Devices, systems, and methods for transeptal atrial puncture using an engagement catheter platform

• US 8,540,674 B2
• Filed: 04/11/2011
• Issued: 09/24/2013
• Est. Priority Date: 04/27/2007
• Status: Active Grant

• Current Assignee: CVDEVICES, LLC
• Original Assignee: CVDEVICES, LLC
• Inventors: Kassab, Ghassan S., Navia, Jose A. Sr.
• Primary Examiner(s): Stigell, Theodore J
• Assistant Examiner(s): Price, Nathan R
• Application Number:
  US13/084,102
• Publication Number:
  US 20110245800A1
• Time in Patent Office: 897 Days
• Field of Search: 604/103.07, 604/104, 604/164.01, 604/164.03, 604/174, 604/176, 604/164.04, 604/164.08, 604/164.13, 607/120, 607/122, 607/126, 607/129, 607/130
• US Class Current: 604/164.01
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00601 Implements entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/00876 magnetic
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61B 2017/308 with suction cups
• CPC Class Codes: A61B 2017/3419 Sealing means between cannula and body
• CPC Class Codes: A61B 2017/3454 Details of tips
• CPC Class Codes: A61B 2017/3488 Fixation to inner organ or inner body tissue
• 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 2025/0039 characterized by lumina being arranged coaxially
• CPC Class Codes: A61M 2025/004 characterized by lumina being arranged circumferentially
• CPC Class Codes: A61M 2025/0089 Single injection needle protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip
• 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 25/04 : in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence

Abstract

Multichannel systems for engaging a bodily tissue and methods of using the same. In at least one embodiment of an exemplary multichannel system for engaging a tissue of the present disclosure, the system comprises an engagement catheter comprising a proximal end, a distal end, and defining a first lumen and second lumen extending between the proximal end and the distal end, an inducer sheath having a proximal portion and a distal portion, and defining a lumen extending therethrough, the inducer sheath configured for insertion into the second lumen of the engagement catheter, and a dilator defining a first channel and a second channel extending therethrough and a tapered tip at the distal end of the dilator, the dilator sized and shaped for inserted into the lumen of the inducer sheath.

Claims

1. A multichannel system for engaging a tissue, the system comprising:

an engagement catheter comprising a proximal end and a distal end, and defining a first lumen extending between the proximal end and the distal end;

an inducer sheath having a proximal portion and a distal portion, and defining a lumen extending therethrough, the inducer sheath configured for insertion into the first lumen of the engagement catheter;

a dilator defining a first channel and a second channel extending therethrough and a tapered tip at a distal end of the dilator, the dilator sized and shaped for insertion into the lumen of the inducer sheath; and

a needle device having a needle tip, the needle device capable of insertion into the first channel of the dilator, wherein the needle tip is capable of puncturing a tissue positioned at or near the distal end of the dilator to form a mammalian tissue aperture, wherein the tapered tip of the dilator is configured for insertion of the tapered tip into the mammalian tissue aperture formed using the needle tip.

2. The system of claim 1, wherein the second channel is sized and shaped to allow passage of at least a portion of a first catheter therethrough.

3. The system of claim 1, wherein the dilator further defines a third channel extending therethrough, the third channel sized and shaped to allow passage of at least a portion of a second catheter therethrough.

4. The system of claim 3, wherein the dilator further defines a separation member extending therethrough and separating the first channel, second channel and third channel of the dilator.

5. The system of claim 4, wherein the separation member is removable from the dilator, and upon removal merges the first channel, second channel and third channel into a central channel.

6. The system of claim 1, further comprising:

a blocking member configured for insertion into the second channel of the dilator to occlude the second channel of the dilator.

7. The system of claim 1, further comprising:

a visualization device configured for insertion into the first channel of the dilator, wherein the visualization device is operable to gather location information.

8. The system of claim 7, wherein the visualization device is selected from the group consisting of an endocardial visualization device, an endoscope, and a catheter.

9. The system of claim 1, wherein the engagement catheter further defines a second lumen and further comprises a skirt operatively connected to the distal end of the engagement catheter, the skirt comprising a proximal end having a circumference substantially similar to an outer circumference of the engagement catheter, the skirt further comprising a distal end having a circumference larger than the outer circumference of the engagement catheter;

and

wherein the system further comprises;

a vacuum port located at the proximal end of the engagement catheter, the vacuum port operably connected to the second lumen of the engagement catheter and capable of operative connection to a vacuum source;

wherein the second lumen of the engagement catheter includes a suction port located at or near the distal end of the engagement catheter, the suction port configured to allow the distal end of the skirt to removably engage a surface of a bodily tissue such that the skirt is capable of forming a reversible seal with the surface of the tissue when a vacuum source is operatively attached to the vacuum port.

10. The system of claim 1, further comprising:

a guide wire configured for insertion into the first channel of the dilator.

11. The system of claim 10, wherein the needle defines a needle lumen therethrough, the needle lumen sized and shaped to receive the guide wire therethrough.

12. The system of claim 1, further comprising:

an inflatable balloon at or near the distal portion of the inducer sheath.

