Vasospasm relieving device

Abstract

A spasm relief device for enhancing vasodilation of a blood vessel includes an adjustment member, a support structure, a stimulation circuit, and a conductive path. The modulation member includes at least one electrode, and the support structure supports the modulation member within a blood vessel. A conductive path extends along the support structure and electrically connects the stimulation circuit and the adjustment member, and the spasm relief device has an independent configuration.

Description

Technical Field

[0001] Embodiments of the present disclosure are generally directed to neural, cardiac, and / or peripheral vasospasm relief devices. Background Art

[0002] Vasospasm is a response of vascular smooth muscle cells to different stimuli like temperature changes, injury, inefficient metabolism, trauma, intoxication, and possible contact of catheters with the vascular lumen.

[0003] Catheter-induced spasm is a known complication during the catheterization procedure that can cause delays during the interventional procedure and can cause blood clot formation in the brain or other procedures.

[0004] Vasospasm that occurs during medical treatment due to, for example, trauma and / or other possible disease-related events may lead to flow restriction and subsequent diagnostic or therapeutic difficulties.

[0005] Common approaches to managing vasospasm phenomena in clinical interventions may be the use (alone or in combination): intra-arterial lidocaine injection, intra-arterial nicardipine injection, warm compresses, angioplasty balloon (etc). Summary of the invention

[0006] According to some embodiments of the present disclosure, various aspects of the present disclosure relate to a spasm relief device. More specifically, but not exclusively, according to some embodiments of the present disclosure, various aspects of the present disclosure relate to a spasm relief device configured to pass through a barrier of vascular closure caused by spasm by inducing an electrical signal to a spasmodic vascular target.

[0007] The spasm relief devices and methods of the present disclosure allow for the recanalization of spasmodic, difficult-to-pass vessels to minimize damage to surrounding vascular tissue. Advantageously, the spasm relief devices of the present disclosure use electrical pulses to stimulate the endothelium to release nitric oxide (NO) molecules to the smooth muscle of the vessel, thereby activating the relaxation mechanism. Thus, the use of drugs or angioplasty devices or dilation devices can be avoided and / or reduced, thereby reducing the risk of vessel wall perforation or dissection.

[0008] According to one aspect of some embodiments, there is provided an invention for relaxing vasospasm by a device comprising a proximal hub, a device shaft and a tip. Energy and a regulating circuit located at the proximal hub can be activated by a user applying a small pressure to a button located on the connecting hub to activate the device to function. The control button can activate the regulating circuit to induce current to the target tissue.

[0009] The pulse introduction can be achieved through a unipolar or bipolar effect. The cathode or anode group of each individual electrode can be controlled by the operating mode, regardless of the most recent activation. The operating mode can be selected by the operator by pressing a power button or by a programmed sequence. In some cases, the electrical regulation circuit is capable of delivering a current in the range of about 0.1 microamperes to about 100 milliamperes.

[0010] The electrodes can be exposed in the operating part of the device, mainly the distal end. The number of electrodes can vary from 1 to about 100 units. The distribution of electrodes on the tip and the shaft can vary between axial and radial modes or in a combination of axial and radial modes. The power pack of the present invention can accommodate a sufficient amount of energy to complete clinical intervention, for example, a total energy capacity of up to about 1000 microamperes. In some cases, the battery pack can be configured to provide a potential of up to about 75V. The hollow member can be designed to deliver the generated pulses to the device tip through a conductive element contained in the shaft. The shaft can be made of a combination of metal and plastic or any equivalent used in the field of medical device manufacturing methods and standards.

[0011] The shaft can be designed to be flexible to allow navigation traceability and pushability in the vascular anatomy in a safe manner. The diameter of the shaft can vary from about 0.1 mm to about 30 mm, parallel or tapered. The length can vary from about 3 cm to about 300 cm. In some cases, the tip can include an exposed electrode capable of inducing the generated signal into the spasmodic tissue, and the non-invasive tip can be designed to be advanced and retracted in the blood vessel without substantially compromising safety and avoiding perforation and stripping of the vessel wall.

[0012] Further aspects of the invention are exemplified below:

[0013] 1. A vasospasm relief device for use in traversing a vascular occlusive disorder, the vasospasm relief device comprising:

[0014] a connection hub facilitating a button mechanism, a power pack, and circuitry configured for selective power delivery;

[0015] a strain-relieved, elongated flexible member configured to gradually diffuse a bending moment applied to the hollow member-connecting hub joint to avoid kinking of the hollow member;

[0016] a hollow member that is elongated and includes a main portion and a distal portion configured to deliver electrical current to the tip;

[0017] a tip, the distal end of the hollow member, facilitating an exposed electrode wired to circuitry located in a connection hub configured for noninvasive device advancement and retraction within a vascular lumen and for the introduction of electrical current into contact and adjacent vascular tissue;

[0018] Therein, the tip is configured to relieve vasospasm by inducing current based on intervention needs when affecting smooth muscle cells by electrically stimulating the endothelial layer of the blood vessel to activate the secretion of NO molecules, thereby causing smooth muscle cell relaxation.

