Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B6/00—Apparatus or devices for radiation diagnosis; Apparatus or devices for radiation diagnosis combined with radiation therapy equipment
  • A61B6/48—Diagnostic techniques
  • A61B6/481—Diagnostic techniques involving the use of contrast agents
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B6/00—Apparatus or devices for radiation diagnosis; Apparatus or devices for radiation diagnosis combined with radiation therapy equipment
  • A61B6/50—Apparatus or devices for radiation diagnosis; Apparatus or devices for radiation diagnosis combined with radiation therapy equipment specially adapted for specific body parts; specially adapted for specific clinical applications
  • A61B6/504—Apparatus or devices for radiation diagnosis; Apparatus or devices for radiation diagnosis combined with radiation therapy equipment specially adapted for specific body parts; specially adapted for specific clinical applications for diagnosis of blood vessels, e.g. by angiography
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
  • A61M25/0041—Catheters; Hollow probes characterised by the form of the tubing pre-formed, e.g. specially adapted to fit with the anatomy of body channels
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
  • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
  • A61M25/0133—Tip steering devices
  • A61M25/0136—Handles therefor
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B6/00—Apparatus or devices for radiation diagnosis; Apparatus or devices for radiation diagnosis combined with radiation therapy equipment
  • A61B6/50—Apparatus or devices for radiation diagnosis; Apparatus or devices for radiation diagnosis combined with radiation therapy equipment specially adapted for specific body parts; specially adapted for specific clinical applications
  • A61B6/507—Apparatus or devices for radiation diagnosis; Apparatus or devices for radiation diagnosis combined with radiation therapy equipment specially adapted for specific body parts; specially adapted for specific clinical applications for determination of haemodynamic parameters, e.g. perfusion CT
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M2025/0004—Catheters; Hollow probes having two or more concentrically arranged tubes for forming a concentric catheter system
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/0043—Catheters; Hollow probes characterised by structural features
  • A61M25/0054—Catheters; Hollow probes characterised by structural features with regions for increasing flexibility

Definitions

• the present invention relates to catheters for use in cardiac diagnosis and treatment.
• a further aspect of the present invention relates to a catheter with a flexible, hollow, inner member to which a self expanding basket is attached.
• a further aspect of the present mvention relates to a method of passing a radio-opaque contrast fluid through a shunt located in a heart wall, the shunt providing fluid communication between a heart chamber and a coronary artery.
• a further aspect of the present invention relates to inserting a wire into a coronary artery through a shunt located in a heart wall, the shunt providing fluid communication between a heart chamber and the coronary artery.
• a still further aspect of the present invention relates to a catheter including an inner tube with a self-expanding basket and an outer sheath about the inner tube.
• a further aspect of the present invention relates to a catheter with a flexible inner member with a shunt locating element at a distal end and an outer sheath about the inner member.
• FIG. 1 is a side view of an embodiment of an assembled catheter of the present invention.
• FIG. 2 is a closer detail view the distal end of the assembled catheter of FIG.
• FIG. 3 is a side view of the outer sheath of the assembled catheter of FIG. 1.
• FIG. 4 is an end view of the distal end of the outer sheath of FIG. 3.
• FIG. 5 is a side view of the inner tube of the assembled catheter of FIG. 1.
• FIG. 6 is a closer detail view of the distal end of the inner tube of FIG. 5
• FIG. 7 is a schematic illustration with a heart in partial cutaway of an embodiment of a catheter of the present invention to catheterize the left ventricle of a patient's heart via the femoral artery.
• FIG. 8 is a close-up of the heart of FIG. 7, showing a distal end of the catheter within the patient's left ventricle and a shunt in place in the wall of the patient's heart.
• FIG. 9 is a cross-sectional view of the heart wall with a shunt in place between the heart chamber and a coronary artery and the distal end of the catheter with the stabilizing collapsible basket attached to the inner tube collapsed and retracted within the outer sheath.
• FIG. 10 is the cross-sectional view of FIG. 9 showing the distal end of the outer sheath of the catheter retracted to permit the basket to expand.
• FIG. 11 is the cross-sectional view of FIG.9, with the expanded basket now placed overlaying the protruding end of the shunt.
• FIG. 12 is the cross-sectional view of FIG. 9 with the distal end of the outer sheath being extended toward the distal end of the inner tube causing the basket to collapse about the protruding end of the shunt and stabilize the catheter with respect to the shunt.
• FIG. 13 is the cross-sectional view of FIG. 9, with the heavy arrows representing the flow of fluid being passed through the inner tube of the catheter and through the shunt, into the coronary artery.
• FIG. 14 is the cross-sectional view of FIG. 9, showing a wire being inserted through the inner tube and through the shunt into the coronary artery.
