Systems for engaging a bodily tissue and methods of using the same

• US 9,050,064 B2
• Filed: 09/14/2010
• Issued: 06/09/2015
• 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): Price, Nathan R
• Application Number:
  US12/881,953
• Publication Number:
  US 20110060182A1
• Time in Patent Office: 1,729 Days
• Field of Search: 604/103.07, 604/104, 604/164.01, 604/164.03, 604/164.04, 604/164.08, 604/164.13, 604/174, 604/176, 607/120, 607/122, 607/126, 607/129, 607/130
• US Class Current: 1/1
• 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 17/3478 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 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked

Abstract

Systems for engaging a bodily tissue and methods of using the same. In at least one embodiment of an exemplary system for use with a vacuum source for engaging a tissue of the present disclosure, the system comprises 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, an inducer sheath having a proximal portion, a distal portion, and a lumen extending therethrough, the inducer sheath configured so that it is capable of insertion into the second lumen of the engagement catheter, a dilator comprising a tapered tip at a distal end and a hollow channel extending therethrough, the dilator sized and shaped for insertion into the lumen of the inducer sheath, and 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. In various embodiments, the systems further comprise an inflatable balloon at or near the distal portion of the inducer sheath.

Claims

1. A system for use with a vacuum source 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, and a lumen extending therethrough, the inducer sheath configured so that it is capable of insertion into the second lumen of the engagement catheter;

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

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;

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 a surface of a bodily tissue such that the skirt is capable of forming a reversible seal with the surface of the bodily tissue when a vacuum source is operatively attached to the vacuum port;

wherein the engagement catheter having the inducer sheath and the dilator positioned therein is sized and shaped for percutaneous insertion of the distal end of the engagement catheter into a patient via a patient'"'"'s vein and further has a sufficient length to permit advancement of the distal end of the engagement catheter to the bodily tissue through the patient'"'"'s vein, and wherein the skirt is configured to removably engage the surface of the bodily tissue after introduction of a portion of the system into the patient'"'"'s vein.

2. The system of claim 1, wherein the system is capable of enlarging a pericardial space between the bodily tissue and a pericardial sac that surrounds a heart by retracting the bodily tissue away from the pericardial sac.

3. The system of claim 1, further comprising:

a needle device having a needle tip, the needle device capable of insertion into the hollow channel of the dilator, wherein the needle tip is capable of puncturing the bodily tissue positioned at or near the distal end of the dilator.

4. The system of claim 1, further comprising:

a guide wire capable of insertion into the hollow channel of the dilator, the guide wire further capable of insertion into a pericardial space of a pericardial sac positioned at or near the distal end of the dilator.

5. The system of claim 3, wherein the needle defines a needle lumen therethrough, the needle lumen sized and shaped to receive a guide wire therethrough.

6. The system of claim 1, further comprising:

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

7. The system of claim 1, wherein the inducer sheath is comprised of Teflon.

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

9. The system of claim 1, wherein the inflatable balloon is comprised of a radiopaque material.

10. The system of claim 9, wherein the radiopaque material comprises a polyamide elastomer and tungsten.

11. The system of claim 1, wherein the inducer sheath has a length of no more than about 5 mm to about 6 mm of a length of the engagement catheter.

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

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

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

15. 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.

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

17. The system of claim 1, wherein the skirt comprises a deformable configuration, and wherein the deformable configuration of the skirt is capable of expanding to an expanded configuration.

18. The system of claim 1, further comprising:

a sleeve comprising a proximal end, a distal end, and a lumen extending between the proximal end and the distal end, wherein the sleeve is positioned around the engagement catheter, wherein the sleeve slidingly engages the engagement catheter.

19. The system of claim 1, further comprising:

a lead capable of insertion into the hollow channel of the dilator, the lead further capable of insertion into a pericardial space of a pericardial sac positioned at or near the distal end of the dilator.

20. A system for use with a vacuum source for engaging an atrial wall and accessing a pericardial space, 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;

a sleeve comprising a proximal end, a distal end, and a lumen extending between the proximal end and the distal end, wherein the sleeve is positioned around the engagement catheter, wherein the sleeve slidingly engages 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 second lumen of the engagement catheter;

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

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 needle device having a needle tip, the needle device capable of insertion into the hollow channel of the dilator;

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;

wherein the needle tip is capable of piercing the atrial wall when the atrial wall is adjacent thereto to create a tissue aperture so that the inducer sheath and the dilator can advance therethrough into the pericardial space; and

wherein the engagement catheter having the inducer sheath and the dilator positioned therein is sized and shaped for percutaneous insertion of the distal end of the engagement catheter into a patient via a patient'"'"'s vein and further has a sufficient length to permit advancement of the distal end of the engagement catheter to the atrial wall through the patient'"'"'s vein, and wherein the skirt is configured to removably engage the surface of the atrial wall after introduction of a portion of the system into the patient'"'"'s vein.

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

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

an engagement catheter comprising a proximal end, a distal end, and 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, and a lumen extending therethrough, the inducer sheath configured so that it is capable of insertion into the second lumen of the engagement catheter,

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

a needle positioned within the lumen of the dilator, and

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 operable connection to a vacuum source;

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 a surface of the targeted tissue such that the skirt is capable of forming a reversible seal with the surface of the targeted tissue when a vacuum source is operatively attached to the vacuum port; and

wherein the engagement catheter having the inducer sheath and the dilator positioned therein is sized and shaped for percutaneous insertion of the distal end of the engagement catheter into the mammalian body via the vein of the mammalian body and further has a sufficient length to permit advancement of the distal end of the engagement catheter to the targeted tissue through the vein;

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 a 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.

22. The method of claim 21, 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.

23. The method of claim 21, wherein the advancing step further comprises withdrawal of the needle from at least part of the lumen of the dilator.

24. The method of claim 21, 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.

25. The method of claim 21, 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 an atrial wall aperture and into a pericardial space.

26. The method of claim 21, 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.