WO2018128644A1

WO2018128644A1 - Trans-ventricular introducer sheath with intracardiac/extracardiac stabilization and a suture retention system

Info

Publication number: WO2018128644A1
Application number: PCT/US2017/038870
Authority: WO
Inventors: Scott Koss; Robert GESSERT; Erik Olson
Original assignee: Scott Koss; Gessert Robert; Erik Olson
Priority date: 2017-01-09
Filing date: 2017-06-22
Publication date: 2018-07-12

Abstract

An intra-cardiac introducer device for performing transventricular "beating heart" endovascular thoracic aortic surgery and structural heart surgery, including mitral/aortic/tricuspid/pulmonic valve replacement and suture mediated repair of mitral/tricuspid valves. The intra-cardiac introducer device includes an introducer sheath, intra-cardiac and extra-cardiac stabilization, a hub containing hemostatic valves, and a suture retention system for managing sutures when performing suture mediated transventricular surgeries. The device provides cardiothoracic surgeons a transventricular-specific introducer sheath system making the surgery safer for patients by minimizing blood loss, enhancing device delivery making the surgery more precise and efficient, and providing a platform for fewer surgical instruments in the small surgical window.

Description

TRANS- VENTRICULAR INTRODUCER SHEATH WITH

INTRACARDIAC/EXTRACARDIAC STABILIZATION AND A

SUTURE RETENTION SYSTEM

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application is a non-provisional of and claims priority to U.S. Provisional Application No. 62/444,347, filed on January 9, 2017, the contents of which are incorporated herein by reference.

BACKGROUND OF THE INVENTION

[0002] During transventricular "beating heart" endovascular thoracic aortic surgery and structural heart surgery, including mitral/aortic/tricuspid/pulmonic valve replacement and suture mediated repair of mitral/tricuspid valves, there is a need for a safe and stable transventricular introducer sheath to minimize blood loss and reduce myocardial injury during insertion and removal of intracardiac/endovascular devices. With suture mediated transventricular structural heart surgery, there are numerous sutures that protrude through the ventriculotomy at the left or right ventricular apical region. The organization of the valve sutures and minimization of instruments on the field (which are at risk for inadvertent removal), along with a stable and hemostatic introducer sheath are critical to the safety and success of the surgery.

SUMMARY OF THE INVENTION

[0003] Embodiments of the invention address the intra-operative needs of cardiothoracic surgeons performing transventricular "beating heart" endovascular thoracic aortic surgery and structural heart surgery, including mitral/aortic /tricuspid/pulmonic valve replacement and suture mediated repair of mitral/tricuspid valves. Embodiments of the invention are intended to provide a stable and hemostatic introducer sheath, as well as providing a platform to safely secure and organize exiting sutures for those surgeries that are suture mediated.

[0004] In one embodiment, the invention provides a dedicated introducer sheath system designed for use with a variety of transventricular intracardiac/endovascular surgical treatments of structural heart disease including mitral valve and aortic valve pathology, as well as endovascular treatment of the thoracic aorta. [0005] In one embodiment, the invention provides an intra-cardiac introducer device comprising a sheath having a distal end and a proximal end, the sheath being configured to penetrate cardiac tissue, a hub connected to the proximal end of the sheath, an intracardiac stabilization balloon coupled to the distal end of the sheath, and an external stabilization disc slidingly positioned along the sheath. The cardiac tissue is sandwiched between the intracardiac stabilization balloon and the external stabilization disc to secure position of the sheath in the cardiac tissue.

[0006] In another embodiment, the invention provides an intra-cardiac introducer device comprising a sheath having a distal end and a proximal end, a hub connected to the proximal end of the sheath, and a suture retention system removably coupled to the hub. The suture retention system includes a body, a plurality of slots on the body configured to receive sutures, and an orientation marker configured to identify a position of the sutures relative to a patient's heart.

[0007] Embodiments of the invention also include a method of performing a ventriculotomy. The method comprises inserting a sheath over a guidewire positioned through cardiac tissue forming an opening in the cardiac tissue, inflating a balloon inside a cardiac cavity, the balloon positioned on an exterior surface of the sheath and adjacent an interior surface of the cardiac tissue, positioning a stabilization disc opposite the inflated balloon, the stabilization disc in contact with an exterior of the cardiac tissue, positioning purse strings in the stabilization disc, positioning sutures in slots on a suture retention system coupled to a hub at a distal end of the sheath, suturing anatomy in the cardiac cavity using the sutures, removing the sheath from the cardiac tissue, and closing the opening in the cardiac tissue with the purse string sutures.