• FIG. 15 is a cross-sectional view of an alternative embodiment of a distal end of a catheter according to the present invention with the gripping element inverted within the inner tube.
• FIG. 16 is a cross-sectional view of the catheter of FIG. 15 with a shaft inserted through the inner tube and forcing the gripping element from its inverted postion.
• FIG. 17 is a cross-sectional view of the catheter of FIG. 16 with the shaft removed from the inner tube.
• FIG. 18 is a cross-sectional view of the catheter of FIG. 17 with the gripping element retracted within the outer sheath.
• FIG. 19 is an alternative embodiment of a distal end of a catheter according to the present invention for injecting dye into a heart chamber.
• FIG. 20 is an alternative embodiment of a distal end of a catheter according to the present invention for injecting dye into a heart chamber.
• FIG. 21 is an alternative embodiment of a distal end of a catheter according to the present invention for injecting dye into a heart chamber.
• FIG. 22 is a side view of an alternative embodiment of a catheter in accordance with the present invention.
• FIG. 23 is a cross-sectional view of a catheter body of the catheter of FIG. 22 taken at line 23-23.
• FIG. 24 is a cross-sectional view of an alternative embodiment of an catheter body of a catheter in accordance with the present invention including four deflection wires.
• FIG. 25 is a cross-sectional view of an alternative embodiment of an catheter body of a catheter in accordance with the present invention including two flat deflection tensioning members.
• FIG. 26 is a cross-sectional view of an alternative embodiment of a catheter body of a catheter in accordance with the present invention including four flat deflection tensioning members.
• FIG. 27 is a closer detail view of the distal end of the catheter body of the catheter of FIG. 22.
• FIG. 28 is a cross-sectional view of the catheter body of the catheter of FIG. 24, taken along line 28-28.
• FIG. 29 is a closer detail view of the distal end of the catheter body of the catheter of FIG. 22, showing both bending portions bent.
• FIG. 30 is a view of the catheter of FIG. 29 with the first bend portion bent at a more acute angle.
• FIG. 31 is a view of the catheter of FIG. 30 with the first bend portion bent at a more acute angle.
• FIG. 32 is a schematic illustration with a heart in partial cutaway of a catheter including the catheter body shown in FIG. 22 used to catheterize the left ventricle of a patient's heart via the femoral artery.
• FIG. 33 is a close-up of the heart of FIG. 32, showing a distal end of the catheter within the patient's left ventricle and a shunt in place in the wall of the patient's heart.
• FIG. 34 is a schematic representation of the top cross-sectional view of the patient's left ventricle of FIG. 33, with the distal end of the catheter extending into the heart.
• FIG. 35 is the heart and catheter of FIG. 34 with the first bending portion of the catheter bent in an arc.
• FIG. 36 is the heart and catheter of FIG. 35 with the second bending portion of the catheter bent into an arc but not yet aligned with the shunt.
• FIG. 37 is the heart and catheter of FIG. 36 with the distal end aligned with the shunt and a collapsible basket extending from within the catheter projecting over a leg of the shunt protruding into the left ventricle.
• FIG. 38 is a side view of a handle in accordance with the present invention for use with the catheter of FIG. 1, with provision to apply tension to a single deflection wire.
• FIG. 39 is a cross-sectional view of the handle of FIG. 38.
• FIG. 40 is a cross-sectional view of an alternative handle for use with the catheter of FIG. 22 with provision to apply tension to two deflection wires.
• FIG. 41 is a cross-sectional view of a second alternative handle for use with the catheter of FIG. 22 with provision to apply tension to a single deflection wire by a ratcheting mechanism.
• FIG, 42 is a cross-sectional view of a third alternative handle for use with the catheter of FIG. 22 with provision to apply tension to a single deflection wire by an alternative ratcheting mechanism.
• FIG. 43 is a cross-sectional view of a fourth alternative handle for use with the catheter of FIG. 22 with provision to apply tension to two deflection wires with the ratcheting mechanism of FIG. 41.
• FIG. 44 is a cross-sectional view of a fifth alternative handle for use with the catheter of FIG. 22 with provision to apply tension to two deflection wires with the ratcheting mechanism of FIG. 42.
• a shunt has been placed in the heart wall as described in U.S. Patent No. 5,944,019, there may arise the need to access the shunt for diagnostic or other reasons.
• a physician may desire to inject radio-opaque chemical contrast material through the shunt to permit the use of cardiac imaging techniques to verify blood flow through the affected coronary artery downstream of the site of the shunt.
• it may be desirable to reach through the shunt to insert angioplasty tools to a site in the affected coronary artery downstream of the site of the shunt.