13. The system of claim 12, wherein the inflatable balloon is comprised of a radiopaque material.

14. The system of claim 13, wherein the radiopaque material comprises a polyamide elastomer and tungsten.

15. The system of claim 1, wherein the inducer sheath is comprised of polytetrafluoroethylene.

16. The system of claim 1, wherein the inducer sheath has a wall thickness from about 0.2 mm to about 0.3 mm.

17. The system of claim 1, wherein the inducer sheath has a length of within about 5 mm to about 6 mm of a length of the engagement catheter.

18. The system of claim 1, wherein the proximal portion of the inducer sheath is affixed to the proximal end of the engagement catheter.

19. The system of claim 1, wherein the tapered tip of the dilator has a conical shape.

20. The system of claim 1, wherein the dilator is comprised of polyethylene.

21. The system of claim 1, wherein the dilator further comprises a dilator lock capable of preventing the dilator from backward movement after the dilator is inserted into the lumen of the inducer sheath and the dilator lock is locked.

22. The system of claim 1, wherein the tapered tip is comprised of polyurethane.

23. The system of claim 9, wherein the skirt comprises a deformable configuration, and wherein the deformable configuration of the skirt is capable of expanding to an expanded configuration.

24. A multichannel system for engaging a tissue, the system comprising:

an engagement catheter comprising a proximal end, a distal end, first and second lumens extending between the proximal end and the distal end, and a skirt operatively connected to the distal end, the skirt comprising a proximal end having a circumference substantially similar to an outer circumference of the engagement catheter, the skirt further comprising a distal end having a circumference larger than the outer circumference of the engagement catheter;

an inducer sheath having a proximal portion, a distal portion, a lumen extending therethrough, and a radiopaque inflatable balloon at or near the distal portion of the inducer sheath, the inducer sheath configured so that it is capable of insertion into the first lumen of the engagement catheter;

a dilator comprising a first and second channel extending therethrough and a tapered tip at a distal end of the dilator, the dilator sized and shaped for insertion into the lumen of the inducer sheath;

a needle device having a needle tip, the needle device capable of insertion into the first channel of the dilator, wherein the needle tip is capable of puncturing a tissue positioned at or near the distal end of the dilator to form a mammalian tissue aperture, wherein the tapered tip of the dilator is configured for insertion of the tapered tip into the mammalian tissue aperture formed using the needle tip;

a vacuum port located at the proximal end of the engagement catheter, the vacuum port being operatively connected to the first lumen of the engagement catheter and capable of operative connection to a vacuum source; and

a visualization device capable of insertion into the first channel of the dilator, wherein the visualization device is capable of gathering location information,

wherein the first lumen of the engagement catheter includes a suction port located at or near the distal end of the engagement catheter, the suction port configured to allow the distal end of the skirt to removably engage an atrial wall when the atrial wall is adjacent thereto, such that the skirt is capable of forming a reversible seal with the surface of the atrial wall when a vacuum source is operatively attached to the vacuum port.

25. A method of engaging a tissue to access a space adjacent thereto, the method comprising the steps of:

introducing a multichannel system into a mammalian body so that at least part of the system is adjacent to a targeted tissue, the system comprising;

an engagement catheter having a skirt coupled thereto,

an inducer sheath positioned within a lumen of the engagement catheter,

a dilator positioned within a lumen of the inducer sheath, the dilator having a tapered tip,

a needle device having a needle tip positioned within a first channel of the dilator, the needle device capable of insertion into the first channel of the dilator, wherein the needle tip is capable of puncturing a tissue positioned at or near the distal end of the dilator to form a mammalian tissue aperture, wherein the tapered tip of the dilator is configured for insertion of the tapered tip into the mammalian tissue aperture formed using the needle tip, and

a catheter positioned within a second channel of the dilator;

engaging the targeted tissue using the skirt of the engagement catheter by applying a vacuum to the engagement catheter;

piercing the targeted tissue using the needle tip to create the tissue aperture;

advancing at least part of the inducer sheath and at least part of the dilator into the tissue aperture and into a space behind the targeted tissue; and

inserting at least a portion of the catheter into the space behind the targeted tissue.

26. The method of claim 25, wherein the step of advancing causes a balloon coupled to the inducer sheath to be positioned into the space behind the targeted tissue, and wherein the method further comprises the step of:

inflating the balloon to reversibly secure the inducer sheath to the targeted tissue.

27. The method of claim 25, wherein the advancing step further comprises withdrawal of the needle from at least part of the lumen of the dilator.

28. The method of claim 25, further comprising the steps of:

removing the dilator from the inducer sheath; and

performing a procedure, the procedure selected from the group consisting of introducing a substance into the space, removing a substance from the space, and introducing a device into the space.

29. The method of claim 25, wherein the step of engaging the targeted tissue comprises engaging an atrial wall, and wherein the step of advancing comprises advancing at least part of the inducer sheath and the dilator into and through an atrial wall aperture.

30. The method of claim 25, wherein the step of engaging the targeted tissue comprises engaging an atrial septum, and wherein the step of advancing comprises advancing at least part of the inducer sheath and the dilator into an atrial septum aperture and into a left atrium.