|Numéro de publication||USRE42959 E1|
|Type de publication||Octroi|
|Numéro de demande||US 10/246,030|
|Date de publication||22 nov. 2011|
|Date de dépôt||17 sept. 2002|
|Date de priorité||2 déc. 1996|
|Autre référence de publication||US6120520, WO2000054660A1, WO2000054660A9|
|Numéro de publication||10246030, 246030, US RE42959 E1, US RE42959E1, US-E1-RE42959, USRE42959 E1, USRE42959E1|
|Inventeurs||Vahid Saadat, John H. Ream|
|Cessionnaire d'origine||Abbott Cardiovascular Systems Inc.|
|Exporter la citation||BiBTeX, EndNote, RefMan|
|Citations de brevets (104), Citations hors brevets (42), Référencé par (1), Classifications (39), Événements juridiques (1)|
|Liens externes: USPTO, Cession USPTO, Espacenet|
The present application is a continuation-in-part application of commonly assigned U.S. patent application Ser. No. 08/863,791, now U.S. Pat. No. 5,931,848, Ser. No. 08/863,877, now U.S. Pat. No. 5,910,150, and Ser. No. 08/863,925, now U.S. Pat. No. 5,941,839, all filed May 27, 1997.The present application is a continuation-in-part application of commonly assigned U.S. patent application Ser. No. 08/863,791, now U.S. Pat. No. 5,931,848, and Ser. No. 08/863,877, now U.S. Pat. No. 5,910,150, and Ser. No. 08/863,925, now U.S. Pat. No. 5,941,893, all filed May 27, 1997, all of which claim the benefit of the filing date of U.S. provisional patent application Ser. No. 60/032,196, filed Dec. 2, 1996.
The present invention relates to apparatus and methods for stimulating revascularization and tissue growth in an interior region of an organ or vessel, such as the heart. More particularly, the present invention provides a device that enables a clinician to stimulate a healing response, or deposit a bioactive agent at, a series of sites within in interior region of an organ or vessel to stimulate revascularization.
A leading cause of death in the United States today is coronary artery disease, in which atherosclerotic plaque causes blockages in the coronary arteries, resulting in ischemia of the heart (i.e., inadequate blood flow to the myocardium). The disease manifests itself as chest pain or angina. In 1996, approximately 7 million people suffered from angina in the United States.
Coronary artery bypass grafting (CABG), in which the patient's chest is surgically opened and an obstructed artery replaced with a native artery harvested elsewhere, has been the conventional treatment for coronary artery disease for the last thirty years. Such surgery creates significant trauma to the patient, requires long recuperation times, and causes a great deal of morbidity and mortality. In addition, experience has shown that the graft becomes obstructed with time, requiring further surgery.
More recently, catheter-based therapies such as percutaneous transluminal coronary angioplasty (PTCA) and atherectomy have been developed. In PTCA, a mechanical dilatation device is disposed across an obstruction in the patient's artery and then dilated to compress the plaque lining the artery to restore patency to the vessel. Atherectomy involves using an end effector, such as a mechanical cutting device (or laser) to cut (or ablate) a passage through the blockage. Such methods have drawbacks, however, ranging from re-blockage of dilated vessels with angioplasty to catastrophic rupture or dissection of the vessel during atherectomy. Moreover, these methods may only be used for that fraction of the patient population where the blockages are few and are easily accessible. Neither technique is suitable for the treatment of diffuse atherosclerosis.
A more recent technique which holds promise for treating a larger percentage of the patient population, including those patients suffering from diffuse atherosclerosis, is referred to as transmyocardial revascularization (TMR). In this method, a series of channels are formed in the left ventricular wall of the heart. Typically, between 15 and 30 channels about 1 mm in diameter and up to 3.0 cm deep are formed with a laser in the wall of the left ventricle to perfuse the heart muscle with blood coming directly from the inside of the left ventricle, rather than traveling through the coronary arteries. Some researchers believe that the resulting channels improve perfusion of the myocardium with oxygenated blood. Apparatus and methods have been proposed to create such channels both percutaneously and intraoperatively (i e., with the chest opened).
