US-12616419-B2 - Structurally dynamic and reconfigurable smart medical devices

US12616419B2US 12616419 B2US12616419 B2US 12616419B2US-12616419-B2

Abstract

The present invention relates to fully autonomous self-navigational medical devices which can be transported within a host subject without existing physical constraints, including those of current physical force limitations, and which are free to undergo a variety of structural and functional adaptations including the ability to perform real-time dynamic adjustment and adaptability to ever changing physiologic, anatomic, and pathologic conditions within the host subject.

Inventors

Bruce Reiner

Assignees

Bruce Reiner

Dates

Publication Date: 20260505
Application Date: 20230731

Claims (20)

1 . A medical device for use in vivo, comprising: a device body; at least one sensor disposed in said device body, to receive and/or transmit real-time data; wherein said at least one sensor detects an obstruction to a path of said device body to a predetermined destination in vivo based on said data; a processor disposed in said device body; and a self-propulsion device disposed in said device body; wherein said processor utilizes said data and based on an analysis of said data, implements a change in a configuration of the medical device; and wherein said change in configuration of the medical device includes at least one of a structural integrity, a size, a shape, a consistency or a flexibility of the medical device, such that the medical device autonomously self-navigates utilizing said self-propulsion device, said obstruction to said path of the medical device.
2 . The medical device of claim 1 , wherein the medical device is configured to be disassembled into constituent individually operable parts and reassembled into an original configuration.
3 . The medical device of claim 1 , further comprising a camera located at one end of said device body; wherein said camera and said at least one sensor are positioned at least at one end of said device body.
4 . The medical device of claim 3 , wherein the medical device is a catheter.
5 . The medical device of claim 4 , wherein said processor actuates one of a programmable material or a programmable object in said device body which changes said at least one of structural integrity, size, shape, consistency or flexibility of the medical device.
6 . The medical device of claim 5 , wherein said processor implements one of a first triggering mechanism or a first signal which actuates said at least one of programmable object or programmable material.
7 . The medical device of claim 6 , wherein said one of said programmable material or said programmable object is made from one of self-transforming carbon fibers, programmable printed wood grains, custom composites, meta-surfaces constructed from a matrix of filamentary metal traces, programmable atom equivalents, synthetic condensates, programmable rubbers or programmable plastics.
8 . The medical device of claim 4 , wherein said consistency of the medical device includes one of a liquid, a gel, an elastomer, or a solid.
9 . The medical device of claim 5 , wherein said programmable object includes actuators that are independently activated to change said configuration of the medical device.
10 . The medical device of claim 9 , wherein said actuators are disposed in outer walls of said catheter.
11 . The medical device of claim 6 , wherein a second triggering mechanism or a second signal restores the medical device to a baseline state.
12 . The medical device of claim 10 , wherein said outer walls contain embedded components including at least one of said at least one sensor, said camera, a computer system, a propulsion system, a drug reservoir, an injection system, or a release mechanism.
13 . The medical device of claim 1 , wherein multiple individual medical devices are contained with the medical device.
14 . A medical device for use in vivo, comprising: a device body; at least one sensor disposed in said device body, to receive and/or transmit real-time data; wherein said at least one sensor detects an obstruction to a path of said device body to a predetermined destination in vivo based on said data; and a processor disposed in said device body which utilizes said data and based on an analysis of said data, and implements a change in a configuration of the medical device including at least one of a structural integrity, a size, a shape, a consistency or a flexibility of the medical device, such that the medical device navigates said obstruction to said path of the medical device; wherein an authentication process is required before said processor implements said change in said configuration.
15 . A medical device for use in vivo, comprising: a device body; at least one sensor disposed in said device body, to receive and/or transmit real-time data; wherein said at least one sensor detects an obstruction to a path of said device body to a predetermined destination in vivo based on said data; and a processor disposed in said device body which utilizes said data and based on an analysis of said data, and implements a change in a configuration of the medical device including at least one of a structural integrity, a size, a shape, a consistency or a flexibility of the medical device, such that the medical device navigates said obstruction to said path of the medical device; wherein the medical device is configured to be disassembled into constituent individually operable parts and reassembled into an original configuration; and wherein said individually operable parts include one of individual segments or sub-components which are configured to detach from said device body and navigate independently to said predetermined destination where said individually operable parts re-attach to attain said original configuration.
16 . The medical device of claim 15 , wherein said individually operable parts include embedded components including at least one of said at least one sensor, said camera, a computer system, a propulsion system, a drug reservoir, an injection system, or a release mechanism.
17 . The medical device of claim 15 , wherein said individually operable parts include individual segments which exhibit independent movement from a neighboring segment.
18 . The medical device of claim 17 , wherein said individual segments are joined together using attachment mechanisms.