• a physician may access the shunt to insert an arterial stent into the affected coronary artery at a site downstream from the shunt.
• One of the least traumatic methods of accessing the heart and any shunts that might be implanted in the heart wall is with a catheter which enters the body via insertion through the femoral artery in the patient's groin and is advanced through the femoral artery, descending aorta and ascending aorta, into the heart.
• Catheters for femoral insertion are known.
• When accessing a shunt placed in the heart wall of a patient without cardiopulmonary bypass actually inserting a tool or other device into the shunt and the artery downstream of the shunt can be quite difficult. Without cardiopulmonary bypass, the patient's heart must necessarily be contracting during the catheterization, making the environment around the shunt quite dynamic.
• a catheter can be inserted into the artery directly via the aorta and contrast injected directly into the artery through the catheter.
• this method is less feasible, since a new arterial path bypassing the occlusion most likely has not been created, meaning that injecting contrast into the artery via the aorta will be injecting contrast at a site above the occlusion which necessitated the bypass procedure. Rather, the shunt permits blood from a heart chamber with oxygenated blood to flow directly into the coronary artery at a site downstream of the occlusion.
• the contrast is preferably injected though the shunt into the artery so that flow downstream of the occlusion can be explored.
• the cardiac catheter With a cardiac shunt in place, the cardiac catheter is preferably inserted through the aorta into the heart chamber for contrast to be injected into the shunt and the artery downstream of the shunt.
• the contrast is preferably injected directly into and through the shunt to permit effective imaging and flow analysis.
• the present invention relates to a technique and devices for accessing shunts through heart walls.
• One aspect of the present invention relates to a technique and apparatus for allowing a catheter to enter the heart and align with or attach to an object imbedded in the heart wall with a high degree of certainty while a normal cardiac rhythm is maintained.
• FIGS. 1 through 6 an embodiment of a catheter apparatus 14 is shown.
• outer sheath 108 of catheter 14 is shown in detail.
• Hub 142 includes a pair of wings 144 extending radially from hub 142 to assist in the manipulation of the catheter and control the orientation of the curvature of catheter 14 when catheter 14 is inserted in a patient's body.
• Wings 144 extend on opposite sides of hub 142 and are oriented so as to be coplanar with primary curve 146 of catheter 14.
• Primary curve 146 and secondary curve 148 are designed to improve access to shunt 30 located in heart wall 32 within heart chamber 22.
• FIGS. 7 and 8 The relationship of primary curve 146 and secondary curve 148 of outer sheath 108, and the anatomic shape of the left ventricle, as well as the relationship of distal end 100 to shunt 30, are illustrated in FIGS. 7 and 8.
• Primary curve 146 and secondary curve 148 combine to form a three- dimensional bend profile, as shown in FIGS. 3 and 4.
• Curves 146 and 148 separate outer sheath 108 and define three distinct segments.
• a first segment 145 extends from hub 142 to primary curve 146.
• First segment 145 is predominantly straight and preferably sized to extend from the femoral stick to the bottom of the left ventricle.
• a second segment 147 extends between primary curve 146 and secondary curve 148.
• a preferred length of the second segment is in the range of 1 to 9 centimeters.
• a third segment 149 is defined between secondary curve 148 and distal end 100.
• a preferred length of the third segment is in the range of 0.5 to 3 centimeters.
• Outer sheath 108 is preferably made of a material that is flexible enough to allow catheter 14 to be straightened for insertion into and passage through the arterial path to the heart. At the same time, the material preferably has the elastic memory for returning to a pre-set shape, such as that shown in FIGS. 3 and 4.
• First segment 145, primary curve 146 and second segment 147 define a first plane AA.
• Primary curve 146 traverses an angle A in the range of one hundred forty to one hundred eighty degrees, preferably approximately one hundred and sixty degrees.
• secondary curve 148 traverses an angle B in the range of sixty to one hundred twenty degrees, most preferably approximately eighty degrees.
• Third segment 149 is inclined from plane AA by an angle C in the range often to fifty degrees, most preferably approximately 30 degrees. As shown in FIG. 4, third segment 149 is offset in a clockwise direction from second segment 147. In other embodiments, third segment 149 can be offset in a counter-clockwise direction from second segment 147. As shown in FIG. 4, third segment 149 is aligned along line 115 that does not intersect first segment 145. However, line 115 is preferably within a plane 117 (shown in FIG. 3) that intersects first segment 145 at an angle D in the range of sixty to one hundred forty degrees, most preferably approximately one hundred degrees.
• the preferred embodiment has outer sheath 108 made of medical grade thermoplastic elastomer resin. Other materials with similar qualities may be used for the outer sheath. It is also anticipated that the outer sheath will have no preset bends but may be capable of being formed into the above-described shape once the catheter has been inserted into the left ventricle.
