Device for radiosurgical treatment of uterine fibroids
Removable marker implants having fiducial markers disposed on multiple elongate members extend and splay laterally outward when deployed thereby providing improved 3D localization and tracking of a portion of the patient's body for stereotactic radiosurgery. Such an approach is particularly useful for tracking of the uterus during radiosurgery treatment of uterine fibroids. Such implants can include an outer sheath that contains the multiple elongate members during delivery into the portion of the body. The elongate members can be slidably disposed within the shaft and advanced into an expanded deployed position by advancement of an applicator shaft or rod within the sheath. Marker implant can also be integrally formed implants with flexible arms having fiducial markers thereon that can be constrained in a sheath for delivery and resiliently splay laterally outward when released from the shaft. Methods of delivery and deployment are also provided.
1. A device for placing one or more radiosurgical fiducial markers into a uterus, the device comprising:
the one or more radiosurgical fiducial markers disposed on a distal portion of each of a plurality of elongate members; and
a sheath in which the plurality of elongate members are at least partly disposed, wherein the plurality of elongate members are movable between a delivery configuration and a deployed configuration,
wherein in the delivery configuration, the plurality of elongate members are substantially contained within the sheath,
wherein in the deployed configuration, the distal portions of each of the plurality of elongate members having the one or more radiosurgical fiducial markers extend through one or more openings in the sheath for placement along the uterus to facilitate 3D visualization and/or tracking of the uterus,
wherein the one or more radiosurgical fiducial markers are fixed relative to each other in the deployed configuration, and
wherein the plurality of elongate members comprise a rigid material thereby fixing the one or more radiosurgical fiducial markers relative to each other in the deployed configuration.
2. The device of claim 1 , wherein the sheath comprises at least one of the one or more radiosurgical fiducial markers and each of the plurality of elongate members comprises at least one of the one or more radiosurgical fiducial markers at or near a distal of each of the plurality of elongate members, whereby, when in the deployed configuration, 3-dimensional spatial positions of the one or more radiosurgical fiducial markers facilitate tracking of the uterus by visualization techniques.
3. The device of claim 1 , wherein the plurality of elongate members comprises a pair of elongate members or three elongate members.
4. The device of claim 1 , wherein the plurality of elongate members are slidably disposed within a lumen of the sheath and movable between the delivery and deployed configurations by sliding within the lumen.
5. The device of claim 4 , wherein each of the plurality of elongate members comprises a distal barb for penetrating engagement with a tissue of the uterus when deployed.
6. The device of claim 4 , wherein each of the plurality of elongate members comprises a distal atraumatic tip to engage a tissue of the uterus without penetration.
7. The device of claim 4 , wherein the plurality of elongate members are proximally coupled to a base that is slidable through the lumen in the sheath.
8. The device of claim 7 , further comprising:
an applicator that is releasably attachable to the base for distal advancement of the base within the lumen to deploy the plurality of elongate members.
9. The device of claim 1 , further comprising:
an applicator that is releasably attachable to the sheath to facilitate deployment and retraction of the plurality of elongate members and removal of the sheath after therapy.
10. The device of claim 9 , wherein the applicator comprises an engagement shaft that releasably engages with the sheath by mating corresponding coupling features.
11. The device of claim 10 , wherein the applicator further comprises a rod advanceable through the engagement shaft that releasably engages with a base of the plurality of elongate members by mating the corresponding coupling features.
12. The device of claim 11 , wherein the corresponding coupling features comprise a male feature selected from the group consisting of: one or more protrusions, ridges, flanges and threads and a female feature selected from the group consisting of: one or more recesses and internal threads.
13. The device of claim 11 , wherein the engagement shaft comprises a finger tab at a proximal end of the engagement shaft and the rod comprises a thumb flange at a proximal end of the rod, to facilitate manual manipulation of the engagement shaft relative the rod.
14. The device of claim 9 , wherein the applicator is releasably attachable to the sheath via linear engagement means or rotational engagement means.
15. The device of claim 1 , wherein the plurality of elongate members are configured such that, in the deployed configuration, the plurality of elongate members splay laterally outwards in a distributed array.
16. The device of claim 15 , wherein the plurality of elongate members are formed of a shape memory material.
17. The device of claim 15 , wherein the plurality of elongate members are formed, at least in part, of a flexible material.
18. The device of claim 1 , wherein the sheath is dimensioned and configured for placement of a distal portion of the sheath within the uterus by insertion through a cervix.
19. The device of claim 18 , wherein the sheath comprises a proximal flange dimensioned to engage tissues and prevent insertion beyond the cervix.
20. The device of claim 1 , wherein the one or more radiosurgical fiducial markers and the sheath are sufficiently rigid and sized such that, in the deployed configuration, the one or more radiosurgical fiducial markers and the sheath remain in a substantially fixed position within the uterus to facilitate tracking the uterus during radiosurgery therapy.
21. A removable marker implant device for inserting one or more radiosurgical fiducial markers into a uterus, the implant device comprising:
a removable implant having a plurality of elongate members extending laterally outward from a central rod; and
the one or more radiosurgical fiducial markers disposed on a distal portion of each of the plurality of elongate members of the implant device,
wherein the plurality of elongate member are flexible so as to be movable between a constrained delivery configuration and a deployed configuration, wherein:
in the delivery configuration, the plurality of elongate members are flexed towards the central rod by a sheath to facilitate delivery into the uterus, and
in the deployed configuration the plurality of elongate members extend and splay laterally outward to engage the uterus when released from the sheath,
wherein the one or more radiosurgical fiducial markers are fixed relative to each other in the deployed configuration, and
wherein the plurality of elongate members comprise a rigid material thereby fixing the one or more radiosurgical fiducial markers relative to each other in the deployed configuration.
22. The implant device of claim 21 , wherein the plurality of elongate members and the central rod are formed as a unitary component.
23. The implant device of claim 21 , wherein the plurality of elongate members and the central rod are formed of a shape memory material.
24. The implant device of claim 21 , wherein each of the plurality of elongate members have distal atraumatic tips and the implant device is configured for delivery and deployment in the uterus.