Patent Application
20230026776
There has been an increase in the use of various implantable medical treatment devices. For example, a medical treatment device or a portion thereof may be positioned at a target region within a body to apply a treatment. A relatively precise positioning of the medical treatment device with respect to the target region may be important for a treatment to be effective. However, precise initial positioning may be challenging, and maintaining the precise positioning over time may pose an additional challenge. For example, it may be desirable in certain medical applications for the medical treatment device to be maintained in the body for days, weeks or even indefinitely, depending on the treatment provided. The body may react over time to the presence of the medical treatment device, such as by movement or settlement of tissue surrounding the device, fluid build-up, and/or formation of scar tissue. Such reactions can cause movement (e.g., migration) of the device, which can result in a reduction in effectiveness of the treatment, or delivery of the treatment to the wrong site.
The target region may be, or may be adjacent to, an anatomic feature having a curved outer surface such as a nerve, an artery, a vein, a luminal organ, a bone, a tendon, a ligament, musculature, or a fascia. For such regions, a component of the medical treatment device may be used to circumscribe the anatomic feature to initially position the device and then subsequently hold the device in position. The component may be a cuff. A conventional means for securing and maintaining a cuff or other component is to place a suture around the component. This technique relies on the skill of the person doing the suturing to apply an appropriate amount of tension on the suture. If the suture is too tight, the anatomic feature may be damaged. If the suture is too loose, the medical treatment device may not make adequate contact with the anatomic feature, and thus may fail to provide effective treatment, and/or may deliver treatment to non-target or surrounding tissue.
Embodiments provide medical treatment devices and methods for delivering treatment to a target region within a body. Additionally, a self-closing cuff is described that is particularly suited for coupling to anatomic features with curved outer surfaces, and a placement tool is described for positioning the self-closing cuff with respect to the anatomic feature.
The self-closing cuff may be a cuff electrode structured to provide electrical stimulation to a target region such as a nerve. The cuff electrode may be structured to be coupled to a stimulator, which may be implanted in a body, or may be external to the body.
The self-closing cuff may be attached to a housing of an implantable medical treatment device. The self-closing cuff may be attached to a catheter or cannula.
A medical treatment device can be introduced into an animalia body, and a self-closing cuff of the medical treatment device can be used to position a treatment portion of the medical treatment device at a target treatment location within the body. A placement tool may be used to open the self-closing cuff to position the cuff on the anatomic feature. The placement tool is then removed, leaving the cuff.
Further aspects of the technology described herein will be brought out in the following portions of the specification, wherein the detailed description is for the purpose of fully disclosing embodiments of the technology without placing limitations thereon.
The technology described herein will be more fully understood by reference to the following drawings which are for illustrative purposes only:
Embodiments provide medical treatment devices and methods for delivering treatment to a target region within a body. Additionally, a self-closing cuff is described that is particularly suited for coupling to anatomic features with curved outer surfaces, and a placement tool is described for positioning the self-closing cuff with respect to the anatomic feature.
In an embodiment, a self-closing cuff is a cuff electrode structured to provide electrical stimulation to a target region such as a nerve. The cuff electrode may be structured to be coupled to a stimulator, which may be implanted in a body, or may be external to the body.
In an embodiment, a self-closing cuff is attached to a housing of an implantable medical treatment device. In an embodiment, a self-closing cuff is attached to a catheter or cannula.
In an embodiment of a medical treatment application or process, a medical treatment device can be introduced into an animalia body, and a treatment portion of the medical treatment device positioned at a target treatment location within the body. The introduction of the medical treatment device can be performed by a doctor or medical professional, often through the use of an imaging modality (e.g., fluoroscopy, ultrasound, endoscopic image capture, or other imaging technique) or using one or more sensing devices that allow attending personnel to position the medical treatment device relatively precisely. It may then be desirable for the medical treatment device to retain its position for days, weeks, months or years with little movement, to improve eventual success of the treatment being applied.
A placement tool may be used to open a self-closing cuff to deliver the cuff on the anatomic feature. The placement tool is then removed.