• Inner catheter 106 includes a hub 152 at proximal end 150, a hollow catheter shaft 156 and distal end 104. At distal end 104 is attached expanding basket 102.
• Hub 152 includes a pair of wings 154 extending radially from hub 152 on opposite sides. Wings 152 permit the rotation and manipulation of inner tube 106 within outer sheath 108 and provide a reference for the user of catheter 14 as to the extent of movement and orientation of inner tube 106.
• Rings 158 aid the user in determining the relative extent of insertion of inner tube 106 within outer sheath 108.
• a series of circumferential reference rings 160 are also placed about catheter shaft 156. Rings 160 include a radio-opaque material so that a fluoroscope or similar device can be used during the insertion and manipulation of catheter 14 to determine the location of distal end of inner tube 106 within the patient's body.
• a fiber optical viewing system may be inserted within catheter shaft 156 with a viewing end located at the distal end of catheter 14 to provide visual imagery regarding the location of the distal end of catheter 14 and assist with its insertion and manipulation.
• Basket 102 is shaped so that in a collapsed form 116 (shown in FIG. 12), it can be inserted within outer sheath 108 and completely contained within outer sheath 108. Provision may be made for permitting passage of objects such as an optical fiber viewing system through the distal end 104 of inner tube 106 to the distal end of catheter 14, while collapsed basket 116 is held within outer sheath 108. Basket 102 is preferably sized and shaped to allow overlay on first end 34 of shunt 30 in heart wall 32 (see FIG. 11). A frustal conical shape is shown in FIG.
• Narrow end 112 of basket 102 is attached to distal end 104 of inner tube 106.
• Wide end 110 opens away from distal end 104 of inner tube 106 when basket 102 is allowed to expand.
• the preferred embodiment has basket 102 made of an elastic or super-elastic material such as nickel-titanium alloy. Other materials may be suitable for this application as well, as long as they have sufficient flexibility and resilience to permit being collapsed within outer sheath 108 and expending without additional influence when distal end 114 of outer sheath 108 is retracted.
• the gripping element may also be in the form of a lass-type snare.
• Inner tube 106 is preferably made of a material with sufficient column strength to permit the axially movement of inner tube 106 within outer sheath 108 and controlled manipulation of distal end 104 and basket 102 attached thereto when catheter 14 is within the heart of a patient.
• the preferred embodiment has inner tube 106 made of a medical grade thermoplastic elastomer resin. Other plastic and metallic materials may be used provided they have the required physical characteristics.
• the material used to construct inner tube 106 preferably has a degree of lubricity with respect to the inner surface of outer catheter 108 to promote smoother relative movement of the two catheter components. If inner tube 106 material does not have a sufficient lubricity with respect to outer sheath 108 material, a low friction coating material can be applied to inner tube 106 prior to insertion into outer sheath 108.
• Assembled catheter 14 including inner tube 106, outer sheath 108 and basket
• FIGS. 1 and 2 Inner tube 106 is axially slidably contained within outer sheath 108.
• assembled catheter 14 is shown with basket 102 extended from distal end 114 of outer sheath 108 and in a fully expanded shape.
• the relationship of hub 152 of inner tube 106 and hub 142 of outer sheath 108 is shown by way of an example. Other relative orientations of the hubs are possible as long as the user is provided with a consistent reference as to the relationship of distal end 104 of inner tube 106 and distal end 114 of outer sheath 108.
• FIGS. 7 through 14 the use of one embodiment of the catheter of the present invention to perform an endo vascular catheterization of a patient to access a shunt already in place in the left ventricle of the patient's heart will be described in detail.
• a preferred embodiment of the current invention involves a method of passing a radio-opaque chemical contrast fluid through a shunt which has been installed in the wall of a patient's heart for the purpose of allowing oxygenated blood to flow from within a chamber of the heart directly into a coronary artery.
• a common reason for performing such a task is to enable imaging of the heart and the blood flow in the arteries surrounding the heart to determine the efficacy of the shunt in providing improved flow in the coronary artery.
• the distal end of the catheter 14 is inserted into the femoral artery 10 of a patient, via a site 12 in the patient's groin.
• the distal end of catheter 14 (shown in FIG. 8) is then advanced along femoral artery 10 in retrograde fashion.
• catheter 14 is then directed into the descending aorta 16.
• catheter 14 is further advanced in retrograde fashion into the arch of aorta 18.
• Advancing through arch of aorta 18 retrograde the distal end of catheter 14 passes through the ascending aorta 20 directly into the heart 26.
