Source: http://www.google.com/patents/US7147633?dq=7,172,682
Timestamp: 2013-12-10 05:26:58
Document Index: 369011694

Matched Legal Cases: ['Application No. 60', 'Application No. 60', 'Application No. 60', 'Application No. 2', 'Application No. 60', 'art 800', 'art 800', 'art 800', 'art 800']

Patent US7147633 - Method and apparatus for treatment of atrial fibrillation - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Advanced Patent Search | Sign inAdvanced Patent SearchPatentsMethods and apparatus of embodiments of the invention are adapted to treat tissue inside a patient's body. Aspects of the invention can be used in a wide variety of applications, but certain embodiments provide minimally invasive alternatives for treating atrial fibrillation by delivering a tissue-damaging...http://www.google.com/patents/US7147633?utm_source=gb-gplus-sharePatent US7147633 - Method and apparatus for treatment of atrial fibrillationPublication numberUS7147633 B2Publication typeGrantApplication numberUS 10/099,528Publication dateDec 12, 2006Filing dateMar 14, 2002Priority dateJun 2, 1999Fee statusPaidAlso published asUS8187251, US20020183738, US20070055230, US20120238996Publication number099528, 10099528, US 7147633 B2, US 7147633B2, US-B2-7147633, US7147633 B2, US7147633B2InventorsU. Hiram Chee, Richard L. Mueller, James R. Kermode, Curtis P. Tom, Douglas Murphy-ChutorianOriginal AssigneeBoston Scientific Scimed, Inc.Export CitationBiBTeX, EndNote, RefManPatent Citations (103), Non-Patent Citations (19), Referenced by (9), Classifications (35), Legal Events (6) External Links: USPTO, USPTO Assignment, EspacenetMethod and apparatus for treatment of atrial fibrillationUS 7147633 B2Abstract Methods and apparatus of embodiments of the invention are adapted to treat tissue inside a patient's body. Aspects of the invention can be used in a wide variety of applications, but certain embodiments provide minimally invasive alternatives for treating atrial fibrillation by delivering a tissue-damaging agent to selected areas of the heart. One exemplary embodiment of the invention provides a method of treating cardiac arrhythmia. This method includes positioning a distal tissue-contacting portion of a body in surface contact with a tissue surface of cardiac tissue; detecting the surface contact between the tissue-contacting portion and the tissue surface; and thereafter, injecting a tissue-ablating agent into the cardiac tissue through the tissue-contacting portion of the body.
9. The medical device of claim 8 wherein the pressure control is operable to establish an elevated delivery pressure of about 600�2000 psi.
19. The medical device of claim 17 wherein the pressure control is operable to establish an elevated delivery pressure of about 600�2000 psi.
CROSS-REFERENCE TO RELATED APPLICATION(S) This application claims priority from the following U.S. patent applications, each of which is incorporated herein by reference in its entirety: U.S. Provisional Patent Application 60/137,265, filed Jun. 2, 1999; U.S. patent application Ser. No. 09/585,983, titled �Devices and Methods for Delivering a Drug� filed Jun. 2, 2000; International Application No. PCT/US00/15386, titled �Devices and Methods for Delivering a Drug� filed Jun. 2, 2000 (which was published in English 7 Dec. 2000 as International Publication No. WO 00/72908); U.S. Provisional Patent Application No. 60/275,923, titled �Sensor Device and Apparatus for Affecting a Body Tissue at an Internal Target Region� filed Mar. 14, 2001; U.S. Provisional Patent Application No. 60/327,053, titled �Method and Apparatus for Guided Interventional Procedures� filed Oct. 3, 2001; and U.S. Provisional Patent Application No. 60/340,980, titled �Method and Apparatus for Treatment of Atrial Fibrillation� filed Dec. 7, 2001.
TECHNICAL FIELD Embodiments of the invention relate generally to medical procedures and interventional medical devices that can be used to treat cardiac arrhythmias and other conditions. Many of these embodiments have particular utility in treating atrial fibrillation.
BACKGROUND A wide variety of diseases and maladies can be treated by surgical intervention. Increasingly, however, less invasive procedures are sought to achieve similar objectives while reducing risks and recovery time associated with more traditional surgical approaches. For example, a variety of thoracic surgical procedures, such as treatment of aortic aneurysms and arterial stenosis, were traditionally performed via a gross thoracotomy. Less invasive procedures, such as balloon-expanded stents and PTCA, have been developed which avoid the need for a gross thoracotomy, requiring instead only a small incision to gain access to the thoracic cavity intravascularly or through an intercostal opening.
Atrial fibrillation may be treated with medication intended to maintain normal sinus rhythm and/or decrease ventricular response rates. Not all atrial fibrillation may be successfully managed with medication, though. A surgical approach was developed to create an electrical maze in the atrium with the intention of preventing the atria from fibrillating. Known, appropriately, as the �maze� procedure, this technique involves making atrial incisions which interrupt pathways for reentry circuits which can cause atrial fibrillation and instead direct the cardiac electrical impulse through both atria before allowing the signal to activate the ventricles. As a result, virtually the entire atrial myocardium, with the exception of the atrial appendages and the pulmonary veins, can be electrically activated. The maze procedure is very effective in reducing or eliminating atrial fibrillation. Unfortunately, the procedure is difficult to perform and has traditionally required a gross thoracotomy and cardiopulmonary bypass to permit the surgeon appropriate access to the patient's heart.
SUMMARY Embodiments of the present invention provide methods and apparatus adapted to treat tissue inside a patient's body. Some of the embodiments of the invention can be used in a wide variety of applications to treat a number of diseases or conditions. For example, embodiments of the invention can be used to accurately deliver a therapeutic agent (e.g., DNA for gene therapy) to a diseased tissue or deliver an angiogenic substance to induce angiogenesis in hypoxic tissue.
BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a diagram of an embodiment of a catheter apparatus.
FIG. 17 is an exploded view of the apparatus of FIGS. 16A�B.
FIG. 22 shows a portion of a steerable catheter positioned with its distal end adjacent a target region of an endocardial wall of a patient's left ventricle, with the catheter being adapted to maintain its distal end at such position notwithstanding �action-reaction� forces due to high-energy jets emanating therefrom that would tend to push it away from the wall.
FIGS. 28A�C are top, lateral and front views, respectively, of a tissue treatment device in accordance with still another embodiment of the invention having a flexible tissue-contacting member.
FIGS. 29�32 are top views of tissue treatment devices having tissue-contacting members in accordance with other embodiments of the invention.
FIG. 34 is a partial side view of the tissue treatment device of FIG. 33 taken along line 34�34 in FIG. 33.
FIG. 35 is a schematic cross sectional view of the tissue treatment device of FIGS. 33�34 taken along line 35�35 in FIG. 34.
DETAILED DESCRIPTION Various embodiments of the present invention provide medical devices that can be used in a wide range of applications and several methods that can be used for, among other things, treating cardiac arrhythmia. The following description provides specific details of certain embodiments of the invention illustrated in the drawings to provide a thorough understanding of those embodiments. It should be recognized, however, that the present invention can be reflected in additional embodiments and the invention may be practiced without some of the details in the following description. In the following discussion, embodiments of the invention employing tissue contact sensors are discussed first, followed by embodiments including needles, embodiments providing for needleless injection, and treatment methods in accordance with embodiments of the invention.