As an example of an embodiment of a medical treatment application or process, a self-closing cuff is a cuff electrode that may encircle or partially encircle an external curved surface of an anatomic feature to provide electrical stimulation to, or adjacent to, the anatomic feature. Such electrical stimulation may be applied, for example, to a nerve (e.g., for pain management, for blocking of signal conduction along the nerve to avoid a responsive action by the body, or for inducing signal conduction along the nerve to induce a responsive action by the body), or to a muscle (e.g., to allow or to inhibit muscle contraction). In an embodiment, a stimulation controller in electrical communication with the cuff electrode may provide energy for, and control of, electrical stimulation provided by the cuff electrode.
In an embodiment, a self-closing cuff electrode is provided for use in a treatment system for control of urination (e.g., initiating and/or terminating urination) by stimulation of one or more nerves, such as including stimulation of a pudendal nerve. Other treatment locations suitable for a self-closing cuff electrode for stimulation of nerves include, for example, nerves leading to or within the spinal cord, or nerves in association with heart, stomach, bladder, or other organ.
While embodiments of the present disclosure are particularly suited for self-closing cuff electrodes for providing stimulation to nerves, it is appreciated that a self-closing cuff may be used on a variety of different anatomic features, and used for a number of different treatment and/or detection modalities. For example, a self-closing cuff may position a catheter or cannula to deliver a medication at a particular treatment site, to position a sensor at a particular detection site, to position a thermal device at a particular treatment site, to position a vibratory or ultrasonic device at a particular treatment site, to reposition one anatomic feature with respect to another anatomic feature, or to couple two anatomic features together. Accordingly, embodiments of a self-closing cuff may be used to interface with an artery, a vein, a luminal organ, a bone, a tendon, a ligament, the urethra, musculature, a fascia, or other anatomic feature.
Having provided an overview, some examples of embodiments illustrated by the figures will be described in detail. First, however, some conventions are provided for the convenience of the reader.
Various abbreviations may be used herein for standard units, such as deciliter (dl), milliliter (ml), microliter (μl), international unit (IU), centimeter (cm), millimeter (mm), nanometer (nm), inch (in), kilogram (kg), gram (gm), milligram (mg), microgram (μg), millimole (mM), degrees Celsius (° C.), degrees Fahrenheit (° F.), millitorr (mTorr), hour (hr), or minute (min). Also used herein is the standard unit mmHg, which refers to a unit of pressure equal to the pressure exerted by a column of mercury 1 millimeter high at 0° C. and under the acceleration of gravity.
When used in the present disclosure, the terms “e.g.,” “such as”, “for example”, “for an example”, “for another example”, “examples of”, “by way of example”, and “etc.” indicate that a list of one or more non-limiting example(s) precedes or follows; it is to be understood that other examples not listed are also within the scope of the present disclosure.
As used herein, the singular terms “a,” “an,” and “the” may include plural referents unless the context clearly dictates otherwise. Reference to an object in the singular is not intended to mean “one and only one” unless explicitly so stated, but rather “one or more.”
The term “in an embodiment” or a variation thereof (e.g., “in another embodiment” or “in one embodiment”) refers herein to use in one or more embodiments, and in no case limits the scope of the present disclosure to only the embodiment as illustrated and/or described. Accordingly, a component illustrated and/or described herein with respect to an embodiment can be omitted or can be used in another embodiment (e.g., in another embodiment illustrated and described herein, or in another embodiment within the scope of the present disclosure and not illustrated and/or not described herein).
The term “component” refers herein to one item of a set of one or more items that together make up a device, formulation or system under discussion. A component may be in a solid, powder, gel, plasma, fluid, gas, or other form. For example, a device may include multiple solid components which are assembled together to structure the device and may further include a liquid component that is disposed in the device. For another example, a formulation may include two or more powdered and/or fluid components which are mixed together to make the formulation.