19 . A medical device for use in vivo, comprising: a device body: at least one sensor disposed in said device body, to receive and/or transmit real-time data; wherein said at least one sensor detects an obstruction to a path of said device body to a predetermined destination in vivo based on said data; and a processor disposed in said device body which utilizes said data and based on an analysis of said data, and implements a change in a configuration of the medical device including at least one of a structural integrity, a size, a shape, a consistency or a flexibility of the medical device, such that the medical device navigates said obstruction to said path of the medical device; wherein said processor implements said change in configuration to reduce a diameter of the medical device.
20 . A method of navigating an obstruction of a medical device in vivo, comprising: receiving and/or transmitting real-time data from at least one sensor disposed in a device body; detecting an obstruction to a path of the medical device to a predetermined destination in vivo based on said data; analyzing said data for real-time modifications or interventions and based on said analysis of said data, and changing a configuration of the medical device including at least one of a structural integrity, a size, a shape, a consistency or a flexibility of the medical device; and autonomously self-navigating using a self-propulsion device, said obstruction to said path to the medical device.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS The present invention claims priority from U.S. Provisional Patent Application Nos. 63/422,616 filed Nov. 4, 2022, and 63/394,823 filed Aug. 3, 2022, and is a Continuation-in-Part (CIP) of U.S. Nonprovisional patent application Ser. No. 17/836,742 filed Jun. 9, 2022, U.S. Nonprovisional patent application Ser. No. 17/712,693 filed Apr. 4, 2022, and U.S. Nonprovisional Ser. No. 17/575,048 filed Jan. 13, 2022, the contents of all of which are herein incorporated by reference in their entirety. BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to fully autonomous self-navigational medical devices which can be transported within a host subject without existing physical constraints, including those of current physical force limitations, and which are free to undergo a variety of structural and functional adaptations including the ability to perform real-time dynamic adjustment and adaptability to ever changing physiologic, anatomic, and pathologic conditions within the host subject. 2. Description of the Related Art In current practice, in vivo medical devices are positioned into the host subject by either traditional invasive techniques (e.g., surgery) or percutaneously, using minimally invasive techniques (e.g., coronary artery catheterization). Minimally invasive device placement is generally preferred due to reduced patient morbidity and recovery time. The disadvantage of minimally invasive device placement is that it is both operator, patient, and technology dependent. Patient dependence is often determined by patient clinical status, body habitus, and ability to follow commands. At the same time, a patient's underlying pathology (e.g., arterial occlusive disease) will often serve as a determining factor in procedural success or failure. Simply stated, when device placement involves inherent deficiencies in the operator and/or patient, success is far from guaranteed and may incur high rates of iatrogenic complication (e.g., bleeding, tissue injury). When any one of these factors is deficient, the end result may be suboptimal. For minimally invasive vascular catheter placement, the operator (which can be human or robotic), routinely makes a skin incision through which the device (e.g., catheter) and guidewire will be inserted. Guidewires are metallic wires which facilitate the passage of the catheter, which on its own, would be limited due to physical constraints. The components of guidewires include an inner core made of stainless steel or nitinol, an outer body made of coils or polymers, a distal flexible tip made of platinum or tungsten alloy, and a surface coating. The passage of the vascular catheter is determined by two often opposing forces, pushability and navigation. Pushability refers to the force required to advance the catheter to its designated site, while navigation refers to the ability of the catheter to move freely through a non-linear pathway like the vascular system. One can see that these forces of pushability and navigation often act in opposition to one another, creating challenges for minimally invasive device placement. Thus, in order to advance the catheter, sufficient push force must be exerted by the operator to overcome the friction forces between the outer surface of the catheter shaft and the interior vessel wall. For devices introduced using currently available minimally invasive techniques, device maneuverability and steering capabilities are limited by torque and the frictional forces between the catheter and blood vessel walls, as defined by Euler-Bernoulli beam and Cosserat rod theories. As the catheter advances and vascular surface contact increases, the push force must also increase in order to continue advancement of the catheter. Using conventional push-pull and twisting techniques, the operator will attempt to maneuver the device, often incurring damage to the vessel. Further, as these push forces increase, the catheter shaft is prone to buckle and kink, which impedes successful placement. Thus, it is common for underlying vascular tortuosity and/or obstruction to prevent successful navigation, even in the hands of an experienced and technically proficient operator (where a successful outcome is often dictated by the individual skills, expertise, and experience of the operator). A number of technical developments in catheter design and construction have been created in an attempt to address these challenges. For example, the tendency to kink can be addressed by a variety of structural modifications including increased catheter shaft diameter, wall thickness, and flexural modulus of the catheter shaft material (which is the ability of the material to bend). Further, reducing catheter shaft diameter, wall thickness, and flexural modulus can improve catheter flexibility and navigation, so that the catheter shaft remains flexible in order to easily bend to accommodate to the curvature of the blood ve