FIG. 3A is a diagram showing the distal end probe 22 and the tissue surface 18. The tissue surface 18 is part of a target region of cardiac tissue 34, e.g., a heart interior wall or exterior wall. A heart-wall trabecula 38 is also shown. Heart-wall trabeculae are typically about 2�3 mm in diameter and have a depth of 1.5 to 2 mm. As an example of an application, the target region can be a hypoxic region identified as lacking sufficient oxygen, presumably due to poor vascularization in the region. The therapeutic objective is to stimulate angiogenesis in the hypoxic region by introducing an angiogenic agent and/or by stimulating the tissue with an angiogenic injury. The tissue surface 18 in this example may comprise part of a heart chamber wall. The heart chamber may be filled with blood in contact with the tissue surface 18. A second example is the injection of cells for tissue regeneration in an infarcted region of the heart. In accordance with another embodiment useful in treating cardiac arrhythmia, particularly atrial fibrillation, the cardiac tissue 34 shown in FIGS. 3A�E may comprise a portion of an atrial wall. For example, the cardiac tissue 34 may be located adjacent a pulmonary vein such that forming a cardiac lesion at the site could help electrically isolate a pulmonary vein.
FIG. 3B illustrates the angle of contact a between the distal end probe 22 and the tissue surface 18. This is another component of optimal distal end probe 22 placement. The angle of contact a should be within a desired range, e.g., no more than 10��30�, with respect to an axis 40 that is normal to the tissue surface 18. Typically, as the angle a increases, the distal end probe 22 is less in contact with the tissue surface 18, and consequently the therapeutic stimulus is distributed over a wider area rather than being concentrated in the target region. If the therapeutic stimulus comprises a tissue-damaging agent for use in creating lesions to treat cardiac arrhythmia, for example, dispersing the agent over a wider or less precisely controlled area may lead to collateral tissue damage.
FIGS. 8A�8C are diagrams of an embodiment of a distal end probe 88 that facilitates a determination of the angle of contact between the probe face 92 and a tissue surface. The distal end probe 88 further facilitates a determination of a degree to which the distal end probe 88 intrudes into the tissue surface. The probe face 92 is rounded, as seen in cross-section in FIG. 8B. Annular electrodes, or sensors, 94, 96, and 98 are arranged at increasing radii about a lumen 93. Insulators 100, 102, 104, and 106 separate the electrodes 94, 96, and 98. The electrodes 94, 96, and 98 are electrically connected to connected to circuitry, such as that described with reference to the control unit 28 of FIG. 1, through conductors 108, 110, and 112. Voltages are separately applied to each of the electrodes 94, 96, and electrode 98 through the respective conductors 108, 110, and 112, creating a current flow in proportion to amount and location of contact between the electrodes and the tissue surface.
The distal end probe 116, as shown in FIG. 10B, has a rounded probe face 118 that includes the electrodes 120, 122, and 124 at distances d1, d2, and d3, respectively, from the distal end of the distal end probe 118. Each of the sections a, b, c, and d of the electrodes 120, 122, and 124 are electrically connected to circuitry, such as that described with reference to the control unit 28 of FIG. 1, through conductors. For example, the coupling 128 b is connected to the electrode section 124 b, the coupling 126 b is connected to the electrode section 120 b, and the coupling 126 a is connected to the electrode section 120 a. FIG. 11A illustrates the distal end probe 116 in contact with the tissue surface 18 such that the electrodes, or sensors, 120, 122, and 124 are partially in contact with the tissue surface 18, including partial intrusion into the tissue surface 18. FIG. 11B is an embodiment of a display with four groups of indicators. The indicators are arranged to suggest the manner in which the plurality of sensors is arranged on the distal end probe 116. The arrangement of the indicators generally corresponds to locations about the distal end probe 116. Each of the indicators is similar to exemplary indicators 122 and 124. Indicators 122 are shaded to indicate contact between the distal end probe 116 and the tissue surface 18. Indicators 124 are not shaded to indicate no contact between the distal end probe 116 and the tissue surface 18. In one embodiment, the indicators are lights, such as light emitting diodes (LEDs), and are lit when a corresponding electrode is in contact with tissue. Within each of the four groups of indicators, four indicators are in a line with a central indicator 125, indicated as lines 1. These indicators indicate the current flow through electrode sections at probe depth d1 thus indicating contact at depth d1. The four indicators in lines 2 indicate the current flow through electrode sections at depth d2. The next four indicators in lines 3 indicate the current flow through electrode sections at depth d3. The display pattern in FIG. 11B indicates that the electrode sections at all three depths at an arbitrarily designated �lower� portion of the distal end probe 116 are in contact with the tissue surface, as shown by the shaded indicators. The inner electrode sections on two �sides� of the distal end probe 116 adjacent the lower portion are also in contact with the tissue surface. The �upper� electrode sections are not in contact with the tissue, as indicated by unshaded indicators. This display reflects the contact situation shown in FIG. 11A.
In FIG. 12A, the distal end probe 130 is in a deployment configuration with the needle 134 in a retracted position wherein the distal end of the needle is received within the lumen 132 of the distal end probe 130. The needle 134 may be axially slidable in the lumen 132 of the distal end probe 130. An operator may control movement of the needle 134 along the lumen 132 manually, under control of a control unit (28 in FIG. 1), or through any other means known in the art. FIG. 12B shows the distal end probe 130 in a treatment configuration with the needle 134 advanced distally into an extended position. In one embodiment, the needle 134 may be advanced after the sensors 136�140 detect surface contact with a patient's tissue. This will advance the needle 134 into the tissue, facilitating delivery of a therapeutic stimulus, e.g., injection of a tissue-damaging agent to create a cardiac lesion in treating atrial fibrillation.
FIGS. 12�14 illustrate embodiments employing a single needle. It should be understood that the invention may be practiced with a plurality of needles. The needles may communicate with a common reservoir of injectate, or may be used to deliver different injectates. If the needles are retractable during deployment, they may be deployed individually or with a common deployment mechanism. If multiple needles are employed, they need not all be oriented for deployment distally from a distal end of the injectate delivery device. For example, they may be spaced along a length of an elongate tissue-contacting member (e.g., member 434 of FIG. 29 or member 454 of FIG. 30) adapted to position the needles in close proximity to the surface of the target tissue prior to deployment.
The catheter assembly 212 of FIG. 15 includes a hand unit 214 attached to a steerable catheter shaft or jacket 216 having a controllably deflectable distal-end portion, as at 216 a. Steering of the catheter assembly can be accomplished in a variety of ways. For example, the catheter assembly can include steering components like those disclosed in U.S. Pat. No. 5,876,373, entitled �Steerable Catheter,� to Giba et al.; and/or in U.S. Pat. No. 6,182,444, entitled, �Drug Delivery Module,� to Glines et al.; and/or in published European Patent Application No. EP 0 908 194 A2; each of which is incorporated entirely herein by reference. In one exemplary arrangement, a conventional pull wire (not shown) is secured at a distal tip of the jacket and extends through a wire-guide channel, formed longitudinally through a sidewall of the jacket, to the hand unit, whereat the wire's proximal end is coupled to a deflection or steering actuator assembly. Rotation of a deflection knob, such as 220, which is threadedly mounted along a forward end of the hand unit, causes the pull wire to be pulled backward, and/or the jacket to be pushed forward, relative to one another, thereby inducing deflection of the distal end of the jacket. Rather than running the pull wire through a channel extending through a sidewall of the jacket, another embodiment provides the pull wire extending longitudinally along an interior sidewall of the jacket. An advantage of the steerable catheter embodiment of the present embodiment over Giba's steerable catheter is the omission of the third inner tool, housed within the second, steerable catheter of Giba. Embodiments of the present invention provide for a unified structure of the tool and steerable catheter making the device simpler, more easily operated, and less costly to manufacture than Giba's triaxial, or coaxial arrangement. Another embodiment of the invention provides for a single catheter unified system where the jet device is integrated into a steerable catheter and omitting the outer, non-steering sheath catheter of Giba, discussed above. Alternatively, the inner tool or fiber optic of Giba may be omitted resulting in a steerable catheter slidably housed within an outer sheath. Other navigation mechanisms and arrangements, suitable for use herein, will be apparent to those skilled in the art. For example, the catheter shaft or jacket can be configured with a fixed shape (e.g., a bend) at its distal end to facilitate navigation as described in application Ser. No. 08/646,856 by Payne filed May 8, 1996, entirely incorporated by reference herein. Another embodiment of the present invention provides for an arrangement that includes a dual steering mechanism where both the inner and outer catheter are steerable with either or both catheters steering as a result of either or both having a pull wire or a pre-shaped member. FIG. 25 illustrates a double steerable catheter device 1100, having a first outer steerable catheter 1102 slidably housing a second inner catheter 1104 having a jet discharge tip 1106 located on its distal end 1108.