[0019] 2. A vasospasm relief device for use in traversing a vascular occlusive disorder, the vasospasm relief device comprising:

[0020] a connection hub facilitating a button mechanism, a power pack, and circuitry configured for selective power delivery;

[0021] an elongated member constructed of a solid material or a coaxial assembly of at least 2 members or an elongated tangentially attached member and comprising a main portion and a distal portion configured to deliver electrical current to the tip;

[0022] a tip, the distal end of the elongated member, facilitating an exposed electrode wired to circuitry located in a connection hub configured for noninvasive device advancement and retraction within a vascular lumen and introduction of electrical current into contacted and adjacent vascular tissue;

[0023] Therein, the tip is configured to relieve vasospasm by inducing current based on intervention needs when affecting smooth muscle cells by electrically stimulating the endothelial layer of the blood vessel to activate the secretion of NO molecules, thereby causing smooth muscle cell relaxation.

[0024] 3. A vasospasm relief device for use in traversing a vascular occlusive disorder, the vasospasm relief device comprising:

[0025] a connection hub facilitating a button mechanism, a power pack, and circuitry configured for selective power delivery;

[0026] a strain-relieved, elongated flexible member configured to gradually diffuse a bending moment applied to the hollow member-connecting hub joint to avoid kinking of the hollow member;

[0027] a hollow member which is single-lumen or multi-lumen or partially multi-lumen or coaxially elongated and includes a main portion and a distal portion configured to deliver an electric current to the tip;

[0028] a balloon, which is applied on the distal section of the hollow member, is compliant or semi-compliant or non-compliant and is inflated with a liquid or a gas and is covered with a conductive metal or plastic material and exposed electrodes;

[0029] a tip, the distal end of the hollow member, facilitating an exposed electrode wired to circuitry located in a connection hub configured for noninvasive device advancement and retraction within a vascular lumen and introduction of electrical current into contacted and adjacent vascular tissue;

[0030] Therein, the tip is configured to relieve vasospasm by inducing current based on intervention needs when affecting smooth muscle cells by electrically stimulating the endothelial layer of the blood vessel to activate the secretion of NO molecules, thereby causing smooth muscle cell relaxation.

[0031] 4. A vasospasm relief device according to aspects 1 to 3, wherein the hollow member is made of metal and plastic for obtaining the flexibility required for effective vascular navigation, including an axial conductive material that allows electrical signals to be transferred from the hub to the device tip.

[0032] 5. The vasospasm relieving device according to aspect 4, wherein the diameter of the hollow member may be in the range of 0.1 mm to 30 mm, parallel or tapered, and the length may be in the range of 3 cm to 300 cm.

[0033] 6. The vasospasm relief device according to aspect 4, wherein the tip protrudes distally from the distal end of the distal portion.

[0034] 7. The vasospasm relief device according to aspects 1 to 6, wherein the number of exposed electrodes is at least one.

[0035] 8. The vasospasm relieving device according to aspect 7, wherein the exposed electrodes are distributed axially or radially or in combination.

[0036] 9. The vasospasm relief device of aspect 8, wherein the circuit regulates single, paired and group discharges through the electrodes regardless of the last operation.

[0037] 10. The vasospasm relief device of aspect 8, wherein the circuit adjusts the polarization cathode or anode of each electrode regardless of recent operation.

[0038] 11. A vasospasm relief device according to aspects 8 to 10, wherein polarization and single or paired or group discharge functions are adjustable by a button or a programmed sequence.

[0039] 12. The vasospasm relief device of aspect 11, wherein the power button facilitates ergonomic design and allows a user to selectively and on demand induce an electrical signal to the tip of the device.

[0040] 13. The vasospasm relief device of aspect 11, wherein the power pack is attached to the circuit and stores a sufficient amount of energy to complete the interventional procedure while being used in an appropriate manner.

[0041] 14. The vasospasm relief device of aspect 11, wherein the power pack provides a potential of up to 5V.

[0042] 15. The vasospasm relief device of aspect 11, wherein the power pack stores a total electrical energy of up to 1000 mAh.

[0043] 16. A vasospasm relief device according to aspect 11, wherein the circuit is powered by energy from the power pack and activated by a power button, wired to the tip.

[0044] 17. The vasospasm relief device of aspect 16, wherein the circuit regulates the release current within the range of 0.1 microamperes to 100 milliamperes.

[0045] 18. The vasospasm relief device of aspect 16, wherein the distal end of the hollow member is converted to a sharp tip, facilitating an atraumatic distal end, thereby allowing advancement and retraction in the vascular anatomy in a safe manner without puncturing or stripping the vessel wall. The diameter of the atraumatic distal end may be in the range of 0.1 mm to 30 mm, parallel or tapered.

[0046] Certain embodiments of the present disclosure may include some, all, or none of the above advantages. One or more other technical advantages may be apparent to those skilled in the art from the drawings, descriptions, and claims included herein. Moreover, although specific advantages are listed above, various embodiments may include all, some, or none of the listed advantages.

[0047] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the present disclosure belongs. In the event of a conflict, the patent specification, including definitions, shall prevail. As used herein, the indefinite articles "a" and "an" mean "at least one" or "one or more", unless the context clearly indicates otherwise. BRIEF DESCRIPTION OF THE DRAWINGS

[0048] Some embodiments of the present disclosure are described herein with reference to the accompanying drawings. Together with the accompanying drawings, the description makes it apparent to one of ordinary skill in the art how some embodiments may be practiced. The accompanying drawings are for illustrative purposes and are not intended to show the structural details of the embodiments in more detail than is necessary for a basic understanding of the present disclosure. For clarity, some objects depicted in the drawings are not drawn to scale.

