Interventional diagnostic catheter and a method for using a catheter to access artificial cardiac shunts

• US 20030036698A1
• Filed: 08/16/2001
• Published: 02/20/2003
• Est. Priority Date: 08/16/2001
• Status: Abandoned Application

• Current Assignee: Percardia, Inc.
• Original Assignee: Percardia, Inc.
• Inventors: Conrad, Timothy R., Mowry, David, Kohler, Robert
• Application Number:
  US09/931,655
• Publication Number:
  US 20030036698A1
• Time in Patent Office: Days
• US Class Current: 600/435
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 6/481 involving the use of contrast agents
• CPC Class Codes: A61B 6/504 for diagnosis of blood vessels, e.g. by angiography
• CPC Class Codes: A61B 6/507 for determination of haemodynamic parameters, e.g. perfusion CT
• CPC Class Codes: A61M 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 25/0041 pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 25/0069 Tip not integral with tube
• CPC Class Codes: A61M 25/0119 Eversible catheters
• CPC Class Codes: A61M 25/0136 Handles therefor

Abstract

One aspect of the present invention relates to a method for passing a fluid through a shunt located in the wall of a heart, the shunt providing fluid communication between a heart chamber and a coronary artery, with a hollow catheter. Another aspect of the present invention relates to a method of inserting a wire through a shunt located in the wall of a heart with a hollow catheter. A further aspect of the present invention relates to passing fluid through a shunt located in the wall of a heart, the shunt providing fluid communication between a heart chamber and a coronary artery, by injecting fluid into the heart chamber. 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 invention 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.

Claims

1. A method of passing a fluid through a shunt in a heart wall of a heart, the heart wall having inner and outer sides, the shunt being in fluid communication with a coronary artery, the shunt extending at least partially through the heart wall, the method comprising the steps of:

providing a hollow catheter, a distal end of which extends into a chamber of the heart where the shunt is located;

aligning the distal end of the catheter with the first end of the shunt; and

passing the fluid through the distal end of the catheter and through the shunt into the coronary artery.

2. The method of claim 1, wherein a portion of the shunt protrudes beyond the inner side of the heart wall into a chamber of the heart, and the method further comprising releasably attaching the distal end of the catheter to the protruding portion of the shunt, and passing the fluid through the distal end of the catheter and through the shunt into the coronary artery after attachment.

3. A method of inserting a wire through a shunt in a heart wall of a heart, the heart wall having inner and outer sides, the shunt being in fluid communication with a coronary artery, the shunt extending at least partially through the heart wall, the method comprising the steps of:

providing a hollow catheter, a distal end of which extends into a chamber of the heart where the shunt is located;

aligning the distal end of the catheter with the shunt; and

inserting the wire through the distal end of the catheter and through the shunt into the coronary artery.

4. The method of claim 3, wherein a portion of the shunt protrudes beyond the inner side of the heart wall into a chamber of the heart, and the method further comprising releasably attaching the distal end of the catheter to the protruding portion of the shunt, and inserting the wire through the distal end of the catheter and through the shunt into the coronary artery after attachment.

5. A method of passing diagnostic fluid through a shunt in a heart wall, the shunt extending through the heart wall and providing fluid communication between a heart chamber and a blood vessel located adjacent an outer side of the heart wall, the method comprising the steps of:

positioning a catheter within the heart chamber; and

while the catheter is in the heart chamber, directing the diagnostic fluid from the catheter through the shunt and into the vessel.

6. The method of claim 5, further comprising the step of aligning a distal end of the catheter with the shunt prior to directing the diagnostic fluid through the catheter.

7. The method of claim 6, further comprising the step of releasably attaching a distal end of the catheter with the shunt prior to directing the diagnostic fluid through the catheter.

8. The method of claim 5, wherein a portion of the catheter proximate the distal end comprises a narrow-waisted structure with one or more openings spaced about the structure and the catheter includes an opening at the distal end, the openings allowing the diagnostic fluid to pass into the heart chamber.

9. The method of claim 5, wherein a portion of the catheter proximate the distal end comprises a cylindrical structure including one or more openings spaced about the structure and the catheter includes an opening at the distal end, the openings allowing the diagnostic fluid to pass into the heart chamber.

10. The method of claim 5, wherein a portion of the catheter proximate the distal end comprises a balloon-shaped structure including one or more openings spaced about the structure, the openings allowing the diagnostic fluid to pass into the heart chamber.

