Source: http://www.google.fr/patents/US20020183738
Timestamp: 2017-11-24 07:52:58
Document Index: 494366829

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

Brevet US20020183738 - Method and apparatus for treatment of atrial fibrillation - Google Brevets
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...http://www.google.fr/patents/US20020183738?utm_source=gb-gplus-shareBrevet US20020183738 - Method and apparatus for treatment of atrial fibrillation
Numéro de publication US20020183738 A1
Numéro de demande US 10/099,528
Autre référence de publication US7147633, US8187251, US20070055230, US20120238996
Numéro de publication 099528, 10099528, US 2002/0183738 A1, US 2002/183738 A1, US 20020183738 A1, US 20020183738A1, US 2002183738 A1, US 2002183738A1, US-A1-20020183738, US-A1-2002183738, US2002/0183738A1, US2002/183738A1, US20020183738 A1, US20020183738A1, US2002183738 A1, US2002183738A1
Inventeurs U. Chee, Richard Mueller, James Kermode, Curtis Tom, Douglas Murphy-Chutorian
Cessionnaire d'origine Chee U. Hiram, Mueller Richard L., Kermode James R., Tom Curtis P., Douglas Murphy-Chutorian
Citations de brevets (99), Référencé par (106), Classifications (30), Événements juridiques (7)
US 20020183738 A1
1. A medical device for treating patient tissue comprising:
a first tissue contacting member adapted to be manipulated into contact with a surface of a target tissue, the first tissue contacting member having a body, first and second tissue-contacting surfaces spaced from one another to define a gap therebetween, and a recess proximate to the gap; and
a first fluid delivery conduit in fluid communication with the reservoir and having a plurality of outlet ports, the first fluid delivery conduit having a length received in the recess with the outlet ports oriented toward, but spaced from, the gap.
9. The medical device of claim 8 wherein the pressure control is operable to establish an elevated delivery pressure of about 600-2000 psi.
12. A medical device for treating patients tissue comprising:
a tissue grasping member comprising a first tissue contacting member and an opposed second tissue contacting member, the first and second tissue contacting members being operatively associated with one another and movable between a first configuration wherein they have a first relative orientation adapted to receive the tissue therebetween and a second configuration wherein they have a second relative orientation adapted to grasp tissue therebetween; and
first and second fluid delivery conduits in fluid communication with the reservoir, the first fluid delivery conduit having a distal length carried by the first tissue contacting member and a plurality of outlet ports spaced along that distal length, and the second fluid delivery conduit having a distal length carried by the second tissue contacting member and a plurality of outlet ports spaced along that distal length, the outlet ports of the first and second fluid delivery conduits being oriented generally inwardly toward one another when the tissue grasping member is in the second configuration.
an elongate body adapted for introduction into a thoracic cavity, the body having a distal tissue-contacting member having a length adapted to lie in contact with a surface of a target tissue;
a plurality of outlet ports spaced along the length of the tissue-contacting member;
19. The medical device of claim 17 wherein the pressure control is operable to establish an elevated delivery pressure of about 600-2000 psi.
24. The medical device of claim 23 wherein the electrodes are operatively coupled to an EKG display
33. A method of treating cardiac arrhythmia comprising:
positioning a tissue grasping member adjacent a target tissue of a heart atrium or a pulmonary vein, the target tissue having two spaced-apart wall segments;
moving opposed tissue-contacting members of the tissue grasping member toward one another to deform the target tissue such that the wall segments are moved closer to, but remain spaced from, one another; and
ablating target tissue in contact with the tissue contacting members to create a lesion extending through both wall segments.
34. A method of at least partially electrically isolating a pulmonary vein from a heart atrium having two spaced-apart wall segments, comprising:
juxtaposing the two wall segments along a first plane;
ablating tissue in both wall segments along the first plane with an ablating member to form a lesion along a first length of each wall segment;
moving the ablating member;
juxtaposing the two wall segments along a second plane; and
ablating tissue in both wall segments along the second plane with the ablating member to form a lesion along a second length of each wall segment, the second length adjoining the first length.
moving the ablating member again;
juxtaposing the two wall segments along a third plane; and
ablating tissue in both wall segments along the third plane with the ablating member to form a lesion along a third length of each wall segment.