[0049] In the attached picture:

[0050] Figure 1A is a schematic top view of a vasospasm relief device configured for vasodilation to enhance vascular occlusion, according to some embodiments;

[0051] Figure 1B According to some embodiments Figure 1A A schematic side view of the proximal end of a spasticity relief device;

[0052] Figure 1CAccording to some embodiments Figure 1A A schematic side view of a distal end of a spasm relief device;

[0053] Figure 2A is a schematic top view of a vasospasm relief device configured for vasodilation to enhance vascular occlusion, according to some embodiments;

[0054] Figure 2B According to some embodiments Figure 2A A schematic side view of the proximal end of a spasticity relief device;

[0055] Figure 2C According to some embodiments Figure 2A A schematic side view of a distal end of a spasm relief device;

[0056] Figure 3A is a schematic top view of a vasospasm relief device configured for vasodilation to enhance vascular occlusion, according to some embodiments;

[0057] Figure 3B According to some embodiments Figure 3A A schematic side view of the proximal end of a spasticity relief device;

[0058] Figure 3C According to some embodiments Figure 3A A schematic side view of a distal end of a spasm relief device;

[0059] FIG. 4A to FIG. 4C is a schematic diagram of a stimulation circuit of certain spasticity relief device embodiments of the present invention;

[0060] Figure 5 is a schematic diagram of an adjustment member and a conductive path of a spasticity relief device according to various embodiments of the present invention;

[0061] Figure 6 is a schematic diagram showing the Figure 5 possible use of substantially similar modulating members and conductive pathways in forming wave pulses for enhancing vasodilation in blood vessels;

[0062] Figure 7 is a schematic diagram illustrating examples of wave pulses that may be generated by at least some spasticity relief device embodiments of the present invention; and

[0063] Figure 8 to Fig.10 is a schematic diagram of an exemplary conventional interventional device or apparatus that may be implemented to include various aspects of the spasticity relief device embodiments of the present invention. DETAILED DESCRIPTION

[0064] The principles, uses and implementations of the teachings herein may be better understood with reference to the attached description and drawings. After careful reading of the description and drawings herein, those skilled in the art will be able to implement the teachings herein without undue effort or experimentation. In the drawings, the same reference numerals refer to the same parts throughout.

[0065] In the description and claims of this application, the words "including" and "having" and forms thereof are not limited to the members of the list with which the words are associated.

[0066] In the specification and claims of the present application, the expression "at least one of A and B" (for example, where A and B are elements, method steps, claim definitions, etc.) is equivalent to "only A, only B, or both A and B". In particular, the expressions "at least one of A and B", "at least one of A or B", "one or more of A and B", and "one or more of A or B" are interchangeable.

[0067] As used herein, the term "approximately" may be used to specify that the value of a quantity or parameter (e.g., the length of an element) is within a continuous range of values ​​around (and including) a given (described) value. According to some embodiments, "approximately" may specify that the value of a parameter is between 80% and 120% of the given value. For example, the expression "the length of the element is equal to about 1 m" is equivalent to the expression "the length of the element is between 0.8 m and 1.2 m". According to some embodiments, "approximately" may specify that the value of a parameter is between 90% and 110% of the given value. According to some embodiments, "approximately" may specify that the value of a parameter is between 95% and 105% of the given value.

[0068] As used herein, the terms "substantially" and "approximately" may be interchangeable according to some embodiments.

[0069] For ease of description, in some of the figures, a three-dimensional Cartesian coordinate system (with orthogonal axes x, y, and z) is introduced. Note that the orientation of the coordinate system relative to the objects depicted may vary from figure to figure. Furthermore, the symbol ⊙ may be used to indicate an axis pointing "out of the page", while the symbol Can be used to represent axes pointing "inside the page".

[0070] Embodiments of the present disclosure relate to electrical stimulation that can be applied directly to specific nerves that control, for example, the dilation of blood vessels. This can be accomplished through an invasive procedure, such as implanting electrodes near the target nerves, and by delivering electrical pulses to these nerves in order to promote, for example, the relaxation of smooth muscle cells in the blood vessel wall, thereby causing vasodilation.

[0071] Figure 7An alternative example of a square wave pulse that can be used to enhance vasodilation according to various embodiments of the present invention is provided. The square wave has an amplitude of about 64 millivolts, a frequency of about 16 Hz, a pulse width of about 2 milliseconds, and can be generated by an embodiment of a spasticity relief device having a distance between electrodes of about 10 mm.

[0072] In one broad aspect of the present disclosure, at least some spasm relief device embodiments of the present invention, such as those exemplified herein, may have a standalone configuration. That is, such standalone device embodiments may be designed to be capable of operating for their intended purpose of vasospasm relief in a standalone manner substantially without the need for external connections or additional equipment. In other words, such a standalone configuration may be defined as being substantially self-contained and designed to perform its intended function substantially without reliance on other external devices or systems.

