Steering engagement catheter devices, systems, and methods

• US 9,901,710 B2
• Filed: 08/13/2008
• Issued: 02/27/2018
• Est. Priority Date: 04/27/2007
• Status: Active Grant

• Current Assignee: CVDEVICES, LLC
• Original Assignee: CVDEVICES, LLC
• Inventors: Kassab, Ghassan S., Navia, Sr., Jose A.
• Primary Examiner(s): PATEL, SHEFALI DILIP
• Application Number:
  US12/866,433
• Publication Number:
  US 20110144572A1
• Time in Patent Office: 3,485 Days
• Field of Search: 604 27, 604 28, 604 35, 604 43, 604 44, 604506, 604507, 604508, 604510, 604 9501, 604 9504, 604104, 60416401, 60416409, 6041641, 60416411, 60416413, 60417003
• CPC Class Codes: A61B 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61M 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 2025/0006 which can be secured against axial movement, e.g. by using a locking cuff
• CPC Class Codes: A61M 2025/0024 Expandable catheters or sheaths
• CPC Class Codes: A61M 2025/0036 with more than four lumina
• CPC Class Codes: A61M 2025/0039 characterized by lumina being arranged coaxially
• CPC Class Codes: A61M 2025/004 characterized by lumina being arranged circumferentially
• CPC Class Codes: A61M 2025/015 Details of the distal fixation of the movable mechanical means
• CPC Class Codes: A61M 2025/0161 wherein the distal tips have two or more deflection regions
• CPC Class Codes: A61M 25/003 characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves catheter tips A61M25/0067
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0071 Multiple separate lumens multiple separate lumens throughout the catheter A61M25/0026
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/0084 being one or more injection needles
• CPC Class Codes: A61M 25/0105 Steering means as part of the catheter or advancing means; Markers for positioning systems for detection of markers A61B
• CPC Class Codes: A61M 25/0133 : Tip steering devices
• CPC Class Codes: A61M 25/0147 : with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 29/02 : Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: A61N 1/0587 : Epicardial electrode systems; Endocardial electrodes piercing the pericardium
• CPC Class Codes: C12Q 1/6888 : for detection or identification of organisms

Abstract

Steering engagement catheter devices, systems, and methods of using the same for accessing a tissue, including internal and external tissues of a heart, are disclosed. In at least one embodiment, a steering engagement catheter is provided, comprising an elongated tube having a proximal end, a distal end, and a first wall positioned circumferentially along a length of the elongated tube, the elongated tube configured such that a delivery catheter is capable of at least partial insertion into the elongated tube, at least one steering wire having a proximal end and a distal end, the distal end of the at least one steering wire coupled to the first wall of the elongated tube at or near the distal end of the elongated tube, and a controller operably coupled to the at least one steering wire at or near the proximal end of the at least one steering wire.

Claims

1. A steering engagement catheter, comprising:

an elongated tube having a proximal end, a distal end, and a first wall positioned circumferentially along a length of the elongated tube, the elongated tube configured such that a device is capable of at least partial insertion into the elongated tube;

at least one steering wire having a proximal end and a distal end, the distal end of at least one of the at least one steering wire attached directly to the first wall of the elongated tube at an attachment site located at or near the distal end of the elongated tube and at least one of the at least one steering wire anchored to the first wall of the elongated tube at one or more anchor positions, each of the one or more anchor positions coupled with and extending inwardly from the first wall at a location other than the distal end of the elongated tube; and

a controller operably coupled to the at least one steering wire at or near the proximal end of the at least one steering wire, the controller positioned along the elongated tube at or near the proximal end of the elongated tube;

wherein the elongated tube is configured to reversibly engage a tissue at the distal end of the elongated tube when the distal end of the elongated tube contacts the tissue and a vacuum is applied through the elongated tube; and

wherein the elongated tube is configured to bend in a same direction in at least two distinct places in response to movement of one or more of the at least one steering wire.

2. The steering engagement catheter of claim 1, wherein the at least one steering wire anchored to the first wall of the elongated tube at the one or more anchor positions slidingly engages each of the one or more anchor positions.

3. The steering engagement catheter of claim 2, wherein operation of the controller causes the at least one steering wire to slide along the one or more anchor positions, causing the elongated tube to bend in response to movement of the at least one steering wire.