36. The method of claim 34 wherein the first and second lengths at least substantially circumscribe the pulmonary vein.
37. The method of claim 34 further comprising repositioning the ablating member and ablating tissue to form at least one additional lesion which, together with the first and second lengths, forms a series of lesions which at least substantially circumscribes the pulmonary vein.
38. A method for creating a line of ablated tissue on a hollow organ or vessel having opposed walls, comprising:
bringing the opposed walls of the organ closer together, but not in contact with one another, along a distance within a plane; and
ablating tissue in the opposing walls along the plane to form a corresponding line of ablated tissue through the opposed walls.
39. A method of treating cardiac arrhythmia comprising:
guiding a body of an injectate delivery device within a patient's thoracic cavity to position a distal tissue-contacting portion of the body in surface contact with a tissue surface of cardiac tissue;
thereafter, injecting a tissue-ablating agent into the cardiac tissue through the tissue-contacting portion of the body.
40. The method of claim 39 wherein the tissue-ablating agent is pressurized to a delivery pressure of at least about 400 psi to inject the tissue-ablating agent into the cardiac tissue.
41. The method of claim 39 wherein the tissue-ablating agent is pressurized to a delivery pressure of about 600-2000 psi to inject the tissue-ablating agent into the cardiac tissue.
42. The method of claim 39 wherein the tissue-ablating agent is injected into the cardiac tissue to a depth of at least about 2 mm.
43. The method of claim 39 wherein the tissue-ablating agent is injected into the cardiac tissue at an elevated pressure through a plurality of outlet ports along the tissue-contacting portion.
44. The method of claim 43 wherein the tissue-ablating agent is injected through the outlet ports into the cardiac tissue to a depth of at least about 2 mm.
45. The method of claim 43 wherein the tissue-ablating agent is injected through the outlet ports into the cardiac tissue at a pressure sufficient to penetrate an entire thickness of a patient's myocardium
46. The method of claim 39 wherein the tissue-ablating agent comprises a fluid selected from the group consisting of alcohols, hypertonic saline, hot saline, hot glycerine, hot ethylene glycol, cold saline, cold glycerine, cold ethylene glycol, sodium tetradecyl sulfate, and polyethyleneglycolmonododecylether.
47. The method of claim 39 wherein the tissue-contacting portion of the body comprises a blunt distal tip of the body having a tissue-contact sensor, the tissue-contact sensor being used to detect the surface contact.
48. The method of claim 39 wherein the tissue-contacting portion of the body comprises an elongate surface of a distal length of the body.
49. The method of claim 48 wherein the tissue-contacting portion includes a plurality of outlet ports, injecting the tissue-ablating agent comprising pressurizing the tissue-ablating agent to a delivery pressure of at least about 600 psi.
50. The method of claim 39 wherein the tissue-contacting portion of the body comprises an elongate surface of a distal length of the body having a tissue-contact sensor, the tissue-contact sensor being used to detect the surface contact.
51. The method of claim 50 wherein the tissue-contacting portion of the body has a curved configuration in a relaxed state, guiding the body further comprising allowing the tissue-contacting portion to relax to conform to the tissue surface.
52. The method of claim 39 wherein the injectate delivery device further comprises a selectively deployable needle, injecting the tissue-damaging agent comprising advancing the needle through the tissue surface into the cardiac tissue and delivering a tissue-damaging fluid through a lumen of the needle.
53. The method of claim 39 wherein detecting surface contact comprises supplying an excitation voltage to a plurality of electrodes positioned on the tissue-contacting portion of the body and measuring a level of at least one current conducted by the plurality of electrodes, wherein the level depends upon a degree of contact between at least two of the electrodes and the tissue surface.
54. The method of claim 53 further comprising displaying an indication of an orientation of the tissue-contacting portion with respect to the tissue surface.
55. The method of claim 53 further comprising displaying an indication of a degree to which the tissue-contacting portion intrudes into the tissue surface.
56. The method of claim 39 wherein surface contact is detected with a plurality of electrodes positioned on the tissue-contacting portion of the body, further comprising measuring an EKG of the cardiac tissue with the electrodes.