The term “design” or a grammatical variation thereof (e.g., “designing” or “designed”) refers herein to characteristics intentionally incorporated based on, for example, estimates of tolerances (e.g., component tolerances and/or manufacturing tolerances) and estimates of environmental conditions expected to be encountered (e.g., temperature, humidity, external or internal ambient pressure, external or internal mechanical pressure, stress from external or internal mechanical pressure, age of product, or shelf life, or, if introduced into a body, physiology, body chemistry, biological composition of fluids or tissue, chemical composition of fluids or tissue, pH, species, diet, health, gender, age, ancestry, disease, or tissue damage); it is to be understood that actual tolerances and environmental conditions before and/or after delivery can affect characteristics so that different components, devices, formulations, or systems with a same design can have different actual values with respect to those characteristics. Design encompasses also variations or modifications before or after manufacture.
The term “manufacture” or a grammatical variation thereof (e.g., “manufacturing” or “manufactured”) as related to a component, device, formulation, or system refers herein to making or assembling the component, device, formulation, or system. Manufacture may be wholly or in part by hand and/or wholly or in part in an automated fashion.
The term “structured” or a grammatical variation thereof (e.g., “structure” or “structuring”) refers herein to a component, device, formulation, or system that is manufactured according to a concept or design or variations thereof or modifications thereto (whether such variations or modifications occur before, during, or after manufacture) whether or not such concept or design is captured in a writing.
The term “body” refers herein to an animalia body. The term “subject” refers herein to a body into which an embodiment of the present disclosure is, or is intended to be, delivered. For example, with respect to humans, a subject may be a patient under treatment of a health care professional.
The terms “substantially” and “about” are used herein to describe and account for small variations. For example, when used in conjunction with a numerical value, the terms can refer to a variation in the value of less than or equal to ±10%, such as less than or equal to ±5%, less than or equal to ±4%, less than or equal to ±3%, less than or equal to ±2%, less than or equal to ±1%, less than or equal to ±0.5%, less than or equal to ±0.1%, or less than or equal to ±0.05%.
As used herein, a range of numbers includes any number within the range, or any sub-range if the minimum and maximum numbers in the sub-range fall within the range. Thus, for example, “<9” can refer to any number less than nine, or any sub-range of numbers where the minimum of the sub-range is greater than or equal to zero and the maximum of the sub-range is less than nine. Ratios may also be presented herein in a range format. For example, a ratio in the range of about 1 to about 200 should be understood to include the explicitly recited limits of about 1 and about 200, and also to include individual ratios such as about 2, about 35, and about 74, and sub-ranges such as about 10 to about 50, about 20 to about 100, and so forth.
Attention is now drawn to the figures.
The cuff 10a further includes a pair of longitudinal apertures 18. In the embodiment of
In the embodiments of
In an embodiment, the retainer 14 includes an approximately c-shaped flat ribbon spring.
While the embodiments of
In an embodiment, the cuff 10a is a bi-polar cuff electrode including two electrodes 16 (shown as electrodes 16a, 16b) housed within or on the inner circumferential surface of the band 12 at axially spaced-apart locations along the band 12. By way of example in the embodiment of
If the electrodes 16a, 16b are present in an embodiment, electrical conduits 22 that preferably pass through one or more openings in the band 12 are electrically coupled to the electrodes 16a, 16b (e.g., by thermal or vibration welding, or soldering) and are further electrically coupled to electronics (not shown) that provide electrical energy through the electrical conduits 22 to the electrodes 16a, 16b. Such electronics may be on the cuff 10a or apart from the cuff 10a (either internal or external to the body). Each of the electrical conduits 22 may be, for example, implemented as a wire or wires (e.g., single strand wire, or multi-strand wire, and the electrical conduits 22 may be, for example, twisted, helically arranged, or braided), or implemented as an electrical trace or traces (e.g., flat conductors or printed conductive traces), or a combination thereof. Each of the electrical conduits 22 may include more than one type of conductor, such as a printed trace within the cuff 10a and a wire or wires extending from outside of the band 12 to the electronics. The electrical conduits 22 or portions thereof may be contained in a flexible sleeve 20.
