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EP-3866680-B1 - APPARATUS FOR SENSOR DEPLOYMENT AND FIXATION

EP3866680B1EP 3866680 B1EP3866680 B1EP 3866680B1EP-3866680-B1

Inventors

  • EIDENSCHINK, TRACEE
  • PARK, JIN WOO
  • WHITE, Jason, A.

Dates

Publication Date
20260513
Application Date
20191014

Claims (15)

  1. An intracorporeal device delivery system (400) comprising: a delivery shaft (404) comprising a distal coupling feature (410); a sheath (402) adapted to receive a guidewire (406) and defining a delivery shaft lumen (407), the delivery shaft (404) disposed within the delivery shaft lumen (407); and an intracorporeal device (450) comprising a proximal coupling feature (452) and a device body (451), the device body (451) defining an axial envelope (454) extending proximally from the device body (451); wherein the distal coupling feature (410) is releasably coupled to the proximal coupling feature (452) such that, when coupled, the distal coupling feature (410) is disposed within the axial envelope (454) defined by the device body (451), and wherein the intracorporeal device (450) is a pressure sensor configured to be located and fixed in a vessel, characterized in that the sheath (402) defines a guidewire lumen (408) separate from the delivery shaft lumen (407), the guidewire lumen (408) shaped to receive the guidewire (406).
  2. The intracorporeal device delivery system of claim 1, further comprising the guidewire (406).
  3. The intracorporeal device delivery system of claim 1 or 2, wherein the distal coupling feature (410) of the delivery shaft (404) is a threaded extension extending distally from the delivery shaft (404) and the proximal coupling feature (452) of the intracorporeal device (450) is a threaded hole shaped to receive the distal coupling feature (410).
  4. The intracorporeal device delivery system of any one of claims 1 to 3, further comprising a hub (430) coupled to a proximal end of the delivery shaft (404).
  5. The intracorporeal device delivery system of claim 4, wherein the hub (430) comprises a shaft manipulation feature (440) coupled to the delivery shaft (404), the shaft manipulation feature (440) configured to release the distal coupling feature (410) from the proximal coupling feature (452).
  6. The intracorporeal device delivery system of claim 5, wherein the shaft manipulation feature (440) is a rotatable knob (440) coupled to the delivery shaft (404) such that rotation of the rotatable knob (440) rotates the delivery shaft (404) to decouple the distal coupling feature (410) from the proximal coupling feature (452).
  7. The intracorporeal device delivery system of any one of claims 4 to 6, wherein the hub (430) comprises at least one port (318) in communication with an auxiliary lumen (408) of the sheath (402) such that the port (318) is in fluid communication with a distal end of the sheath (402).
  8. The intracorporeal device delivery system of claim 7, wherein the auxiliary lumen (408) is one of the distal shaft lumen or the guidewire lumen (408).
  9. The intracorporeal device delivery system of any one of claims 1 to 8, wherein the sheath (402) comprises braided tubing.
  10. The intracorporeal device delivery system of any one of claims 1 to 9, wherein the intracorporeal device (450) comprises a guide (456) defining a passage (458) shaped to receive the guidewire (406), the passage (458) disposed outside the axial envelope (454).
  11. The intracorporeal device delivery system of any one of claims 1 to 10, wherein the delivery shaft (404) comprising the distal coupling feature (410) extending from a distal end of the delivery shaft (404), the distal coupling feature (410) comprising a threaded extension (410); the proximal coupling feature (452) comprising a threaded hole shaped to receive the threaded extension (410) of the delivery shaft (404).
  12. The intracorporeal device delivery system of claim 11, further comprising a hub coupled to a proximal end of the delivery shaft and comprising at least one port in communication with an auxiliary lumen of the sheath such that the port is in fluid communication with a distal end of the sheath.
  13. The intracorporeal device delivery system of claim 12, wherein the auxiliary lumen is one of the delivery shaft lumen or the guidewire lumen.
  14. The intracorporeal device delivery system of any one of claims 11 to 14, wherein the sheath comprises braided tubing.
  15. The intracorporeal device delivery system of any one of claims 11 to 14, wherein the intracorporeal device (450) comprises a guide (456) defining a passage (458) shaped to receive the guidewire (406), the passage (458) disposed outside the axial envelope (454).

