Apical puncture access and closure system

• US 9,055,937 B2
• Filed: 03/29/2012
• Issued: 06/16/2015
• Est. Priority Date: 04/01/2011
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Rowe, Stanton J., Wu, Ming, Schneider, Ralph, Corso, Philip P. Jr.
• Primary Examiner(s): Nguyen, Victor
• Application Number:
  US13/434,633
• Publication Number:
  US 20120253386A1
• Time in Patent Office: 1,174 Days
• Field of Search: 623/1.26, 623/2.12, 600/184, 606/213
• US Class Current: 1/1
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• 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 17/02 for holding wounds open; Tractors specula A61B1/32 ; drainage appliances for wounds A61M27/00
• CPC Class Codes: A61B 17/0293 with ring member to support retractor elements
• 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 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00579 Barbed implements
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00597 Implements comprising a membrane
• 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 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/00628 T-shaped occluders
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00668 the implement being a tack or a staple
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/00991 Telescopic means
• CPC Class Codes: A61B 2017/0237 for heart surgery
• CPC Class Codes: A61B 2017/3425 for internal organs, e.g. heart ports

Abstract

A device, system, and method for providing access to, and sealing of, a body organ includes an implant device. An implant device has a main body having an internal access lumen, with a plurality of prongs extending from a distal end of the main body. The main body can include two lumens, one slidable within the other, to form a single continuous lumen with an adjustable length. The main body has an expanded configuration with an expanded diameter, and an unexpanded configuration with an unexpanded diameter. The prongs have a generally straight configuration where they extend distally of the distal end of the main body, and a bent configuration where the prongs bend around so that their tips extend proximally of the distal end of the main body. The device may include a hemostatic barrier to prevent fluid leakage therethrough when the main body is in the unexpanded configuration.

Claims

1. A method for providing access through an organ wall, comprising:

providing a hemostatic sealing device comprising a main body having a distal portion with a distal lumen and a proximal portion with a proximal lumen, where the distal lumen is sized to receive the proximal lumen to create a continuous lumen through the main body, the sealing device further comprising a plurality of prongs extending from a distal end of the distal portion of the main body, wherein the main body lumen has a first diameter, and the plurality of prongs are radially retracted with respect to the main body;

forming a hole in an organ wall of an organ from an outside surface to an interior surface;

advancing the hemostatic sealing device into the hole in the organ wall until the distal end of the main body is advanced at least partially into an interior space of the organ;

adjusting the overall length of the device by sliding the proximal lumen into or out of the distal lumen such that the distal portion of the main body is within the interior space of the organ and the proximal portion of the main body is positioned outside the organ wall;

extending the prongs so that the prong tips are extended radially away from the main body; and

securing the hemostatic sealing device in the organ wall by retracting the distal portion of the main body at least partially out of the interior space of the organ and embedding the prong tips into the organ wall from the interior surface thereof, thereby providing access to the interior space of the organ from the outside surface through the sealing device.

2. The method of claim 1, comprising the further steps of:

after securing the hemostatic sealing device to the organ wall, radially expanding the main body lumen from the first diameter to a second diameter, wherein the second diameter is larger than the first diameter; and

advancing an access sheath into the sealing device.

3. The method of claim 2, wherein radially expanding the main body lumen comprises advancing a dilator into the main body lumen, and wherein the method comprises the further step of:

after advancing the access sheath into the sealing device, retracting the dilator from the sealing device while leaving the access sheath positioned within the sealing device.

4. The method of claim 2, comprising the further steps of:

advancing a treatment catheter through the main body lumen and into an interior of the organ;

performing a treatment via the treatment catheter within the interior of the organ; and

withdrawing the treatment catheter from the interior of the organ via the main body lumen.

5. The method of claim 4, wherein the treatment catheter comprises a device delivery catheter, and performing the treatment comprises deploying the device within the interior of the organ.

6. The method of claim 2, wherein the organ is a heart, and forming the hole in the organ wall comprises forming a hole in the apex of the heart, and securing the hemostatic device in the organ wall comprises securing the hemostatic device in the apex of the heart.

7. The method of claim 6, wherein the first diameter is in the range of 3 to 5 millimeters, wherein the second diameter of the main body is in the range of 10 to 20 millimeters, wherein the main body has a length of about 6 to 15 millimeters, and wherein the prongs have a length of about 6 to 22 millimeters.

8. The method of claim 1, wherein the proximal portion of the main body is positioned at an incision site in the patient'"'"'s skin.