4. The steering engagement catheter of claim 2, wherein:

the one or more anchor positions comprises two or more anchor positions, and wherein operation of the controller causes one or more of the at least one steering wire to slide along the two or more anchor positions and the elongated tube to bend in the at least two distinct places in the same direction in response to movement of the at least one steering wire; and

the steering engagement catheter is configured for a percutaneous intravascular insertion into a patient.

5. The steering engagement catheter of claim 2, wherein operation of the controller in a first direction of the controller causes the at least one steering wire to slide along the one or more anchor positions in a direction toward the controller, causing the elongated tube to bend in a first direction of the elongated tube.

6. The steering engagement catheter of claim 2, wherein operation of the controller in a second direction causes the at least one steering wire to slide along the one or more anchor positions in a direction away from the controller, causing the elongated tube to straighten at least partially from an initially bent configuration.

7. The steering engagement catheter of claim 1, wherein the at least one steering wire comprises two or more steering wires, with a distal end of a first steering wire attached directly to the first wall of the elongated tube at an attachment site located at or near the distal end of the elongated tube, the first steering wire anchored to and slidingly engaged with the elongated tube at two or more anchor positions coupled with and extending from the first wall of the elongated tube at locations other than the distal end of the elongated tube, and wherein the two or more steering wires are each positioned within a single lumen defined within the elongated tube.

8. The steering engagement catheter of claim 1, wherein the at least one steering wire comprises two steering wires, wherein the controller comprises a first handle coupled to one of the two steering wires at or near a proximal end of the one of the two steering wires, and wherein the controller comprises a second handle coupled to the other of the two steering wires at or near a proximal end of the other of the two steering wires.

9. The steering engagement catheter of claim 1, wherein the controller comprises a rotatable spool coupled to the at least one steering wire at or near the proximal end of the at least one steering wire, the rotatable spool operable to collect and dispense the at least one steering wire, wherein the rotatable spool is coupled to a rotatable dial so that rotation of the rotatable dial causes rotation of the rotatable spool, and wherein rotation of the rotatable spool causes the elongated tube to bend in response to movement of the at least one steering wire.

10. The steering engagement catheter of claim 1, further comprising a skirt operatively connected to the distal end of the elongated tube, the skirt comprising a proximal end having a circumference substantially similar to an outer circumference of the elongated tube, the skirt further comprising a distal end having a circumference larger than the outer circumference of the elongated tube.

11. The steering engagement catheter of claim 10, wherein the skirt comprises a deformable configuration, and wherein the deformable configuration of the skirt is capable of expanding to an expanded configuration.

12. The steering engagement catheter of claim 1, wherein the elongated tube further comprises:

a second wall positioned circumferentially along the length of the elongated tube, wherein the first wall and the second wall form at least one suction channel along the length of the elongated tube between the first wall and the second wall;

a vacuum port in communication with the proximal end of the elongated tube, the vacuum port being operatively connected to the at least one suction channel and capable of operative connection to a vacuum source;

and a suction port in communication with the at least one suction channel at the distal end of the elongated tube, the suction port configured to engage a surface of the tissue.

13. The steering engagement catheter of claim 12, further comprising at least one internal lumen support positioned within the at least one suction channel and attached to the first wall and the second wall, the at least one internal lumen support extending from the distal end of the elongated tube along at least a substantial portion of the length of the elongated tube.

14. The steering engagement catheter of claim 12, further comprising an injection channel formed along the length of the elongated tube, the injection channel having at a distal end of the injection channel at least one opening for administering a fluid to the tissue, the injection channel being capable of operable attachment to an external fluid source at a proximal end of the injection channel, such that the fluid from the external fluid source can flow through the injection channel to the tissue when the external fluid source is operatively attached to the injection channel.

15. The steering engagement catheter of claim 1, wherein the at least one steering wire is present within a first lumen, and wherein the elongated tube is configured so that the vacuum can be applied through the first lumen to facilitate engagement of the tissue.

