Conformal, non-occluding sensor array for cardiac mapping and ablation
Systems, methods, and devices having improved conformal properties for biomedical signal measurement are disclosed. A device can have a first polymer substrate coupled to a conductive layer forming a conductive trace electrically coupled to a conductive pad exposed via an opening. The device can have a second polymer substrate forming a first cavity between the first polymer substrate and the second polymer substrate. The device can have a first inlet portion that receives a fluid that expands the first cavity causing the device to conform to an anatomical structure. The structure can be an atrium, such as the left atrium, of the heart of a patient. The device can conform to the walls of the tissue structure, and the conductive pad exposed via the opening can detect a signal from the wall of the tissue structure. The signal can be provided to an external measurement device for processing.
1 . A medical device comprising:
a first polymer substrate having a first surface and a second surface;
a conductive layer coupled to the first polymer substrate, the conductive layer comprising a conductive trace electrically coupled to an electrode pad;
an opening extending through the first polymer substrate between the first surface and the second surface, wherein the electrode pad is exposed through the opening at the second surface;
a second polymer substrate forming one or more cavity portions between the first polymer substrate and the second polymer substrate; and
a first inlet portion to receive a fluid;
wherein the conductive trace electrically couples the electrode pad with a component of the medical device;
wherein the first polymer substrate, the second polymer substrate, and the first inlet portion form a first soft-electronic beam of a plurality of soft-electronic beams; and
wherein introduction of the fluid via the first inlet portion expands the one or more cavity portions such that the plurality of soft-electronic beams form a three-dimensional structure that conforms to an anatomical structure.
2 . The medical device of claim 1 , wherein the first inlet portion is configured to receive the fluid and thereby expand the medical device from a first size to a second size that is larger than the first size.
3 . The medical device of claim 1 , wherein the plurality of soft-electronic beams are arranged such that, when expanded, the three-dimensional structure conforms to multiple regions of the anatomical structure.
4 . The medical device of claim 1 , wherein at least one of the first polymer substrate or the second polymer substrate comprises at least one of a urethane polymer, a polyurethane polymer, a copolymer, a silicone polymer, or an elastomer.
5 . The medical device of claim 1 , wherein the medical device is configured to detect signals at a biological tissue when the electrode pad is directly exposed to the biological tissue or a predetermined distance away from the biological tissue.
6 . The medical device of claim 1 , wherein the component comprises a sensor, and wherein the electrode pad detects a signal at a biological tissue and provides the signal to the component.
7 . The medical device of claim 1 , wherein the medical device is configured to provide signals detected at the electrode pad to a catheter that transmits the signals to an external measurement device.
8 . The medical device of claim 1 , wherein the conductive trace is coupled to a portion of a flexible printed-circuit board substrate that is coupled to at least one of the first polymer substrate or the second polymer substrate.
9 . The medical device of claim 1 , wherein the component is coupled to at least one of the first polymer substrate, the second polymer substrate, or a flexible printed-circuit board layer coupled to the conductive layer and to at least one of the first polymer substrate or the second polymer substrate.
10 . The medical device of claim 1 , wherein the electrode pad is a first electrode pad, the conductive trace is a first conductive trace, and the medical device further comprises a second electrode pad electrically coupled to a second conductive trace, wherein the first electrode pad is configured to be coupled to a first sensor or configured to deliver energy to biological tissue, and the second electrode pad is configured to be coupled to a second sensor or configured to deliver energy to biological tissue.
11 . The medical device of claim 1 , wherein the conductive trace comprises a non-linear pattern such that the conductive trace stretches in response to expansion of the medical device.
12 . A method comprising:
positioning a medical device at, or within, an anatomical structure of a patient, the medical device comprising a plurality of soft-electronic beams, each soft-electronic beam comprising:
a first polymer substrate;
a conductive layer coupled to the first polymer substrate, the conductive layer comprising a conductive trace electrically coupled to an electrode pad;
a second polymer substrate forming one or more cavity portions between the first polymer substrate and the second polymer substrate; and
a first inlet portion configured to receive a fluid;
introducing the fluid via the first inlet portion to expand the one or more cavity portions such that the plurality of soft-electronic beams form a three-dimensional structure that conforms to the anatomical structure; and
using the medical device to pass a signal between the-at least one electrode pad and a biological tissue of the anatomical structure.
13 . The method of claim 12 ,
wherein the medical device further comprises: a lumen coupled to the first inlet portion; and
wherein the method further comprises:
providing, via the lumen, a first amount of the fluid to cause the medical device to expand to a first size;
determining that the signal is not detected by at least one electrode pad responsive to providing the first amount of the fluid; and
providing, responsive to determining that the signal is not detected, a second amount of the fluid that causes the medical device to expand to a second size larger than the first size.
14 . The method of claim 13 , wherein providing the first amount of fluid comprises determining the first amount of the fluid based on at least one of a type of the anatomical structure, a volume of the medical device, or information from an image of the anatomical structure.
15 . The method of claim 12 , further comprising monitoring signals from the biological tissue using the medical device, wherein monitoring the signals comprises measuring at least one of a force value, a shear force value, an ultrasound value, a temperature value, a position value, an electrocardiogram value, or an electrochemical value.
16 . The method of claim 12 , wherein the anatomical structure is an atrium of a heart of the patient, and wherein positioning the medical device at, or within, the anatomical structure is performed using at least a transseptal puncture.
17 . The medical device of claim 1 , wherein the plurality of soft-electronic beams carry a plurality of electrodes arranged as a sensor array.
18 . The medical device of claim 1 , wherein the three-dimensional structure formed by the plurality of soft-electronic beams defines an open-frame structure that permits fluid flow therethrough when expanded.
19 . A medical device comprising:
a polymer structure defining a plurality of expandable regions comprising cavity portions formed between polymer layers, the plurality of expandable regions being arranged to form a three-dimensional configuration that conforms to an anatomical structure when expanded;
a fluid inlet fluidly coupled to the plurality of expandable regions and configured to receive a fluid to expand the plurality of expandable regions; and
a plurality of electrodes arranged as a sensor array on the polymer structure and electrically coupled to conductive traces.
20 . The medical device of claim 19 , wherein the three-dimensional configuration defines an open-frame structure that permits fluid flow therethrough when expanded.