[0008] Other aspects of the invention will become apparent by consideration of the detailed description and accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0009] FIG. 1 illustrates an intra-cardiac introducer device according to an embodiment of the present invention. [0010] FIGS. 2A-D illustrate additional views of the intra-cardiac introducer device illustrated in FIG. 1 in different states.

[0011] FIG. 3 is a top view of an extra-cardiac stabilization disc according to an embodiment of the present invention.

[0012] FIG. 4 is a cross-section view of a valve system according to an embodiment fo the present invention.

[0013] FIG. 5 is a top view of a first valve of the valve system illustrated in FIG. 4.

[0014] FIG. 6 is a perspective view of a second valve of the valve system illustrated in FIG. 4.

[0015] FIG. 7 is a top view of a suture retention system connected to the hemostatic hub according to an embodiment of the present invention.

[0016] FIG. 8 illustrates a portion of a transventricular "beating heart" suture mediated repair of the mitral valve.

[0017] FIG. 9 illustrates a portion of a transventricular "beating heart" suture mediated repair of the mitral valve.

[0018] FIG. 10 illustrates a portion of a transventricular "beating heart" suture mediated repair of the mitral valve, demonstrating suture retention properties of an embodiment of the present invention.

[0019] FIG. 11 is a top view of the suture retention system connected to the hemostatic hub used during a portion of a transventricular "beating heart" suture mediated repair of

mitral/tricuspid valves.

[0020] FIG. 12 is a top view of the suture retention system removed from the hemostatic hub used during a portion of a transventricular "beating heart" suture mediated repair of

mitral/tricuspid valves. [0021] FIG. 13 illustrates a further rendering of the intra-cardiac introducer device shown in FIG. 1 being utilized to access the mitral valve.

[0022] FIG. 14 illustrates a further rendering of the intra-cardiac introducer device shown in FIG. 1 being utilized to access the aortic valve.

[0023] FIG. 15 illustrates a further rendering of the intra-cardiac introducer device shown in FIG. 1 being utilized to access the tricuspid valve.

[0024] FIG. 16 illustrates a further rendering of the intra-cardiac introducer device shown in FIG. 1 being utilized to access the pulmonic artery.

[0025] FIGS. 17A-B illustrate an intra-cardiac introducer device according to another embodiment of the present invention.

DETAILED DESCRIPTION

[0026] Before any embodiments of the invention are explained in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the following drawings. The invention is capable of other embodiments and of being practiced or of being carried out in various ways.

[0027] FIGS. 1-3 illustrate an intra-cardiac introducer device 10 for use when performing transventricular "beating heart" suture mediated repair of mitral and aortic valves. The intracardiac introducer device 10 includes an introducer sheath 14, a hub 18, an intra-cardiac stabilization balloon 34, an external stabilization disc 42, a valve system 54, and a suture retention system 74. In one construction, the introducer sheath 14 is a short, large caliber vascular sheath (e.g., 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, and 36 French).

[0028] The introducer sheath 14 is a generally tubular structure or shaft 22 having a distal end 26 and a proximal end 30. The introducer sheath 14 is configured to be delivered through cardiac tissue over a short stiff guide wire (e.g., 0.035 inch). The distal end 26 of the introducer sheath 14 is tapered for insertion through and dilation of the cardiac tissue. [0029] The introducer sheath 14 also includes an intra-cardiac stabilization balloon 34 connected to an outer surface 38 of the tubular structure 22. The balloon 34 is an integrated, soft, compliant balloon in communication with an insufflation port 40 to be inflated with fluid (e.g., saline). In one construction, the balloon 34 comprises a low durometer material resulting in an ultra-compliant balloon to improve sheath maneuverability and reduce the risk of balloon rupture. The balloon 34 is configured to be in a deflated state while the introducer sheath 14 is being inserted into the left or right ventricle and in an inflated state after the introducer sheath 14 is properly positioned within the intraventricular cavity. The inflated state of the balloon 34 prevents removal of the device 10 from the left or right ventricle, provides intraventricular stabilization of the introducer, and minimizes hemostasis.