57. A method of treating atrial fibrillation comprising:
guiding an elongate, flexible body into proximity with an exterior tissue surface of a predetermined portion of a cardiac tissue;
bringing an elongate tissue-contacting portion of the body into surface contact with the tissue surface, the tissue-contacting portion including a plurality of electrodes;
measuring a level of at least one current conducted by the plurality of electrodes, wherein the level depends on a degree of contact between at least two of the electrodes and the tissue surface; and
thereafter, injecting a tissue-damaging fluid into the cardiac tissue at an elevated pressure through a plurality of outlets in the tissue-contacting portion of the body to define a plurality of jets of the tissue-damaging fluid which pass through an entire thickness of the cardiac tissue, creating a transmural signal-impeding lesion in the cardiac tissue.
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 No. 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/US00115386, titled “Devices and Methods for Delivering a Drug” filed Jun. 2, 2000 (which was published in English Dec. 7, 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.
Several less invasive techniques have been proposed for achieving a similar maze-like effect in the atrial myocardium without requiring direct surgical intervention. For example, U.S. Pat. Nos. 6,267,760 (Swanson) and 6,237,605 (Vaska et al.), both of which are incorporated entirely herein by reference, suggest RF ablation devices intended to ablate cardiac tissue and create atrial myocardial lesions to achieve much the same purpose as the surgical incisions of the standard maze procedure. U.S. Pat. No. 6,161,543 (Cox et al.), which is also incorporated entirely herein by reference, suggests that a cryogenic probe be employed to freeze tissue instead of using the RF ablation devices to heat tissue. Each of these approaches leaves something to be desired, however.
[0017]FIG. 1 is a diagram of an embodiment of a catheter apparatus.
[0018]FIG. 2 is a diagram of an embodiment of a catheter apparatus.
[0019]FIG. 3A is a diagram of the distal end of an embodiment of an apparatus showing the relative position of the distal end to body tissue.
[0020]FIG. 3B is a diagram of the distal end of an embodiment of an apparatus showing the relative position of the distal end to body tissue.
[0021]FIG. 3C is a diagram of the distal end of an embodiment of an apparatus showing the relative position of the distal end to body tissue.
[0022]FIG. 3D is a diagram of the distal end of an embodiment of an apparatus showing the relative position of the distal end to body tissue.
[0023]FIG. 3E is a diagram of the distal end of an embodiment of an apparatus showing the relative position of the distal end to body tissue.
[0024]FIG. 4A is an end view of an embodiment of a probe with sensors.
[0025]FIG. 4B is a cross-sectional view of an embodiment of a probe with sensors.
[0026]FIG. 5A is a diagram of an embodiment of a probe with sensors, showing the relative position of the probe and the sensors to body tissue.
[0027]FIG. 5B is a graph of current as a function of percentage of contact between sensors and body tissue.
[0028]FIG. 6A is an end view of an embodiment of a probe with sensors.
[0029]FIG. 6B is a cross-sectional view of the embodiment of FIG. 6A.
[0030]FIG. 7A is an end view of an embodiment of a probe with sensors, illustrating partial contact between the sensors and body tissue.
[0031]FIG. 7B is a diagram of an embodiment of a display that indicates partial contact between sensors and body tissue.
[0032]FIG. 8A is an end view of an embodiment of a probe with sensors.
[0033]FIG. 8B is a cross-sectional view of an embodiment of a probe with sensors.
[0034]FIG. 8C is a cross-sectional view of an embodiment of a probe with sensors.
[0035]FIG. 9A is a diagram of an embodiment of a probe with sensors partially intruding into body tissue.
[0036]FIG. 9B is a graph of current as a function of percentage of contact between sensors and body tissue.
[0037]FIG. 10A is an end view of an embodiment of a probe with sensors.
[0038]FIG. 10B is a cross-sectional view of an embodiment of a probe with sensors.
[0039]FIG. 11A is a diagram of an embodiment of a probe with sensors partially intruding into body tissue such that the probe is not perpendicular to the body tissue surface.
[0040]FIG. 11B is a diagram of a display of one embodiment that indicates the position of the probe with respect to the body tissue surface and a degree of intrusion into the body tissue.