Another distinction between the cuff 10b of
In an embodiment, one or more retainers 14 (e.g., one or more of the retainers 14, 14a, and/or 14b) are structured to provide a closure force for the self-closing cuff 10 upon release of the spreading force applied to open the circumferential opening 25. Examples of materials that can be used in a retainer 14 to provide the closure force include a metal (e.g., stainless steel), a polymer, a composite, or any other material or combination of materials with sufficient rigidity to retain the retainer 14 (and thus the self-closing cuff 10) in a closed configuration, sufficient flexibility to allow the retainer 14 (and thus the self-closing cuff 10) to be moved into an open configuration, and sufficient resiliency (e.g., memory) to automatically return the retainer 14 (and thus the self-closing cuff 10) to its closed configuration.
In an embodiment, one or more retainers 14 (e.g., one or more of the retainers 14, 14a, and 14b) are structured with multiple components that collectively provide sufficient rigidity to retain the retainer 14 (and thus the self-closing cuff 10) in a closed configuration, sufficient flexibility to allow the retainer 14 (and thus the self-closing cuff 10) to be moved into an open configuration, and sufficient resiliency (e.g., memory) to automatically return the retainer 14 (and thus the self-closing cuff 10) to its closed configuration.
A material of the retainer 14 is generally more rigid than a material of the self-closing cuff 10 to which the retainer 14 is incorporated.
In some situations, a person applying the self-closing cuff 10 may wish to provide a securing mechanism additional to or alternative to a retainer 14 (e.g., additional to or alternative to the retainer 14, 14a, and/or 14b).
In an embodiment, one or more of the electrodes 16 (e.g., one or more of the electrodes 16a, 16b, and/or 16c) may be attached to the inner circumferential surface of the band 12 via a medical grade adhesive (e.g., MED-2000) or other attachment means. One or more of the electrodes 16 may alternatively be integrated with the band 12. A surface of an electrode 16 exposed within a central channel of the cuff 10 may be co-linear with, protrude from, or be recessed from, the inner circumferential surface of the band 12.
In an embodiment, the tube 27 includes a silicone tube (e.g., inner diameter (“ID”)=0.025 inch (or 0.635 mm), outer diameter (“OD”)=0.047 inch (or 1.19 mm)) attached to the band 12, such as via medical grade adhesive (e.g., MED-2000). Alternatively, the tube 27 may be integrated into the cuff 10d wall (e.g., via injection molding or other process), such that a radial channel is created running around a portion of the outer circumference or surface of the band 12.
While the embodiment of the self-closing cuff in
In an embodiment, it is desirable to have an inner diameter of a self-closing cuff (e.g., the cuff 10a, 10b, 10c, or 10d) to be roughly equal to or slightly small than an outer diameter of the target anatomic feature to apply a specified compressive force on the anatomic feature, the specified compressive force being minimized so as not to damage the anatomic feature or alter a nominal function of the target anatomic feature as a result of the specified force. In an embodiment including one more ring electrodes (e.g., one or more of the electrodes 16a, 16b, 16c), an inner diameter of the self-closing cuff may be partially defined by an inner surface of the electrode(s) when the cuff is secured to ensure proper contact between the electrode(s) and the anatomic feature. The term “ring” refers to having a generally arcuate shape (e.g., round) which may or may not be a closed shape as positioned on the anatomic feature (the ends of the ring may or may not touch). Sensitivity of, or tolerance by, an anatomic feature to a compressive force may vary. For example, a nerve, or a lumen susceptible to closure, may tolerate a much smaller force as compared to other anatomic features (e.g., bone, ligaments, or muscles). Further, different persons have differently sized anatomic features. Accordingly, a number of different sized bands (e.g., band 12) and/or a number of different-sized retainers (e.g., retainers 14, 14a, 14b) may be provided in a kit so as to more closely match the anatomic feature for which the cuff is selected. A diagnostic procedure (e.g., imaging procedure such as fluoroscopy, ultrasound, endoscopic image capture, CT, MRI, or other imaging technique) may be performed to estimate a size of the target anatomic feature prior to installation of the cuff so that an appropriate retainer and/or band can be selected.
In an embodiment, the inner diameter of the cuff is somewhat larger than the diameter of the target anatomic feature.
