intended to be protected is not to be construed as limited to the particular embodiments described. Further, the embodiments described herein are to be regarded as illustrative rather than restrictive. Variations and changes may be made by others, and equivalents employed, without departing from the spirit of the present invention. Accordingly, it is expressly intended that all such variations, changes and equivalents which fall within the spirit and scope of the invention be embraced thereby.
Number | Date | Country | Kind |
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2003-172621 | Jun 2003 | JP | national |