Visualization enhancement aids, including but not limited to radiopaque markers, tantalum and/or platinum bands, foils, and/or strips may be placed on the various components of the catheter assembly, including on the deflectable end portion 216 a of catheter jacket 216. In one embodiment, for example, a radiopaque marker (not shown) made of platinum or other suitable radiopaque material is disposed adjacent the distal tip for visualization via fluoroscopy or other methods. In addition, or as an alternative, one or more ultrasonic transducers can be mounted on the catheter jacket at or near its distal tip to assist in determining its location and/or placement (e.g., degree of perpendicularity) with respect to a selected tissue in a subject, as well as to sense proximity with, and/or wall thickness of, the tissue. Ultrasonic transducer assemblies, and methods of using the same, are disclosed, for example, in published Canadian Patent Application No. 2,236,958, entitled, �Ultrasound Device for Axial Ranging,� to Zanelli et al., and in U.S. Pat. No. 6,024,703, entitled, �Ultrasound Device for Axial Ranging,� to Zanelli et al., each of which is incorporated entirely herein by reference. In one embodiment, for example, two transducers are angle mounted at the distal tip of the catheter shaft in the axis or plane of pull-wire deflection. This construction permits an operator to determine, by comparing signal strength, whether the catheter tip region is perpendicular to a selected tissue surface or wall. Additionally, this two-transducer arrangement provides an operator with information useful for determining an appropriate adjustment direction for improving perpendicularity, as compared to single-transducer arrangements that, while capable of indicating perpendicularity by signal strength amplitude, are generally incapable of indicating a suitable direction in which to move the tip to improve perpendicularity. In a related embodiment, third and fourth transducers (not shown) are added, off of the deflection axis, to aid an operator with rotational movement and rotational perpendicularity in the non-deflecting plane of the subject tissue surface. Additional details of the just-described embodiment are provided in co-pending U.S. patent application Ser. No. 09/566,196, filed May 5, 2000, entitled, �Apparatus and Method for Delivering Therapeutic and Diagnostic Agents,� to R. Mueller; incorporated entirely herein by reference. Ultrasonic transducers may, preferably, be substituted with one or more force contact transducers as described in U.S. Provisional Patent Application No. 60/191,610, filed Mar. 23, 2000 by Tom, entirely incorporated by reference herein.
With respect to hand held, open surgery devices, it is often important to insure that proper contact force is created between the device and a target tissue before discharging the device. Otherwise, the device may inadvertently discharge as it is manipulated towards a target tissue, or it may, in the case where too much force is applied, cause perforation of a tissue that is thinned out as a result of distention caused by excessive force. A force sensing interlock may be incorporated into the invention thus only permitting discharge when such force is within a certain range, both minimally and maximally. For example, ultrasound transducers, force contact transducers, and mechanical interlocks having a minimal and maximal limit. Consequently, hand held needleless hypodermic injector devices, such as those described in U.S. Pat. Nos. 3,057,349, 3,859,996, 4,266,541, 4,680,027, 5,782,802, each entirely incorporated by reference herein, lacking interlocks altogether, or only providing interlocks that activate at a minimum threshold force, without regard to a maximum force limit, are often inadequate. These handheld needleless injectors are further limited in that their structure is not amenable for use inside of a patient cavity created by open surgery, thoroscopic or other �portal� procedures. For example, each of those disclosures provides for a snub nosed hand-held gun for use against a patient's skin, typically a shoulder region of a human. The present invention provides for an elongated jacket portion of the tool to facilitate reaching inside a remote region of the patient. The tool distal end may further be angled or bent, either fixedly, or by bending on demand, or by remote steering of the distal region of the tool. FIG. 26 illustrates an open surgical tool where device 1200 has an elongated jacket portion 1202 having a bend portion 1204, ending in jet tip 1206 located at distal end 1212 which is where liquid is ejected when actuator 1208 is compressed thereby causing a liquid reservoir located around 1210 to deliver fluid to tip 1206 through a fluid conduit not shown.
Internal to the jacket is one or more lumens, extending between the jacket's distal and proximal ends. The lumens serve as passages through which one or more selected agents can pass en route to a selected tissue or organ. In the arrangement of FIGS. 16A�B and 17, for example, a single lumen, denoted as 222, extends longitudinally through jacket 216. In another embodiment, shown in FIG. 18, a plurality of elongate tubes, such as 224 a�d, extend through a primary lumen 222 defined by the jacket 216. In this latter embodiment, each of the tubes includes an internal longitudinal conduit or channel, defining a respective sub-lumen or delivery lumen through which one or more agents can pass. Advantageously, this configuration reduces the dead volume in the system. Also, the �on/off� response is optimized, and the pressure limit requirement for the conduit can be readily met.
Catheter jacket 216 terminates at a distal-end face, indicated generally at 226, defining one or more narrow outlet ports or orifices, such as 228 a�d (FIG. 17). Face 226 is configured with a relatively broad distal surface region of sufficient area to accommodate a desired number of outlet ports such that each port can be placed against, or very close to (e.g., within about 5 mm, and preferably within about 2 mm), a selected wall or surface region of a target body organ or tissue. Accordingly, one embodiment provides the distal-end face as a generally blunt structure with a broad distal surface. For example, in FIGS. 16�18, a cylindrical plate 232 defines the distal-end face, with the plate having a distal surface that is substantially planar. Alternatively, the distal surface can be somewhat curved (e.g., convex). One or more bores extend through the plate, between its proximal and distal broad surfaces, defining outlet ports for the passage of selected agents.
The plate 232 can be secured along the distal-end region of the jacket 216 in any suitable manner. In one embodiment, for example, the plate is attached directly to the distal tip of the jacket, or in a counterbore formed from the distal tip. Another embodiment, shown in FIGS. 16�18, contemplates the use of an intermediate adapter plug or cap, denoted as 234, having a proximal end configured to fit snugly over the outer circumference of a distal-end region of jacket 216. The distal portion of the adapter cap 234 includes an annular counterbore, or stepped region, configured to receive a peripheral region of the plate 232. Adapter cap 234 can be formed of a suitable plastic material, such as polyethylene or nylon, or of a metallic material such as stainless steel, and bonded to the jacket by heat sealing and/or a conventional adhesive, or other bonding means. The outlet port(s) can be formed, for example, by laser boring, photochemical machining, or other suitable technique; or the plate and bores can be formed together as a molded component.
