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1. WO2020193975 - SHEATH SPLITTING APPARATUS

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[ EN ]

Claims

1. Sheath splitting apparatus for use with a medical device delivery system for deploying a sheathed medical device; the sheath splitting apparatus comprising:-a body having a medical device pathway for receiving a medical device, and one or more arm members having one or more guide elements defining a sheath pathway for guiding sheath material removed from the sheathed medical device; wherein at least a section of the one or more arm members is movable towards and away from the longitudinal axis of the medical device pathway.

2. Sheath splitting apparatus according to claim 1 , wherein two arm members are provided, each with one or more guide elements for guiding sheath material.

3. Sheath splitting apparatus according to claim 1 or 2, wherein at least a section of each arm member is formed of resiliently deformable material.

4. Sheath splitting apparatus according to any preceding claim, wherein at least a section of each arm member is hingeably mounted.

5. Sheath splitting apparatus according to any preceding claim, wherein said each arm member section is configured to deflect radially inwardly under the action of sheath material being pulled along the sheath pathway.

6. Sheath splitting apparatus according to any preceding claim, wherein a proximal end of each arm member naturally extends to a position radially outwardly from a medical device within the apparatus.

7. Sheath splitting apparatus according to any preceding claim, wherein each arm member is at its proximal end configured to present a profile accommodating outward deflection of the arm member on distally directed flow through a medical device present in the apparatus.

8. Sheath splitting apparatus according to claim 7, wherein each arm member has a curved profile at its proximal end.

9. Sheath splitting apparatus according to any preceding claim, wherein each arm extends longitudinally, substantially parallel with the axis of the medical device pathway and has a first guide element at a proximal extent thereof.

10. Sheath splitting apparatus according to any preceding claim, wherein the sheath pathway further comprises a second guide element, provided distally of the first guide element and circumferentially aligned with the first guide element.

11. Sheath splitting apparatus according to claim 10, wherein the first and second guide elements are provided either side of a hinge point of each arm member.

12. Sheath splitting apparatus according to any preceding claim, wherein the one or more guide elements are slots in the arm member.

13. Sheath splitting apparatus according to claim 12, wherein the slots are open slots.

14. Sheath splitting apparatus according to any preceding claim, wherein the sheath pathway extends from inside each arm member, through a first guide element to the exterior of the arm member, along the exterior of the arm member and through the second guide member provided distally of the first guide element.

15. Sheath splitting apparatus according to any preceding claim, wherein the body has clamping means for reducing the cross-sectional area of the medical device pathway.

16. Sheath splitting apparatus according to claim 15, wherein the clamping means defines a central aperture dimensioned for compressing the medical device sufficiently against a delivery shaft to prevent blood leakage there-between, but loose enough to allow the delivery shaft to slide within the medical device.

17. Sheath splitting apparatus according to any preceding claim, wherein the body comprises a plurality of body sections couplable together for housing around said medical device to be delivered.

18. Sheath splitting apparatus according to claim 17, wherein said body has two body sections are hingeably couplable.

19. Sheath splitting apparatus according to claim 17 or 18, wherein each body section carries a clamp profile, the clamp profiles of the body sections inter-engaging on coupling of the body sections for compressing the material of a medical device present in the apparatus.

20. Sheath splitting apparatus according to claim 19, wherein the clamp profile on each body section is tooth-like, and defines a central aperture when the body sections are coupled, the central aperture being dimensioned for compressing the medical device sufficiently against a delivery shaft to prevent blood leakage there between, but loose enough to allow the delivery shaft to slide within the medical device.

21. Sheath splitting apparatus according to claim 20, wherein the clamp profile on one body section has a single tooth profile and the inter-engaging profile on the other body section has a pair of tooth profiles, that slidably interlock when the body sections are coupled together.

22. A method of removing a sheath from a medical device using the sheath splitting apparatus of any preceding claim, the method comprising the steps:-inserting the sheathed medical device into a vessel, with clamping means of the apparatus compressing onto the medical device to create a seal preventing blood leakage between a delivery shaft and the medical device;

pulling on the sheath material tails from the distal end of the apparatus, the or each arm member consequently deflecting radially inwardly, closer to alignment with the sheath profile;

removing the sheath from the device so that the device expands radially outwardly to engage the vessel; and

allowing blood flow through the medical device, the blood flow forcing the or each arm to deflect radially outwardly while still preventing blood leakage from the delivery system access branch.

23. A medical device delivery system for deploying a sheathed medical device, the system comprising:-a medical device delivery shaft for holding a deployable medical device;

a sheathed medical device provided on said delivery shaft; and

a sheath splitting apparatus comprising a body having a medical device pathway for receiving said medical device provided on said delivery shaft, the sheath splitter apparatus comprising one or more arm members having one or more guide elements defining a sheath pathway for guiding sheath material removed from the sheathed medical device;

wherein the one or more arm members are movable towards and away from the longitudinal axis of the medical device pathway.

24. A medical device delivery system according to claim 23, wherein the or each arm member is configured to deflect radially inwardly on sheath removal towards said delivery shaft and then radially outwardly post sheath removal.

25. A medical device delivery system according to claim 23 or 24, wherein the sheath splitter apparatus comprises clamping means configured to compress the medical device against the delivery shaft to prevent blood leakage;