• catheter 14 is advanced into a heart chamber 22 through the aortic valve 24.
• the catheterization has been to the left ventricle of a patient's heart.
• First segment 145 is preferably of sufficient length to permit the insertion of catheter 14 in femoral artery 10 of a patient and extension of catheter 14 into patient's heart 26.
• FIG. 8 an enlarged view of the left ventricle of the patient is shown, with the catheter 14 entering chamber 22 from ascending aorta 20 and a shunt 30 in place in the wall 32 of heart chamber 22 being shown.
• the basket 102 at distal sheath 108 as catheter 14 was inserted into heart chamber 22.
• Catheter 14 is advanced into heart 26 so that first segment 145 extends through aortic valve 24.
• Primary curve 146 rests substantially on the inferior wall of heart chamber 22 with second segment 147 extending superior within the chamber 22.
• Secondary curve 148 directs third segment 149 substantially anterior.
• Shunt 30 is located on the anterior wall of chamber 22 and includes two ends, the first end 34 (shown in FIG. 9) extending into heart chamber 22 through heart wall 32, and the second end 36 (shown in FIG. 9) extending into a coronary artery 38 (illustrated is the left anterior descending coronary artery). It is anticipated that second end 36 of shunt 30 may be placed in any of the coronary arteries extending across the left ventricle. First end 34 and second end 36 have openings 44 and 46, respectively, which are connected by an open passageway 40 through the center of the shunt. The first end of the shunt extends into the heart chamber beyond wall 32 of the heart. This protrusion of first end 34 facilitates the stabilization of the diagnostic catheter 14.
• Opening 46 in second end 36 is directed so that blood flowing through shunt 30 from heart 26 will exit opening 46 in the direction of normal blood flow in coronary artery 38, the direction of normal blood flow being shown by the arrow in FIGS. 9 through 14. Also in FIGS. 9 through 14, an occlusion 42 is shown in coronary artery 38 upstream from shunt 30. It is anticipated that catheters conforming with the present invention may be used with other stent configurations as well (e.g., valved, unvalved, natural graft, mesh, flexible rigid, etc.) Also, catheters conforming with the present invention could be used to access side anastomosis sites.
• third segment 149, secondary curve 148, second segment 147, primary curve 146 and a portion of first segment 145 of catheter 14 has entered heart chamber 22 via ascending aorta 20, distal end 100 can be directed to the vicinity of first end 34 of shunt 30 in heart wall 32, as shown in FIG. 9.
• the relative orientation of primary and secondary curves 146 and 148 and the angular offset of third segment 149 allow the distal end of catheter 14 to be directed to any of the interior of chamber 22.
• third segment 149 is coaxially aligned with first end 34.
• distal end 112 of outer sheath 108 When in position near first end 34 of shunt 30, distal end 112 of outer sheath 108 is retracted with respect to distal end 104 of inner tube 106 to uncover collapsed basket 116 attached to distal end 104 of inner tube 106, thus permitting collapsed basket 116 to expand to expanded basket 102, as shown in FIG. 10.
• Expanded basket 102 includes a wide end 110 which is cone shaped and located opposite of a narrow end 112, narrow end 112 being attached to distal end 104 of inner tube 106. Expanded basket 102 is of an open design so that wide end 110 and narrow end 112 are in fluid and physical communication with each other. Once expanded basket 102 has been allowed to expand, expanded basket 102 is positioned so that wide end 110 of expanded basket 102 overlays upon first end 34 of shunt 34 in heart wall 32, as shown in FIG. 11.
• distal end 114 of outer sheath 108 of catheter 14 is advanced with respect to distal end 104 of inner tube 106, so that distal end 114 of outer sheath 108 once again begins to interfere with expanded basket 102 and cause basket 102 to collapse, reverting back to collapsed basket 116.
• wide end 110 is narrowed until it contacts first end 34 of shunt 30 and captively holds distal end 100 of catheter 14 to shunt 30, as shown in FIG. 12.
• a radio-opaque fluid 120 can be passed through inner tube 106 of catheter 14 and flow straight through the distal end of catheter 14, into shunt 30 and into coronary artery 38, as shown in FIG. 13.
• FIG. 14 Another embodiment of the method of the invention is shown in FIG. 14.
• the steps are identical to the steps above, except, a wire 130 is passed though inner tube 106 and through shunt 30 into coronary artery 38 instead of radio-opaque fluid 120.
• Wire 130 can then be used as the foundation for performing a variety of other procedures within coronary artery 38 downstream of shunt 30. These procedures might include but not be limited to, inserting an arterial stent in the coronary artery, or performing angioplasty, atherectomy or pyroplasty in the coronary artery.