11. The method of claim 5, wherein the diagnostic fluid is a radio-opaque contrast fluid.

12. A catheter comprising:

a flexible first catheter member defining at least one lumen, the first catheter having a distal end and a proximal end;

a self-expanding element mounted to the distal end of the first catheter, the self-expanding element being movable between an expanded orientation and a compressed orientation, the self-expanding element being sized for insertion through a patient'"'"'s vasculation when in the compressed orientation, the self-expanding element defining an inner cavity when in the expanded orientation, the inner cavity having a first cross-sectional area adjacent the distal end of the first catheter member and a second cross-sectional area distally spaced apart from the distal end of the first catheter member, the second cross-sectional area being larger than the first cross-sectional area.

13. The catheter of claim 12, further comprising an outer sheath for moving the self-expanding element between the expanded orientation and the compressed orientation.

14. The catheter of claim 13, wherein the self-expanding element comprises a mesh basket.

15. The catheter of claim 14, wherein the cavity defines a frustal conical shape in the expanded orientation having minor diameter at the distal end of the first catheter member and major diameter distally spaced apart from the distal end of the first catheter member.

16. The catheter of claim 13, wherein the cavity has a cross-sectional area that gradually increases as the self-expanding element extends distally from the distal end of the first catheter member.

17. The catheter of claim 13, wherein the outer sheath is slidable is an axial direction relative to the first catheter member.

18. A method of passing radio-opaque contrast fluid through a shunt in a heart wall, for the purpose of enhancing cardiac imaging techniques, the method comprising:

(a) providing a catheter including;

(1) an outer sheath with a continuous hollow core, defining inner and outer walls, and distal and proximal ends;

(2) an inner tube with a continuous hollow core including a collapsible, gripping element at a distal end,

(3) the gripping element having a narrow end attached to the distal end of the inner tube and an expanding wide end positioned opposite the narrow end, the narrow end including an opening aligned with the hollow core of the inner tube;

(4) the inner tube being slidably contained within the outer sheath; and

,

(5) the distal end of the inner tube being withdrawn into the distal end of the outer sheath so that the gripping element is maintained in a collapsed position;

(b) inserting a distal end of the catheter into a femoral artery of a patient;

(c) after inserting the catheter into the femoral artery, advancing the distal end along the femoral artery, through the descending aorta and the ascending aorta, and into a heart chamber containing oxygenated blood where the shunt in the heart wall is located;

(d) the shunt being in fluid communication with the heart chamber and a coronary artery, allowing oxygenated blood from the heart chamber to flow through the heart wall and into the coronary artery, wherein the heart wall defines inner and outer faces, and wherein the shunt has a first end including a portion protruding beyond the inner face and into the heart chamber, and a second end which is connected with the coronary artery;

(e) after directing the catheter into the heart chamber, directing the distal end of the catheter to a position proximate the portion of the first end of the shunt protruding into the heart chamber;

(f) after positioning the distal end of the catheter proximate the first end of the shunt, retracting the distal end of the outer sheath with respect to the distal end of the inner tube so as to extend the expanding gripping element beyond the distal end of the outer sheath and permit the gripping element to expand within the heart chamber;

(g) after allowing the gripping element to expand, directing the distal end of the inner tube with the gripping element attached proximate to and overlaying the protruding first end of the shunt;

(h) after positioning the gripping element proximate to and overlaying the protruding first end of the shunt, extending the outer sheath with respect to the inner tube, without disturbing the position of the gripping element, so that the inner wall of the outer sheath interferes with the gripping element, causing the gripping element to collapse about and securely hold the protruding first end of the shunt;

(i) after capturing the protruding first end of the shunt, passing the radio-opaque contrast material through the hollow core of the inner tube from the proximal end so that the radio-opaque contrast material flows through the catheter, through the gripping element, through the shunt and into the coronary artery;

(j) while passing the radio-opaque contrast material through the shunt into the coronary artery, performing a cardiac imaging technique to observe the magnitude and extent of blood flow in the coronary artery;

(k) while the protruding first end of the shunt is held by the gripping element, withdrawing the outer sheath with respect to the inner tube so that the inner wall of the outer sheath no longer holds the gripping element collapsed about and secured to the protruding first end of the shunt, allowing the gripping element to expand and release the protruding first end of the shunt;

(l) after the gripping element has released the protruding first end of the shunt, moving the distal end of the catheter to a position within the heart chamber not overlaying the protruding first end of the shunt and extending the outer sheath with respect to the inner tube so that the inner wall of the outer sheath causes the gripping element to collapse and the gripping element to be contained wholly within the outer sheath; and

(m) extracting the distal end of the catheter from the heart chamber, from the aorta and from the femoral artery, removing the catheter from the patient.