With further regard to the outlet ports, each is adapted for communication with one or more of the agent-delivery lumens extending through the jacket. In a preferred embodiment, there are from about 1�12 outlet ports (e.g., four, in the illustrated arrangement), each having a diameter of no greater than about 0.025″; and preferably within a range of from about 0.00025″ to about 0.020″ (e.g., 0.006″). The size and orientation of each outlet port serves to direct agents passed through the catheter lumen(s) in an axial direction, or at an angle no greater than about 35 degrees off axis (i.e., relative to the catheter's longitudinal axis at its distal-end region), in the form of a narrow jet or stream. Axially directed jets or streams can help to maximize penetration depth, while angled jets or streams can help to increase the treated area/volume of tissue. Axially directed jets are illustrated in FIG. 16B, wherein four outlet ports are configured to direct an agent passed through lumen 222 (indicated by the large, darkened arrow) axially into a selected tissue 228 as four separate jets or streams (indicated by the four smaller, substantially parallel arrows).
The outlet ports can be configured to achieve desired jet or spray patterns by modifying, for example, the port diameter, length and/or internal shape. The pressure at the port can also be adjusted to influence the patterns. Injection streams can be further modified with secondary injection of additional drug, or a compatible gas, such as CO2 and/or other absorbable gas. Such a gas can be a good accelerator. In addition, a pulsed injection pattern can be employed to capitalize on tissue recoil effects. In these regards, attention is directed to FIG. 20A which shows an exemplary agent-delivery port 268 and a secondary drug or gas port 272 that meets the delivery port 268 at an angle. Also depicted are several exemplary jet or spray patterns, denoted as �A,� �B� and �C.� Pattern �A� (FIG. 20B) can be achieved by passing an agent through port 268 under pressure, without the use of a secondary port. Pattern �A� is modified to that of pattern �B� (FIG. 20C) by additionally passing an agent or gas through secondary port 272. Pattern �C� (FIG. 20D) is a pulsed spray pattern that can be used to take advantage of tissue recoil effects. This pattern can be achieved by passing an agent through port 268 as rapid, controlled bursts, without the use of a secondary port.
FIGS. 23A�D are partial side views of the apparatus of FIG. 18 as it is placed near a tissue T, such as cardiac tissue (FIG. 23A); urged against the tissue T (FIG. 23B), thus creating a contact force between the device and the tissue T, the application of hydraulic force causing ejection of a fluid stream from each outlet port thus propelling the fluid into the tissue T (FIG. 23C); and the removal of hydraulic force and the retention of fluid by the tissue T within pockets created by hydraulic erosion (FIG. 23D).
Employing a needleless injection system such as that shown in FIGS. 16�19 can reduce the tissue damage often associated with the use of needles. Nevertheless, it should be noted that in certain circumstances a limited amount of tissue damage at or about the injection site may be desirable. For example, where angiogenic agents are being delivered, tissue injury can be beneficial in creating an environment where the action of such agents is enhanced. Likewise, when creating a lesion in cardiac tissue to treat atrial fibrillation, damaging the tissue during the process of injection may enhance lesion formation by the agent being injected. Thus, it will sometimes be desired to configure the outlet ports to produce jet or spray patterns appropriate for effecting a desired amount of tissue damage over a selected area.
In addition to the lumen arrangements described above with respect to FIGS. 16�18, the present invention further contemplates an assembly including one or more elongate tubular elements that can be removably received within a primary lumen defined by an outer elongate sleeve. Each removable tubular element, in this embodiment, defines a sub-lumen or delivery lumen through which one or more selected agents can pass, and includes a distal-end face defining one or more respective outlet ports. Preferably, each tubular element is adapted to slide longitudinally through the primary lumen of the elongate sleeve for placement therein and removal therefrom, as desired.
Another embodiment provides such a tubular element extending side-by-side with a guidewire lumen from a proximal to a distal end of an elongate sleeve. In still a further embodiment, such a tubular element is incorporated in a rapid-exchange external-guidewire apparatus. In an exemplary construction of the latter, the tubular element extends longitudinally from a proximal to a distal end of the elongate sleeve, and runs side-by-side with a guidewire lumen along a distal region (e.g., about 3�5 mm) of the sleeve. For example, the present invention can be incorporated in a rapid-exchange apparatus substantially as taught in U.S. Pat. No. 5,061,273, which is incorporated entirely herein by reference. In yet a further embodiment, such a tubular element is adapted to be removed from a lumen extending longitudinally through the sleeve and replaced with a guidewire for facilitating catheter advancement across an anatomical structure such as a heart valve.
An agent reservoir can be utilized for holding a selected therapeutic and/or diagnostic agent until delivery. The reservoir can be of any suitable type. In one exemplary construction, the reservoir is configured to hold a fluidic agent (e.g., in liquid form) for introduction, using a substantially closed system, into an agent-delivery lumen of the jacket. For example, the agent can be held within a chamber provided inside the catheter jacket, or it can be introduced from an external reservoir (shown schematically as reservoir 221 in FIG. 15), such as a syringe or bag, via a conventional introduction port located along the hand unit or along a proximal region of the jacket. In one embodiment, the hand unit is provided with a fixed internal reservoir for holding a supply of a selected agent to be dispensed. In this embodiment, a supply reservoir, such as a syringe, can communicate with the internal reservoir via a connector provided in the hand unit's outer housing. The connector is preferably a substantially sterile connector, such as a standard Luer-type fitting or other known standard or proprietary connector. In another embodiment, the supply reservoir comprises a syringe, pre-loaded with a selected agent, that can be removably fit into a holding area inside the housing of the hand unit, as taught, for example, in U.S. Pat. No. 6,183,444, entitled, �Drug Delivery Module,� to Glines et al, incorporated entirely herein by reference.
The depth to which each jet penetrates the tissue being treated may depend, at least in part, on the pressure at which the fluid is delivered through the outlet ports and the length of time during which fluid is delivered. In one embodiment, the operating parameters are selected such that the jets penetrate to a tissue depth of at least about 2�10 mm, e.g., about 5 mm. The injection may be carried out over a time period of about 1�15 seconds. In certain embodiments, suitable fluid delivery pressures, i.e., the fluid pressure adjacent the outlet ports, may be about 20�4,500 psi. Lower delivery pressures (e.g., 100 psi or less) may be useful in introducing low viscosity materials in a more superficial portion (e.g., less than 2 mm deep) of the tissue being treated. Higher delivery pressures, such as 400 psi or greater may be employed where deeper tissue penetration is desired.
In one embodiment particularly well suited for treatment of atrial fibrillation, delivery pressures are selected to permit the jets to penetrate the entire thickness of the myocardium. Delivery pressures in excess of 100 psi, more likely at least about 400 psi, may suffice; delivery pressures of about 600�2,000 psi are expected to work well. If the jets penetrate the entire thickness of the myocardium, a tissue-ablating agent may be retained throughout the entire thickness of the tissue, creating a fairly precisely positioned lesion which can extend from one surface of the tissue to the opposite tissue surface.
