Coil shaped vein closure device with cooling and heating capability

Abstract

A medical system includes a medical device having an elongate member configured from placement within a vein experiencing chronic vein insufficiency. A sheath of the elongate member includes a temperature member extending along the sheath within a sheath lumen. The temperature member includes a coil at a distal end that is expandable to contact an inside surface of the vein. The coil transitions between a heated state and a cooled state. The coil also transitions between an expanded state extending distally beyond the sheath and a contracted state within the sheath lumen. A power source and a cooling source coupled with the coil transition the coil between the heated state and a cooled state. The sheath displaces longitudinally with respect handle to deploy and retrack coil. Cooling the coil causes vein tissue to adhere to the coil and heating the coil releases the tissue from the coil.

Description

COIL SHAPED VEIN CLOSURE DEVICE WITH COOLING AND HEATINGCAPABILITYBACKGROUND

[0001] Chronic venous insufficiency (CVI) occurs when valves become damaged, allowing the blood to leak backward. Valve damage may occur as the result of aging, extended sitting or standing or a combination of aging and reduced mobility. When the veins and valves are weakened to the point where it is difficult for the blood to flow up to the heart, blood pressure in the veins stays elevated for long periods of time, leading to CVI. Chronic venous insufficiency that develops as a result of DVT is also known as post- thrombotic syndrome. Current treatments for CVI include surgical treatments such as ligation and stripping. These two procedures are often performed together. Vein ligation includes cutting and tying off the problem veins. Stripping includes surgical removal of larger veins through two small incisions. Another surgical treat includes creating a vein bypass which includes taking part of a healthy vein from somewhere else in the body and using it to reroute blood around a damaged vein. Other less invasive surgical treatments are also performed for veins close to the surface.

[0002] Disclosed herein are systems and methods for treating chronic venous insufficiency using less invasive procedures.SUMMARY

[0003] Disclosed herein is a medical system that, according to some embodiments, includes a medical device having an elongate member configured for placement within a blood vessel (e.g., a vein) of a patient. The elongate member includes a sheath defining a lumen extending between proximal and distal ends of the sheath and a temperature member disposed within the lumen, where the temperature member defines an elongate shape extending between a proximal end of the temperature member and a coil disposed at a distal end of the temperature member. The coil is configured to transition between a heated state and a cooled state. The coil is also configured to transition between an expanded state defining a first diameter and a contracted state defining a second diameter that is less than the first diameter. A handle of the medical device is coupled with the sheath at the proximal end. A cooling source is also coupled with the temperature member, where the cooling source is configured to define the cooled state when the cooling source is activated.

[0004] In some embodiments, the temperature member is slidably disposed within the lumen such that the temperature member is transitionable between a distal position where the coil extends beyond the distal end of the sheath and a proximal position where the coil is disposed within the lumen.

[0005] In some embodiments, the sheath is configured to constrain the coil in the contracted state when the coil is disposed within the lumen.

[0006] In some embodiments, the coil is configured to expand toward the first diameter so that the coil contacts an inside surface of the blood vessel when the temperature member is transitioned to the distal position and the coil extends beyond the distal end of the sheath.

[0007] In some embodiments, the cooled state is defined to cause tissue of the blood vessel to adhere to the coil, where upon transitioning of the temperature member from the distal position toward the proximal position, the tissue is separated from the blood vessel. In some embodiments, the heated state is defined such that the tissue is released from the coil.

[0008] In some embodiments, the temperature member includes first and second lumens extending between the proximal end and the distal end of the temperature member including the coil, where the first and second lumens are in fluid communication with each other at the distal end of the temperature member.

[0009] In some embodiments, a proximal end of at least one of the first and second lumens is fluidly coupled with the cooling source, and the cooling source is configured to deliver a cooling fluid to the coil via the at least one of the first and second lumens. In some embodiments, the cooling source is configured to provide the cooling fluid to the coil at a temperature that is below zero degrees Celsius. In some embodiments, the cooling fluid includes one of liquid Nitrogen or alcohol cooled with dry ice.

[0010] In some embodiments, the system includes a power source coupled with the temperature member, where the power source is configured to define the heated state when the power source is activated. In some embodiments, the temperature member includes a heating element extending along the coil, where the heating element is electrically coupled with the power source such that the heating element defines the heated state of the coil based on electrical energy provided by the power source.

[0011] In some embodiments, the coil includes an abrasive outside surface configured to abrade the inside surface of the blood vessel when the coil is in contact with the inside surface.

[0012] In some embodiments, the handle includes at least one actuator operatively coupled with the temperature member or the sheath, where the at least one actuator is configured to transition the temperature member between the proximal position and the distal position with respect to the sheath via manipulation of the at least one actuator by a user.

[0013] In some embodiments, the handle includes a latch mechanism operatively coupled between a housing of the handle and the temperature member or the sheath, where the latch mechanism is configured to (i) allow distal displacement of the temperature member toward the distal position with respect to the sheath in response to a deliberate action by the user and (ii) prevent distal displacement of the temperature member toward the distal position with respect to the sheath in the absence of the deliberate action by the user.

[0014] The handle may include a power actuator configured to selectively activate and deactivate the power source via manipulation of the power actuator by the user. Similarly, the handle may include a cooling actuator configured selectively activate and deactivate the cooling source via manipulation of the cooling actuator by the user.

[0015] In some embodiments, the medical device further includes a fluid lumen extending along the sheath. The fluid lumen defines an open end at the distal end of the sheath. The medical device may further include a fluid connector in fluid communication with the fluid lumen at a proximal thereof, where the fluid connector is configured to couple the fluid lumen with a fluid source. In some embodiments, the fluid lumen is incorporated into the sheath.