[0073] focus on Figure 4A , an embodiment of a stimulation circuit 111 that may be suitable for facilitating such a stand-alone mode of operation of a vasospasm relief device can be seen, comprising the following components: a pulse generator 1, an optional amplifier 2, a battery 3, and a power source 4. A power button 5 provided on such a stand-alone spasm relief device may be used to activate and power the stimulation circuit 111.

[0074] Figure 4B and Figure 4C Various implementations of the stimulation circuit 111 are illustrated.

[0075] exist Figure 4B , an embodiment of a stimulation circuit 111 is shown having a battery 3, a power source 4 and a pulse generator 1. In this example, the battery 3 provides an input voltage Vin to the power source 4, which in turn outputs an output voltage Vs towards the pulse generator.

[0076] exist Figure 4C In FIG. 1 , an embodiment of a stimulation circuit 111 is shown which also includes an optional amplifier 2. Here, a battery 3 provides an input voltage Vin to a power supply 4 which in turn outputs an output voltage Vs towards a pulse generator and amplifier 2.

[0077] The amplifier 2 in various embodiments may be any of the following amplifiers: a voltage amplifier, a current amplifier, or a combined voltage and current amplifier. By using the amplifier 2, the output wave pulses delivered toward the target area in the body to promote vasodilation may have a higher voltage amplitude and / or power than would otherwise be provided from the signal generator alone.

[0078] In a non-constrained example: pulse generator 1 can be the LMC555 or MIC1555 / 57 version of the 555 timer integrated circuit manufactured by Texas Instruments; amplifier 2 can be the LM4916 or LM2621MM / NOPB power amplifier manufactured by Texas Instruments; battery 3 can be the SR421SW model of the silver oxide button battery from Seiko Instruments; power supply 4 can be the TPS61098 low input voltage, 4.3-V output voltage, synchronous boost converter with integrated LDO; and the power button 5 can be used to activate / deactivate the TL3305 series ultra-small SMT tactile switch from E-Switch, a wholly owned subsidiary of Stein Industries.

[0079] A vasospasm relief device including such a stimulation circuit 111 may be arranged to transmit an electrical signal along a conductive path 6 towards a regulating member 7 of the device including one or more electrodes, which may be supported by a support structure 8 of the device in a blood vessel experiencing vasoconstriction (see Figure 6 In the blood vessels 99).

[0080] Thus, by widening or relaxing the blood vessels, stimulation of the regulating member 7 may result in vasodilation of these blood vessels, causing their diameter to increase, which in turn promotes increased blood flow and reduced vascular resistance.

[0081] In a broad aspect of the invention, the conductive path 6 of various embodiments of the vasospasm relief device, in addition to functioning as a transmission path for electrical signals to and from the regulating member 7, can also be configured to function as a structural component that enhances the structural stability of the device, particularly its support structure 8.

[0082] In certain embodiments, this dual functionality may be achieved by forming the conductive path 6 as a braided structural element, wherein one or more conductive strands may be interwoven or interlaced, possibly with other non-conductive strands.

[0083] This weaving can be any of the following: one thread above two threads - two threads below; two threads above two threads - two threads below; one thread above one thread - one thread below.

[0084] Possibly, such a braided conductive path 6 may be encased in an insulating material in order to avoid significant interference with other components of the device, such as electrodes. Additionally or alternatively, each wire within the braid may be encased in an insulating material.

[0085] exist Figure 1B and Figure 2C In the enlarged portion provided, two examples of such dual-function conductive paths 6 are shown. Figure 1B In the enlarged portion of FIG. 1 , a conductive path is shown having conductors 61 , 62 of opposite polarity that are interwoven or staggered.

[0086] Here it can be seen that the braided conductive path is placed in a peripheral structure between an inner layer 81 and an outer layer 82 of a support structure 8, wherein, possibly, these layers may be insulating materials. The inner layer 81 may form the periphery of the lumen of a microcatheter type interventional device as seen in FIG.

[0087] focus on Figure 5 , schematic diagrams are provided illustrating various ways in which the electrodes of the conditioning member 7 may be electrically connected to the wires of the conductive paths 6 (woven or non-woven).

[0088] In this figure, a support structure 8 of a vasospasm relief device is shown, including an adjustment member 7 optionally having six electrodes. For illustrative purposes only, the electrodes are presented with different widths to help distinguish different electrode groups according to their use in the device (i.e., as anode or cathode).

[0089] In this example, the conductive lines of the conductive path are shown using "dashed lines", and as can be seen, a single line 61 acting as the "common" (either "positive" or "negative" pole) is connected to all electrodes of one electrode group (i.e., the "wider" electrode group), while in this example, each electrode in the other group (i.e., the "thinner" electrode group) is connected to a dedicated line 62 of the opposite pole.

[0090] In this way, a total of four wires can be used in the conductive path 6 for connection between the stimulation circuit 111 and the conditioning member 7 .

[0091] In some embodiments, the minimum number of conductor lines of the conductive path can be calculated according to the following formula:

[0092]

[0093] focus on Figure 6 , which illustrates an optional example of providing wave pulses to enhance vasodilation in a blood vessel by using an embodiment of a vasospasm relief device having a Figure 5 The substantially similar regulating member 7 and conductive path 6 are seen in FIG.