U.S. Pat. No. 5,389,096 to Aita et al. describes a catheter-based laser apparatus for use in percutaneously forming channels extending from the endocardium into the myocardium. The catheter includes a plurality of control lines for directing the tip of the catheter. As the laser ablates the tissue during the channel forming process, the surrounding tissue necroses, resulting in fibroid scar tissue surrounding the channels. U.S. Pat. No. 5,380,316 to Aita et al. describes an intraoperative laser-based system for performing TMR.
U.S. Pat. No. 5,591,159 to Taheri describes mechanical apparatus for performing TMR comprising a catheter having an end effector formed from a plurality of spring-loaded needles. The catheter first is positioned percutaneously Within the left ventricle. A plunger is then released so that the needles are thrust into the endocardium. The needles core out small channels that extend into the myocardium as they are withdrawn. The patent suggests that the needles may he withdrawn and advanced repetitively at different locations under fluoroscopic guidance. The patent does not appear to address how tissue is ejected from the needles between the tissue-cutting steps
Although it is generally agreed that TMR benefits many patients, researchers do not agree upon the precise mechanism by which TMR provides therapeutic benefits. One theory proposes that TMR channels remain patent for long periods of time, and provide a path by which oxygenated blood perfuses the myocardium. However, relatively recent histological studies indicate that TMR channels may close within a short time following the procedure. For example, Fleischer et al., in “One-Month Histologic Response Of Transmyocardial Laser Channels With Molecular Intervention,” Ann. Soc. Thoracic Surg., 62:1051-58 (1996), evaluated histologic changes associated with laser TMR in a 1-month nonischemic porcine model, and was unable to demonstrate channel patency 28 days after TMR.
Other researchers have observed that in laser-based TMR patients, there appears to he enhanced vascularization of the tissue on the margins of the scar tissue resulting from the laser channel-forming process. It has therefore been hypothesized that the act of causing trauma to portions of the myocardium may invoke a regenerative process, that enhances the development of neovascularization and endothelialization in the tissue.
To investigate these alternative theories, researchers have studied the use of gene therapy in promoting blood vessel growth in the tissue surrounding laser TMR channels. In one study, researchers intraoperatively administered a single dose of vascular endothelial growth factor (VEGF) at the time of laser TMR. Although the study showed no significant increase in myocardial vascularity, the researchers hypothesized that a longer duration of VEGF residence may be necessary to stimulate angiogenesis.
In view of the foregoing, it would be desirable to provide apparatus and methods for stimulating revascularization and tissue growth in an interior region of an organ or vessel, such as the heart, by stimulating native revascularization and tissue growth mechanisms.
It would also be desirable to provide apparatus and methods for stimulating revascularization and tissue growth by controlling the placement and size of tissue treatment sites, thereby resulting in a controlled degree of scar tissue formation.
It would be still further desirable to provide apparatus and methods for stimulating revascularization and tissue growth by depositing a controlled amount of a bioactive agent, such as an angiogenic growth factor, at the treatment sites.
In view of the foregoing, it is an object of this invention to provide apparatus and methods for stimulating revascularization and tissue growth in an interior region of an organ or vessel, such as the heart, by stimulating native revascularization and tissue growth mechanisms.
It is another object of the present invention to provide apparatus and methods for stimulating revascularization and tissue growth by controlling the placement and size of tissue treatment sites, thereby resulting in a controlled degree of scar tissue formation.
It is a still further object of this invention to provide apparatus and methods for stimulating revascularization and tissue growth by depositing a controlled amount of a bioactive agent, such as a drug or an angiogenic growth factor, at the treatment sites.
These and other objects of the present invention are accomplished by providing apparatus having a directable end region carrying an end effector that induces trauma at a treatment site to stimulate revascularization. The apparatus may optionally include electrodes for depositing RF energy to form a controlled degree of scar tissue formation, means for depositing a controlled amount of a bioactive agent at the treatment site, or both.