[0041]FIG. 12A is a cross-sectional view of an embodiment of a probe with a working element and sensors, showing the working element in a retracted position.
[0042]FIG. 12B is a cross-sectional view of an embodiment of a probe with a working element and sensors, showing the working element in an extended position.
[0043]FIG. 13 is a cross-sectional view of an embodiment of a probe with a working element and sensors, showing the working element in a retracted position.
[0044]FIG. 14 is a cross-sectional view of an embodiment of a probe with a working element that is a sensor.
[0045]FIG. 15 illustrates a steerable catheter-type device for delivering selected diagnostic and/or therapeutic agents to target sites within a selected body tissue using high-energy jets, in accordance with an embodiment of the present invention.
[0046]FIG. 16A is an enlarged, side-sectional view of a distal-end region of the device shown in FIG. 15.
[0047]FIG. 16B shows the device of FIGS. 15 and 16A being used to direct four high-energy jets carrying one or more selected therapeutic and/or diagnostic agents through a wall of a selected body organ and into the tissue.
[0048]FIG. 17 is an exploded view of the apparatus of FIGS. 16A-B.
[0049]FIG. 18 is a partial, side-sectional view of a further embodiment of an agent-delivery apparatus for delivering selected diagnostic and/or therapeutic agents to target sites within a selected body tissue using high-energy jets, according to the teachings of the present invention.
[0050]FIG. 19 shows the distal-end region of a steerable catheter-type device for delivering selected diagnostic and/or therapeutic agents to target sites within a selected body tissue using ultrasonic energy, according to one embodiment of the present invention.
[0051]FIG. 20 shows, in partial side-sectional view, an exemplary agent-delivery port and a secondary drug or gas port that meets the delivery port at an angle, as well as several exemplary jet or spray patterns.
FIGS. 20A-C schematically illustrate exemplary spray patterns which may be achieved using the apparatus of FIG. 20.
[0053]FIG. 21 is a partial side view, with portions shown in section, of an exemplary valving mechanism operable to regulate fluid flow through an agent-delivery lumen and/or outlet port.
[0054]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.
[0055]FIG. 23 is a partial side view of an example of the invention as it is placed near a tissue (9 a), urged against the tissue (9 b) thus creating a contact force between the device and the tissue, the application of hydraulic force causing ejection of a fluid stream from each outlet port thus propelling the fluid into the tissue (9 c), and the removal of hydraulic force and the retention of fluid by the tissue within pockets created by hydraulic erosion (9 d).
[0056]FIG. 24A illustrates an example of the invention where the device is conveyed to the target tissue via a steerable catheter with having an axial lumen where the device is slidably directed towards the target tissue.
[0057]FIG. 24B illustrates how the device of FIG. 24A is “steered” towards a target.
[0058]FIG. 25 illustrates an example of the invention where the device is combined with a steerable catheter in one structure.
[0059]FIG. 26 illustrates an example of the invention where the device is combined with a first steerable catheter in one structure which resides in a second steerable catheter having an axial lumen where the first steerable catheter is slidably maintained.
[0060]FIG. 27A is an end view of an injection device incorporating tissue contact sensors.
[0061]FIG. 27B is a cross-sectional view of the injection device of FIG. 27A.
[0064]FIG. 33 is a top view of another embodiment of a tissue treatment device.
[0065]FIG. 34 is a partial side view of the tissue treatment device of FIG. 33 taken along line 34-34 in FIG. 33.
[0066]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.
[0067]FIG. 36 is a schematic illustration of the device of FIG. 33 being used to treat tissue of a pulmonary vein.
[0068]FIG. 37A is a side view of a tissue treatment device in accordance with still another embodiment of the invention.
[0069]FIG. 37B is a side view of a modified version of the embodiment of FIG. 37A.
[0070]FIGS. 38A and 38B are isolation views of a distal portion of the tissue treatment device of FIG. 37A in an open configuration and in a closed configuration, respectively.
[0071]FIGS. 39A and 39B are isolation views of an alternative distal portion, useful in the tissue treatment device of FIG. 37A, in an open configuration and in a closed configuration, respectively.
[0072]FIG. 40 is a side view of a tissue treatment device in accordance with still another embodiment of the invention.