[0094] Figure 6 The upper side shows an example of a distal region of a vasospasm relief device 900, such as having an alternative design as seen in FIG. 3, positioned within a blood vessel 99 - while the lower three illustrations show the distal region of a vasospasm relief device 900 during three activation phases. Figure 5 The regulating member 7 and the conductive path 6 are provided.

[0095] Thus, a single wire 61 (of either positive or negative polarity) is here connected to all electrodes of a "wider" "group" of electrodes, while a dedicated wire 62 of a given opposite polarity is connected to each electrode of a second "thinner" "group" of electrodes.

[0096] According to certain embodiments of the present invention, by selectively controlling only one of the dedicated wires 62 to be connected to a given pole of the device power supply at a time, only one pair of electrodes at a time can be controlled to generate a wave pulse at a given axial position along the blood vessel (as seen by a moving "wave pattern").

[0097] like Figure 6 Shown from top to bottom, an optional example of generating a wave pulse can be seen that starts more proximal to the portion of the vessel and gradually moves in a distal direction. This distally moving waveform can, in some cases, assist in the propagation of the widening of the vessel in its distal (possibly downstream) direction.

[0098] Figure 1A An alternative example of an embodiment of a vasospasm relief device 100 for enhancing vasodilation of a blood vessel is schematically depicted. The vasospasm relief device 100 comprises a proximal connection hub 101 and a support structure 8, in this example in the alternative form of a strain relief portion 102 and an elongated hollow member 103 connected to the hub 101.

[0099] In this example, the proximal end of the hollow member 103 can be seen supported to the hub, optionally via a strain relief 102, so as to provide flexibility that facilitates bending between the hollow member 103 and the hub 101, thereby avoiding or limiting kinking.

[0100] The distal end of the hollow member 103 extends toward a tip 104 of the device, which can be configured to provide an atraumatic distal end for the device. According to some embodiments, the hollow member 103 can be made of metal and / or plastic for flexibility and effective vascular navigation.

[0101] Also pay attention to Figure 1B , it can be seen that the hub 101 includes a catheter connection interface 114 and a stimulation circuit 111 connected to and / or embedded within the hub. Note that although seen here in association with the hub, other locations within the device may also be used to house the stimulation circuit 111 in various embodiments of the present invention.

[0102] Coupling (e.g., embedding) the stimulation circuit 111 with the hub may enable embodiments of the vasospasm relief device 100 to function in a standalone mode. In other embodiments (not shown), the stimulation circuit 111 may be external to the device, thus resulting in a non-standalone vasospasm relief device embodiment.

[0103] like Figure 1B As seen in FIG. 1 , vasospasm relief device 100 includes a conductive path 6 extending along a support structure 8 of the device for conducting electrical signals from a hub 101 toward an adjustment member 7 that may be located along the support structure and possibly also adjacent to a tip 104 .

[0104] As disclosed herein, the regulating member 7 can be embodied as a plurality of electrodes (see, for example, Figure 1C ), while the conductive path 6 can be adapted to conduct electrical signals toward one or more electrodes of the regulating member, possibly without causing significant interference to other electrodes of the device.

[0105] According to some embodiments, the diameter of the hollow member 103 may range from about 0.3 mm to about 30 mm, and may extend generally in a parallel or tapered configuration. The length of the hollow member 103 may range from about 3 cm to about 300 cm.

[0106] like Figure 1B As seen in FIG. 1 , in this example, a power button 5 may be included in the hub, thereby facilitating ergonomic design and allowing a user of the device to selectively and as needed activate components of the stimulation circuit 111 to induce electrical signals toward the regulating member 7. The battery 3 included in the stimulation circuit 111 may be adapted to store a sufficient amount of energy to complete the vasodilation process.

[0107] In one example, the battery 3 can provide a potential of up to about 5V and can store a total amount of electrical energy of up to about 1000 mAh. The components of the stimulation circuit 111 powered by the battery 3 and activated by the button 5 can be arranged to direct current to the electrodes in the adjustment member 7, individually to each electrode, to pairs of electrodes, or to groups of electrodes. The type of vasodilation action to be activated can be selected by the button 5 or by a programmed sequence. In some cases, the stimulation circuit 111 can be arranged to adjust the release current in the range of about 0.1 microamperes to about 100 milliamperes.

[0108] Figure 1C According to some embodiments Figure 1A Schematic side view of the distal end of the spasm relief device. The distal end of the hollow member 103 transitions to a tip 104, thereby facilitating an atraumatic distal end 142, thereby allowing advancement in the vascular anatomy in a safe manner without puncturing or stripping the vessel wall. The diameter of the atraumatic distal end 142 can range from about 0.3 mm to about 30 mm, parallel or tapered.

[0109] In this example, the adjustment member 7 includes electrodes 77 that are partially exposed at the tip 104 to allow induction of current to nearby or contacting tissue. The number of exposed electrodes on the hollow member 103 and the tip 104 can range from 1 unit to 100 units. The electrodes 77 can be distributed on the support structure 8 axially or radially (as seen here) or in any such combination.