Apparatus constructed in accordance with the present invention comprises a catheter having a longitudinal axis, an end region that is deflectable relative to the longitudinal axis, and a tissue piercing end effector. The end effector may optionally include an RF electrode for causing a controlled degree of necrosis at a treatment site, the capability to deposit a controlled amount of a bioactive agent at the treatment site, or both.
Methods of using the apparatus of the present invention to stimulate revascularization and/or tissue growth are also provided.
Further features of the invention, its nature and various advantages will be more apparent from the accompanying drawings and the following detailed description of the preferred embodiments, in which:
The present invention relates generally to apparatus and methods for treating a plurality of tissue sites within a vessel or organ to stimulate tissue growth and revascularization. The apparatus of the present invention comprises a catheter having an end region that may be selectively articulated to a position at an angle relative to the longitudinal axis of the catheter, including a position substantially orthogonal to the longitudinal axis.
The end region carries a tissue piercing end effector to induce trauma to stimulate native tissue repair and revascularization mechanisms. The end effector may optionally include an RF electrode to cause a controlled degree of necrosis, means for depositing a controlled amount of a bioactive agent at the treatment site, or both. The deflectable end region of the catheter provides precise control over the location of the end region, and thus, the end effector.
End region 22 includes one or more control wires 27 disposed for sliding movement within catheter 21, such as described in U.S. Pat. Nos. 5,389,073 and 5,330,466 to Imran, which are incorporated herein by reference. Application of a predetermined proximal force on control wire 27 (indicated by arrow A), deflects end region 23 a predetermined amount (shown in dotted lines in
In a preferred embodiment, wherein the end effector comprises a flexible wire having a sharpened tip, controller 26 includes a hydraulic or pneumatic piston, valve assembly and control logic for extending and retracting the end effector beyond the distal endface of end region 23 responsive to commands input at handle assembly 24 or a footpedal (not shown) Controller 26 optionally may further contain RF generator circuitry for energizing electrodes disposed on the end effector to cause a controlled degree of necrosis at the treatment site. Alternatively, or in addition, controller 26 may include a source of a bioactive agent, and means for delivering controlled amounts of the bioactive agent to the treatment site.
Referring now to
Piston 45 is enclosed within cylinder 46 for proximal and distal movement. High pressure source 47 is connected to valve 48 and pressure lines 49a and 49b; low pressure source 50 is connected to valve 51 and pressure lines 52a and 52b. Pressure lines 49a and 52a communicate with proximal volume 53a of cylinder 46, whereas pressure lines 49b and 52b communicate with distal volume 53b of cylinder 46. Valves 48 and 51 are synchronized so that when high pressure source 47 is coupled to pressure line 49a (but not 49b), low pressure source 50 is coupled to line 52b (but not 52a), thus driving piston 45 in the distal direction.
Likewise, when valve 48 couples high pressure source 47 to pressure line 49b (but not 49a), and valve 51 couples low pressure source 50 to line 52a (but not 52b), piston 45 is driven in the proximal direction. Valves 48 and 51 are coupled by wiring (not shown) to control logic 54, which actuates the valves responsive to control commands received from handle assembly 26 or a footpedal (not shown). Cylinder 46 may employ any suitable medium for moving piston 45, and may be either pneumatic or hydraulic.
Controller 26 optionally includes RF generator circuitry 55 which generates a high frequency (e.g., greater than 100 MHZ) voltage signal. RF generator circuitry 55 is coupled via suitable bushings and conductors (not shown) to electrodes 42a and 42b. Electrodes 42a and 42b may be arranged to conduct current through tissue located in contact them, in a bipolar mode, or may conduct current through the tissue and to a ground plate (not shown) in a monopolar mode. In embodiments of controller 26 where RF generator circuitry 55 is provided, control logic 54 may be programmed to energize electrodes 42a and 42b when piston 45 has attained its maximum distal stroke. Control logic 54 may energize electrodes 42a and 42b for a user selected interval to provide a controlled degree of necrosis in the tissue surrounding the treatment site created by end effector 23.