In another embodiment, a selected therapeutic and/or diagnostic agent is held within a distal-end region of a catheter or endoscope-type device and propelled into a target tissue or organ using a biolistic particle-delivery or bombardment assembly. In one embodiment, the biolistic assembly (e.g., a so-called �gene gun� incorporated along a distal-end region of the agent-delivery device) introduces nucleic acid-coated microparticles, such as DNA-coated metals, into a tissue at high energies. The coated particles can be propelled into the tissue using any suitable means, e.g., an explosive burst of an inert gas e.g., (helium), a mechanical impulse, a centripetal force, and/or an electrostatic force (See, e.g., U.S. Pat. No. 5,100,792 to Sanford et al.; incorporated entirely herein by reference). In an exemplary embodiment, a spark discharge between electrodes placed near the distal-end region of the catheter, proximal of a distal-end agent-holding region, is employed to vaporize a water droplet deposited therebetween, which then creates a shock wave capable of propelling the DNA-coated particles. The technique allows for the direct, intracellular delivery of DNA. The carrier particles are selected based on their availability in defined particle sizes (e.g., between about 10 and a few micrometers), as well as having a sufficiently high density to achieve the momentum required for cellular penetration. Additionally, the particles used are preferably chemically inert to reduce the likelihood of explosive oxidation of fine microprojectile powders, as well as non-reactive with DNA and other components of the precipitating mixes, and display low toxicity to target cells (See, e.g., Particle Bombardment Technology for Gene Transfer, (1994) Yang, N. ed., Oxford University Press, New York, N.Y., pages 10�11, incorporated entirely herein by reference). For example, tungsten and/or gold particle microprojectiles can be employed to achieve adequate gene transfer frequency by such direct injection techniques. Alternatively, or in addition, diamond particles, as well as glass, polystyrene and/or latex beads can be used to carry the DNA. The DNA-coated particles can be maintained in the agent-holding region by any suitable means, e.g., precipitated on the distal face of a carrier sheet suspended across a lumen at or near the distal end of the jacket. In this latter embodiment, the propulsion means propels the DNA-coated particles from a distal face of the carrier sheet into a selected target tissue or organ adjacent thereto.
It will be appreciated that, especially with regard to catheter-type delivery apparatus, an agent directed from a distal end of the apparatus with sufficiently high energy may cause such end to move away from a target tissue wall or surface. FIG. 22, for example, shows a portion of a steerable catheter 292 having a distal end positioned adjacent a target region of an endocardial wall 228 of a patient's left ventricle 294. Arrows �A� and �B� depict an �action-reaction� phenomenon, with (i) arrow �A� representing an injection force provided by one or more high-energy fluid jets or streams directed against the wall 228, with the jet(s) carrying, for example, an angiogenic agent (e.g., �naked� DNA), and (ii) arrow �B� representing a resultant, oppositely-directed force tending to push the distal tip of the catheter away from the endocardial wall. To counter the latter, means are provided for maintaining the distal end of the catheter proximate the endocardial wall. In the illustrated embodiment, a secondary lumen 296 extends longitudinally along the catheter and terminates at a distal orifice 298, short of the catheter's distal end (e.g., by between about 1�4 cm). An elongate wire 302 is slidably received within the secondary lumen 296 and has its distal end attached to the catheter at, or near, the catheter's distal end. From a remote (proximal) location, wire 302 can be moved between a retracted position, with the distal region of the wire positioned closely adjacent the catheter (not shown), and an extended position, with a distal region of the wire extended beyond the secondary lumen's distal orifice so as to bow away from the catheter shaft (shown in FIG. 22). At such extended position, a central region of the bowed portion of the wire presses against a back wall of the ventricle, as at arrows �E,� thereby causing a distal region of the bowed portion to urge the catheter's distal end toward the target region of the endocardial wall, as indicated by arrow �C.� In another embodiment, a region of the catheter, toward its distal end, is configured with a pre-formed (normal) bend of sufficient stiffness or rigidity to maintain the distal tip of the shaft proximate the target region of the endocardial wall, notwithstanding such �action-reaction� forces. For example, a reinforced external sleeve can be placed over the region �D� of the catheter shaft to impart the desired bend along such region. Alternatively, the bend along region �D� can be inducible from a remote position.
In one embodiment, wherein the agent includes DNA, controlled-release preparations are formulated through the use of polymers to complex or absorb the selected gene sequence (with or without an associated carrier, e.g., liposomes, etc.). The agents can be formulated according to known methods to prepare pharmaceutically useful compositions, whereby these materials, or their functional derivatives, are combined in admixture with a pharmaceutically acceptable carrier vehicle. Suitable vehicles and their formulation are described, for example, in Nicolau, C. et al. (Crit. Rev. Ther. Drug Carrier Syst. 6:239�271 (1989)), which is incorporated entirely herein by reference. In order to form a pharmaceutically acceptable composition suitable for effective administration, such compositions will contain an effective amount of the desired gene sequence together with a suitable amount of carrier vehicle.
FIGS. 27A and 27B illustrate a distal length of a treatment apparatus 360 in accordance with another embodiment of the invention that incorporates tissue contact sensors and needleless injection capabilities. In a manner analogous to the distal end probe 116 of FIGS. 10A�B, the treatment apparatus 360 includes a series of sensors 370 a�d, 372 a�d, and 374 a�d. These electrodes 370�374 may be arranged concentrically about the lumen 362 of the treatment apparatus 360. The distal end of the treatment apparatus is rounded to facilitate detection of the degree of penetration of the treatment apparatus 360 in a patient's tissue. Unlike the probe 116 of FIG. 10, the treatment apparatus 360 of FIGS. 27A�B includes a distribution plate 364 adjacent a distal end of the lumen 362. This distribution plate 364 may include a plurality of outlet ports 366, similar to the plate 232 and outlet ports 228 of FIGS. 16�18. The sensors 370�374 permit an operator to detect, prior to injecting an agent through the outlet ports 366, when the distal end of the treatment apparatus 360 (and hence the plate 364) is in contact with the tissue to be treated.
FIGS. 28A�C illustrate a treatment apparatus 400 in accordance with another embodiment of the invention. The treatment apparatus 400 comprises an elongate body 410, e.g., a catheter, having an elongate proximal length 412 and a tissue-contacting member 414. A distal end 416 of the body 410 may be sealed to prevent fluid delivered through the lumen of the body from exiting the distal end 416. In one embodiment, the tissue-contacting member 414 of the body 410 is relatively rigid and retains the curved shape shown in FIGS. 28A�C. The proximal length 412 and the tissue-contacting member 414 may be coplanar. In the illustrated embodiment, which is well suited for thoracic approaches to the exterior of a patient's myocardium, the proximal length 412 and tissue-contacting member 414 meet at an angle θ of about 90�. The angle θ can be varied as desired, with a suitable range depending on the nature of the procedure for which the apparatus 400 is employed and the manner in which the targeted tissue is approached.
If so desired, at least a portion of the length of the tissue-contacting member 414 of the body 410 may be flexible, permitting it to deform from the rest configuration. For example, the tissue-contacting member 414 may be deformed to pass through a steerable outer sleeve (e.g., sleeve 340 in FIG. 24) or an intercostally positioned guide canula, then resiliently assume the curved rest configuration shown in FIGS. 28A�C. The rest configuration of the tissue-contacting member 414 may be selected as desired to permit it to conform to a surface of the tissue to be treated. For example, the shape shown in FIGS. 28A�C may be adapted to encircle a portion of a junction between a patient's myocardium and a pulmonary vein.
A plurality of outlet ports 420 a�e are arranged along a tissue-contacting inner surface of the tissue-contacting member 414. Each of these outlet ports 420 a�e may be in fluid communication with the lumen of the body 410 so pressurized jets of fluid (shown schematically by arrows in FIG. 28A) can be directed toward tissue in contact with the tissue-contacting surface 422.