[0016] Also disclosed herein is a system method for treating chronic venous insufficiency that, according to some embodiments, includes displacing a sheath proximally with respect to a coil disposed with a lumen of the sheath such that the coil is extended beyond a distal end of the sheath, where the sheath is disposed within a blood vessel, and where the coil is configured to radially expand so as to contact an inside surface of the blood vessel when extended. The system method further includes (i) cooling the coil to cause tissue from the blood vessel to adhere to the coil, (ii) distally displacing the sheath with respect to the coil such that the coil is drawn into the lumen thereby causing the tissue to separate from the blood vessel, and (iii) heating the coil to cause the tissue to release from the coil.

[0017] In some embodiments of the method, cooling the coil includes passing a cooling fluid through a lumen of the coil, and in some embodiments of the method, heating the coil includes passing an electrical current through a heating element of the coil.

[0018] These and other features of the concepts provided herein will become more apparent to those of skill in the art in view of the accompanying drawings and following description, which describe particular embodiments of such concepts in greater detail.DRAWINGS

[0019] FIG. 1 illustrates a medical system for treating chronic vein insufficiency, according to some embodiments.

[0020] FIG. 2A is an illustration of the distal end of a device of the system of FIG. 1 disposed within a vein, where a coil of the device is in a deployed state, according to some embodiments.

[0021] FIG. 2B is an illustration of the distal end of a device of the system of FIG. 1 disposed within the vein, where the coil is in a retracted state, according to some embodiments.

[0022] FIG. 3A is a side view illustration of a temperature member of the system of FIG. 1, according to some embodiments.

[0023] FIGS. 3B-3D are detailed views of various portions of the temperature member of FIG. 3 A, according to some embodiments.

[0024] FIG. 4 is a perspective illustration of an advancement mechanism of the device of the system of FIG. 1, according to some embodiments.

[0025] FIG. 5 is a perspective view of a handle including controls of the device of the system of FIG. 1, according to some embodiments.

[0026] FIG. 6 is a block diagram of a method of the system of FIG. 1, according to some embodiments.

[0027] FIG. 7A illustrates another embodiment the medical device of FIG. 1 that includes a fluid lumen extending along the sheath, according to some embodiments.

[0028] FIGS. 7B-7E illustrate various embodiments of the fluid lumen of FIG. 7 A, according to some embodiments.DESCRIPTION

[0029] Before some particular embodiments are disclosed in greater detail, it should be understood that the particular embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that a particular embodiment disclosed herein can have features that can be readily separated from the particular embodiment and optionally combined with or substituted for features of any of a number of other embodiments disclosed herein.

[0030] Regarding terms used herein, it should also be understood the terms are for the purpose of describing some particular embodiments, and the terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps in a group of features or steps, and do not supply a serial or numerical limitation. For example, “first,” “second,” and “third” features or steps need not necessarily appear in that order, and the particular embodiments including such features or steps need not necessarily be limited to the three features or steps. Labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” and the like are used for convenience and are not intended to imply, for example, any particular fixed location, orientation, or direction. Instead, such labels are used to reflect, for example, relative location, orientation, or directions. Singular forms of “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise.

[0031] The phrases “connected to,” “coupled with,” and “in communication with” refer to any form of interaction between two or more entities, including but not limited to mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interaction. Two components may be coupled with each other even though they are not in direct contact with each other. For example, two components may be coupled with each other through an intermediate component.

[0032] The terms “proximal” and “distal” refer to opposite ends of a medical device, including the devices disclosed herein. More specifically, the proximal end of a medical device is the end nearest a practitioner during use, and the distal end of a medical device is the end or portion nearest a patient during use. For example, the distal end or portion of a sheath is theend or portion of the catheter furthest disposed within the patient. Conversely, the proximal end or portion of the sheath is the end or portion disposed outside the patient.

[0033] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art. References to approximations are made throughout this specification, such as by use of the term “substantially.” For each such reference, it is to be understood that, in some embodiments, the value, feature, or characteristic may be specified without approximation. For example, where qualifiers such as “about” and “substantially” are used, these terms include within their scope the qualified words in the absence of their qualifiers. For example, where the term “substantially straight” is recited with respect to a feature, it is understood that in further embodiments, the feature can have a precisely straight configuration.

[0034] Any methods disclosed herein include one or more steps or actions for performing the described method. The method steps and / or actions may be interchanged with one another. In other words, unless a specific order of steps or actions is required for proper operation of the embodiment, the order and / or use of specific steps and / or actions may be modified. Moreover, sub-routines or only a portion of a method described herein may be a separate method within the scope of this disclosure. Stated otherwise, some methods may include only a portion of the steps described in a more detailed method. Additionally, all embodiments disclosed herein are combinable and / or interchangeable unless stated otherwise or such combination or interchange would be contrary to the stated operability of either embodiment.

[0035] FIG. 1 illustrates a medical system (system) 100 for treating chronic vein insufficiency (CVI) of a patient. The system 100 is generally configured to inflict damage to an inside surface of a blood vessel (e.g., a vein) leading to an inflammatory response resulting in a relatively fast and high degree of fibrosis in the vein and further causing closure of the vein.

[0036] The system 100 generally includes a medical device (device) 110 coupled with a cooling source 120 and a power source 130. The device 110 includes a handle 150 configured for grasping and holding by a user (e.g., a medical clinician) coupled with an elongate member 160 configured for insertion within and advancement along a vasculature (e.g., a vein) of a patient. More specifically, the elongate member 160 is configured for insertion into thevasculature at an insertion site and advanced along the vasculature to a location of CVI treatment. As such, a length of the elongate member 160 may be defined to extend between a defined insertion site and a defined location of CVI treatment. In various implementations of the system 100, the length of the elongate member extending between a proximal end 160 A coupled with handle 150 and distal end 160B may include a range of 30 cm to 90 cm or more. In other embodiments, the range may include length of the elongate member 160 may be less than 30 cm or greater that 90 cm.

[0037] The elongate member 160 is coupled with the handle 150 so that longitudinal displacement of the handle 150 results in a corresponding longitudinal displacement of the elongate member 160. The coupling of the elongate member 160 with the handle 150 may also define co-rotation of the elongate member 160 and the handle 150 about a longitudinal axis111 of the device 110. The handle 150 includes a number of controls 152 configured to enable the user to govern the operation of the system 100.