9. A method for providing access through an organ wall, comprising:

providing a hemostatic sealing device comprising a main body having a distal portion with a distal lumen and a proximal portion with a proximal lumen, where the distal lumen is sized to receive the proximal lumen to create a continuous lumen through the main body, the sealing device further comprising a plurality of prongs extending from a distal end of the distal portion of the main body, wherein the main body lumen has a first diameter, and the plurality of prongs are radially retracted with respect to the main body;

forming a hole in an organ wall of an organ, wherein the organ is a hemi, and forming the hole in the organ wall comprises forming a hole in the apex of the hemi;

advancing the hemostatic sealing device into the hole in the organ wall until the distal end of the main body is advanced at least partially into an interior space of the organ;

adjusting the overall length of the device by sliding the proximal lumen into or out of the distal lumen such that the distal portion of the main body is within the interior space of the organ and the proximal portion of the main body is positioned outside the organ wall;

extending the prongs so that the prong tips are extended radially away from the main body;

securing the hemostatic sealing device in the organ wall by retracting the distal portion of the main body at least partially out of the interior space of the organ and embedding the prong tips into the organ wall from an interior surface thereof, wherein securing the hemostatic device in the organ wall comprises securing the hemostatic device in the apex of the heart;

after securing the hemostatic sealing device to the organ wall, radially expanding the main body lumen from the first diameter to a second diameter, wherein the second diameter is larger than the first diameter; and

advancing an access sheath into the sealing device;

wherein the first diameter is in the range of 3 to 5 millimeters, wherein the second diameter of the main body is in the range of 10 to 20 millimeters, wherein the main body has a length of about 6 to 15 millimeters, and wherein the prongs have a length of about 6 to 22 millimeters.

10. The method of claim 9, wherein radially expanding the main body lumen comprises advancing a dilator into the main body lumen, and wherein the method comprises the further step of:

after advancing the access sheath into the sealing device, retracting the dilator from the sealing device while leaving the access sheath positioned within the sealing device.

11. The method of claim 9, comprising the further steps of:

advancing a treatment catheter through the main body lumen and into an interior or the organ;

performing a treatment via the treatment catheter within the interior of the organ; and

withdrawing the treatment catheter from the interior of the organ via the main body lumen.

12. The method of claim 11, wherein the treatment catheter comprises a device delivery catheter, and performing the treatment comprises deploying the device within the interior of the organ.

13. The method of claim 9, wherein the proximal portion of the main body is positioned at an incision site in the patient'"'"'s skin.

14. A method for providing access through an organ wall, comprising:

providing a hemostatic sealing device comprising a main body having a distal portion with a distal lumen and a proximal portion with a proximal lumen, where the distal lumen is sized to receive the proximal lumen to create a continuous lumen through the main body, the sealing device further comprising a plurality of prongs extending from a distal end of the distal portion of the main body, and the plurality of prongs are radially retracted with respect to the main body, wherein the main body has a length of about 6 to 15 millimeters, and wherein the prongs have a length of about 6 to 22 millimeters;

forming a hole in an organ wall of an organ;

advancing the hemostatic sealing device into the hole in the organ wall until the distal end of the main body is advanced at least partially into an interior space of the organ;

adjusting the overall length of the device by sliding the proximal lumen into or out of the distal lumen such that the distal portion of the main body is within the interior space of the organ and the proximal portion of the main body is positioned outside the organ wall;

extending the prongs so that the prong tips are extended radially away from the main body; and

securing the hemostatic sealing device to the organ wall by retracting the distal portion of the main body at least partially out of the interior space of the organ and embedding the prong tips into the organ wall from an interior surface thereof.

15. The method of claim 14, wherein the main body lumen has a first diameter, wherein the first diameter is in the range of 3 to 5 millimeters, and comprising the further steps of:

radially expanding the main body lumen from the first diameter to a second diameter, wherein the second diameter is larger than the first diameter, wherein the second diameter of the main body is in the range of 10 to 20 millimeters; and

advancing an access sheath into the sealing device.

16. The method of claim 15, wherein radially expanding the main body lumen comprises advancing a dilator into the main body lumen, and wherein the method comprises the further step of:

after advancing the access sheath into the sealing device, retracting the dilator from the sealing device while leaving the access sheath positioned within the sealing device.

17. The method of claim 14, comprising the further steps of:

advancing a treatment catheter through the main body lumen and into an interior of the organ;

performing a treatment via the treatment catheter within the interior of the organ; and

withdrawing the treatment catheter from the interior of the organ via the main body lumen.

18. The method of claim 17, wherein the treatment catheter comprises a device delivery catheter, and performing the treatment comprises deploying the device within the interior of the organ.

19. The method of claim 14, wherein the organ is a heart, and forming the hole in the organ wall comprises forming a hole in the apex of the heart, and securing the hemostatic device in the organ wall comprises securing the hemostatic device in the apex of the heart.

20. The method of claim 14, wherein the proximal portion of the main body is positioned at an incision site in the patient'"'"'s skin.