Detachable hemostasis valve and splittable sheath assembly

1. A delivery system for delivering a medical instrument, the system comprising

a hemostasis device having a first engagement structure;

a splittable sheath;

a sheath hub joined with a proximal end of the splittable sheath, the sheath hub further having a second engagement structure disposed on a proximal end thereof;

a third engagement structure disposed on the hemostasis device proximally displaced from the first engagement structure;

a fourth engagement structure disposed on the sheath hub; and

a pair of handles joined with the sheath hub, wherein each handle is positioned on an opposing lateral half of the sheath hub; wherein

the first engagement structure is adapted to engage the second engagement structure to couple the hemostasis device with the splittable sheath;

the third engagement structure is adapted to engage the fourth engagement structure to axially couple the hemostasis device with the splittable sheath; and

the second engagement structure is adapted to disengage from the first engagement structure and the fourth engagement structure is adapted to disengage from the third engagement structure when the opposing lateral halves of the sheath hub are separated from each other in order to split the splittable sheath.

2. The delivery system of claim 1 further comprising a fluid-tight seal for engagement between the hemostasis device and the sheath hub.

3. The delivery system of claim 1 , wherein the third engagement structure engages the fourth engagement structure to axially couple the hemostasis device with the splittable sheath without impeding rotational movement between the hemostasis device and the splittable sheath.

4. A delivery system for delivering a medical device, the system comprising

a hemostasis device having a cannula portion and a first coupler and a first connector disposed on the cannula portion;

a splittable sheath;

a bifurcated sheath hub formed of opposing lateral halves joined with a proximal end of the splittable sheath, the bifurcated sheath hub comprising a second coupler and a second connector; wherein

the first coupler is adapted to engage the second coupler to couple the hemostasis device with the splittable sheath;

the first connector is adapted to engage the second connector to axially connect the hemostasis valve with the splittable sheath; and

the second coupler is adapted to disengage from the first coupler and the second connector is adapted to disengage the first connector when the opposing lateral halves of the bifurcated sheath hub are separated from each other to split the splittable sheath.

5. The delivery system of claim 4 , further comprising a pair of handles joined with the bifurcated sheath hub, wherein each handle is positioned on one of the opposing lateral halves of the bifurcated sheath hub.

6. The delivery system of claim 4 , wherein the bifurcated sheath hub further comprises a pair of tabs, each extending distally from one of the opposing lateral halves of the bifurcated sheath hub and adhered to an outer wall of the splittable sheath.

7. The delivery system of claim 6 , further comprising a pair of handles joined with the bifurcated sheath hub, wherein each handle is positioned on one of the tabs, respectively.

8. The delivery system of claim 4 , wherein

the bifurcated sheath hub further comprises an annular wall with an interior surface defining a lumen;

the hemostasis device further comprises an O-ring disposed about the cannula portion, the O-ring of slightly larger diameter than the interior surface of the annular wall of the bifurcated sheath hub, for creating a fluid-tight seal with the bifurcated sheath hub when the cannula portion is seated within the lumen.

9. The delivery system of claim 4 , wherein

the bifurcated sheath hub further comprises an annular wall with an interior surface defining a lumen;

the first coupler comprises a first snap ring disposed about a distal end of the cannula portion, wherein the first snap ring is of slightly larger diameter than the interior surface of the annular wall of the sheath hub; and

the second coupler comprises a second snap ring formed on the interior surface of the annular wall, wherein the second snap ring is of slightly smaller diameter than the diameter of the interior surface of the annular wall adjacent the second snap ring; and

wherein when the hemostasis device is coupled with the splittable sheath, the first snap ring is positioned distal and adjacent to the second snap ring.