[0038] The elongate member 160 includes a sheath 112 that defines a lumen 113 extending along a length of the sheath 112. In the illustrated embodiment, the lumen 113 extends along an entire length of the sheath. Although other embodiments are considered where the lumen 113 extends along only a portion of the entire length of the sheath 112. The sheath112 may be formed of any suitable material configured for placement within a patient vasculature. An outside diameter of the sheath 112 may be defined for insertion within a defined vein or portion of the vasculature. In other words, various implementations of the system may include different diameters of the sheaths consistent with different diameters of defined veins. By way of summary, different models (embodiments) the device 110 may be provided as having different dimensions (i.e., length and / or diameter) of the elongate member 160.

[0039] The elongate member 160 includes a temperature member 114 disposed within the lumen 113 of the sheath 112. The temperature member 114 includes a coil 116, i.e., a coiled portion of the temperature member 114 at a distal end of the temperature member 114. The coil 116 is oriented such that windings of the coil 116 encircle (i.e., wrap around) the longitudinal axis 111. The temperature member 114 is slidably coupled with the sheath 112 so that the temperature member 114 may be selectively transitioned between a distal position with respect to the sheath 112 as shown in FIG. 1 and proximal position described below. Similar to the elongate member 160, the different models of the device 110 may include coils having differentcharacteristics, such as a coil length, a coil diameter, a number of coil windings, a winding pitch, or a stiffness of the coil windings, for example. FIG. 1 shows the coil 116 expanded to a diameter 116A in a free state, where the diameter 116A is sized to be larger than an inside diameter of a vein at the treatment location so that the coil 116 contacts the inside surface of the vein. A pitch of the coil 116 may be less when the coil 116 is disposed is the expanded state than when the coil 116 is disposed that contracted state.

[0040] The coil 116 is operatively coupled with the cooling source 120 and the power source 130 so that the coil 116 may be selectively cooled to a cooled state and heated to a heated state as further described below. The cooled state is defined to cause blood vessel tissue to adhere to the coil 116, e.g., freeze to the coil 116. Conversely, the heated state is defined to allow the adhered blood vessel tissue to separate from the coil 116. The heated state may include a temperature between zero (0) degrees C and 37 degrees C. Similar, the cooled state may include a temperature between zero (0) degrees C and -50 degrees C.

[0041] The coil 116 may be configured to accommodate relatively high positive and negative temperature slew rates as induced by the power source 130 and cooling source 120, respectively. In other words, the system 100 may be configured to rapidly transition the coil116 between the cooled state and the heated state. For example, the system 100 may be configured to transition the coil 116 from the heated state to the cooled state over a short duration, such as 10 seconds, 5 seconds, 3 seconds or less. Similarly, the system 100 may be configured to transition the coil 116 from the cooled state to the heated state over a short duration, such as 30 seconds, 10 seconds, 5 seconds, 3 seconds or less.

[0042] The cooling source 120 is generally configured to transition the coil 116 toward the cooled state, such as from the heated state to the cooled state. In the illustrated embodiment, the cooling source 120 is configured to provide a cooling fluid 124 (liquid or gas) to a lumen117 of the coil 116, where the lumen 117 of the coil 116 extends along the coil 116, i.e., along the coiled portion of the temperature member 114 that defines the coil 116. As such, the lumen 117 is fluidly coupled with the cooling source 120. The cooling source 120 may be configured for selective activation and deactivation via one or more of the controls 152. In the illustrated embodiments, the cooling source 120 includes a container (or tank) containing the cooling fluid 124. In some embodiments, the cooling fluid 124 may include liquid nitrogen. In another embodiment, the cooling fluid 124 may include alcohol cooled with dry ice and the coolingsource 120 may include a pump (not show) configured to circulate the alcohol through the coil 116 via the lumen 117.

[0043] The power source 130 is generally configured to transition the coil 116 toward the heated state, such as from the cooled state to the heated state. In the illustrated embodiment, the power source 130 is configured to provide electrical power to a heating element (See FIG. 3A) of the coil 116. As such, the heating element of the coil 116 is electrically coupled with the power source 120 via a number of conducting elements, e.g., wires. The power source 130 may be configured for selective activation and deactivation via one or more of the controls 152.

[0044] The device 110 may be coupled with the cooling source 120 and the heating source 130 via a cable 155, where the cable 155 includes a number of fluid lumens (e.g., tubes) extending along the cable 155, such as a delivery line 121 and a return line 122, providing flow paths between the cooling source 120 the device 110. Similarly, the cable 155 may include conducting elements, such as the wires 131 extending along the cable 155, where the wires 131 electrically couple the power source 130 to the device 150. In some embodiments, the cable 155 may include control wires (not shown) extending along the cable 155 in addition to the wires 131. The control wires may enable control of the cooling source 120 and / or the power source 130 via the device 110. For example, the cooling source 120 may include an electromechanical valve (not shown), and one of the controls 152 may be operatively coupled with the electro-mechanical valve.

[0045] In some embodiments, the cable 155 may include a connector 156 including a first connector portion 156A attached to a device portion of the cable 155 and a corresponding second connector portion 156B attached to a source portion of the cable 155, where the source portion is coupled with cooling source 120 and the power source 130. The connector 156 allows the device 110 to be selectively coupled with and decoupled from the cooling source 120 and the power source 130. In some embodiments, the device 110 may be configured for a single use, whereas the cooling source 120 and the power source 130 may be configured for multiple uses, including multiple connections to and disconnections from multiple devices 110. In some embodiments, the second connector portion 156B may include a valve 121 A disposed in line with the delivery line 121. The valve 121 A may be configured to automatically close upon decoupling of the second connector portion 156B from the first connector portion 156A and automatically open upon coupling of the second connector portion 156B with the firstconnector portion 156A. The valve 121A may prevent leakage or loss of cooling fluid 124 when the second connector portion 156B is decoupled from the first connector portion 156A.

