Separate positionable hemostasis valve for implantable medical lead introducer hub

1 . A medical system comprising:

an implantable medical lead comprising a lead body and a helical electrode at least one of extending or extendable from a distal end of the lead body; and

a hemostasis valve coupled to the lead body proximal the distal end of the lead body, the hemostasis valve coupled to the lead body without insertion of the distal end of the lead body through the hemostasis valve, the hemostasis valve configured to slide along the lead body,

wherein the distal end of the lead body is configured for insertion into an introducer hub positioned in an opening into a vasculature of a patient and the lead body is configured for subsequent advancement through the introducer hub to facilitate securing the hemostasis valve to the introducer hub,

wherein the hemostasis valve is configured to at least one of: slide along an outer surface of the lead body to secure the hemostasis valve to the introducer hub or move distally with the lead body to secure the hemostasis valve to the introducer hub, and

wherein the hemostasis valve is configured for slidable advancement of the lead body therethrough for continued advancement of the lead body through the introducer hub.

2 . The medical system of claim 1 , wherein the hemostasis valve extends from a proximal end to a distal end configured for insertion into an opening in the introducer hub, wherein a cross-sectional dimension of the hemostasis valve is tapered from a larger value at the proximal end to a smaller value at the distal end.

3 . The medical system of claim 2 , wherein the cross-sectional dimension of the proximal end of the hemostasis valve is larger than a corresponding dimension of the opening of the introducer hub.

4 . The medical system of claim 1 , wherein the hemostasis valve further comprises:

a constricted gasket configured to resist blood flow between the gasket and the lead body when coupled to the lead body.

5 . The system of claim 1 , wherein the hemostasis valve directly contacts the outer surface of the lead body.

6 . The medical system of claim 4 , wherein the constricted gasket is configured to slide along the lead body, wherein the constricted gasket maintains a hemostatic seal between the lead body and the hemostatic valve.

7 . The medical system of claim 6 , wherein an inner seal comprises leaflets configured to create the hemostatic seal.

8 . The medical system of claim 1 , wherein the implantable medical lead further comprises a balloon proximal of the distal end of the lead body, wherein the hemostasis valve is coupled to the lead body proximal of the balloon.

9 . A method of using a medical system comprising:

inserting a distal end of a lead into an introducer hub, the lead comprising a lead body, a helical electrode at least one of extending or extendable from the distal end, and a hemostasis valve coupled to the lead body proximal the distal end of the lead;

securing the hemostasis valve to the introducer hub via at least one of sliding the hemostasis valve along the lead body towards the introducer hub or moving the lead body and the hemostasis valve together distally; and

further inserting the lead into the introducer hub positioned in an opening into a vasculature of a patient, wherein the hemostasis valve is configured for slidable advancement of the lead body therethrough for continued advancement of the lead body through the introducer hub.

10 . The method of claim 9 , wherein securing a hemostasis valve further comprises inserting the hemostasis valve, extending from a proximal end to a distal end, into an opening in the introducer hub, wherein a cross-sectional dimension of the hemostasis valve is tapered from a larger value at the proximal end to a smaller value at the distal end.

11 . The method of claim 10 , wherein inserting the hemostasis valve is stopped by the cross-sectional dimension of the proximal end being larger than a corresponding dimension of the opening of the introducer hub.

12 . The method of claim 9 , wherein securing the hemostasis valve further comprises:

constricting a gasket of the hemostasis valve around the lead body, thereby configuring the hemostasis vale to resist blood flow between the gasket and the lead body.

13 . The method of claim 9 , wherein further inserting the lead further comprises:

sliding an inner seal along the lead body, wherein the inner seal is configured to create a hemostatic seal between the lead body and the hemostatic valve.

14 . The method of claim 9 , wherein sliding an inner seal does not disrupt the hemostatic seal between the gasket and the lead body.

15 . A medical system kit comprising:

an implantable medical lead comprising a lead body and a helical electrode at least one of extending or extendable from a distal end of the lead body;

a hemostasis valve coupled to the lead body proximal the distal end of the lead body, hemostasis valve configured to slide along the lead body; and

a package containing the implantable medical lead with the hemostasis valve coupled thereto,

wherein the distal end of the lead body is configured for insertion into an introducer hub positioned in an opening into a vasculature of a patient and the lead body configured for subsequent advancement through the introducer hub to facilitate securing the hemostasis valve to the introducer hub,

wherein the hemostasis valve is configured for slidable advancement of the lead body therethrough for continued advancement of the lead body through the introducer hub.

16 . The medical system kit of claim 15 , wherein the hemostasis valve extends from a proximal end to a distal end configured for insertion into an opening in the introducer hub, wherein a cross-sectional dimension of the hemostasis valve is tapered from a larger value at the proximal end to a smaller value at the distal end.

17 . The medical system kit of claim 15 , wherein the cross-sectional dimension of the proximal end is larger than a corresponding dimension of the opening of the introducer hub.

18 . The medical system of claim 15 , wherein the hemostasis valve further comprises:

a constricted gasket configured to resist blood flow between the gasket and the lead body when coupled to the lead body.

19 . The medical system kit of claim 18 , wherein the constricted gasket comprises silicone rubber.

20 . The medical system kit of claim 18 , wherein the constricted gasket is configured to slide along the lead body, wherein the constricted gasket maintains a hemostatic seal between the lead body and the hemostatic valve.

21 . The medical system kit of claim 20 , wherein an inner seal comprises leaflets configured to create the hemostatic seal.

22 . The medical system kit of claim 15 , wherein the implantable medical lead further comprises a balloon proximal of the distal end of the lead body, wherein the hemostasis valve is coupled to the lead body proximal of the balloon.

23 . A method of manufacturing a medical system kit comprising:

forming implantable medical lead comprising a lead body and a helical electrode at least one of extending or extendable from a distal end of the lead body;

forming a hemostasis valve configured to slide along the lead body;

coupling the hemostasis valve to the lead body proximal the distal end of the lead body; and

placing the implantable medical lead with the hemostasis valve coupled thereto within a package,

wherein the distal end of the lead body is configured for insertion into an introducer hub positioned in an opening into a vasculature of a patient and the lead body configured for subsequent advancement through the introducer hub to facilitate securing the hemostasis valve to the introducer hub, wherein the hemostasis valve is configured for slidable advancement of the lead body therethrough for continued advancement of the lead body through the introducer hub.

24 . The method of claim 23 , further comprising placing the introducer hub within the package separated from the hemostasis valve.

25 . The method of claim 23 , wherein the hemostasis valve extends from a proximal end to a distal end configured for insertion into an opening in the introducer hub, wherein a cross-sectional dimension of the hemostasis valve is tapered from a larger value at the proximal end to a smaller value at the distal end.

26 . The method of claim 25 , wherein the cross-sectional dimension of the proximal end is larger than a corresponding dimension of the opening of the introducer hub.

27 . The method of claim 23 , wherein coupling the hemostasis valve further comprises:

constricting a gasket of the hemostasis valve around the lead body, thereby configuring the hemostasis vale to resist blood flow between the gasket and the lead body.

28 . The method of claim 27 , wherein the gasket is configured to slide along the lead body, wherein the gasket is configured to maintain a hemostatic seal between the lead body and the hemostatic valve.

29 . The method of claim 23 , wherein the implantable medical lead further comprises a balloon proximal of the distal end of the lead body, wherein the hemostasis valve is coupled to the lead body proximal of the balloon.