[0030] With more particularity and with reference to FIGS. 2A-D, the intra-cardiac stabilization balloon 34 when in a deflated first state, is located at the distal end 26 of the sheath 14 with minimal outer diameter profile change compared to the outer diameter of the sheath shaft 22. When inflated to the second state, with fluid (e.g., saline), the balloon 34 expands radially from the sheath 14, which is located within the ventricular cavity (FIG. 2B). The radial expansion ranges from about 3 mm to about 12 mm depending on the volume of fluid infused into the inflation port and into the balloon 34. When inflated, a distal end of the balloon 34 is located at the distal end 26 of the sheath shaft 22. When the balloon 34 is inflated with fluid (e.g., saline), the sheath 14 is retracted to contact the inner myocardial surface of the ventricle as shown at state 3 (FIG. 2C).

[0031] An inner dilator is then removed from the sheath shaft 22, and the trans myocardial purse strings sutures are then secured to the extra-cardiac stabilization disc 42 as shown at state 4 (FIG. 2D). The intra-cardiac stabilization balloon 34 and the extra-cardiac stabilization disc 42 work together to maintain sheath stability throughout the transventricular surgery.

[0032] In an alternative embodiment, rather than an intra-cardiac stabilization balloon 34, a compliant coated nitinol disc 200 may be employed for internal stabilization as illustrated in FIGS. 17A-B. When the nitinol disc 200 is slidingly actuated, it expands to form an intracardiac stabilization platform with similar stabilization features as described above with respect to the balloon 34. [0033] The hub 18 is coupled to the proximal end 30 of the introducer sheath 14. The hub 18 is generally "bowl-shaped" and includes a gradually increasing diameter from the coupling at the distal end 26 to the hub's proximal end. The hub 18 includes a cavity 50 and is in fluid communication with the tubular structure 22 to receive blood exiting the heart due to the surgical procedure.

[0034] The hub 18 includes a dual, valve system 54 to facilitate easy passage of the introducer sheath 14 and provide sufficient hemostasis during the procedure. With reference to FIGS. 4-6, the valve system 54 includes a first valve 58 and a second valve 62. The first valve 58 is at least partially positioned within the cavity 50 of the hub 18. A portion of the first valve 58 is visible at the proximal end of the hub 18. The first valve 58 is circular in shape having a perimeter generally consistent with the perimeter of the proximal end of the cavity 50. The first valve 58 includes a central aperture 66 that is configured to receive an

intraventricular/endovascular device 70 intended for use with a transventricular method and provide hemostasis while the device 70 is within the introducer sheath 14. The second valve 62 is positioned within the cavity 50 of the hub 18 and includes a double, reinforced duckbill design to provide hemostasis following removal of the device 70 and with exiting sutures crossing the hub valves 58, 62

[0035] The extra-cardiac stabilization disc 42, illustrated in FIG. 3, is positioned

circumferentially on the tubular structure 22 forward of the hub 18 and along the outer surface of the left or right ventricle. The extra-cardiac stabilization disc 42 is slidingly coupled to the exterior surface of the tubular structure 22 and can be comprised of silicone, silastic, or other suitable materials. The extra-cardiac stabilization disc 42 includes a plurality of slots 44 for receiving purse string sutures via tourniquets 46 to further enhance stabilization of the sheath 14.

[0036] The extra-cardiac stabilization disc 42 includes two components, functioning as one unit. The larger diameter component contacts the epicardial surface of the ventricle and includes the slots 44 for inserting and securing the trans myocardial purse-string sutures. The smaller, and more proximal, diameter component limits proximal migration of the extra-cardiac stabilization disc 42. The extra-cardiac stabilization disc 42 and intracardiac balloon 34 work together to provide a stable transventricular introducer sheath, yet maintaining maneuverability for medical device insertion and removal.

[0037] With reference to FIG. 7, the device 10 also includes a suture retention system 74 according to one embodiment of the present invention. The removable suture retention system 74 is coupled to the hub 18 via a mechanism that allows a bottom surface to snap onto or mate with the hub 18. The suture retention system 74 includes a central aperture 78 configured to align with the proximal end of the hub 18. During suture mediated transventricular structural heart surgery, there are anywhere from 2-8 or more additional sutures attached to the mitral valve leaflet exiting the left ventriculotomy. There is a need for organization of the sutures, as well as retention during the surgery to limit the number of additional instruments in the narrow surgical window.