A test was performed to evaluate cuff closure force and equivalent cuff pressure of a cuff designed similarly to cuff 10a of
In the embodiments detailed in
In addition to urinary tract control, electrical stimulation can be used for a variety of other treatments. Electrical stimulus may be used, for example, for treatment to control bladder, sphincter, or pelvic floor muscles, treatment of pain, numbness, or tingling, and treatment of disease or disorders (e.g., stimulation of vagus nerve for treatment of epilepsy or rheumatoid arthritis, or facial nerve stimulation for treatment of facial palsy). Accordingly, a self-closing cuff can be, for example, positioned around a nerve associated with vertebra (e.g., peripheral nerve, or spinal cord), a sacral nerve, a sciatic nerve, or a cranial nerve (e.g., vagus nerve), to perform one or more treatments with respect to the nerve.
Furthermore, a self-closing cuff may be implemented for treatment of anatomic features outside the nervous system. For example, a self-closing cuff may be installed on vasculature within the body, such as arteries or veins, for providing various cardiovascular treatments or diagnostics. In an embodiment, a self-closing cuff may be sized and shaped to encircle or partially encircle an anatomic feature of, or closely coupled to, the heart (e.g., the pulmonary artery), for providing a circumferential conduction block, stimulation, other treatment, or diagnostic at the installed location.
Although the embodiments detailed in
In each of the embodiments in
In an embodiment, the band 12 includes a compliant but shape-retaining biocompatible material such as urethane, silicone, or the like (e.g., HelixMark silicone medical tubing from Freudenberg Medical Inc.). However, other materials, or material combinations, are contemplated. The band 12 material is preferably sufficiently elastic to be compliant while having sufficient radial spring force to clamp down on and remain on the anatomic feature once installed. Suitable materials include those having a Shore A durometer hardness measurement between 20 A and 60 A, and preferably around 50 A hardness for ease of handling and installation. In an embodiment, band 12 is formed of, or includes, a high consistency silicone elastomer such as MED-4750 available from Avantor. In embodiments provided for nerve stimulation, the dimensions and mechanical and material properties of the assembled cuff (e.g., the cuff 10a, 10b, 10c, or 10d) may be such that the cuff desirably exerts no more than about 150 millimeters (mmHg) of pressure or about 0.5 Newtons of force on an anatomic feature, as forces below this amount may serve to maintain the health of the anatomic feature. The band 12, in particular the inner surface of the band 12, is preferably constructed from atraumatic biomaterials such as one or more of silicone, polyurethane, TEFLON, or the like so as to be atraumatic to the anatomic feature. The inner surface of band 12 may include one more drug eluting coatings to improve the biocompatibility of the self-closing cuff and reduce inflammation or tissue adherence at the interface of the band 12 with the anatomic feature. In a cuff electrode, band 12 is constructed from one or more electrically insulative materials to prevent or minimize possible leaking of electrical current outside of the band 12, and thus prevent or minimize unwanted treatment/stimulation to non-target tissues or anatomic features (e.g., another nerve, a portion or branch of the same nerve, or adjacent tissue).
In one example embodiment of a cuff electrode (e.g., an embodiment of the self-closing cuff 10a, 10b, 10c, or 10d) for providing electrical stimulation to a pudendal nerve, the band 12 includes a silicone tube structure having a Shore A durometer measurement of 50, inner diameter of 2.5 mm, outer diameter of 4 mm and length of 10 mm (e.g., MED-4750).
In an embodiment of a cuff electrode (e.g., an embodiment of the self-closing cuff 10a, 10b, 10c, or 10d), an electrode (e.g., the electrode 16a, 16b or 16c) is about 0.002 inch (or 0.051 mm) thick by about 0.019 inch (or 0.483 mm) wide, in a sheet fabricated from flattened 0.008 inch (or 0.203 mm) diameter platinum wire.
