Systems, devices, and methods for transeptal atrial puncture using an engagement catheter platform

• US 9,955,999 B2
• Filed: 09/24/2013
• Issued: 05/01/2018
• Est. Priority Date: 04/27/2007
• Status: Active Grant

• Current Assignee: CVDEVICES, LLC
• Original Assignee: CVDEVICES, LLC
• Inventors: Kassab, Ghassan S., Navia, Jose A.
• Primary Examiner(s): GRAY, PHILLIP A
• Application Number:
  US14/035,338
• Publication Number:
  US 20140025038A1
• Time in Patent Office: 1,680 Days
• Field of Search: 604264
• 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 inducer sheath having a proximal portion and a distal portion and defining a lumen extending therethrough, the inducer sheath configured for insertion into a first lumen of an engagement catheter; and

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, wherein the tapered tip is configured to facilitate insertion of the dilator into a mammalian tissue aperture, wherein the mammalian tissue aperture is created using a device positioned within the first channel or the second channel of the dilator.

2. The system of claim 1, further comprising:

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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. The system of claim 7, wherein the skirt comprises a deformable configuration, and wherein the deformable configuration of the skirt is capable of expanding to an expanded configuration.

9. The system of claim 1, further comprising:

a needle defining a needle lumen therethrough, the needle lumen sized and shaped to receive a guide wire therethrough.

10. The system of claim 1, further comprising:

an inflatable balloon at or near the distal portion of the inducer sheath, the inflatable balloon comprising a radiopaque material.

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

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

13. 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.

14. 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 having a proximal portion and a distal portion and defining a lumen extending therethrough, the inducer sheath configured for insertion into and positioned within a lumen of the engagement catheter,

a dilator positioned within a lumen of the inducer sheath, the dilator defining a first channel and a second channel extending therethrough and having a tapered tip at a distal end of the dilator, the dilator sized and shaped for insertion into the lumen of the inducer sheath, the tapered tip configured to facilitate insertion of the dilator into a mammalian tissue aperture,

a needle positioned within a first channel of the dilator, 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 to create the tissue aperture; and

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.

15. The method of claim 14, further comprising the step of:

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

16. The method of claim 14, 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.

17. The method of claim 14, 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.

performing a procedure, the procedure selected from the group consisting of introducing a substance into the space, removing a substance from the space, placing a lead within the mammalian body distal to the tissue aperture, and introducing a device into the space.

18. The method of claim 14, wherein the step of engaging the targeted tissue comprises engaging an atrial wall or an atrial septum, 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 or an atrial septum aperture.

19. 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 inducer sheath having a proximal portion and a distal portion and defining a lumen extending therethrough, the inducer sheath configured for insertion into and positioned within a lumen of the engagement catheter, and

a dilator positioned within a lumen of the inducer sheath, the dilator defining a first channel and a second channel extending therethrough and having a tapered tip at a distal end of the dilator, the dilator sized and shaped for insertion into the lumen of the inducer sheath, the tapered tip configured to facilitate insertion of the dilator into a mammalian tissue aperture;

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

piercing the targeted tissue to create the tissue aperture; and

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;

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, placing a lead within the mammalian body distal to the tissue aperture, and introducing a device into the space.

20. The method of claim 19, 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.