[0110] like Figure 1A to Figure 1C The vasospasm relief device 100 shown in the figure is specifically implemented on a so-called microcatheter type interventional device, however, as will be seen in the embodiments discussed below, the vasospasm relief device embodiments of the present disclosure can be implemented in various other conventional interventional devices or instruments, such as guidewires, balloon catheters, stent retrievers (etc.). In addition, the vasospasm relief device embodiments can also be implanted in a dedicated interventional device customized for vasodilation, and not necessarily only in existing types of interventional devices.

[0111] Pay attention to Figure 8 Fig.10 , such implementation of various aspects of the vasospasm relief device embodiments can be seen in conventional interventional devices or instruments.

[0112] exist Fig. 8A and Figure 8B In the figure, it can be seen that according to various embodiments of the present invention, the stent retriever type interventional device is implemented to include a hub having a stimulation circuit 111, and in this example, it can be seen that the multiple electrodes 77 forming its adjustment member 7 are optionally formed at the intersection of the struts of its mesh, which is suitable for grasping and extracting blood clots in blocked arteries.

[0113] Some or all of the struts may serve as conductors 61, 62 for directing electrical signals from the stimulation circuit 111 to the modulation member 7 in order to provide wave pulses intended to enhance vasodilation in the treated blood vessel.

[0114] exist Fig. 9 In the figure, the distal region of the balloon-type interventional device can be seen, which is provided with electrodes 77 embedded in or formed on its expandable balloon, at which location the regulating member 7 of the device is at least partially formed.

[0115] It can be seen that the guidance comes from the stimulation circuit 111 (such as see Fig. 8A ) extend along the catheter shaft toward the proximal side of the electrode 77 so as to transmit the electrical signal toward the adjustment member 7 to provide a wave pulse intended to enhance vasodilation in the treated blood vessel.

[0116] exist Fig.10 , an example of the distal side of an embolic protection device is shown, which is typically introduced into a treated blood vessel to capture and remove potentially dangerous debris.

[0117] Here, it can be seen that the electrodes 77 forming the adjustment member 7 of the device are optionally formed on the proximal side of the protection device, which is generally the widest and most likely to contact the treated blood vessel.

[0118] It can also be seen here that the guidance from the stimulation circuit 111 (such as see Fig. 8A ) extend along the catheter shaft toward the electrodes so as to transmit the electrical signal toward the adjustment member 7, thereby providing a wave pulse intended to enhance vasodilation in the treated blood vessel.

[0119] Figure 2A Another alternative example of an embodiment of a vasospasm relief device 200 for enhancing vasodilation of a blood vessel is schematically depicted. The vasospasm relief device 200 comprises a support structure 8 connected to a hub 201, embodied here as a guidewire-like longitudinal member 203, which is elongated and attached to the hub 201. In this example, the distal end of the longitudinal member 203 transitions to a tip 204, thereby facilitating atraumatic distal end. According to some embodiments, the longitudinal member 203 is made of metal and / or plastic that is flexible enough for effective vascular navigation.

[0120] As can be seen in the figure, the vasospasm relief device 200 also includes a conductive path 6 (see Figure 2B ), which extends along the support structure 8 to allow electrical signals to be directed from the stimulation circuit 111 coupled to the hub 201 toward the tip 204 (see FIG. 2 ) located along the support structure 8 and possibly adjacent to the device. Figure 2C )'s regulating member 7 is transmitted.

[0121] Signals directed to specific electrodes of the modulation member 7 may be performed without substantially interfering with other electrodes of the modulation member 7. According to some embodiments, the diameter of the longitudinal member 203 may be in the range of about 0.1 mm to about 30 mm, parallel or tapered, and in the range of about 3 cm to about 300 cm in length.

[0122] Figure 2B According to some embodiments Figure 2A Schematic side view of the proximal end of the spasticity relief device of FIG. Hub 201 includes a catheter connection interface 214, a power button 5, and a stimulation circuit 111. The power button 5 can be designed to facilitate ergonomic design and allow the user of the device to selectively and on demand induce an electrical signal to the adjustment member 7.

[0123] In principle, the parameters of the components of the stimulation circuit 111 in this and other examples provided herein may be substantially similar to the parameters of the previous embodiments already discussed. Moreover, the stimulation circuit 111 may be embedded within the hub of the various embodiments discussed to impart a standalone configuration as already discussed above to the various vasospasm relief devices, or may be external to the device and separate from the device to impart a non-standalone device embodiment.

[0124] Figure 2C According to some embodiments Figure 2A Schematic side view of the distal end of the spasm relief device. The distal end of the longitudinal member 203 can be converted to a tip 204, facilitating an atraumatic distal end 242, thereby allowing advancement in the vascular anatomy in a safe manner without puncturing or stripping the vessel wall. The diameter of the atraumatic distal end 242 can range from about 0.1 mm to about 30 mm, parallel or tapered or twisted or braided.

[0125] The electrodes 77 of the adjustment member 7 of the device 200 can be partially exposed at the tip 204 to allow induction of current to nearby or contacting tissue. The number of exposed electrodes along the support structure 8 and / or the tip 204 can range from 1 unit to 100 units. The electrodes 77 can be distributed axially or radially or in combination along the support structure 8 and / or the tip 204.