The tissue-contacting member 414 may include a plurality of sensors or electrodes 425 adapted to detect surface contact between the tissue-contacting surface 422 of the body 410 and a surface of tissue to be treated. In many of the embodiments noted above, the sensors (e.g., sensors 94�98 of FIGS. 8A�B) are carried at a distal tip of the apparatus. In the embodiment of FIGS. 28A�C, though, the sensors are spaced along the tissue-contacting surface 422, with one electrode pair 420 a�d between each pair of adjacent outlet ports 420 a�e. By connecting the sensors 425 to an appropriate control system (e.g., control system 28 in FIG. 1), the areas of the tissue-contacting surface 422 in contact with tissue can be detected and displayed in a suitable display (e.g., display 32 in FIG. 1).
FIGS. 29�32 illustrate alternative embodiments employing differently shaped tissue-contacting members. The body 430 of FIG. 29 includes a proximal length 432 and a tissue-contacting member 434 with a generally straight tissue-contacting surface 436. A plurality of outlet ports 440 a�d are spaced along the tissue-contacting surface 436 and a sensor 442 a�c or a sensor pair (not shown) may be positioned between each adjacent pair of outlet ports 440.
The body 450 of FIG. 30 includes a proximal length 452 and a tissue-contacting member 454 with a generally concave tissue-contacting surface 456. This tissue-contacting member 454 is similar to the tissue-contacting member 414 of FIGS. 28A�C, but the proximal and tissue-contacting members 452 and 454 are substantially coplanar rather than meeting at an angle θ as in FIGS. 28A�C. A plurality of outlet ports 458 are spaced along the tissue-contacting surface 456 and a sensor 459 may be positioned between each adjacent pair of outlet ports 458.
In FIG. 31, the body 460 includes a proximal length 462 and a tissue-contacting member 464 with an arcuate, generally concave tissue-contacting surface 466. The tissue-contacting member 464 of FIG. 31 is similar to the tissue-contacting member 454 of FIG. 30, but extends through a longer arc. A series of outlet ports 468 a�g are spaced along the tissue-contacting surface 466. Three sensors 469 a�c are spaced from one another along the tissue-contacting surface 466.
FIGS. 33�35 illustrate a tissue treatment apparatus 500 in accordance with another embodiment of the invention. The tissue treatment apparatus 500 generally includes a tissue grasping member 510 and at least one fluid delivery conduit 520. The tissue grasping member shown in FIG. 33 takes the general form of a pair of medical pliers or a medical clamp. The tissue grasping member 510 may include a pair of grasping actuators 512 a�b which are pivotally connected to one another. The distal length 514 of each of the grasping actuators 512 a�b is adapted to contact tissue and is desirably formed of a biocompatible material, e.g., stainless steel. Hence, the grasping actuator 512 a has a tissue contacting member 514 a and the other grasping actuator 512 b has a tissue contacting member 514 b. As best seen in FIGS. 34 and 35, the tissue contacting member 514 a includes a tissue-contacting face 516 and a recess 518. The recess 518 may take any desired shape. In the illustrated embodiment, the recess 518 comprises a generally U-shaped channel which extends along a center line of the tissue contacting member 514 a. This bisects the face 516 into two tissue-contacting surfaces separated by a gap. The gap may be thought of as a plane extending between the two tissue-contacting surfaces.
The tissue grasping member 510 is adapted to carry at least one fluid delivery conduit 520 for delivering a fluid to treat a patient's tissue. In the illustrated embodiment, the tissue treatment apparatus 500 includes two fluid delivery conduits 520 a�b. The first fluid delivery conduit 520 a is associated with the first tissue contacting member 514 a and the second fluid delivery conduit 520 b is associated with the second tissue contacting member 514 b. The fluid delivery conduits 520 a�b are in fluid communication with a fluid reservoir (not shown in FIG. 33 for purposes of simplicity). The two conduits 520 a�b can be separately connected to the reservoir. Alternatively, the two conduits can be joined proximally of the tissue contacting members 514 and communicate with the fluid reservoir through a common conduit (not shown). In another embodiment, only one of the tissue contacting members 514 a�b includes a fluid delivery conduit 520. The other tissue contacting member 514 may simply be used to position tissue against the tissue-contacting face 516 of the member 514 carrying the fluid delivery conduit for treatment, as described below. If one of the tissue contacting members 514 does omit a fluid deliver conduit 520, that tissue contacting member 514 may have a flat tissue-contacting face 516 without a recess 518 to receive the conduit 520.
The two tissue contacting members 514 a�b are placed on opposite sides of the pulmonary vein 542. The grasping actuators 512 a�b are moved toward one another to bring the tissue-contacting faces 516 of the tissue contacting members 514 a�b against the target tissue 544 of the pulmonary vein 542. In particular, the two opposed tissue contacting members 514 are in contact with the target tissue 544 on opposite sides of the pulmonary vein 542. The fluid delivery ports 524 of each of the fluid delivery conduits 520 are oriented inwardly for the pulmonary vein 542. In the illustrated embodiment, the fluid delivery ports 524 of each conduit 520 are oriented generally toward the other fluid delivery conduit 520.
As shown in FIG. 36, when the tissue contacting members 514 are urged against the target tissue 544, the distal length 522 of each fluid delivery conduit 520 a or 520 b is spaced a distance from the surface of the target tissue 544. A treatment fluid, e.g., a tissue ablating agent, can be delivered through the conduits 520 a�b and directed out of the ports 524 in a series of fluid jets 532. In one embodiment, the pressure of the jets is sufficient to drive fluid through the entire thickness of the wall of the pulmonary vein 542, with an excess volume of the fluid being delivered into the lumen 546 of the vein 542. In another embodiment, the pressure may be reduced to permeate only partially through the thickness of the target tissue 544. Delivering the pressurized fluid jets in this fashion permits the apparatus 500 to treat tissue along lines on opposite sides of the tissue. In the context of treating a pulmonary vein 542 with a tissue-damaging fluid, this can create lesions on opposite sides of the pulmonary vein 524 which extend through the entire thickness of both walls.
The embodiment illustrated in FIGS. 33�36, which includes a pair of opposed tissue contacting members 514 a�b, can also help ensure proper positioning of the outlet ports 524 with respect to the tissue being treated. Urging the members 514 a�b toward one another will compress the tissue. Urging the members 514 a�b against the tissue can pull the tissue more taut, reducing the tendency of the tissue to recoil under the impact of the pressurized jets 532. The force against the tissue should not be too great, though. In one embodiment, the members 514 urge the opposite sides of the pulmonary vein 542 toward one another, but not far enough to come into contact.
A fluid delivery conduit 630 may be employed to deliver a fluid to treat tissue from a reservoir (not shown in FIG. 37A) to a series of distally located ports. Although not shown in detail in FIG. 37A, the fluid delivery conduit 630 may bifurcate distally to provide a pair of distal lengths similar to the distal lengths 522 of the fluid conduits 520 a�b in the previous embodiment.
FIGS. 38A and 38B illustrate the distal grasping member 620 in greater detail. The distal grasping member 620 includes a first tissue contacting member 622 a and a second tissue contacting member 622 b which can be moved with respect one another between an open position (FIG. 38A) wherein the tissue contacting members 622 are spaced from one another and a closed position (FIG. 38B) wherein the tissue contacting members 622 are closer to one another. A first branch 632 a of the fluid delivery conduit 630 may be associated with the first tissue contacting member 622 a and a second branch 632 b of the fluid delivery conduit 630 may be associated with the second tissue contacting member 622 b. The first tissue contacting member 622 a may include a first tissue contacting face 624 a and the second tissue contacting member 622 b may include an opposed second tissue contacting face 624 b. If so desired, the tissue contacting members 622 may include a recess for receiving the associated portion of the fluid delivery conduit 630 in a fashion directly analogous to that described above in connection with FIGS. 34�36.