Referring now also to FIG. 6 3, when piston 45 is driven in the distal direction, end effector 23 extends beyond the distal endface of catheter 21 and pierces and extends into tissue T. End effector 23 thereby induces trauma to tissue T in the form of needle track N. If electrodes 42a and 42b and RF generator circuitry 55 are provided, control logic 55 may energize the electrodes to cause necrosis of tissue T in a region R surrounding the end effector. Control logic 54 then reverses the orientation of valves 48 and 51, thus causing end effector 23 to be retracted from tissue T and into end region 22.
Applicants expect that the trauma caused by needle track N will stimulate naturally occurring mechanisms to repair the wound at the treatment site. It is further expected that by generating a matrix of treatment sites, a network of small vessels may become established in the tissue as it heals. In addition, by providing a controlled degree of necrosis, a preselected degree of scar tissue may be induced, thus mimicking the conditions observed to induce revascularization at the margins of laser-formed TMR channels.
With respect to
Piston 64 is enclosed within a cylinder in controller 66 for proximal and distal movement. High pressure source 67 is connected to valve 68 and pressure lines 69a and 69b; low pressure source 70 is connected to valve 71 and pressure lines 72a and 72b. Pressure lines 69a and 72a communicate with proximal volume 73a of the cylinder, whereas pressure lines 69b and 72b communicate with distal volume 73b of the cylinder Valves 68 and 71 are synchronized as described hereinabove with respect to like components of
Drive shaft 62 includes a plurality of outlet ports 75 located adjacent to cone 61 and a plurality of inlet ports 76 disposed in chamber 77. Chamber 77 contains bioactive agent 80 suspended in a biocompatible high viscosity liquid or paste, and is selectively pressurized by pressure source 78. Bioactive agent 80, may comprise a drug or an angiogenic growth factor, for example, vascular endothelial growth factor (VEGF), fibroblast growth factor, type I (FGF-I) or type II (FGF-II), a gene vector, cardio myocytes, or other suitable agent for stimulating tissue growth and/or revascularization.
Inlet ports 76 and outlet ports 75 communicate with lumen 63. In accordance with one aspect of the present invention, when high pressure source 78 is actuated to pressurize chamber 77, a controlled amount of bioactive agent 80 is injected into inlet ports 76 of lumen 63. This in turn causes an equal amount of bioactive agent 80 to be expelled through outlet ports 75 of end effector 60 into the adjacent tissue. Control logic 74 preferably is programmed to actuate high pressure source 78 when piston 64 has attained its maximum distal stroke. Controller 66 may in addition include an RF generator circuitry similar to RF generator circuitry 55 of the embodiment of
With respect to
If the bioactive agent exits the ports with sufficiently high velocity, it is expected that the bioactive agent will form pockets 81 in the tissue. Alternatively, if the bioactive agent exits outlet ports 75 at lower velocity, it is expected that the bioactive agent will form a layer that coats the interior surface of needle track N. Once the bioactive agent has been deposited, control logic 74 reverses the orientation of valves 68 and 71, thus causing end effector 60 to be retracted from tissue T and into the end region of the catheter. If provided, RF electrodes 65a and 65b may be activated to cauterize tissue in the vicinity of needle track N.
As described hereinabove, applicants expect that the trauma caused by needle track N will stimulate the release of naturally tissue regenerative mechanisms to repair the wound at the treatment site. Moreover, the introduction of bioactive agent 80 along needle track N is expected to further stimulate revascularization By generating a matrix of treatment sites within which a bioactive agent has been deposited, it may be possible to promote the development of a network of small vessels that will perfuse the tissue.