16. A system for use with a vacuum source for engaging a tissue, the system comprising:

a steering engagement catheter, comprising;

an elongated tube having a proximal end, a distal end, and first and second walls positioned circumferentially along a length of the elongated tube, the first and second walls defining first and second lumens extending between the proximal end and the distal end of the elongated tube;

a vacuum port located at or near the proximal end of the elongated tube, the vacuum port being operatively connected to the first lumen of the elongated tube and capable of operative connection to the vacuum source;

a suction port located at or near the distal end of the elongated tube, the suction port being operatively connected to the first lumen of the elongated tube, the suction port configured to engage a surface of the tissue when the vacuum source is operatively attached to the vacuum port;

at least one steering wire having a proximal end and a distal end, the distal end of at least one of the at least one steering wire attached directly to the first wall of the elongated tube at an attachment site located at or near the distal end of the elongated tube and positioned within the first lumen of the elongated tube, and at least one of the at least one steering wire anchored to the first wall of the elongated tube at one or more anchor positions, each of the one or more anchor positions coupled with and extending inwardly from the first wall at a location other than the distal end of the elongated tube; and

a controller operably coupled to the at least one steering wire at or near the proximal end of the at least one steering wire, the controller positioned along the elongated tube at or near the proximal end of the elongated tube; and

a delivery catheter comprising;

a hollow tube having, a proximal end and a distal end, the delivery catheter configured such that the hollow tube is capable of insertion into the second lumen of the elongated tube; and

a needle located at the distal end of the hollow tube or positioned within the hollow tube;

wherein the delivery catheter is operable to deliver a substance to a target site;

wherein the elongated tube is configured to reversibly engage the tissue at the distal end of the elongated tube when the distal end of the elongated tube contacts the tissue and a vacuum is applied through the elongated tube; and

wherein the elongated tube is configured to bend in a same direction in at least two distinct places in response to sliding movement of one or more of the at least one steering wire along the one or more anchor positions.

17. The system of claim 16, wherein:

the at least one steering wire anchored to the first wall of the elongated tube at the one or more anchor positions slidingly engages the elongated tube at one or more of the one or more anchor positions; and

operation of the controller in a first direction of the controller causes the at least one steering wire to slide along the one or more anchor positions coupled therewith in a direction toward the controller, causing the elongated tube to bend in a first direction at the location of each of the one or more anchor positions coupled with the at least one steering wire.

18. The system of claim 16, wherein the controller comprises a rotatable spool coupled to the at least one steering wire at or near the proximal end of the at least one steering wire, the rotatable spool operable to collect and dispense the at least one steering wire, and wherein the rotatable spool is coupled to a rotatable dial so that rotation of the rotatable dial causes rotation of the rotatable spool, and wherein rotation of the rotatable spool causes the elongated tube to bend in response to movement of the at least one steering wire.

19. The system of claim 16, wherein the at least one steering wire comprises two steering wires, wherein the controller comprises a first rotatable spool coupled to one of the two steering wires at or near a proximal end of the one of the two steering wires, and wherein the controller further comprises a second rotatable spool coupled to the other of the two steering wires at or near a proximal end of the other of the two steering wires, and wherein the first rotatable spool and the second rotatable spool are operable to each collect and dispense one of the two steering wires.

20. The system of claim 16, further comprising a skirt operatively connected to the distal end of the elongated tube at or near the suction port, the skirt comprising a proximal end having a circumference substantially similar to an outer circumference of the elongated tube, the skirt further comprising a distal end having a circumference larger than the outer circumference of the elongated tube.

21. The system of claim 16, further comprising a sleeve comprising a proximal end, a distal end, and a lumen extending between the proximal end and the distal end of the sleeve, wherein the sleeve is positioned circumferentially around the steering engagement catheter, wherein the sleeve slidingly engages the steering engagement catheter.

22. The system of claim 16, wherein the system is capable of enlarging a pericardial space between the tissue and a pericardial sac that surrounds a heart by retracting the tissue away from the pericardial sac.

23. The system of claim 22, further comprising a guide wire for insertion into the pericardial space.

24. The system of claim 23, wherein the needle comprises a hollow needle in communication with the hollow tube, and the guide wire is capable of insertion through the hollow tube and the hollow needle into the pericardial space.

25. The system of claim 16, wherein the tissue engaged by the steering engagement catheter is a tissue surrounding a heart, and wherein the needle is positioned to be capable of piercing the tissue when the hollow tube is inserted into the second lumen and the suction port is attached to the tissue, such that, when the tissue is pierced, access to a pericardial space is achieved.

26. The system of claim 16, wherein the steering engagement catheter further comprises an injection channel formed along the length of the elongated tube, the injection channel having at a distal end of the injection channel at least one opening for administering a fluid to the tissue, the injection channel being capable of operable attachment to an external fluid source at a proximal end of the injection channel, such that the fluid from the external fluid source can flow through the injection channel to the tissue when the external fluid source is operatively attached to the injection channel.