[0126] Figure 3A A further alternative example of an embodiment of a vasospasm relief device 300 for enhancing vasodilation of a blood vessel is schematically depicted. The vasospasm relief device 300 comprises a connection hub 301 and a support structure 8, in this example in the optional form of a strain relief 302 and an elongated hollow member 303 connected to the hub 301. In this example, the proximal end of the hollow member 303 can be seen to be supported to the hub, optionally by the strain relief 302, so as to provide flexibility to facilitate bending between the hollow member 303 and the hub 301, thereby avoiding or limiting kinking.

[0127] The distal end of the hollow member 303 extends toward a tip 304 of the device, which can be configured to provide an atraumatic distal end for the device. Figure 3C As seen in the figure, in this example, it can be seen that the vasospasm relief device 300 is embodied as a balloon catheter device, which includes an expansion balloon 305, which in this example is applied over the hollow member 303 along its support structure 8 and connected to the inner lumen of the hollow member to allow the balloon to be expanded. According to some embodiments, the hollow member 303 is made of metal and / or plastic with the flexibility required for effective vascular navigation.

[0128] like Figure 3B and Figure 3CThe vasospasm relief device 300 shown in FIG. 1 also includes a conductive path 6 that allows electrical signals to be transmitted from the stimulation circuit 111 within the hub 301 to the device's regulating member 7, which includes electrodes positioned along the support structure 8, possibly adjacent to the tip 304 of the device or the outer surface of the balloon 305. Signals can be directed to specific electrodes and may not interfere with the remaining other electrodes. According to some embodiments, the diameter of the hollow member 303 can be in the range of about 0.1 mm to about 30 mm, parallel or tapered, and in the range of about 3 cm to about 300 cm in length.

[0129] exist Figure 3B In some embodiments, there is provided Figure 3A Schematic side view of the proximal end of the spasticity relief device of FIG. The hub 301 of the device includes a catheter connection interface 314, a power button 5 and a stimulation circuit 111 such as previously described above.

[0130] The power button 5 may be designed to facilitate the ergonomic design of the device and the hub, and to allow a user to selectively and as desired induce an electrical signal towards the adjustment member 7 .

Claims

1. A spasm relief device for enhancing vasodilation of a blood vessel, The spasm relief device comprises: The regulating member, the supporting structure, the stimulation circuit and the conductive path, The regulating member comprises at least one electrode, The support structure is adapted to support the adjustment member within a blood vessel, and The conductive path extends along the support structure and electrically connects the stimulation circuit and the adjustment member, wherein, The spasm relief device has a stand-alone configuration.

2. The spasticity relief device according to claim 1, wherein: The stimulation circuit includes a pulse generator, a battery and a power supply.

3. The spasticity relief device according to claim 2, wherein: The stimulation circuit also includes an amplifier.

4. The spasticity relief device according to claim 3, wherein: The amplifier is any of the following: a voltage amplifier, a current amplifier, or a combined voltage and current amplifier.

5. The spasticity relief device according to claim 2, wherein: The conductive paths also serve as structural components for enhancing the structural stability of at least the support structure.

6. The spasticity relief device according to claim 5, wherein: The conductive path is formed as a braided structural element.

7. The spasticity relief device according to claim 6, wherein: The braided structural element is formed in any one of the following ways: one wire / thread is above two wires / threads - below two wires / threads; two wires / threads are above two wires / threads - below two wires / threads; one wire / thread is above one wire / thread - below one wire / thread.

8. The spasticity relief device according to claim 7, wherein: The conductive path includes one or more conductive lines that are interwoven or interlaced together.

9. The spasticity relief device according to claim 6, wherein: The braided structural element has a generally cylindrical structure surrounding an inner lumen of the device.

10. The spasticity relief device of claim 9, wherein: The braided structural element is formed between an inner layer and an outer layer, and wherein the inner layer surrounds the inner cavity.

11. The spasticity relief device of claim 10, wherein: The inner layer and the outer layer are formed of an electrically insulating material.

12. The spasticity relief device of claim 2, wherein: The regulating member includes a plurality of electrodes.

13. The spasticity relief device of claim 12, wherein: The conductive path includes a plurality of wires.

14. The spasticity relief device of claim 13, wherein: The plurality of electrodes of the regulating member are divided into two groups of electrodes, wherein all electrodes of one of the groups are connected to a single wire of the conductive path and each of the electrodes of the other group is connected to a different and separate wire of the conductive path.

15. The spasticity relief device of claim 14, wherein: Each of the groups includes a plurality of electrodes.

16. A method for enhancing vasodilation of a blood vessel, comprising the steps of: providing a spasticity relief device having a stand-alone configuration and comprising an adjustment member including at least one electrode, a support structure supporting the adjustment member, a stimulation circuit, and a conductive path extending along the support structure and electrically connecting the stimulation circuit and the adjustment member; inserting at least the support structure and the adjustment member distally into a blood vessel; as well as The stimulation circuit is activated to transmit an electrical signal via the conductive path toward the conditioning member to generate a wave pulse at the conditioning member that is delivered toward the vicinity of the blood vessel to enhance vasodilation of the blood vessel.

17. The method according to claim 16, wherein: The stand-alone configuration enables the spasticity relief device to be operated in a stand-alone manner without the need for external connections or additional equipment.