• FIGS. 15 through21 Further alternative embodiments for distal end 104 of inner tube 106 are shown in FIGS. 15 through21.
• FIGS. 15 tlirough 18 illustrate a trumpet 202, which operates in a similar fashion to basket 102.
• Trumpet 202 includes a narrow end 212 and a wide end 214, with narrow end 212 attached to distal end 104 of inner tube 106.
• FIG. 15 shows trumpet 202 configured for insertion into a patient, with wide end 214 inverted within the hollow interior of inner tube 106.
• a shaft 215 is extended through the interior of inner tube 106 to eject wide end 214 and allow trumpet 202 to expand, as shown in FIG. 16. Shaft 215 is then withdrawn from catheter shaft 156, as shown in FIG.
• FIGS. 19 through 21 show alternative embodiments of devices that may be attached at distal end 104 of inner tube 106 for injecting dye into heart chamber 22.
• FIG. 19 shows a bullet or torpedo shaped inner catheter distal end device 220 with a tapered or narrowed waist 226 attached at distal end 104 of inner tube 106.
• Inner catheter distal end device 230 shown in FIG. 20, provides an end to inner tube 106 cylindrically shaped with a series of similarly sized openings 232 along the sides and at the extreme distal end of the device.
• Device 230 is attached to distal end 104 of inner tube 106 and permits fluid to be injected through catheter 14 into heart chamber 22.
• FIG. 21 shows a balloon shaped inner catheter distal end device 240 attached to distal end 104 of inner tube 106.
• Device 240 incorporates a series of spaced-apart openings 242 which permit fluid to be injected through catheter 14 into heart chamber 22.
• Device 240 is held collapsed within outer sheath 108 until outer sheath 108 has entered heart chamber 22.
• Inner tube 106 is then extended relative to outer sheath 108 as shown in FIG. 21, allowing device 240 to expand into a balloon shape.
• catheter 310 with an outer sheath or catheter body 312 including a proximal end 314 and a distal end 316 is shown. Attached to catheter 310 at proximal end 314 is a handle 318.
• Catheter body 312 includes a distal segment 322, a first bending portion 324, a mid segment 326, a second bending portion 328 and a proximal segment 330. Segments 322, 326 and
• Bending portions 324 and 328 are made of a similar material with a lower durometer than segments 322, 326 and 330, meaning pending portions 324 and 328 are more easily bent, while segments 322, 326 and 330 are relatively more rigid. Bending portions 324 and 328 may be made of material of the same durometer, or alternatively, first bending portion 324 may be made of a lower durometer material than second bending portion 328.
• Handle 318 includes two tensioning mechanisms 320, discussed in more detail below, and an access port 332 allowing items to be introduced into catheter 310.
• Catheter body 312 includes an outer wall 334 which defines a central lumen 336 having a longitudinal central axis 338.
• Outer wall 334 defines an inner diameter ID and an outer diameter OD separated by a wall thickness T.
• Inner diameter ID is preferably at least 50% as large as outer diameter OD, more preferably at least 75% as large as outer diameter OD.
• Within wall thickness T of outer wall 334 are a first wire 342 in a first wire lumen 340 and a second wire 346 in a second wire lumen 344.
• First wire lumen 340 extends at least from handle 318 to a point distal to first bending portion 324.
• First wire 342 is attached to a first tensioning mechanism 320 in handle 318 and extends to a point immediately distal to first bending segment 324, where it is anchored within outer wall 334.
• First wire 342 is sized to slide freely within first wire lumen 340 except where first wire 342 is anchored to outer wall 334.
• a second wire 346 within a second wire lumen 344 is located in outer wall 334, offset from first wire 342 by an angle 348.
• Second wire 346 is attached to a second tensioning mechanism 320 in handle 318 and extends to a point immediately distal to second bending segment 328, where it is anchored within outer wall 334.
• Second wire 346 is sized to slide freely within second wire lumen 344 except where second wire 346 is anchored to outer wall 334. Applying tension to first wire 342 will cause first bending portion 324 to bend in an arc along a first plane 341 defined by central axis 338 of catheter body 312 and first wire lumen 340 in first bending segment 324. Applying tension to second wire 346 will cause second bending portion 328 to bend in an arc along a second plane 345 defined by central axis 338 and second wire lumen 344 in second bending portion 328. Angle 348 defines the degree of angular separation between planes 341 and 345.
• catheter 310 may include only first wire 342 within first wire lumen 340, with wire 342 anchored to outer wall 334 immediately distal first bending segment 324 and attached to a tensioning mechanism 320 within handle 318.