[0046] FIGS. 2A, 2B are a detailed illustrations of the distal end 160B of the elongate member 160 disposed within a vein 200 (shown in cross section). FIG. 2A illustrates the temperature member 114 in the distal position with respect to the sheath 112 (shown in crosssection) so that the coil 116 is extended beyond a distal end 212 of the sheath 112. The coil 116 include a number (e.g., 1, 2, 3, 4, 5, or more) coil windings 216. In some embodiments, temperature member 114 may include a distal tip section 217 disposed distal the coil 116, where the distal tip section 217 is disposed parallel to the longitudinal axis 111 and in some embodiments, extends along the longitudinal axis 111. The distal tip section 217 may serve as a guide to the coil 116 during advancement along the vasculature and / or the sheath 112.

[0047] The coil is expanded toward the diameter 116A such that the coil 116 is in contact with the inside surface 210 of the vein wall 205 of the vein 200, i.e., so that at least a portion of the coil windings 216 engage the inside surface 210. In some embodiments, an entire length of the coil windings 216 disposed at the circumference of the coil 116, in the expanded state as shown, is in contact with the inside surface 210. FIG. 2A further illustrates the coil 116 in the cooled state and as such, contact portions 211 of the vein wall 205 (i.e., blood vessel tissue) are adhered to the coil windings 216 of the coil 116.

[0048] FIG. 2B illustrates the temperature member 114 having been drawn into the sheath 112 so that the temperature member 114 is in the proximal position with respect to the sheath 112 and the coil 116 is disposed within the lumen 113 of the sheath 112. The coil 116 is in a contracted state as constrained by the sheath 112. FIG. 2B also illustrates the coil 116 in the cooled state and as such, the contact portions 211 of the vein wall 205 remain adhered to the coil windings 216 of the coil 116. As such, the contact portions 211 have been separated from the vein wall 205 leaving voids 213 in place of the separated contact portions 211. Although not specifically shown, the contact portions 211 may be released or allowed to separate from the coil windings 216 when the coil 116 is transitioned to heated state. The coil 116 may be transitioned to the heated state when the coil 116 is disposed in the expanded state within the blood vessel and / or when the coil 116 is disposed in the contacted state within the lumen 113.

[0049] FIGS. 3 A-3D illustrate various views of the temperature member 114. FIG. 3 A is a side view of the temperature member 114 showing the coil 116, the distal tip section 217 extending distally away from the coil 116, and a proximal section 314 extending proximally away from the coil 116. As stated above, the coil 116 is composed of a coiled section of the temperature member 114 and is configured to transition between a cooled state and a heated state. More specifically, the coil 116 is configured to present a contact surface 316A to the inside surface 210 of the vein wall 205 (see FIG. 2 A) the cooled state and / or the heated state. The coil 116 is also configured to radially expand and contract as described above. The coil 116 specifically includes a cooling member 304 and a heating element 305 coupled with the cooling member 304 as further described below.

[0050] The proximal section 314 is generally configured to enable the functionalities of the coil 116. The proximal section 314 generally includes a substantially straight shape in a free state and includes sufficient column strength to push the coil 116 distally with respect to the sheath 112 when the temperature member 114 is transitioned from the proximal position to the distal position with respect to the sheath 112. The proximal section 314 similarly includes a sufficient tensile strength to pull the coil 116 proximally with respect to the sheath 112 when the temperature member 114 is transitioned to the proximal position with respect to the sheath 112, i.e., drawn into the lumen 113. The proximal section 314 also defines the physical coupling of the coil 116 to the handle 150. In some embodiments, the proximal section 314 is fixedly attached to a housing 151 of the handle 150. The proximal section 314 is also configured to provide an energy transfer mechanism between the coil 116 and the cooling and power sources 120, 130 as described below.

[0051] FIG. 3B is a detailed cross-sectional side view illustration of the distal tip section 217 which may be formed of the cooling member 304. As discussed above, the coil 116 or more specially the cooling member 304 includes a lumen 117. In the illustrated embodiment, the lumen 117 includes two lumen portion referred to as a first lumen 317A and a second lumen 317B, disposed side-by-side each other along the coil windings 216. The first lumen 317A and a second lumen 317B are fluidly coupled together at a distal end of the distal tip section 217 so that the lumen 117 defines a loop. In other words, the cooling member 304 includes the first lumen 317A and the second lumen 317B fluidly coupled together at the distal tip section 217. The first and second lumens 317A, 317B are fluid coupled with the delivery and return lines121, 122. So that the cooling fluid 124 flows through each of the first lumen 317A and a second lumen 317B during use.

[0052] FIG. 3C is a detailed cross-sectional end view illustration of the coil winding 216 of the coil 116, i.e., the coiled portion of the temperature member 114. Shown is the cooling member 304 including the first lumen 317A and the second lumen 317B disposed side-by-side each other and the contact surface 316A. The cooling member 304 may be formed of any suitable material configured to provide adequate thermal conduction between the first and second lumens 317A, 317B and the contact surface 316A, such as Ni tinol or stainless steel, for example.

[0053] In some embodiments, the contact surface 316A may include an abrasive surface 318 configured to abrade the inside surface 210 of the blood vessel 200 when the coil 116 is in contact with the inside surface of the blood vessel 220. The abrasive surface 318 may extend across at least the contact surface 316A. The abrasive surface 318 may include an abrasive coating applied to the contact surface 316A or the abrasive surface 318 may be formed by a machining or grinding process.

[0054] In the illustrated embodiment, the heating element 305 is coupled with the cooling element 304 on a side opposite the contact surface 316A, i.e., an inside surface of the coil 116. Although, the heating element 305 may be coupled with the cooling member 304 along any side of the cooling member 304 without disrupting the operation of the coil 116. The heating element 305 is thermally coupled with the cooling member 304 so that heat from the heating element may conduct toward the contact surface 316A. The heating element 305 may extend along the cooling member 304 only along the coil windings 216 so that only the coil windings 216 are heated. The heating element 305 may be coupled with the cooling member 304 via any suitable technique, such as a thermally conductive adhesive, for example. Other attachment mechanisms are also considered such wrapping the heating element 305 around the cooling member 304.