In an embodiment of a self-closing cuff (e.g., an embodiment of the cuff 10a, 10b, or 10c), a retainer (e.g., the retainer 14, 14a, or 14b) is fabricated from 0.002 inch (or 0.051 mm) thick by 0.038 inch (or 0.0.965 mm) wide flat ribbon 304V stainless steel coil with a relaxed or nominal diameter of 2.4 mm-2.6 mm. In another embodiment, a retainer is fabricated from 0.05 mm thick by 1.49 mm wide flat ribbon 316 stainless steel coil with a nominal diameter of 2.66 mm-2.96 mm. In an embodiment, a retainer (e.g., the retainer 14, 14a, or 14b) is cut to have a 3mm gap ‘g’ (see dimension ‘g’ in
While the embodiments disclosed herein are shown with electrodes 16a, 16b and/or 16c that are meant to circumscribe at least a portion of an outer surface of a target anatomic feature, it is appreciated that other electrode configurations may be implemented in combination with or as an alternative to the configurations detailed above and illustrated in
Referring now to the illustrations of
The placement tool 30 includes a pair of crescent (e.g., half-circle) shaped arms 46, 48 joined together at a hinge 44. In the closed configuration (
The arms 46, 48 are disposed on a distal end 42 of an elongate member 34, which allows the distal end 42 to be inserted into the body to access anatomic features that are difficult to reach from a surface of the body. A pair of handles 32a and 32b are pivotably coupled at a hinge 38 at a proximal end of elongate member 34, and are operatively coupled to a proximal end of a slideable extender 36, the distal end of which is coupled to a linkage 40. Upon extension of the handle 32a with respect to handle 32b, the extender 36 translates with respect to the elongate member 34, causing the linkage 40 to actuate and thus articulate the arm 46 with respect to the arm 48 about the axis of the hinge 44. The articulation of the arm 46 with respect to the arm 48 separates the pins 50. It is appreciated that the linkage 40 may include any mechanism (e.g., gears, cam, or the like mechanism) for converting translation of the extender 36 to a rotation of the arm 46 about the axis of the hinge 44. It is also appreciated that the linkage 40 may convert translation of the extender 36 to rotation of the arm 48 rather than rotation of the arm 46 (with the arm 46 retained in a stationary position by integration with, or fixed attachment to, the elongate member 34), or to rotation of both of the arms 46, 48 (with neither of arms 46, 48 retained in a stationary position).
The placement tool 30 may be biased to the closed orientation shown in
In
The cuff 10a/placement tool 30 assembly are then advanced within the body such that the distal end 42 of the placement tool 30 is located in proximity to the target treatment location at the target anatomic feature (e.g., a nerve, which may be, for example one of the pudendal nerves or a branch thereof).
The handles 32a and 32b of the placement tool 30 are then spread apart (see
As shown in
The placement tool 30 is moved longitudinally to withdraw the pins 50 from the longitudinal apertures 18. To retract the placement tool 30 from the body, the handles 32a, 32b are moved apart and correspondingly the arms 46, 48 are opened, and the placement tool 30 is moved away from the anatomic feature. Optionally, handles 32a, 32b may be moved together such that the placement tool 30 is in a closed configuration before withdrawing the placement tool 30 from the body. The cuff 10a may then remain in place at the location where it was applied for an indefinite period of time.
It is appreciated that while the placement tool 30 is shown in
In an embodiment, the self-closing cuff 10e is a cuff electrode including one or more electrodes (e.g., electrode 16a, 16b, and/or 16c). In a method of treatment, a controller (not shown) may be coupled to the cuff 10e via electrical conduits, either prior to or after placement, and then operated to apply a signal to the one or more electrodes for treatment or therapy to the target anatomic feature (e.g., nerve N). In the case of pudendal nerve stimulation, the applied signal includes an electrical signal that either stimulates or forms a conduction block of the pudendal nerve or a branch thereof to cause an opening/closing of the urethral sphincter or contraction/relaxation of a detrusor muscle.
It is appreciated that mating surfaces other than described with respect to
In an embodiment, any one or more of the electrodes 16 (e.g., the electrodes 16a, 16b, and/or 16c) are ring electrodes (e.g., have an arcuate profile that follows a profile of an inner circumferential surface of the band 12).
The self-closing cuffs of the present disclosure (e.g., cuffs 10a, 10b, 10c, 10d, 10e, 10f) are biocompatible, using biocompatible materials and/or shielding one or more components with a shield formed of biocompatible materials.