19. The method of claim 18, wherein the heart chamber containing oxygenated blood is the left ventricle.

20. A method of inserting a wire through a shunt in a heart wall connecting to a coronary artery, the method comprising:

(a) providing a catheter including;

(1) an outer sheath with a continuous hollow core, defining inner and outer walls, and distal and proximal ends;

(2) an inner tube with a continuous hollow core including a collapsible, self-expanding gripping element at a distal end,

(3) the gripping element having a narrow end attached to the distal end of the inner tube and an expanding wide end positioned opposite the narrow end, the narrow end including an opening aligned with the hollow core of the inner tube;

(4) the inner tube being slidably contained within the outer sheath; and

,

(5) the distal end of the inner tube withdrawn into the distal end of the outer sheath so that the gripping element is maintained in a collapsed position;

(b) inserting the distal end of the catheter into a femoral artery of a patient;

(c) after inserting the catheter into the femoral artery, advancing the distal end along the femoral artery, through the descending aorta and the ascending aorta, and into a heart chamber containing oxygenated blood where the shunt in the heart wall is located;

(d) the shunt being in fluid communication with the heart chamber and the coronary artery, allowing oxygenated blood from the heart chamber to flow through the heart wall and into the coronary artery, wherein the heart wall defines inner and outer faces, and wherein the shunt has a first end extending through the heart wall, a portion of the first end protruding beyond the inner face and into the heart chamber, and a second end which is connected with the coronary artery;

(e) after directing the catheter into the heart chamber, directing the distal end of the catheter to a position proximate the portion of the first end of the shunt protruding into the heart chamber;

(f) after positioning the distal end of the catheter proximate the first end of the shunt, retracting the distal end of the outer sheath with respect to the distal end of the inner tube so as to extend the expanding gripping element beyond the distal end of the outer sheath and permit the gripping element to expand within the heart chamber;

(g) after allowing the gripping element to expand, directing the distal end of the inner tube with the gripping element attached proximate to and overlaying the protruding first end of the shunt;

(h) after positioning the gripping element proximate to and overlaying the protruding first end of the shunt, extending the outer sheath with respect to the inner tube, without disturbing the position of the gripping element, so that the inner wall of the outer sheath interferes with the gripping element, causing the gripping element to collapse about and securely hold the protruding first end of the shunt;

(i) after capturing the extended leg of the shunt, inserting the wire through the hollow core of the inner tube so that the wire extends through the catheter, through the gripping element and through the shunt into the coronary artery;

(j) while the protruding first end of the shunt is held by the gripping element, withdrawing the outer sheath with respect to the inner tube so that the inner wall of the outer sheath no longer holds the gripping element collapsed about and secured to the protruding first end of the shunt, allowing the gripping element to expand and release the protruding first end of the shunt;

(k) after the gripping element has been removed from the protruding first end of the shunt and while the wire extends through the inner tube and through the shunt into the coronary artery, moving the distal end of the catheter to a position within the heart chamber not overlaying the protruding first end of the shunt and retracting the distal and of the inner tube with respect to the distal end of the outer sheath so that the inner wall of the outer sheath causes the gripping element to collapse and the gripping element to be contained within the outer sheath, then withdrawing the inner tube from the outer sheath at the proximal end, leaving the outer sheath and the wire in place within the patient;

(l) with the outer sheath extending into the heart chamber and the wire extending through the catheter into the shunt, withdrawing the wire from the shunt and the outer sheath from the proximal end of the catheter; and

(m) extracting the distal end of the catheter from the heart chamber, from the aorta and from the femoral artery, removing the catheter from the patient.

21. The method of claim 20, wherein once the inner tube has been removed and while the wire extends through the hollow core of the outer sheath of the catheter and extends through the shunt, and the outer sheath extends into the heart chamber, performing angioplasty, atherectomy or pyroplasty at a site within the coronary artery downstream of the shunt.

22. The method of claim 20, wherein once the inner tube has been removed and while the wire extends through the hollow core of the outer sheath of the catheter and extends through the shunt, and the outer sheath extends into the heart chamber, inserting a stent at a site within the coronary artery downstream of the shunt.

23. The method of claim 20, wherein the heart chamber is the left ventricle.

24. A catheter comprising:

(a) an inner tube, including;

(1) a hollow cored member defining distal and proximal ends;

(2) an expanding, collapsible gripping element attached at the distal end, the gripping element having a narrow end attached to the distal end of the inner tube and an expanding wide end positioned opposite the narrow end and the narrow end including an opening aligned with the hollow core of the inner tube;

(3) a hub attached at the proximal end;

(4) the hub including an opening aligned with the hollow core of the inner tube;

(b) an outer sheath including;

(1) a hollow cored member defining an inner wall, an outer wall, a distal end and a proximal end;

(2) a hub attached to the proximal end;

(3) the hub including an opening aligned with the hollow core of the outer sheath; and

(c) wherein the inner tube is slidably contained within the inner wall of the outer sheath, so that when the distal end of the inner tube is contained with the inner wall, the expanding gripping element is held in a collapsed position within the outer sheath.