[0038] The suture retention system 74 is generally circular-shaped and includes a body 82 having one or more orientation markers 86, e.g., 12 o'clock, 3 o'clock, 6 o'clock, 8 o'clock, and 9 o'clock, but more or less than these example markers are also contemplated. The orientation markers 86 generally function to orient the position of the sutures relative to the heart and provide an ordering system to ensure correct placement of the sutures. The body 82 also includes a plurality of recesses 90 and slots 94 formed in the body 82 to safely retain the sutures without damaging the suture material. The slots 94 may include a silicone filler for improved suture retention. By color marking the tail ends of the long sutures, the position of the sutures can be organized in a manner that facilitates the most efficient and accurate final placement. The exiting sutures can be secured in the slots 94. The suture retention system 74 maintains proper suture organization and reduces the chance of suture disruption during re-entry of the device 70 into the introducer sheath 14 for additional suture placement(s).

[0039] In operation, initially, the surgeon places purse strings pledget sutures into the cardiac tissue (e.g., left ventricular apical myocardium) (surgical purse string) for future closure of the ventriculotomy, followed by a puncture within the center of the purse string closure using an 18 gauge (or other appropriate size) needle, followed by guide wire advancement into the left atrium, ascending aorta, right atrium, or main pulmonary artery depending on the

transventricular surgery being performed. (See FIG. 8) The myocardial tract is initially dilated with vascular dilators to dilate the ventricular opening to accommodate the introducer sheath. The intraventricular introducer sheath 10 is then positioned into the ventricular cavity with the inner dilator 14 delivered over the guidewire and into the left or right ventricle. (See FIG. 9)

[0040] The introducer sheath 14 includes linear markings indicating whether proper intraventricular placement has been achieved using trans esophageal echocardiographic and/or fluoroscopic guidance. After proper placement of the introducer sheath 14, the balloon 34 is inflated with fluid (e.g., saline). Proper placement assures that there is no inadvertent expansion of the balloon 34 within the myocardium leading to injury. After the balloon 34 is prepped and filled with fluid, the introducer sheath 14 is gently pulled back to provide hemostasis at the inner margin of the ventriculotomy. Then, the external stabilization disc 42 is slid along the tubular structure 22 and positioned on top of felt pledgets 48 (see FIGS. 8-10) to stabilize the position of the introducer sheath 14 from the balloon 34 to the external stabilization disc 42. The previously placed purse string sutures 46 are inserted into the slots 44 in the external stabilization disc 42, that when affixed to the disc 42 via plastic tourniquets afford improved stability and security of the introducer sheath 14. (See FIGS. 9-10)

[0041] Once the surgeon has completed placement of the sutures inside the heart, for mitral valve repair, for example, each suture is positioned in the center of the valve system 54, and then positioned in one of the slots 94 of the suture retention system 74. The sutures are retained at the tips only with color marking on both sides of the slots 94. This is performed for all of the retained sutures. (See FIGS. 10-11) Next, the sutures are cut leaving color markings on the long end of the suture, as well as the short end which is still retained in the slots 94 on the hub 18. (See FIG. 12) Next, in preparation for closure of the ventriculotomy, the tourniquets are removed from the purse string sutures encircling the ventriculotomy, the sutures are then removed from the external stabilization disc 42. The balloon 34 on the sheath is fully deflated, confirmed by trans esophageal echocardiography and/or fluoroscopy, and the sheath is then removed leaving the color coded sutures exiting the ventriculotomy. The purse strings sutures are tightened to maintain hemostasis following sheath removal.

[0042] The color-coded valve repair sutures are then secured to a felt pledget 48 as directed by the instructions for use by the manufacturer of the device in use for the transventricular suture mediated structural heart surgery. The suture retention system 74, with all color-coded retained sutures from surgery, is then detached from the hub 18 of the introducer sheath 14 and then utilized as a reference for the proper suture placement (medial vs. lateral for example) in the felt pledget 48 for surgical procedure completion.