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Non-provisional Application Serial No. 16/162,147 (U.S. Publication No. 2020/0114118), filed on October 16, 2018. TECHNICAL FIELD This disclosure relates generally to implantation of intracorporeal devices into vessels and to systems of delivering such intracorporeal devices to predetermined locations within the vessel. BACKGROUND In recent years, the long-sought goal of implantable biosensors has begun to see realization and, in some cases, clinical use. As this concept has seen continued research and development, issues regarding intracorporeal fixation of the sensor have come to light. Particularly within blood vessels, the sensor is subjected to a continuous, pulsatile flow. This is a difficult environment in which to secure a sensor or other apparatus reliably without unduly restricting blood flow or impairing the vessel wall. One major vessel of interest in the realm of cardiology is the pulmonary artery. The pulmonary artery is a particularly challenging location in which to secure an intracorporeal device because, in addition to the above considerations, the vessel is especially thin, compliant and prone to perforation. Design considerations for an ideal fixation device intended for intravascular fixation are outlined as follows. The fixation device should be passive and maintain a separation distance between the sensor and the vessel wall to maintain blood flow past the sensor. The deployed size and radial strength of the device should be sufficient to prevent its migration into vessels that would be occluded by the dimensions of the sensor while creating minimal stress concentrations where the fixation device contacts the vessel wall. Alternatively, intracorporeal devices can be designed sufficiently small in size so that when deployed in organs or regions with sufficiently redundant blood flow, the device can embolize on its own without harming the organ or the host. Finally, the fixation device should be sufficiently versatile as not to depend, within physiologically relevant ranges, on the size of the vessel in order to maintain its position. Thus, a need exists for devices and methods for fixing intracorporeal devices and, in particular, for delivery and fixation of such devices in a safe, simple and predictable manner. US 2018/0289487 discloses implant delivery systems and methods for controllably deploying an expandable device in a ventricle, the left atrial appendage, or other portion of the heart of a patient. The implant delivery system includes means for loosening or releasing a suture on a perimeter region of the expandable device in order to control the expansion or contraction of the expandable member. The loosening or releasing the suture expands the perimeter region of the expandable device to secure the expandable device in the ventricle of the patient, while tightening the suture contracts the perimeter region of the device. The system may include one or more monitoring devices to monitor aspects of the heart, such as hemodynamics. US 2008/0071339 discloses an apparatus for releasably engaging an implantable medical device during delivery includes an elongate, tubular body having an open distal end a plurality of deflectable jaw members extending distally from the distal end of the body and terminating in distal tip portions, and an actuating member slidably disposed within the body and including a distal end portion operable to prevent inward deflection of the jaw members when positioned proximate the distal tip portions. The jaw members are adapted to releasably engage an engagement feature of the implantable medical device. SUMMARY The present invention is defined in the independent claim. Further embodiments of the invention are defined in the dependent claims. In one aspect of the present disclosure, an intracorporeal device delivery system is provided. The delivery system includes a delivery shaft including a distal coupling feature and a sheath adapted to receive a guidewire and defining a delivery shaft lumen, the delivery shaft being disposed within the delivery shaft lumen. The delivery system further includes an intracorporeal device having a proximal coupling feature and a device body, the device body defining an axial envelope extending proximally from the device body. The distal coupling feature is releasably coupled to the proximal coupling feature such that, when coupled, the distal coupling feature is disposed within the axial envelope defined by the device body. The intracorporeal device is a pressure sensor configured to be located and fixed in a vessel. The sheath defines a guidewire lumen separate from the delivery shaft lumen and shaped to receive the guidewire. In certain implementations, the intracorporeal device delivery system comprises the guidewire. In another implementation, the distal coupling feature of the delivery shaft is a threaded extension extending distally from t