FIGS. 39A and 39B illustrate an alternative distal grasping member 640 that may be used in the tissue treatment apparatus 600 instead of the distal grasping member 620 shown in FIGS. 38A and 38B. The distal grasping member 640 may include a first tissue contacting member 642 a having a first tissue-contacting face 644 a and a second tissue contacting member 642 b having an opposed second tissue-contacting face 644 b. A first branch 632 a of the fluid delivery conduit (630 in FIG. 37A) may be associated with the first tissue contacting member 642 a and a second branch 632 b of the fluid delivery conduit 630 may be associated with the second tissue contacting member 642 b. The primary distinction between the distal grasping member 640 of FIGS. 39A�B and the distal grasping member 620 of FIGS. 38A�B is that the tissue contacting members 642 of FIGS. 39A�B are inwardly concave, whereas the tissue contacting members 622 of FIGS. 38A�B have a relatively straight tissue contacting face 624. As a consequence, the tissue contacting faces 624 may be generally parallel to one another in the closed orientation (FIG. 38B), defining a relatively straight gap, whereas the distal grasping member 640 has a more elliptical space between the tissue contacting faces 644 in the closed configuration (FIG. 39B).
As noted above, forming myocardial lesions to create a �maze� which helps redirect the cardiac electrical impulse can treat atrial fibrillation. In accordance which embodiments of the invention, injecting a tissue-damaging agent into the myocardium may create such lesions. The tissue-damaging agent may comprise any injectable fluid agent which, when injected alone or with another agent into cardiac tissue, will create a lasting, signal-impeding cardiac lesion suitable for the maze approach to treating atrial fibrillation. In certain embodiments, the tissue-damaging agent may comprise a tissue-ablating agent, i.e., a material that will lead to a permanent destruction of a function of the tissue, such as effectively conducting cardiac electrical impulses. The tissue-damaging agent may comprise a liquid, a gas, or both liquid and gas, such as in the embodiment discussed above in connection with FIGS. 20A�20C. For example, the tissue-damaging agent may comprises a fluid ablating agent selected from the group consisting of alcohols (e.g., ethanol), hypertonic saline (e.g., 10�25% wt./vol.), thermally-ablating agents, sclerosing agents, and necrotic antineoplastic agents. Thermally damaging agents may comprise materials that are biocompatible at or near body temperature (e.g., saline, glycerine or ethylene glycol), but are heated so far above or cooled so far below body temperature that their injection will induce permanent tissue ablation. Hot injectates which are hot enough to raise the temperature of the tissue into which it is injected to 50� C.�100� C. should suffice; cold injectates which are delivered at a temperature below 0� C., e.g., minus 0.1�5� C., are expected to work well, too. A variety of sclerosing agents are known in the art and commercially available, including ethanolamine oleate (e.g., ETHANOLIN), sodium tedradecyl sulfate (e.g., SOTRADECOL), ATHOXYSCLEROL, polyethyleneglycol-monododecylether (e.g., POLIDOCANOL), sodium morrhuate, and hypertonic saline with dextrose (e.g., SCLERODEX). Known antineoplastic agents with tissue necrotic effects include CISPLATIN, DOXORUBICIN and ADRIAMYCIN, each of which is commercially available.
The apparatus shown in FIGS. 1�40 and detailed above may be used in a variety of procedures, a number of which are outlined above. Several embodiments of the invention, however, provide methods for treating cardiac arrhythmia. While reference is made in the following discussion to specific apparatus disclosed in the drawings used to treat cardiac arrhythmia, it should be understood that this is solely for purposes of illustration and is not intended to limit the scope of the invention. In particular, devices other than those shown in the drawings or described above may be employed to carry out methods in accordance with the invention, tissues other than cardiac tissue can be treated, and fluids other than tissue ablating agents can be injected into the tissue.
As noted above, forming myocardial lesions to create a �maze� which helps redirect the cardiac electrical impulse can treat atrial fibrillation. In accordance with embodiments of the invention, injecting a tissue-damaging agent into the myocardium may create such lesions. The tissue-damaging agent may comprise any injectable fluid agent which, when injected alone or with another agent into cardiac tissue, will create a lasting, signal-impeding cardiac lesion suitable for the maze approach to treating atrial fibrillation. In certain embodiments, the tissue-damaging agent may comprise a tissue-ablating agent, i.e., a material that will lead to a permanent destruction of a function of the tissue, such as effectively conducting cardiac electrical impulses. The tissue-damaging agent may comprise a liquid, a gas, or both liquid and gas, such as in the embodiment discussed above in connection with FIGS. 20�20 c. For example, the tissue-damaging agent may comprise a fluid ablating agent selected from the group consisting of alcohols (e.g., ethanol), hypertonic saline (e.g., 10�25% wt./vol.), thermally-ablating agents, sclerosing agents, and necrotic antineoplastic agents. Thermally damaging agents may comprise materials that are biocompatible at or near body temperature (e.g., saline, glycerine or ethylene glycol), but are heated so far above or cooled so far below body temperature that their injection will induce permanent tissue ablation. Hot injectates which are hot enough to raise the temperature of the tissue into which it is injected to 50��100� C. should suffice; cold injectates which are delivered at a temperature below 0� C., e.g., minus 0.1�5� C., are expected to work well, too. A variety of sclerosing agents are known in the art and commercially available, including ethanolamine oleate (e.g., ETHAMOLIN), sodium tedradecyl sulfate (e.g., SOTRADECOL), ATHOXYSCLEROL, polyethyleneglycolmonododecylether (e.g., POLIDOCANOL), sodium morrhuate, and hypertonic saline with dextrose (e.g., SCLERODEX). Known antineoplastic agents with tissue necrotic effects include CISPLATIN, DOXORUBICIN and ANDRIAMYCIN, each of which is commercially available.
The tissue-contacting portion of the delivery device may then be brought into surface contact with the tissue surface of the patient's cardiac tissue. For example, the distal face 226 of the catheter assembly 212 (see, e.g., FIG. 18) may be brought into contact with the tissue surface T, as illustrated in FIG. 23 b. As illustrated in FIGS. 28�32, however, devices in accordance with other embodiments of the invention employ elongate tissue-contacting areas and merely urging the distal tip of the device against the tissue may not bring the intended tissue-contacting area against the tissue. For example, the body 410 of FIGS. 28A�C may be guided adjacent the heart with the tissue-contacting member 414 deflected (e.g., straightened) from its relaxed state. Once the tissue-contacting member 414 is determined to be in the desired position, the operator may allow the tissue-contacting member 414 to relax and more closely conform to the tissue surface.