[0043] FIGS. 13-16 illustrate additional renderings of embodiments of intra-cardiac introducer device 10 being utilized to access the mitral valve, aortic valve, tricuspid valve and pulmonic artery, respectively.

[0044] The intra-cardiac introducer device 10 provides cardiothoracic surgeons a stable transventricular specific introducer sheath system making the surgery safer for patients by minimizing blood loss, enhancing device delivery making the surgery more precise and efficient, and providing a platform for fewer surgical instruments in the small surgical window.

[0045] Various features and advantages of the invention are set forth in the following claims.

Claims

CLAIMS What is claimed is:

1. An intra-cardiac introducer device comprising:

a sheath having a distal end and a proximal end, the sheath being configured to penetrate cardiac tissue;

a hub connected to the proximal end of the sheath;

an intracardiac stabilization balloon coupled to the distal end of the sheath; and an external stabilization disc slidingly positioned along the sheath;

wherein the cardiac tissue is sandwiched between the intracardiac stabilization balloon and the external stabilization disc to secure position of the sheath in the cardiac tissue.

2. The device of claim 1, further comprising a valve system coupled to the hub and configured to provide hemostasis during transventricular surgery.

3. The device of claim 2, wherein the valve system comprises a first valve coupled to a proximal end of the hub and a second valve positioned within a cavity of the hub.

4. The device of claim 1, wherein the intracardiac stabilization balloon includes an inflated state and a deflated state.

5. The device of claim 1, wherein the balloon is coupled to the exterior surface of the sheath.

6. The device of claim 1, wherein the stabilization disc includes a plurality of slots configured to receive purse string sutures.

7. The device of claim 1, wherein the sheath includes a hollow interior and is configured to receive a guidewire with an inner dilator in place for device insertion.

8. An intra-cardiac introducer device comprising:

a sheath having a distal end and a proximal end;

a hub connected to the proximal end of the sheath; and

a suture retention system removably coupled to the hub, the suture retention system including

a body,

a plurality of slots on the body configured to receive sutures, and an orientation marker configured to identify a position of the sutures relative to a patient's heart.

9. The device of claim 1, further comprising a valve system coupled to the hub and configured to provide hemostasis during transventricular surgery.

10. The device of claim 9, wherein the valve system comprises a first valve coupled to a proximal end of the hub and a second valve positioned within a cavity of the hub.

11. The device of claim 1, further comprising a balloon coupled to the sheath, and wherein the balloon includes an inflated state and a deflated state.

12. The device of claim 10, further comprising a stabilization disc coupled to an exterior surface of the sheath, and wherein the stabilization disc is positioned between the heart and the hub to stabilize the device when the balloon is in the inflated state.

13. The device of claim 12, wherein the balloon is coupled to the exterior surface of the sheath at the distal end of the sheath.

14. The device of claim 12, wherein the stabilization disc includes a plurality of slots configured to receive purse string sutures.

15. The device of claim 1, wherein the body of the suture retention includes a central aperture configured to receive a distal end of the hub.

16. The device of claim 1, wherein the sheath includes a hollow interior and is configured to receive a guidewire with an inner dilator in place for device insertion.

17. The device of claim 1, further comprising a nitinol disc coupled to the sheath, and wherein the nitinol disc includes an actuated state and a deactuated state.

18. A suture retention system comprising:

a body including

a central aperture, and

a plurality of slots on the body and configured to receive sutures, and an orientation marker configured to identify a position of the sutures relative to a patient's heart, and

wherein the central aperture is configured to removably couple to a hub positioned at a distal end of a vascular sheath sized 16 to 36 French.

19. A method of performing a ventriculotomy, the method comprising:

inserting a sheath over a guidewire positioned through cardiac tissue forming an opening in the cardiac tissue;

inflating a balloon inside a cardiac cavity, the balloon positioned on an exterior surface of the sheath and adjacent an interior surface of the cardiac tissue;

positioning a stabilization disc opposite the inflated balloon, the stabilization disc in contact with an exterior of the cardiac tissue;

positioning purse strings in the stabilization disc;

positioning sutures in slots on a suture retention system coupled to a hub at a distal end of the sheath;

suturing anatomy in the cardiac cavity using the sutures;

removing the sheath from the cardiac tissue; and

closing the opening in the cardiac tissue with the purse string sutures.