[0073]FIG. 41 schematically illustrates positioning of the tissue treatment device of FIG. 33 adjacent to a patient's heart to treat atrial fibrillation.
[0074]FIG. 42 is a close-up view schematically illustrating a step in a process of forming a lesion around a pulmonary vein.
[0075]FIG. 43 schematically illustrates the lesion formed in the process illustrated in FIG. 42.
[0076]FIG. 44 schematically illustrates positioning of an alternative tissue treatment device with respect to two pulmonary veins.
[0077]FIG. 45 schematically illustrates the lesion formed in the process illustrated in FIG. 44.
[0081]FIG. 1 is a diagram of an embodiment of an apparatus 14 for guided interventional procedures. The apparatus 14 includes an assembly 16 for accessing a body tissue surface 18 inside a patient's body, and an actuator 24. The actuator 24 is attached to the assembly 16 in such a way as to steer the assembly 16 by one of several known methods. A distal end probe 22 is placed in contact with the tissue surface 18 in order to perform an interventional procedure. Sensors (not shown in the figure) in the distal probe 22 are electrically connected to a control unit 28. The control unit 28 includes a power source for supplying voltage across the sensors, and circuitry for receiving and processing signals. For example, the control unit 28 includes circuitry for detecting and measuring current levels across the sensors.
[0087]FIG. 2 is a diagram of an embodiment of an apparatus 15 for guided interventional procedures that includes separate display devices for position information and for physiological information. The apparatus 15 includes the assembly 16 and the actuator 24. The apparatus further includes the control unit 28 and the activator 30. The display 37 displays position information from sensors as described below. The display 39 displays EKG information. In one embodiment, the display 39 is a commercially available EKG monitor. In one embodiment, the display 37 and the display 39 receive the same signal and filter out unneeded signal components. In one embodiment, the signal is one or more current levels from electrode sensors, as described below.
[0088]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.
[0090]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.
[0092]FIG. 3D illustrates a surface contact condition between the distal end probe 22 and the tissue surface 18 that is optimal for certain procedures. In this illustrated condition, the longitudinal axis of the distal end probe 22 is substantially perpendicular to the plane of the tissue surface 18. For some procedures to be most effective, the distal end probe 22 should be applied to the tissue surface 18 with a force that is within a predetermined optimal range.
[0095]FIG. 4A is an end view of an embodiment of a distal end probe 42 that allows surface contact between the distal end probe 42 and a tissue surface to be sensed during a procedure. The distal end probe 42 includes a lumen 44 through which a therapeutic stimulus can be administered. A planar front face 46 may be placed in contact with the target tissue when the stimulus is administered. Inner and outer annular electrodes, or sensors, 48 and 50, respectively, surround the lumen 44 and are separated by insulators 52, 54, and 56. In one embodiment, the electrodes 48 and 50 are formed of gold, silver, or another conductive material, and are formed on the probe face by plating or attachment methods.
[0099]FIG. 5A is a diagram showing the distal end probe 22 in partial contact with the tissue surface 18. Inner electrode 48 and outer electrode 50 are also shown schematically. When the distal end probe 22 contacts the tissue surface 18 at an angle other than 90°, as shown in FIG. 5A, the electrode elements in contact with the tissue surface will conduct relatively little current while the exposed electrode elements may remain in contact with a more conductive medium, such as blood. The relationship between the percentage of the probe face 46 in contact with the tissue surface and the current through the electrode elements is shown in FIG. 5B. Little or no contact results in maximum current. The amount of current decreases in the manner shown until complete or substantially complete contact is achieved, thus providing an indication of the amount of contact between the distal end probe 22 and the tissue surface.
[0102]FIG. 6A is an end view of an embodiment of a distal end probe 68 that allows the quality of contact between the distal end probe 68 and a tissue surface to be sensed. The quality of contact includes degree of contact and the angle between the longitudinal axis of the distal end probe 68 and the tissue surface. The distal end probe 68 includes a lumen 71. A probe face 70 (shown in FIG. 6B) of the distal end probe 68 includes an outer annular electrode, or sensor, 74, and an inner annular electrode, or sensor, 72 that includes multiple electrode sections 72 a, 72 b, 72 c, and 72 d. The insulators 78 and 76 separate the electrodes 72 and 74. The insulator 76 further separates the sections of the electrode 72 from each other.