Referring now to
Previously known imaging techniques, such as ultrasound, MRI scan, CT scan, or fluoroscopy, may be used to verify the location of the end region 22 within the heart. Alternatively, means may be provided in end region 22 for emitting an ultrasonic signal which is detectable using an ultrasound imaging system outside of the patient. For example, a piezo-electric transducer may be affixed to the tip of the catheter and tuned to a frequency of a color Doppler ultrasound imaging system so as to appear as a bright orange or yellow spot on the display of the ultrasound system. Yet another way to detect the location of end region 22 is by pinpointing the delay time of an EKG signal at the point of detection, using an electrode disposed in end region 22. By looking at the morphology as well as the temporal characteristics of the EKG signal, the vertical position of the catheter within the heart chamber may be determined.
Controller 26 is then actuated to cause end effector 23 to pierce and extend into the interior of left ventricular wall 206. When the end effector reaches its maximum depth, a burst of RF energy may be applied, if desired, to necrose a depth of tissue, an amount of a bioactive agent may be deposited at the treatment site, or both. Controller 26 then withdraws end effector 23 from the tissue.
As shown in
The foregoing methods enable a matrix of channels to be formed illustratively in the left ventricular wall. It will of course be understood that the same steps may be performed in mirror image to produce a series of needle tracks in the septal region. It is believed that the needle tracks may have a beneficial effect if formed anywhere on the walls of the heart chamber, including the septum, apex and left ventricular wall; the above-described apparatus provides this capability
In addition, a stabilization assembly may be employed, for example, as described in copending, commonly assigned U.S. patent application Ser. No. 08/863,877, filed May 27, 1997, to counteract any reaction forces generated by operation of end effector 23.
As will of course be apparent to one of skill in designing catheter-based systems, controller 130 may optionally include either the RF generator circuitry and electrodes of the embodiment of
Referring now to
With respect to
With respect to
In accordance with one aspect of the present invention, pellets 170 comprise a bioactive agent, as described hereinabove, disposed in a biodegradable binder, such as polycaprolactone or polylactic acid. Pellets 170 are sized to advance through lumen 168 freely and without bunching, so that when posh rod is retracted in the proximal direction past the proximal edge of passageway 169, a single pellet 170 passes into lumen 166 of tube 161. While pellets 170 are illustrative spherical, it is to be understood that the bioactive agent may be readily formed into any of a number of other shapes, such as rods, cones, granules, etc., and that the above-described delivery system may be readily adapted to such other pelletized forms.
Referring now to
Push rod 165 then is retracted in the proximal direction, so that distal endface 171 is positioned proximally of the proximal edge of passageway 169. This in turn permits a single pellet 170 to advance through passageway 169 into lumen 166, as shown in
Push rod 165 then is driven in the distal direction, urging pellet 170 to the end of needle track N, as illustrated in
While preferred illustrative embodiments of the invention are described above, it will he apparent to one skilled in the art that various changes and modifications may be made therein without departing from the invention, and the appended claims are intended to cover all such changes and modifications that fall within the true spirit and scope of the invention.
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|Brevet citant||Date de dépôt||Date de publication||Déposant||Titre|
|US20100234873 *||27 oct. 2008||16 sept. 2010||Yoshitaka Nagano||Drive device, and medical apparatus and training apparatus including the same|
|Classification aux États-Unis||606/7, 604/30|
|Classification internationale||A61B17/22, A61N5/06, A61B17/00, A61B18/14, A61B18/12, A61B17/03, A61B17/34|
|Classification coopérative||A61B2017/00247, A61M37/0069, A61B2017/003, A61B17/3478, A61B2018/00291, A61B2018/00196, A61B2017/00398, A61B2019/5278, A61B2018/00267, A61B2018/00208, A61B2018/00279, A61B2017/00106, A61B19/5225, A61B8/0841, A61B2218/002, A61B2018/1861, A61B2218/007, A61B2018/1437, A61B19/5244, A61B2017/00022, A61B2018/1435, A61B2018/00839, A61B2018/00761, A61B18/1492, A61B2018/00738, A61B2018/00392, A61B2018/00916, A61B2017/00026|
|Classification européenne||A61M37/00P, A61B18/14V|
|21 oct. 2010||AS||Assignment|
Effective date: 20070214
Owner name: ABBOTT CARDIOVASCULAR SYSTEMS INC., CALIFORNIA
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