[0055] The heating element 305 is an electrical heating element configured to convert electrical energy into heat. In the illustrated embodiment, the heating element 305 includes a loop structure similar to the cooling member 304. In other words, the heating element 305 includes first and second heating element sections 306A, 306B which may be disposed side- by-side each other. The first and second heating element sections 306 A, 306B are electricallycoupled together at a distal end of the coil windings 216. Structures other than the loop structure are also considered. The heating element 305 may be formed of stainless steel, Nichrome, or a similar material. The first and second heating element sections 306 A, 306B are electrically coupled with the wires 131.

[0056] The heating element 305 may include a covering or coating to provide for electrical insulation and / or thermal properties. In an embodiment, the covering may include a first cover portion 308 A that includes thermal insulation properties to prevent loss toward the inside of the coil 116. The covering may also include a second cover portion 308B disposed between the first and second heating element sections 306 A, 306B and the cooling member 304, where the second cover portion 308B includes thermal conduction properties to enhance thermal transfer from the first and second heating element sections 306 A, 306B to the cooling member 304 so that the first and second heating element sections 306A, 306B heat the cooling member 304 toward the heated state.

[0057] In some embodiments of the system 100, the transitioning of the coil 116 to the heated state may include receiving heat from the patient. In other words, the thermal energy from the blood or tissue may transfer to the coil 116 to heat the coil 116 away from the cooled state. In such embodiments, the heating element 305, the power source 130, and the associated components may be omitted.

[0058] FIG. 3D is a detailed cross-sectional end view illustration of the proximal section 314. The proximal section 314 includes the cooling member 304 which may define the structural properties of the proximal section 314. The proximal section 314 includes the first and second lumens 317A, 317B to facilitate transport of the cooling fluid 124 to and from the coil 116. The proximal section 314 also includes conductive members (e.g., wires) 307A, 307B electrically coupled with the first and second heating element sections 306 A, 306B and provide the electrical connection between the first and second heating element sections 306A, 306B and the wires 131.

[0059] The proximal section 314 may also include a cover 311 that encapsulates the conductive members 307A, 307B and the cooling member 304. The cover 311 may provide a physical protection to the conductive members 307A, 307B and / or cooling member 304 including the first and second lumens 317A, 317B to prevent damage to either as the proximal section 314 is slidably displaced within the lumen 113 of the sheath 112. The cover 311 mayalso be configured to add column strength to the cooling member 304. The cover 311 may also include a low friction outside surface 311A as may be defined by a low friction coating to reduce the force necessary to slide the proximal section 314 within the lumen 113. Further still, the cover 311 may include thermal insulative properties to inhibit thermal energy transfer to and away from the cooling member 304 within the lumen 113.

[0060] FIG. 4 illustrates an exemplary advancement mechanism of the device 110. As discussed above, the device 110 is configured to (i) deploy the coil 116 in an extended state beyond the distal of the sheath 112 and (ii) retract to coil to a retracted state with the lumen 113 of the sheath 112. The advancement mechanism 410 is generally configured to enable displacement of the temperature member 114 with respect to the sheath 112 between the distal position (the deployed state) as shown in FIG. 2A and the proximal position (retracted state) as shown in FIG. 2B. In the illustrated embodiment, the displacement of the temperature member 114 with respect to the sheath 112 is defined by fixedly attaching the temperature member 114 to the housing 151 of the handle 150 and displacing the sheath 112 with respect to the housing 151. In other words, the sheath 112 is proximally displaced with respect to the handle 150 and the temperature member 114 (which is fixed to the housing 151) so that the distal end of the sheath 112 is proximally displaced with respect to the coil 116 to define the deployed state. By fixing the temperature member 114 to the handle 150 and displacing the sheath 112 with respect to the handle 150, the coil 116 may generally remain substantially stationary with respect to the vein during deployment and retraction of the coil 116. Although, fixing the temperature member 114 to the handle 150 and displacing the sheath 112 with respect to the handle 150 may be the preferred arrangement, fixing the sheath 112 to the handle 150 and displacing the temperature member 114 with respect to the handle 150 is also considered as an alternative embodiment of the device 110.

[0061] The advancement mechanism 410 includes a rack 415 slidably disposed within a slot 416 of the housing 151. The temperature member 114 is attached to the housing 151 and the sheath 112 is attached to the rack 415 so that proximal displacement of the rack 415 with respect to the housing 151 correlates with proximal displacement of the sheath 112 with respect to the temperament member 114. Said another way, proximal displacement of the rack 415 with respect to the housing 151 deploys the coil 116 and distal displacement of the rack 415 with respect to the housing 151 retracks the coil 116. The rack 415 may be formed of any suitable material, such as plastic or metal, for example. The sheath 112 may be attached to rack415 and the temperature member 114 may be attached to the housing 151 via adhesive bonding, clamping, or any other suitable method.

[0062] The advancement mechanism 410 includes a latch mechanism 420. The latch mechanism 420 is configured to control displacement of the rack 416 along the slot 416, thereby controlling displacement of the sheath 112 with respect to the temperature member 114 including the coil 116. In the illustrated embodiment, the latch mechanism 420 is configured to selectively allow and prevent proximal displacement of the rack 415 with respect to the housing 151. Although, in other embodiments, the latch mechanism 420 may be selectively allow and prevent distal displacement of the rack 415 with respect to the housing 151, or both proximal and distal displacement of the rack 415 with respect to the housing 151. The latch mechanism 420 includes a pawl 425 configured to engage teeth 426 of the rack 415. The pawl 425 is rotatably coupled with the housing 151 between an engaged state and a disengaged state. In the engaged state, the pawl 424 is rotated toward the rack 415 so that the pawl 425 contacts the teeth 426 (as shown) thereby preventing proximal displacement of the rack 415 with respect to the housing 151. Conversely, in the disengaged state, the pawl 424 is rotated away from the rack 415 (not shown) so that the pawl 425 does not contact the teeth 426 thereby allowing proximal displacement of the rack 415 with respect to the housing 151.