[0105]FIG. 7B is a diagram of an embodiment of a display 86. The display 86 indicates the angle and degree of contact corresponding to the current flow as shown in FIG. 7A. Indicators 85 are typical of the 17 indicators that are arranged in two lines that intersect at an indicator 87 as shown. The indicators 85 are arranged to suggest the manner in which the plurality of sensors is arranged on the distal end probe 68. The arrangement of the indicators generally corresponds to locations on the probe face 71. A shaded indicator 85 indicates contact between the probe face 71 and the tissue surface at the location of the shaded indicator. An unshaded indicator 85 indicates no contact between the probe face 71 and the tissue surface at the location of the unshaded indicator. 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. The display 86 allows a user to quickly assess angle and degree of contact between the probe face 71 and the tissue surface.
[0108]FIG. 8C is a diagram of an alternative electrode configuration. The distal end probe 89 includes a lumen 91. An inner annular electrode 95 substantially covers the rounded face of the distal end probe 89. The inner annular electrode 95 is separated from an outer annular electrode 99 by an insulator 97. The electrodes 95 and 97 are electrically connected to circuitry, such as that described with reference to the control unit 28 of FIG. 1, through conductors 101 and 103.
[0109]FIGS. 9A and 9B illustrate an example of one application for the distal end probe 88 and the information provided by the electrodes 94, 96, and 98. FIG. 9A shows the distal end probe in contact with the tissue surface 18. The distal end probe 88 intrudes into the tissue surface 18 such that the electrode 94 is in contact with the tissue surface 18, but the electrodes 96 and 98 are not in contact. FIG. 9B shows two graphs that each plot current as a function of degree of contact between an electrode and the tissue surface 18. The curve 112 shows the plot for the distal end probe intruding into the tissue surface 18 to distance d1. The curve 114 shows the plot for the distal end probe intruding into the tissue surface 18 to distance d2. Distances d1 and d2 are illustrated in FIG. 8B.
[0111]FIGS. 10A and 10B illustrate an embodiment of a distal end probe 116 that allows the user to obtain information about the angle of contact of the distal end probe 116 with the tissue, and the depth of intrusion into the tissue. The distal end probe 116, as shown in FIG. 10A, includes electrodes, or sensors, 120, 122, and 124. Each of the electrodes 120, 122, and 124 are annular and arranged concentrically about the longitudinal axis of the distal end probe 116. Each of the electrodes 122, 124, and 126 are divided into four electrode sections (labeled a, b, c, and d) that are each electrically insulated from any other electrode section by an insulating material, indicated by shading.
[0113]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.
[0118]FIGS. 12A, 12B, and 13 illustrate embodiments of distal end probe assemblies for delivering a therapeutic stimulus to tissue. FIG. 12A is a cross-sectional view of a distal end probe 130 that has a rounded contact surface with a central lumen 132 through which a needle 134 can be extended. In one embodiment, a therapeutic solution is administered from a reservoir in the actuator 24 (FIG. 1) into the target tissue through a lumen (not shown) of the needle 134. The distal end probe 130 includes electrodes, or sensors, 136, 138, and 140. The electrodes serve as sensors as previously described with reference to other embodiments, and communicate with a control unit, as previously described, through conductors 142, 144, and 146.
[0122]FIG. 14 is a diagram of an embodiment including a distal end probe 160 and a working element 162 in a lumen 164. The working element 162 may be a needle for delivering a drug, cells, or creating an injury using mechanical or other means. In other embodiments, the working element can be any one of any of a variety of working elements used in conjunction with catheters to perform various medical procedures. The distal end probe 160 includes electrodes, or sensors, 168, 170, and 172. The electrodes 168, 170, and 172 function similarly to the electrodes 136, 138, and 140 described with reference to FIG. 12A. The working element 162 is connected to the coupling 174, which transmits physiological data collected by the working element 162 from tissue the working element is in contact with. In one embodiment, the physiological data is EKG data. The availability of the EKG information from the working element 162 along with the position and/or EKG information from the electrodes 168, 170, and 172 is very useful for obtaining very site-specific information about tissue during a procedure. For example, in the case of non-transmural infarcts, an infarcted area can be isolated between the endocardium and the epicardium. As the working element progresses through the tissue, the EKG signal from the working element gives an accurate indication of relative tissue health at the site of the working element. Thus, information that is not available from the tissue surface becomes available. There may be no electrical activity on the endocardium, but as the working element is advanced through the tissue, electrical activity may be detected closer to the epicardium. Hence, a therapeutic agent may be delivered through a needle 162 to treat tissue and the same needle 162 can be used to monitor physiological data pertaining to the tissue as it is being treated.