10. The delivery system of claim 4 wherein

the bifurcated sheath hub further comprises an annular wall with an interior surface defining a lumen;

the second coupler comprises a pair of clips joined with the bifurcated sheath hub, wherein

each clip is positioned on and extends proximally from a proximal end of one of the opposing lateral halves of the bifurcated sheath hub, respectively;

each clip defines a lip and a recess; and

the first coupler comprises a pair of ledges disposed on opposing sides of the cannula portion;

wherein when the hemostasis device is coupled with the splittable sheath, each ledge is retained within one of the recesses by one of the lips, respectively.

11. The delivery system of claim 4 , wherein

the bifurcated sheath hub further comprises an annular wall with an interior surface defining a lumen;

the second coupler comprises two sets of paired tabs, wherein

each tab forms a portion of the annular wall of the bifurcated sheath hub;

each tab is positioned on the proximal end of the bifurcated sheath hub;

the sets of paired tabs are positioned opposite each other;

each tab in each pair of tabs is positioned apart from the other on one of the opposing lateral halves of the bifurcated sheath hub; and

each tab further comprises a tooth on its proximal end extending radially into the lumen; and

the first coupler comprises a circumferential groove about the cannula portion;

wherein when the hemostasis device is coupled with the splittable sheath, each tooth in each of the tabs is retained within the circumferential groove.

12. The delivery system of claim 4 , wherein

the bifurcated sheath hub further comprises an annular wall with an interior surface defining a lumen;

the second coupler comprises four clips joined with the bifurcated sheath hub, wherein

each clip is positioned on and extends proximally from a proximal end of the bifurcated sheath hub;

each clip is spaced equidistant from each adjacent clip circumferentially about the lumen;

pairs of the four clips are positioned on one of the opposing lateral halves; and

each clip defines a lip and a recess; and

the first coupler comprises four ledges disposed equidistant from each adjacent ledge circumferentially about the cannula portion;

wherein when the hemostasis device is coupled with the splittable sheath, each ledge is retained within one of the recesses by one of the lips.

13. The delivery system of claim 4 , wherein

the bifurcated sheath hub further comprises an annular wall with an interior surface defining a lumen;

the second coupler comprises at least one tab positioned on the proximal end of the bifurcated sheath hub, wherein

the at least one tab forms a portion of the annular wall of the bifurcated sheath hub;

the at least one tab is joined with the bifurcated sheath hub via a structural hinge; and

the at least one tab further comprises a tooth extending radially into the lumen; and

the first coupler comprises a circumferential groove about the cannula portion;

wherein when the hemostasis device is coupled with the splittable sheath, the tooth is retained within the circumferential groove.

14. The delivery system of claim 4 , wherein

the bifurcated sheath hub further comprises an annular wall with an interior surface defining a lumen;

the first coupler comprises a nut retained about the cannula portion, wherein the nut further comprises a pair of ledges disposed on opposing sides of an outer surface of the nut;

the second coupler comprises a pair of clips joined with the bifurcated sheath hub, wherein

each clip extends proximally and is positioned adjacent to one of the opposing lateral halves of the bifurcated sheath hub; and

each clip defines a lip and a recess; and

wherein when the hemostasis device is coupled with the splittable sheath, each ledge is retained within one of the recesses by one of the lips.

15. The delivery system of any of claims 9 - 14 , wherein the hemostasis device further comprises an O-ring disposed about the cannula portion, the O-ring of slightly larger diameter than the interior surface of the annular wall of the bifurcated sheath hub, for creating a fluid-tight seal with the bifurcated sheath hub when the cannula portion is seated within the lumen.

16. The delivery system of any of claims 10 - 14 , wherein

the first connector comprises a first snap ring disposed about a distal end of the cannula portion, wherein the first snap ring is of slightly larger diameter than the interior surface of the annular wall of the sheath hub; and

the second connector comprises a second snap ring formed on the interior surface of the annular wall, wherein the second snap ring is of slightly smaller diameter than the diameter of the interior surface of the annular wall adjacent the second snap ring; wherein

the first snap ring is positioned distal and adjacent to the second snap ring when the hemostasis device is coupled with the splittable sheath; and

the second snap ring disengages from the first snap ring when the opposing lateral halves of the bifurcated sheath hub are separated from each other to split the splittable sheath.