[0063] The latch mechanism 420 may include a ratcheting functionality. In the illustrated embodiment, the pawl 425 may be biased toward the engaged state, and the engagement of the pawl 425 with the teeth 426 is configured to allow distal displacement of the displacement of the rack 415 with respect to the housing 151 when the pawl 425 is in the engaged state, i.e., the pawl 425 may slide over the teeth 426 as the rack 415 is displaced in the distal direction. As such, the latch mechanism 420 may provide for the distal displacement of the rack 415 according multiple sequential steps. In some embodiments, the coil 116 may inherently or intentionally define a bias toward the deployed state during retraction of the coil 116. As such, the coil 116 may accordingly define a bias of the rack 415 in the proximal direction as the rack 416 is displaced in the distal direction. It may therefore be easier for the user to retract the coil 116 (i.e., distally displace the rack 415) using more than one step. In other words, it may be easier for the user to retract a first portion of coil 116 in one step and retract a second portion of the coil 116 is a subsequent second step. Further portions of the coil 116 may be retracted via additional subsequent steps.

[0064] FIG. 5 is perspective view of a portion of the handle 150 including the controls 152. In the illustrated embodiment, the controls 152 includes three actuators or controls. However, in other embodiments, the number of controls may be more or less that three, such as 1, 2, 4, 5, or more. For example, a control may perform more than one function, and as such, may be divided into more than one control. Similarly, a function of one control and a separate function of a different control may be combined to define a control performing more than one function. In the illustrated embodiment, the controls 152 include a coil deployment actuator 501, a latch actuator 503, and temperature actuator 505. Each of the coil deployment actuator 501, a latch actuator 503, and temperature actuator 505 may be located distal of a gripping area 553 of the handle 150 so as to be easily accessible by a thumb or a forefinger of the user. Furthermore, each of the coil deployment actuator 501, a latch actuator 503, and temperature actuator 505 may be located on any of the four sides of the housing 151, i.e., a topside, a backside, right side, or a left side.

[0065] The coil deployment actuator 501 is configured to proximally displace the sheath 112 with respect to the coil 116 to deploy the coil 116 in the extended position and proximally displace the sheath 112 with respect to the coil 116 to retract the coil 116 to the retracted position upon manual actuation by the user. The coil deployment actuator 501 is configured for actuation in each of two opposite directions, such as distal direction and proximal direction, for example. The coil deployment actuator 501 is further configured deploy the coil 116 when actuated in a first direction and retract the coil 116 when actuated in an opposite second direction. In the illustrated, embodiment, the first direction is the distal direction and the second direction is the proximal direction. The coil deployment actuator 501 may include any type of manual actuator configured for bidirectional actuation, such as a lever, a slider, or a thumbwheel, for example.

[0066] In some embodiments, the coil deployment actuator 501 may be omitted. In such embodiments, the user may grasp the sheath 112 and directly displace the sheath 112 proximally and distally with respect to the handle 150.

[0067] In the illustrated embodiment, the coil deployment actuator 501 includes a thumbwheel disposed on the topside of the housing. The thumbwheel is mostly disposed within the housing 152 with a top portion of the thumbwheel extending through an opening in the housing 152. As such, actuation of the coil deployment actuator 501 includes (i) rotating the thumbwheel in a first rotational direction by pushing the top portion of the thumbwheel in thedistal direction and (ii) rotating the thumbwheel in a second opposite rotational direction by pulling the top portion of the thumbwheel in the proximal direction.

[0068] The thumbwheel is operatively coupled with the rack 415 so that (i) rotation of the thumbwheel in the first rotational direction causes the rack 415 distally displace with respect to the housing 151 resulting in deployment of the coil 116 and (ii) rotation of the thumbwheel in the second rotational direction causes the rack 415 proximally displace with respect to the housing 151 resulting in retraction of the coil 116. The thumbwheel may be operatively coupled with the rack via a rack and pinion gearing engagement, a frictional engagement or any other suitable coupling configured to convert rotation of the thumbwheel into linear displacement of the rack 415.

[0069] The latch actuator 501 is configured to selectively engage the pawl 425 with the teeth 426 of rack 415 and disengage the pawl 425 from the teeth 426 of rack 415. In the illustrated embodiment, the latch actuator 501 is a momentary actuator in the form a button. The button is operatively coupled with the pawl 425 such that pushing the button disengages the pawl 425 from the teeth 426 and releasing the button allows the pawl 425 to re-engage the teeth 425. In the illustrated embodiment, the latch actuator 501 is located ahead of (or distal) the coil deployment actuator 501. However, other locations of the latch actuator 501 with respect to the coil deployment actuator 501 are considered, such as behind or to the side of the coil deployment actuator 501.

[0070] In some embodiments, the functionality of the latch actuator 501 may be incorporated into the coil deployment actuator 501. For example, the thumbwheel may include a button function (i.e., may be depressible) as well as the rotating function. As such, depressing the thumbwheel may disengages the pawl 425 from the teeth 426 and releasing the thumbwheel (i.e., allowing the thumbwheel to return the non-depressed state) allows the pawl 425 to reengage the teeth 425. Such an embodiment, may provide for enhanced efficiency and / or simplicity in deploying and retracting the coil 116.