27. A method of engaging a targeted tissue, the method comprising the steps of:

providing a steering engagement catheter, comprising;

an elongated tube having a proximal end, a distal end, and a first wall positioned circumferentially along a length of the elongated tube, the first wall defining a first lumen along the length of the elongated tube;

at least one steering wire having a proximal end and a distal end, the distal end of at least one of the at least one steering wire attached directly to the first wall of the elongated tube at an attachment site located at or near the distal end of the elongated tube and at least one of the at least one steering wire anchored to the first wall of the elongated tube at one or more anchor positions, each of the one or more anchor positions coupled with and extending inwardly from the first wall at a location other than the distal end of the elongated tube; and

a controller operably coupled to the at least one steering wire at or near the proximal end of the at least one steering wire, the controller positioned along the elongated tube at or near the proximal end of the elongated tube;

wherein the elongated tube is configured to reversibly engage the targeted tissue at the distal end of the elongated tube when the distal end of the elongated tube contacts the targeted tissue and a vacuum is applied through the elongated tube, and the elongated tube is configured to bend in a same direction in at least two distinct places in response to movement of one or more of the at least one steering wire; and

inserting the steering engagement catheter into a body via a percutaneous intravascular insertion such that the distal end of the elongated tube is positioned at or near the targeted tissue.

28. The method of claim 27, wherein the steering engagement catheter is capable of enlarging a pericardial space between the targeted tissue and a pericardial sac that surrounds a heart by retracting the targeted tissue away from the pericardial sac.

29. The method of claim 28, wherein the step of inserting the steering engagement catheter into the body comprises an insertion of the steering engagement catheter such that the distal end of the elongated tube is positioned inside the heart and the distal end of the elongated tube is in contact with the targeted tissue on an interior of a wall of the heart.

30. The method of claim 27, wherein the steering engagement catheter further comprises a skirt operatively connected to the distal end of the elongated tube, and wherein the step of inserting the steering engagement catheter into the body comprises an insertion of the steering engagement catheter such that the distal end of the elongated tube is positioned inside a heart and the skirt is in contact with the targeted tissue on an interior of a wall of the heart.

31. A method of engaging a targeted tissue, the method comprising the steps of:

providing a system, the system comprising;

a steering, engagement catheter, comprising;

an elongated tube having a proximal end, a distal end, first and second walls positioned circumferentially along a length of the elongated tube, and at least two anchor positions, each of the at least two anchor positions coupled with and extending inwardly from the first wall at a location on the elongated tube other than the distal end of the elongated tube, wherein the first and second walls define first and second lumens extending between the proximal end and the distal end;

a vacuum port located at or near the proximal end of the elongated tube, the vacuum port being operatively connected to the first lumen of the elongated tube and capable of operative connection to a vacuum source;

a suction port located at or near the distal end of the elongated tube, the suction port being operatively connected to the first lumen of the elongated tube, the suction port configured to engage a surface of the targeted tissue when the vacuum source is operatively attached to the vacuum port;

at least one steering wire having a proximal end and a distal end, the distal end of at least one of the at least one steering wire attached directly to the first wall of the elongated tube at an attachment site located at or near the distal end of the elongated tube and positioned within the first lumen of the elongated tube, and at least one of the at least one steering wire is anchored to the first wall of the elongated tube at one or more of the at least two anchor positions, wherein the elongated tithe is configured to bend in a same direction in at least two distinct places in response to sliding movement of one or more of the at least one steering wire along the one or more of the at least two anchor positions; and

a controller operably coupled to the at least one steering wire at or near the proximal end of the at least one steering wire, the controller positioned along the elongated tube at or near the proximal end of the elongated tube; and

a delivery catheter comprising;

a hollow tube having a proximal end and a distal end, the delivery catheter configured such that the hollow tube is capable of insertion into the second lumen of the elongated tube; and

a needle located at the distal end of the hollow tube; and

inserting the steering engagement catheter into a body via a percutaneous intravascular insertion such that the distal end of the elongated tube is positioned at or near the targeted tissue.

32. The method of claim 31, wherein the steering engagement catheter is capable of enlarging a pericardial space between the targeted tissue and a pericardial sac that surrounds a heart by retracting the targeted tissue away from the pericardial sac, and wherein the step of inserting the steering engagement catheter into the body comprises an insertion of the steering engagement catheter such that the distal end of the elongated tube is positioned inside the heart and the distal end of the elongated tube is in contact with the targeted tissue on an interior of a wall of the heart.