17. A delivery system for delivering a medical instrument intra-arterially or intravenously, the system comprising

a hemostasis device having

a cannula portion extending distally therefrom;

a first snap ring disposed on a distal end of the cannula portion; and

a first engagement structure disposed on the cannula portion proximal to the first snap ring;

a splittable sheath;

a sheath hub connected with a proximal end of the splittable sheath, the sheath hub having

an annular wall defining a lumen;

a second snap ring formed on an interior surface of the annular wall; and

a second engagement structure disposed on a proximal end of the sheath hub;

a pair of handles connected with the sheath hub, each handle positioned on an opposing lateral side of the sheath hub;

wherein when the hemostasis device is connected with the splittable sheath,

the cannula portion seats within the lumen of the sheath hub,

the first snap ring engages the second snap ring, and

the first engagement structure couples with the second engagement structure; and

wherein by exerting an outward radial and distal force on the handles,

the sheath hub and splittable sheath each separate longitudinally,

the second engagement structure disengages from the first engagement structure, and

the second snap ring disengages from the first snap ring.

18. The delivery system of claim 17 , wherein when the hemostasis device is connected with the splittable sheath the first snap ring is positioned distal to the second snap ring.

19. The delivery system of claim 17 , wherein the hemostasis device further comprises an O-ring disposed on the cannula portion for engagement with the interior surface of the annular wall of the sheath hub to create a fluid-tight seal between the hemostasis device and the sheath hub.

20. A delivery system for delivering a medical instrument intra-arterially or intravenously, the system comprising

a hemostasis device having

an outer surface;

a first coupling interface disposed circumferentially on a distal end of the outer surface; and

an O-ring disposed circumferentially on the outer surface proximal to the first coupling interface;

wherein the outer surface of the hemostasis device defines an annular ledge proximal to the O-ring;

a sheath assembly predisposed in construction to longitudinally split into separate first and second halves, wherein

an inner wall surface of the sheath assembly defines a generally cylindrical lumen, and

the inner wall surface further defines a second coupling interface disposed circumferentially about the inner wall surface;

a first handle and a second handle each connected with an outer wall surface of the sheath assembly, the first handle positioned on the first half of the sheath assembly, the second handle positioned on the second half of the sheath assembly, and both the first and second handles positioned at a proximal end of the sheath assembly;

wherein the proximal end of the sheath assembly defines an annular rim;

wherein when the hemostasis device is connected with the sheath assembly,

the first coupling interface engages the second coupling interface, and

the O-ring frictionally engages the inner wall surface of the sheath assembly, and

the annular ledge interfaces with the annular rim; and

wherein by exerting an outward radial and distal force on each of the first and second handles,

the sheath assembly separates longitudinally into the first and second halves, and

the second coupling interface disengages from the first coupling interface.

21. A splittable sheath assembly for joining with a hemostasis device having a first snap ring and a first engagement structure, the splittable sheath assembly comprising

a cannula predisposed to separate longitudinally;

a bifurcated sheath hub formed of opposing lateral halves joined with a proximal end of the cannula, the bifurcated sheath hub further having

an annular wall defining a lumen;

a second snap ring formed on an interior surface of the annular wall; and

a second engagement structure disposed on a proximal end of the sheath hub; and

a pair of handles connected with the bifurcated sheath hub, each handle positioned on an opposing lateral side of the bifurcated sheath hub;

wherein when the splittable sheath assembly is connected with the hemostasis device,

the second snap ring engages the first snap ring, and

the second engagement structure couples with the first engagement structure; and

wherein by exerting an outward radial and distal force on the handles,

the bifurcated sheath hub and cannula each separate longitudinally,

the second engagement structure disengages from the first engagement structure, and

the second snap ring disengages from the first snap ring.