[0071] The temperature actuator 505 is configured to selective activate and deactivate both the cooling source 120 and the power source 130 so as to cool and heat the coil 116, respectively. Similar to the coil deployment actuator 501, the temperature actuator 505 may be bi-directional. The temperature actuator 505 may include three distinct positions, i.e., a cooling position, a heating position, and an “off’ position disposed between a cooling position and theheating position. The temperature actuator 505 may be biased toward the “off’ position so that in the absence of an intentional actuation, the temperature actuator 505 may be disposed in the “off’ position. The temperature actuator 505 is located on the topside of the housing 151. Actuating the temperature actuator 505 may include (i) displacing the temperature actuator 505 or portion thereof in a first direction toward to the cooling position against the bias to activate the cooling source 120, (ii) releasing the temperature actuator 505 to allow the bias to return the temperature actuator 505 to the “off’ position, (iii) displacing the temperature actuator 505 or portion thereof in a second direction toward to the heating position against the bias to activate the power source 130, and (iv) releasing the temperature actuator 505 to allow the bias to again return the temperature actuator 505 to the “off’ position. The temperature actuator 505 may include a lever, a slider, or a thumbwheel. In an alternative embodiment, the temperature actuator 505 may be divided into two separate actuators, e.g., a heating actuator and a cooling actuator.

[0072] The temperature actuator 505 may be operatively coupled with the cooling source 120 via a valve 505 A disposed in line with the delivery line 121. The valve 505 A may be a normally closed valve so that the valve 505A prevents the flow of cooling fluid 124 to the coil 116 in the absence of deliberate actuation. In an embodiment, the valve 505A may be mechanical (i.e., not electro-mechanical), such as a pinch valve or a poppet valve, for example. The temperature actuator 505 may be operatively couple with the valve 505A such that displacing the temperature actuator 505 or portion thereof in the first direction opens the valve 505A and allowing the temperature actuator 505 or portion thereof to return the “off’ position closes the valve 505A.

[0073] The temperature actuator 505 may be operatively coupled with the power source 120 via a switch 505B disposed serially in line with one of the wires 131. The switch 505B may be a normally open switch so that the switch 505B prevents the electrical current from flowing to the heating element 305 of the coil 116 in the absence of deliberate actuation. The temperature actuator 505 may be operatively couple with the switch 505B such that displacing the temperature actuator 505 or portion thereof in the second direction closes the switch 505B enabling current to flow to the heating element 305 and allowing the temperature actuator 505 or portion thereof to return the “off’ position opens the switch 505B.

[0074] FIG. 6 is a block diagram of a method 600 of treating chronic venous insufficiency of a patient that, according to some embodiments, includes all or any subset ofthe following actions, steps, or operations. Each block illustrated in FIG. 6 represents an operation of the method 600 performed any of the medical system embodiments disclosed herein while a portion of the medical device of the medical system is disposed within a blood vessel, such as a vein.

[0075] The method 600 includes displacing a sheath proximally with respect to a coil disposed with a lumen of the sheath such that the coil is extended beyond a distal end of the sheath (block 610). The coil is configured to radially expand so as to contact an inside surface of the blood vessel when extended. The method 600 may further include (i) cooling the coil to cause tissue from the blood vessel to adhere (e.g., freeze) to the coil (block 620). The method 600 may further include distally displacing the sheath with respect to the coil such that coil is drawn into the lumen thereby causing the tissue to separate from the blood vessel (block 630) and heating the coil to cause the tissue to release from the coil (block 640). In some embodiments, the distally displacing the sheath with respect to the coil such that coil is drawn into the lumen thereby causing the tissue to separate from the blood vessel (block 630) may be omitted from the method 600.

[0076] In some embodiments of the method 600, cooling the coil includes passing a cooling fluid through a lumen of the coil (block 625) and in some embodiments of the method 600, heating the coil includes passing an electrical current through a heating element of the coil (block 645).

[0077] FIG. 7 A illustrates another embodiment of the medical device (device) 710 that can, in certain respects, resemble components of the device 110 described in connection with FIGS. 1-5. It will be appreciated that all the illustrated embodiments may have analogous features. Relevant disclosure set forth above regarding similarly identified features thus may not be repeated hereafter. Moreover, specific features of the device 110 and related components shown in FIGS. 1-5 may not be shown or identified by a reference numeral in the drawings or specifically discussed in the written description that follows. However, such features may clearly be the same, or substantially the same, as features depicted in other embodiments and / or described with respect to such embodiments. Accordingly, the relevant descriptions of such features apply equally to the features of the device 710 of FIG. 7A. Any suitable combination of the features, and variations of the same, described with respect to the device 110 and components illustrated in FIGS. 1-5 can be employed with the device 710 and components of FIG. 7A, and vice versa.

[0078] The device 710 is configured to deliver a medical fluid 721 to the patient, such as a sclerosant (liquid or foam) according to a Sclerotherapy. More specifically, the device 710 to receive the medical fluid 721 from a fluid source 720 (e.g., a syringe) and transport the medical fluid 721 from the fluid source 720 to the distal end or near the distal end of the sheath 112. The device 710 includes a fluid lumen 713 extending along the sheath 112. The device 710 includes fluid tubing 715 extending away from the handle 150. A fluid connector 716 (e.g., a Luer connector) is coupled with the fluid tubing 715 at a proximal end thereof. The fluid lumen 713 extends along the fluid tubing 715 so as to define a flow path for the medical fluid 721 to flow from the connector 716 to the distal end of the sheath 112. In use, the medical fluid 721 contained within the fluid source 720 passes through the fluid lumen 713 from the fluid source 720 to the distal end of the sheath 112 where the medical fluid 721 exits an open distal end of the fluid lumen 713 into the patient.

[0079] The sheath 112 may include the fluid lumen 713 according to various embodiments as shown in FIGS. 7B-7E. FIGS. 7B-7E are distal end views of the sheath 112. Note that the temperature member 114 including coil 116 are removed from (not shown in) the FIGS. 7B-7E for convenience in illustrating the fluid lumen 713. FIG. 7B illustrates a first embodiment of the fluid lumen 713, where the tubing 715 having the fluid lumen 713 is disposed within and extends along the lumen 113 of the sheath 112.