25. The catheter of claim 24, wherein the hollow cored member of the outer sheath defines a primary curve and a secondary curve, a first length between the hub and the primary curve, a second length between the primary curve and the secondary curve, and a third length between the secondary curve and the distal end of the outer sheath.

26. The catheter of claim 25, wherein the primary curve traverses an arc in the range of one hundred forty to one hundred eighty degrees and the first and second lengths of the hollow cored member define a first plane, and the second arc traverses an arc in the range of sixty to one hundred twenty degrees in the direction of the first length of the hollow cored member and a second plane defined by the second and third lengths of the hollow cored member lies at an angle in the range of ten to fifty degrees from the first plane.

27. The catheter of claim 25, wherein the hollow cored member of the outer sheath is made of medical grade thermoplastic elastomer resin.

28. The catheter of claim 25, wherein the inner hollow member is made of medical grade thermoplastic elastomer resin.

29. The catheter of claim 25, wherein the inner hollow member is made of flexible metallic material.

30. The catheter of claim 25, wherein the collapsible gripping element is made of a Nickel Titanium alloy.

31. The catheter of claim 25, wherein the inner tube includes a radio-opaque marker band circumferentially placed about the inner tube at the distal end immediately adjacent to the gripping element and additional radio-opaque marker bands circumferentially about the inner tube equally spaced with respect to the distal marking band.

32. The catheter of claim 25, wherein the inner tube hub incorporates a strain relief device.

33. The catheter of claim 24, wherein the hollow cored member of the outer sheath is substantially linear and may be formed into a shape including a primary curve and a secondary curve, a first length between the hub and the primary curve, a second length between the primary curve and the secondary curve, and a third length between the secondary curve and the distal end of the outer sheath, wherein the primary curve traverses an arc in the range of one hundred forty to one hundred eighty degrees and the first and second lengths of the hollow cored member define a first plane, and the second arc traverses an arc in the range of sixty to one hundred twenty degrees in the direction of the first length of the hollow cored member and a second plane defined by the second and third lengths of the hollow cored member lies at an angle in the range of ten to fifty degrees from the first plane.

34. A catheter comprising:

a flexible inner tube defining at least one lumen, the inner tube having a distal end and a proximal end;

a shunt locating element mounted to the distal end of the inner catheter, the shunt locating element being sized for insertion through a patient'"'"'s vasculation, the shunt locating element being configured to releasably attach to a shunt; and

an outer sheath mounted about the inner tube, the inner tube being axially slidable with respect to the outer sheath.

35. The catheter of claim 34, wherein the shunt locating element is a self-expanding basket.

36. A catheter comprising:

a hollow outer sheath defining an interior and an exterior;

a hollow, flexible inner tube defining at least one lumen, the inner tube having an interior space, a distal end and a proximal end;

the inner tube slidably held within the interior of the outer sheath;

a hollow device mounted to the distal end of the inner tube, the device providing fluid communication through the device via a series of axially spaced apart openings.

37. The catheter of claim 36, wherein the device is bullet shaped and includes an opening defined at an end opposite the distal end of the inner tube.

38. The catheter of claim 36, wherein the device is cylindrical in shape and includes an opening defined at an end opposite the distal end of the inner tube.

39. The catheter of claim 36, wherein the device is collapsible, self-expanding and generally spherical in shape, the device having a diameter larger than the interior of the outer sheath and collapsible to fit within the interior of the outer sheath.

40. A catheter comprising:

a catheter body having a pre-set shape including a primary curve and a secondary curve, the pre-set shape also including an intermediate segment connecting the primary and secondary curves and a distal-most segment projecting from the secondary curve, the intermediate segment and the primary curve defining a plane, the distal-most segment being offset from the plane, and the pre-set shape being sized to fit within the left ventricle of a human.

41. A catheter comprising:

a catheter body including a distal end, a proximal end, a pre-set primary curve and a pre-set secondary curve, a first segment extending from the proximal end to the primary curve, a second segment extending from the primary curve to the secondary curve, and a third segment extending from the secondary curve to the distal end, the third segment being co-linear with a line offset from the first segment, the line being positioned within a plane that intersects the first segment at an angle in the range of sixty to one hundred forty degrees.

42. A catheter comprising:

a catheter body including a distal end and a proximal end, the catheter body being shapeable proximate the distal end to form a primary curve and a secondary curve;

the catheter body including a first segment extending from the proximal end to the primary curve, a second segment extending from the primary curve to the secondary curve, and a third segment extending from the secondary curve to the distal end, the third segment being co-linear with a line offset from the first segment, the line being positioned within a plane that intersects the first segment at an angle in the range of sixty to one hundred forty degrees.