[0125]FIG. 15 illustrates a catheter assembly, indicated generally by the reference numeral 212, in accordance with another embodiment of the invention. The catheter assembly 212 (or even just selected aspects thereof) can be used instead of the apparatus 14 or 15 of FIGS. 1 and 2, respectively, (or selected aspects thereof) in the embodiments discussed above. Likewise, aspects of the apparatus 14 and 15 may be used in conjunction with the catheter assembly 212 and other embodiments discussed below.
[0139]FIG. 24 illustrates a steerable treatment device 330 in accordance with one embodiment of the invention. In this embodiment, the steerable treatment device includes a steerable outer sleeve 340 and a delivery catheter 350. The delivery catheter 350 is slidably received in the lumen of the outer sleeve 340. The delivery catheter may include an end member 352 defining a plurality of outlet ports 355 for delivery of a treatment fluid to target tissue at a selected treatment site. A distal length 342 of the guide catheter 340 may be steered by the operator, e.g., by means of control wires (not shown), causing it to deflect from a relaxed state (shown in solid lines) to a curved state (shown in phantom lines). The end member 352 of the delivery catheter 350 can be positioned at a desired location by controlling the axial orientation of the guide catheter 340, the curvature of the distal length 342, and the extent of the end member 352 of the delivery catheter 350 beyond the distal length 342 of the guide catheter 340.
[0159]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.
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.
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.
[0175]FIG. 36 is a schematic cross-sectional view of the tissue treatment device 500 being used to treat a target tissue 544, exemplified in this case as tissue of a pulmonary vein 542. While the following discussion focuses on the use of the tissue treatment apparatus 500 to treat a pulmonary may, it should recognize that the apparatus 500 can be used in a variety of other contexts to inject a suitable treatment fluid in any tissue which needs to be treated.
[0181]FIG. 37A illustrates a tissue treatment apparatus 600 in accordance with another embodiment of the invention. This tissue treatment apparatus 600 includes an elongate body 610 with a manually graspable handle 612 adjacent its proximal end and a distal grasping member 620 adjacent its distal end. The body 610 and the distal grasping member 620 may be sized to be introduced into a patient 's thoracic cavity through an intercostal incision. The body 610 may comprise a generally rigid tubular member having a lumen extending from the handle 612 to the distal end of embodiment adjacent the distal grasping member 620. The handle 612 may include an actuator 614 which can be used to move the distal grasping member 620 between a closed position (shown in FIG. 37A) which may be used when delivering fluid to treat tissue and an open position (not shown) adapted to receive the tissue to be treated. Movement of the actuator 614 can be translated into motion of the distal grasping member 620 in any desired fashion, e.g., by means of a flexible cable (not shown). A number of grasping tools adapted for endoscopic procedures are known in the art and the mechanisms useful in those devices may be employed to remotely manipulate the distal grasping member 620 of the tissue treatment apparatus 600 of FIG. 37A.
[0183]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.
[0184]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 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. 23b. 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.
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.
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.
[0204]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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Classification aux États-Unis 606/41, 606/207, 607/120
Classification internationale A61M25/00, A61M5/30, A61M37/00, A61B17/00, A61B19/00, A61B17/28, A61B17/22
Classification coopérative A61B17/3207, A61B17/282, A61B2018/00392, A61M5/30, A61B2018/00875, A61B2090/067, A61M2025/0089, A61B34/20, A61B2090/064, A61M37/0092, A61B17/32037, A61B2017/00243, A61B2018/00839, A61B2017/00247, A61B2017/22077, A61B2018/1425, A61B2218/002
Classification européenne A61B17/28D4, A61B17/3207, A61B17/3203R