[0080] FIGS. 7C-7E illustrate the fluid lumen 713 incorporated into the sheath 112. FIG. 7C illustrates a second embodiment of the fluid lumen 713, where the fluid lumen 713 is incorporated into a sheath wall 712 of the sheath 112. This second embodiment, may minimize operational interference between the fluid lumen 713 and the coil 116. FIG. 7D illustrates a third embodiment of the fluid lumen 713, where the sheath 112 includes an internal bead 717 extending radially inward of an inside surface of the sheath wall 712 and the fluid lumen 713 is incorporated into internal bead 716. This third embodiment, may allow for the sheath wall 712 to have a minimal thickness and a circular outside shape. FIG. 7E illustrates a fourth embodiment of the fluid lumen 713, where the sheath 112 includes an external bead 717 extending radially outward of an outside surface of the sheath wall 712 and the fluid lumen 713 is incorporated into the external bead 717. This fourth embodiment, may allow for the sheath wall 712 to have a minimal thickness and a circular inside shape thus minimizing operational interference between the fluid lumen 713 and the coil 116.

[0081] While some particular embodiments have been disclosed herein, and while the particular embodiments have been disclosed in some detail, it is not the intention for the particular embodiments to limit the scope of the concepts provided herein. Additional adaptations and / or modifications can appear to those of ordinary skill in the art, and, in broader aspects, these adaptations and / or modifications are encompassed as well. Accordingly, departures may be made from the particular embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

CLAIMSWhat is claimed is:

1. A medical system, comprising: a medical device, comprising: an elongate member configured for placement within a blood vessel of a patient, the elongate member comprising: a sheath defining a lumen extending between proximal and distal ends of the sheath; and a temperature member disposed within the lumen, the temperature member defining an elongate shape extending between a proximal end of the temperature member and a coil disposed at a distal end of the temperature member, wherein the coil is configured to transition between: a heated state and a cooled state, and an expanded state defining a first diameter and a contracted state defining a second diameter that is less than the first diameter; and a handle coupled with the elongate member at the proximal end; and a cooling source coupled with the temperature member, the cooling source configured to define the cooled state when activated.

2. The system according to claim 1, wherein the temperature member is slidably disposed within the lumen such that the temperature member is transitionable between: a distal position with respect to the sheath where the coil extends beyond the distal end of the sheath, and a proximal position with respect to the sheath where the coil is disposed within the lumen.

3. The system according to claim 2, wherein the sheath is configured to constrain the coil in the contracted state when the coil is disposed within the lumen.

4. The system according to either claim 2 or claim 3, wherein the coil is configured to expand toward the first diameter so that the coil contacts an inside surface of the blood vessel when the temperature member is transitioned to the distal position.

5. The system according to claim 4, wherein the cooled state is defined to cause tissue of the blood vessel to adhere to the coil such that upon transitioning of the temperature member from the distal position toward the proximal position, the tissue is separated from the blood vessel.

6. The system according to claim 5, wherein the heated state is defined such that the tissue is released from the coil.

7. The system according to any of the preceding claims, wherein the temperature member includes first and second lumens extending between the proximal end and the distal end of the temperature member including the coil, the first and second lumens in fluid communication with each other at the distal end of the temperature member.

8. The system according to claim 7, wherein: a proximal end of at least one of the first and second lumens is fluidly coupled with the cooling source, and the cooling source is configured to deliver a cooling fluid to the coil via the at least one of the first and second lumens.

9. The system according to claim 8, wherein the cooling source is configured to provide the cooling fluid to the coil at a temperature that is below zero (0) degrees Celsius.

10. The system according to claim 9, wherein the cooling fluid includes one of liquid Nitrogen or alcohol cooled with dry ice.

11. The system according to any of the preceding claims, further including a power source coupled with the temperature member, the power source configured to define the heated state when activated.

12. The system according to claim 11, wherein the temperature member includes a heating element extending along the coil, the heating element electrically coupled with the power source such that the heating element defines the heated state of the coil based on electrical energy provided by the power source.

13. The system according to claim 11 or claim 12, wherein the handle includes a power actuator configured to selectively activate and deactivate the power source via manipulation of the power actuator by the user.

14. The system according to any of claims 4-13, wherein the coil includes an abrasive outside surface configured to abrade the inside surface of the blood vessel when the coil is in contact with the inside surface of the blood vessel.

15. The system according to any of claims 2-14, wherein the handle includes at least one actuator operatively coupled with the temperature member or the sheath, the at least one actuator configured to transition the temperature member between the proximal position and the distal position with respect to the sheath via manipulation of the at least one actuator by a user.

16. The system according to any of claims 2-15, wherein the handle includes a latch mechanism operatively coupled between a housing of the handle and the temperature member or the sheath, the latch mechanism configured to: allow distal displacement of the temperature member toward the distal position with respect to the sheath in response to a deliberate action by the user, and prevent distal displacement of the temperature member toward the distal position with respect to the sheath in the absence of the deliberate action by the user.

17. The system according to any of the preceding claims, wherein the handle includes a cooling actuator configured selectively activate and deactivate the cooling source via manipulation of the cooling actuator by the user.

18. The system according to any of the preceding claims, wherein: the medical device further includes a fluid lumen extending along the sheath, the fluid configured to enable delivery of a medical fluid to the patient, the fluid lumen defines an open end at or near the distal end of the sheath, the fluid lumen includes a fluid connector at a proximal thereof, and the fluid connector is configured to couple the fluid lumen with a fluid source.

19. The system according to claim 18, wherein the fluid lumen is incorporated into the sheath.

20. A system method for treating chronic venous insufficiency, comprising: displacing a sheath proximally with respect to a coil disposed with a lumen of the sheath such that the coil is extended beyond a distal end of the sheath, wherein: the sheath is disposed within a blood vessel, andthe coil is configured to radially expand so as to contact an inside surface of the blood vessel when extended; cooling the coil to cause tissue from the blood vessel to adhere to the coil; distally displacing the sheath with respect to the coil such that the coil is drawn into the lumen thereby causing the tissue to separate from the blood vessel; and heating the coil to cause the tissue to release from the coil.

21. The system method according to claim 20, wherein cooling the coil includes passing a cooling fluid through a lumen of the coil.

22. The system method according to either claim 20 or claim 21, wherein heating the coil includes passing an electrical current through a heating element of the coil.

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