• first bending portion 324 By using material of lower durometer in first bending portion 324 relative to the material used in second bending segment 328, applying tension to wire 342 will initially cause first bending portion 324 to bend in an arc along plane 341. As first bending portion 324 nears its degree of maximum bend, second bending portion 328 will begin to bend in an arc along plane 341.
• FIGS. 24 through 26 and 28 show several alternative embodiments of a catheter in accordance with the present invention. All of these alternative embodiments include an outer wall 334 defining a central lumen 336 having a longitudinal central axis 338.
• FIG. 24 shows a first alternative catheter body 412 which includes four wire lumens 442, 446, 450 and 454, with four wires 444, 448, 452 and 456, respectively, equally spaced apart about outer wall 336. Each wire 444, 448, 452 or 456 is anchored immediately distal of a bending portion.
• FIG. 28 is a longitudinal cross-section taken along line 28-28 in FIG.
• first bending portion 324 can be bent up by applying tension to wire 442, or down by applying tension to wire 452.
• Wires 444 and 454 are similarly opposed and attached immediately distal of second bending portion 328, allowing second bending portion to be moved toward either wire by applying tension to that wire.
• FIGS. 25 and 26 show alternative embodiments 512 and 612, respectively, of a catheter body in accordance with the present invention.
• Catheter bodies 512 and 612 incorporate flat tensioning members 542, 546, 642, 646, 650 and 656, in place of the round wires in the embodiments in the earlier FIGS.
• Catheter body 512 in FIG. 25 is similar to catheter 310 in FIG. 23, including an outer wall 334 defining a central lumen 336 with a central axis 338.
• a first tensioning member 542 is within a first tensioning lumen 540 and a second tensioning member 546 is within second tensioning lumen 544.
• first tensioning member 542 will cause first bending portion 324 to bend in an arc along a first plane 541 defined by central axis 338 of catheter body 512 and first tensioning lumen 540 in first bending segment 324.
• Applying tension to second tensioning member 546 will cause second bending portion 328 to bend in an arc along a second plane 545 defined by central axis 338 and second tensioning lumen 544 in second bending portion 328.
• Angle 548 defines the degree of angular separation between planes 541 and 545.
• Catheter body 612 in FIG. 26 is similar to catheter body 412 in FIG. 24, with four tensioning members 642, 646, 650 and 656, within four tensioning lumen 640, 644, 648 and 654, spaced about outer wall 334.
• FIGS. 29 through 31 illustrate in more detail the angles through which bending segments of catheter 310 may be bent by applying tension to wires or tensioning members within outer wall 334.
• Second bending portion 328 is bent through an angle to form a primary curve 374.
• First bending portion 324 is bent through an angle to form a secondary curve 376.
• Primary curve 374 and secondary curve 376 lie in planes 345 and 341, respectively, and are thus offset from each other by angle 348. This angular offset allows distal segment 322 to overlap and cross proximal segment 330 as shown in FIG. 31.
• Primary curve 374 traverses an angle in the range of one hundred forty to one hundred eighty degrees, preferably approximately one hundred and sixty degrees.
• Secondary curve 376 traverses an angle in the range of sixty to one hundred twenty degrees, most preferably approximately eighty degrees. As shown in FIG. 23, angle 348 is offset in a clockwise direction from plane 341 to plane 345. In other embodiments, angle 348 can be offset in a counter-clockwise direction, such that distal segment 322 in FIG. 31 would pass on the other side of proximal segment 330.
• Proximal segment 330 is predominantly straight and preferably sized to extend from a femoral stick to a desired site within a patient's body. Length of segments 322 and 324 will vary depending on the site to be accessed within a patient's body. For use of catheter 310 to access sites within a patient's heart, length of mid segment 326 is preferably in the range of 1 to 9 centimeters. Similarly, for use of catheter 310 to access sites within a patient's heart, length of distal segment 322 is preferably in the range of 0.5 to 3 centimeters. Referring now to FIGS.
• catheter 310 is inserted into the femoral artery 354 of a patient, via a site 352 in the patient's groin.
• Distal end 316 of catheter 310 is then advanced along femoral artery 354 in retrograde fashion.
• catheter 310 is then directed into the descending aorta 356.
• catheter 310 is further advanced in retrograde fashion into the arch of aorta 358. Advancing through arch of aorta 358 retrograde, distal end 316 of catheter 310 passes through the ascending aorta 360 directly into the heart 350.
• catheter 310 is advanced into a heart chamber 364 through the aortic valve 362.
• Proximal segment 330 is preferably of sufficient length to permit the insertion of catheter 310 in femoral artery 354 of a patient and extension of catheter 310 into patient's heart 350.
• FIG. 33 an enlarged view of the left ventricle of the patient is shown, with the catheter 310 entering chamber 364 from ascending aorta 360 and a shunt 370 in place in the wall 366 of heart chamber 364 being shown.