18. The method according to claim 17, wherein: The stimulation circuit includes a pulse generator, a battery and a power supply.

19. The method according to claim 18, wherein: The stimulation circuit also includes an amplifier.

20. The method according to claim 19, wherein: The amplifier is any of the following: a voltage amplifier, a current amplifier, or a combined voltage and current amplifier.

21. The method according to claim 17, wherein: The conductive paths also serve as structural components for enhancing the structural stability of the support structure.

22. The method according to claim 21, wherein: The conductive path is formed as a braided structural element.

23. The method according to claim 22, wherein: The braided structural element is formed in any one of the following ways: one wire / thread is above two wires / threads - below two wires / threads; two wires / threads are above two wires / threads - below two wires / threads; one wire / thread is above one wire / thread - below one wire / thread.

24. The method according to claim 23, wherein: The conductive path includes one or more conductive lines that are interwoven or interlaced together.

25. The method according to claim 24, wherein: The braided structural element has a generally cylindrical structure surrounding an inner lumen of the device.

26. The method according to claim 25, wherein: The braided structural element is formed between an inner layer and an outer layer, and wherein the inner layer surrounds the inner cavity.

27. The method according to claim 26, wherein: The inner layer and the outer layer are formed of insulating material.

28. The method of claim 17, wherein: The regulating member includes a plurality of electrodes.

29. The method according to claim 28, wherein: The conductive path includes a plurality of wires.

30. The method of claim 29, wherein: The plurality of electrodes of the regulating member are divided into two groups of electrodes, wherein all electrodes of one of the groups are connected to a single wire of the conductive path and each of the electrodes of the other group is connected to a different and separate wire of the conductive path.

31. The method according to claim 30, wherein: Each of the groups includes a plurality of electrodes.

32. The method according to claim 31, wherein: The conditioning member comprises electrode pairs, each electrode pair comprising one electrode from a first one of the groups and another electrode from a second one of the groups.

33. The method of claim 32, wherein: Generating the wave pulses includes selectively controlling only one of the pairs at a time to generate the wave pulses.

34. The method of claim 33, wherein: Selectively controlling only one of the electrode pairs at a time to generate wave pulses is performed by controlling only one of the different and separate wires to be connected to the stimulation circuit of the device at a time.

35. The method of claim 34, wherein: The electrode pairs are axially spaced from one another along the support structure of the device, and the electrode pairs are selectively controlled to generate wave pulses starting from pairs positioned relatively proximally along the support structure toward pairs positioned relatively distally along the support structure.

36. A spasm relief device for enhancing vasodilation of a blood vessel, The spasm relief device comprises: The regulating member, the supporting structure, the stimulation circuit and the conductive path, The regulating member comprises at least one electrode, The support structure is adapted to support the adjustment member within a blood vessel, and The conductive path extends along the support structure and electrically connects the stimulation circuit and the adjustment member, wherein, The conductive paths also serve as structural components for enhancing the structural stability of the support structure.

37. The spasticity relief device of claim 36, wherein: The conductive path is formed as a braided structural element.

38. The spasticity relief device of claim 37, wherein: The braided structural element is formed in any one of the following ways: one wire / thread is above two wires / threads - below two wires / threads; two wires / threads are above two wires / threads - below two wires / threads; one wire / thread is above one wire / thread - below one wire / thread.

39. The spasticity relief device of claim 38, wherein: The conductive path includes one or more conductive lines that are interwoven or interlaced together.

40. The spasticity relief device of claim 39, wherein: The braided structural element has a generally cylindrical structure surrounding an inner lumen of the device.

41. The spasticity relief device of claim 40, wherein: The braided structural element is formed between an inner layer and an outer layer, and wherein the inner layer surrounds the inner cavity.

42. The spasticity relief device of claim 41, wherein: The inner layer and the outer layer are formed of an electrically insulating material.

43. A catheter for use in interventional radiology and / or endovascular surgery, comprising: a medical device adjacent to a distal end thereof for performing a medical procedure within a blood vessel; and a spasm-relieving configuration for enhancing vasodilation of said blood vessels, The spasticity relief configuration includes: The regulating member, the supporting structure, the stimulation circuit and the conductive path, the stimulation circuit being formed as part of a hub at a proximal side of the catheter, The regulating member comprises at least one electrode and is at least partially formed on or together with the medical device, The support structure comprises a portion of the conduit or is a portion of the conduit leading to the medical device and the adjusting member, and The conductive path extends along the support structure and electrically connects the stimulation circuit and the adjustment member, wherein, The spasm relief configuration has an independent configuration.

44. The catheter of claim 43, wherein: The medical device is any one of the following devices: an expandable balloon, a stent retriever, an embolic protection device, etc.

45. The catheter of claim 43, wherein: The stand-alone configuration enables the spasm relief configuration to enhance vasodilation of the blood vessel in a stand-alone manner without the need for external connections or additional equipment for this purpose.

46. ​​The catheter of claim 43, wherein: The stimulation circuit includes a pulse generator, a battery and a power supply.

47. The catheter of claim 46, wherein The stimulation circuit also includes an amplifier.

48. The catheter of claim 47, wherein The amplifier is any of the following: a voltage amplifier, a current amplifier, or a combined voltage and current amplifier.

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