In one or more applications, a self-closing cuff (e.g., the cuff 10a, 10b, 10c, 10d, 10e, or 10f), a placement tool (e.g., the placement tool 30, 30B, or 30C), and corresponding methods of installing the cuff via the placement tool and methods of treatment, are particularly beneficial for treatment/therapy of a target treatment location or region that may be adjacent to or at a curved anatomic feature, which may be in a thin, elongate or otherwise tubular or arcuate form. Such target anatomic features may include nerves, arteries or other vasculature, luminal organs, bones, other tissues such as tendons, ligaments, musculature, or fascia, or other features.
It is appreciated that the configurations provided in this disclosure are provided for example purposes only, and dimensions and material selection may vary according to application and preference.
Embodiments of the present disclosure include improved systems and methods for providing electrical stimulation to a location in or on the body. In particular, the systems and method disclosed herein are directed to a self-closing cuff, along with methods and devices for installation at a target treatment or diagnostic location of the body. Embodiments of the present disclosure include improved systems and methods for retaining a device at a location in or on the body. In particular, the systems and method disclosed herein are directed to a self-closing cuff, along with methods and devices for installation at a target location. From the description herein, it will be appreciated that the present disclosure encompasses multiple embodiments which include, but are not limited to, the following:
1. An implant for providing medical treatment to a treatment location of a target anatomic feature within the body, the target anatomic feature including a curved outer surface, the implant including: a tubular cuff having a central channel defined by an inner surface of the cuff, the cuff including a circumferential opening spanning longitudinally along a length of the cuff to form a c-shaped profile at least partially circumscribing the central channel; one or more electrodes disposed on the inner surface of the cuff, the one or more electrodes structured to deliver an electrical signal to provide treatment at the treatment location of the target anatomic feature; and a retainer structured to secure around at least a portion of an outer surface of the cuff; wherein the circumferential opening is coupled to an engagement surface for application of a spreading force to be applied to the cuff to expand to circumferential opening from a closed configuration to an open configuration sized for placement of the cuff at the target anatomic feature; and wherein the cuff is self-closing such that upon release of the spreading force, the circumferential opening automatically closes toward the closed configuration, the closed configuration ensuring contact between the one or more electrodes and curved surface of the target anatomic feature.
2. The implant, system or method of any of the preceding or subsequent embodiments: wherein the retainer includes a retainer disposed around the cuff; and wherein the retainer is sized, shaped and composed of a material structured to enhance self-closing of the cuff.
3. The implant, system or method of any of the preceding or subsequent embodiments: wherein the retainer includes a suture channel disposed on an outer surface of the cuff; the channel running at least partially along the outer surface in a direction substantially normal to circumferential opening; the suture channel sized to retain a suture for securing closure of the circumferential opening upon installation of the cuff to the target anatomic feature at the treatment location.
4. The implant, system or method of any of the preceding or subsequent embodiments: wherein the cuff includes a pair of apertures running through the cuff at locations proximal to the circumferential opening of the cuff, the pair of apertures providing clearance for a suture.
5. The implant, system or method of any of the preceding or subsequent embodiments: wherein the engagement surface includes a pair of longitudinal apertures running along at least a portion of a length of the cuff, the pair of longitudinal apertures being disposed at opposite sides of the circumferential opening.
6. The implant, system or method of any of the preceding or subsequent embodiments: the one or more electrodes include a pair of axially spaced-apart electrodes housed within or on an inner circumferential surface of the cuff at axially spaced-apart locations the cuff to form a bi-polar electrode configuration.
7. The implant, system or method of any of the preceding or subsequent embodiments: wherein the one or more electrodes include a first electrode having a first pole and second and third electrodes having a second pole, the first, second and third electrodes being housed at axially spaced-apart locations within or on the inner circumferential surface to form a tri-polar electrode configuration.
8. The implant, system or method of any of the preceding or subsequent embodiments: wherein the central channel includes an inner circumferential surface sized and shaped to couple to a target anatomic feature including a nerve, wherein the one or more electrodes contact an outer surface of the nerve at spaced apart locations to provide a stimulation or conduction-block electrical signal to the nerve.