For example, contact between the distal end probe 130 of FIG. 12A and the tissue surface can be can be detected using the sensors 136, 138, and 140 and monitoring the display (32 in FIG. 1) until appropriate surface contact is indicated on the display. Once appropriate surface contact is detected, the needle 134 can be advanced distally into the tissue (not shown in FIG. 12) and the agent can be injected through the needle 134. If a needleless delivery device such as that shown in FIGS. 28A�C is used, surface contact between the tissue and the tissue-contacting surface 422 can be detected using the sensors 425 and, thereafter, the agent can be injected as a series of jets from the outlet ports 420 a�e. As noted above, some embodiments of the invention well suited for treating atrial fibrillation employ pressurized jets of fluid to inject a tissue-ablating agent into the tissue. Fluid delivery pressures may be on the order of 400 psi or higher, e.g., 600�2,000 psi. By selecting pressure and other operating parameters, the jets may be adapted to penetrate 2 mm or more into the cardiac tissue. In one useful embodiment, the jets are adapted to pass through the entire thickness of the myocardium, creating a relatively focused transmural lesion, as discussed above. In such an embodiment, a quantity of the tissue-ablating agent may pass into the patient's bloodstream (for injection into the heart from an external delivery device) or into the thoracic cavity into contact with other organs or tissue (for injections from outlet ports positioned in the interior of the heart). In such embodiments, it may be advantageous to select a tissue-ablating agent that is effective to damage the cardiac tissue in which it is received, but is not overly deleterious to the patient if it enters the bloodstream, for example. For example, ethanol, hypertonic saline and hot saline may all effectively ablate cardiac tissue to create a transmural lesion, but reasonable excess fluid volumes may be introduced into the patient's bloodstream without significant adverse consequences.
By way of example only, one embodiment that has been found to function acceptably employs five spaced-apart outlet ports with diameters of about 0.004�0.008 inches. Delivering about 1 ml of ethanol at a delivery pressure of about 1000�2000 psi adjacent the outlet ports creates a transmural lesion in atrium walls having a thickness of about 3�8 mm. These operating parameters may be suitable for penetrating entirely through even thicker walls, as well.
The medical device may have a relatively small tissue-contacting surface delivering tissue to a relatively focused tissue volume (e.g., the distribution plate 364 of the treatment apparatus 330 of FIGS. 27A�B). If so, a lesion of the desired length may require a series of injections at spaced-apart locations along the tissue surface. Repeated repositioning of the device may be reduced, if not eliminated, by employing a device with an elongate tissue-contacting member, such as the embodiments of FIGS. 28�32.
Another embodiment provides a method of treating tissue which involves urging two opposed tissue-contacting members against the tissue. FIGS. 41�45 schematically illustrate selected applications of this embodiment to ablate tissue in treating cardiac arrhythmia. These drawings schematically illustrate a tissue treatment apparatus 600′ similar to that shown in FIG. 37A, but with the tissue grasping member 620 replaced with the tissue grasping member 640 shown in FIGS. 39A�B.
As shown in FIG. 41, the tissue treatment apparatus 600′ may be positioned within a thoracic cavity adjacent the heart 800. The distally positioned tissue grasping member 640 may be guided toward one of the pulmonary veins 820 a�d, e.g., pulmonary vein 820 a. Positioning the tissue grasping member 640 in an open position, wherein the tissue-contacting members 642 are oriented more away from one another than in the closed position (FIG. 39B), provides an area between the two tissue-contacting members 642 within which the pulmonary vein 820 a can be received. With the pulmonary vein 820 a received between the tissue-contacting members 642, the tissue-contacting members 642 can be moved toward one another and into engagement with a tissue surface of the pulmonary vein 820 a. Although FIG. 36 schematically illustrates use of the tissue treatment apparatus 500 of FIGS. 33�35, the arrangement of the tissue-contacting members 642 when brought into contact with the pulmonary vein 820 a may look much the same in cross-section as the arrangement shown in FIG. 36. In particular, the two tissue-contacting members 642 may contact the target tissue 544 along a plane through the target tissue, which may be thought of as a plane extending between the opposed sets of outlet ports in the fluid delivery conduit 630 (conduits 520 a�b are shown in the embodiment of FIG. 36). In a modification of this environment, the tissue-contacting members are instead brought into contact with a target location on the atrium of the heart 800 proximal of the pulmonary vein at a location wherein the pulmonary vein 820 a can be electrically isolated from the rest of the heart.
A treatment fluid may then be delivered through the fluid delivery conduit 630 of the tissue treatment apparatus 600. If the treatment fluid comprises a tissue-ablating fluid, this will simultaneously ablate a line of tissue on each side of the wall of the pulmonary vein 820 a to form a transmural lesion along a length of the wall. The length of this lesion will depend on the length of the tissue-contacting members 642 and the positioning of the outlet ports on the fluid delivery conduit 630 carried by the tissue-contacting members 642. FIG. 42 illustrates a lesion 830 a that extends only along a portion of the wall of the pulmonary vein 820 a. This partial lesion 830 a may be insufficient to effectively electrically isolate the pulmonary vein 820 a from the atrium of the heart 800. To better isolate the pulmonary vein 820 a, the tissue treatment apparatus 600 may be repositioned so a portion of the pulmonary vein 820 a which remains untreated is positioned between the tissue-contacting members 642 of the tissue grasping member 640. A second lesion may be formed in much the same fashion as lesion 830 a. This second lesion may adjoin the first lesion 830 a to form a longer, effectively continuous lesion. This process can be repeated until the resultant series of lesions forms a relatively continuous lesion 830 that substantially circumscribes the pulmonary vein 820 a, as shown in FIG. 43. Each of the four pulmonary veins 820 a�d can be treated in much the same fashion to effectively electrically isolate the pulmonary veins 820 from the atrium of the heart 800.
FIGS. 44 and 45 schematically illustrate a slightly different adaptation of this embodiment, wherein a lesion is formed in the atrium to isolate to pulmonary veins 820 a�b from the atrium. In the embodiment shown in FIG. 44, much the same distal grasping member 640 of the tissue treatment apparatus 600 is illustrated. In this embodiment, though, the distal grasping member 640 is larger than the distal grasping member shown in FIGS. 41 and 42, permitting a lesion 840 to be formed in a single ablating step rather than requiring a series of separate ablations. As in the embodiment discussed above in connection with FIGS. 41�43, the tissue-contacting members 642 may be urged into contact with the target tissue of the atrium. The opposed inner surfaces of the wall of the atrium may be brought closer together for the urging force of the tissue-contacting members 642 and an ablating fluid may be delivered through the fluid delivery conduit (630 in FIG. 37A) to ablate atrial tissue, creating the lesion 840.
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Inc.Cryotreatment device and method of forming conduction blocksUS8486022Jul 3, 2008Jul 16, 2013Abbott Cardiovascular Systems Inc.Needle catheter with an angled distal tip lumenUS20110190754 *Jan 29, 2010Aug 4, 2011Steven KimApparatus and Methods of Use for Treating Blood VesselsUS20110251585 *Feb 10, 2011Oct 13, 2011Peyman Gholam ASub-mucosal agent delivery, apparatus, system and method* Cited by examinerClassifications U.S. Classification606/41, 607/101, 607/104, 606/51, 606/52, 606/48, 606/49International ClassificationA61B17/28, A61B17/22, A61B17/00, A61B18/18, A61M37/00, A61M25/00, A61B19/00, A61M5/30Cooperative ClassificationA61B19/5244, A61B2017/00243, A61B17/32037, A61B2017/22077, A61B2019/467, A61B2218/002, A61M37/0092, A61M5/30, A61B2018/00392, A61B2018/00839, A61B17/3207, A61B17/282, A61B2017/00247, A61M2025/0089, A61B2018/00875, A61B2019/464, A61B2018/1425European ClassificationA61B17/28D4, A61B17/3207, A61B17/3203RLegal EventsDateCodeEventDescriptionMay 21, 2010FPAYFee 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