• FIGS. 34 through 37 shows catheter 310 in place and unbent within heart chamber 364. Tension is applied to first wire 342 to form first bending portion 324 into secondary curve 376, as shown in FIG. 35. Tension is next applied to second wire 48 to begin forming second bending portion 328 into primary curve 374, as shown in FIG. 35.
• catheter 310 is advanced further into heart chamber 364 so that second bending portion 28 is resting against wall 366, providing support to improve the stability and manipulation of catheter 310 to place distal end 316 proximate shunt 370 in heart wall 366.
• catheter 310 has had bending portions 324 and 328 formed into secondary and primary curves 374 and 376, respectively, which are resting against heart wall 366 to position distal end 316 proximate shunt 370 and allow a snare such as basket 372 or some other type of snare, to be extended from within central lumen 36 and capture and end of shunt 370 extending into chamber 364.
• Positioning of distal end 316 proximate the shunt within heart wall 366 can be accomplished by rotating catheter handle 318 and varying the degree of curvature of secondary curve 376 and primary curve 374 by varying the tension in wires 342 and 346, respectively.
• a snare such as basket 372
• distal end 316 can be moved directly proximate shunt 370 to allow radio- opaque contrast to be injected through shunt 370, to access coronary artery 368 at a point downflow from the shunt 370 or to perform other diagnostic procedures.
• catheter 310 can be used to access other locations within a patient's body and that the length of proximal segment 330, mid segment 326 and distal segment 322 may be varied to suit the location desired to be accessed.
• amount of bend available to form primary curve 374 and secondary curve 376 in bending portions 328 and 324 may be varied to suit the location to be accessed.
• angle 348 defining the angular separation between first plane 341 and second plane 345 may be varied to suit accessing a different location. While its preferred use is for coronary diagnostic procedures, the present invention can be used for other medical procedures where precise control of a catheter tip is desired. It will be appreciated that the size, shape and bend locations can be varied to correspond to different applications.
• handle 18 is shown in detail for use with catheter 310, permitting tension to be applied to wires or tensioning members within outer wall 334.
• Handle 318 is shown with two slides 320, each of which may be moved along an opening 380 and which are attached to first and second wires 342 and 346 by anchors 382. Moving a slide 320 proximally along opening 380 applies tension to the wire attached to that slide, while moving the same slide 320 distally will release tension in the attached wire.
• Anchors 382 include an extension 378 which rides along an internal guide 384.
• catheter body 312 extends through handle 318, with proximal end 314 at the rear of handle 318 where a port 332 is mounted. Port 332 allows access to the central lumen 336 for inserting tools, diagnostic devices, fluids or other similar objects into catheter 310 for insertion within the patient's body at the site being accessed with catheter
• slides 320 While slides 320 are shown on opposite sides of handle 318, slides 320 may be attached to wires 342 and 346 which have an angular offset of less than one hundred eighty degrees. Handle 318 may be used with any single or dual wire embodiment of a catheter in accordance with the present invention.
• a locking mechanism such as a thumb screw or other releasable device, not shown in the FIGS., may be used to hold slide 320 so that the desired amount of tension is being applied to wire 342 or 346.
• FIG. 40 shows an alternative handle 418, which provides a single slide 320 for applying tension to a wire 342.
• FIG. 41 shows another alternative handle 518, similar to 418 in that only a single actuator 388 is provided to apply tension to wire 342.
• Actuator 388 actuates a ratcheting mechanism 386 to apply tension to wire 342 and hold a desired amount of tension.
• the ratchet releases the tension on the wire, allowing the bending segments of the catheter to return to their original shapes.
• Sliding actuator 388 proximally and releasing it causes ratchet 386 to increase and hold tension in wire 342.
• FIG. 42 also shows an alternative handle 618, which is adapted to provide tension to a single wire 342 of catheter 310.
• Handle 618 includes a trigger-style actuator 392 to apply tension to wire 342.
• Actuator 392 actuates a ratcheting mechanism 390 to apply, hold and release tension on wire 342, in a similar fashion as that described above with regard to actuator 388 and ratchet 386.
• FIG. 43 shows a further alternative handle 718, which incorporates two actuators 388 actuating two ratcheting mechanisms 386 to apply, hold and release tension on wires 342 and 346.
• FIG. 44 shows a further embodiment handle 818, which incorporates two trigger- style actuators 392 actuating two ratcheting mechanisms 390 to apply, hold and release tension on wires 342 and 346.
• handle 318 is anticipated which will incorporate actuators and tensioning mechanisms for each of the wires or tensioning devices which may be within outer wall 334 of a catheter 310.

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