9. A system for installing a cuff to a treatment location of a target anatomic feature within the body, the target anatomic feature including a curved outer surface, the system including: a cuff including a tubular electrode cuff having a central channel defined by an inner surface of the cuff, the cuff including a circumferential opening spanning longitudinally along a length of the cuff to form a c-shaped profile at least partially circumscribing the central channel, and one or more electrodes disposed on the inner surface of the cuff, the one or more electrodes structured to deliver an electrical signal to provide treatment at the treatment location of the target anatomic feature, the cuff being biased in a closed configuration, the cuff further including an engagement surface; and a placement tool structured to interface with the engagement surface of the cuff; the placement tool structured to apply a spreading force to the engagement surface while the circumferential opening is in the closed configuration, and expand the circumferential opening, by way of the spreading force, from the closed configuration to an open configuration sized for placement of the cuff on to the target anatomic feature, position the cuff such that the central channel at least partially encircles the target anatomic feature, and articulate the placement tool to release the spreading force on the engagement surface; wherein the cuff is self-closing such that upon release of the spreading force, the circumferential opening automatically closes toward the closed configuration to affect contact between the one or more electrodes and curved surface of the target anatomic feature.
10. The implant, system or method of any of the preceding or subsequent embodiments: the cuff further including a retainer: wherein the retainer includes a retainer disposed around the cuff; and wherein the retainer is sized, shaped and composed of a material structured to enhance self-closing of the cuff.
11. The implant, system or method of any of the preceding or subsequent embodiments: the cuff further including a retainer: wherein the retainer includes a suture channel disposed on an outer surface of the cuff; the channel running at least partially along the outer surface in a direction substantially normal to circumferential opening; the suture channel sized to retain a suture for securing closure of the circumferential opening upon installation of the cuff to the target anatomic feature at the treatment location.
12. The implant, system or method of any of the preceding or subsequent embodiments: wherein the cuff includes a pair of apertures running through the cuff at locations proximal to the circumferential opening of the cuff, the pair of apertures providing clearance for a suture.
13. The implant, system or method of any of the preceding or subsequent embodiments: wherein the engagement surface includes a pair of longitudinal apertures running along at least a portion of a length of the cuff, the pair of longitudinal apertures being disposed at opposite sides of the circumferential opening; and wherein the placement tool includes a pair of articulating pins structured to be slideably received in the pair of longitudinal apertures.
14. The implant, system or method of any of the preceding or subsequent embodiments: wherein the pair of pins are disposed on an articulating pair of arms, the pair of arms when in a closed configuration forming a profile substantially matching the c-shaped profile of the cuff.
15. The implant, system or method of any of the preceding or subsequent embodiments: wherein the one or more electrodes include a pair of axially spaced-apart electrodes housed within or on the inner surface of the cuff at axially spaced-apart locations of the cuff to form a bi-polar electrode configuration.
16. The implant, system or method of any of the preceding or subsequent embodiments: wherein the one or more electrodes include a first electrode having a first pole and second and third electrodes having a second pole, the first, second and third electrodes being housed at axially spaced-apart locations within or on the inner surface of the cuff to form a tri-polar electrode configuration.
17. The implant, system or method of any of the preceding or subsequent embodiments: wherein the central channel includes an inner circumferential surface sized and shaped to couple to a target anatomic feature including a nerve, wherein the one or more electrodes contact an outer surface of the nerve at spaced apart locations to provide a stimulation or conduction-block electrical signal to the nerve.
18. A method for installing a cuff to a treatment location of a target anatomic feature within the body, the target anatomic feature including a curved outer surface, the method including: providing a cuff including a tubular electrode cuff having a central channel defined by an inner surface of the cuff, the cuff including a circumferential opening spanning longitudinally along a length of the cuff to form a c-shaped profile at least partially circumscribing the central channel, and one or more electrodes disposed on the inner surface of the cuff, the one or more electrodes structured to deliver an electrical signal to provide treatment at the treatment location of the target anatomic feature, the cuff being biased in a closed configuration, the cuff further including an engagement surface; coupling a placement tool to the engagement surface of the cuff; articulating the placement tool to apply a spreading force to the engagement surface starting while the circumferential opening is in the closed configuration; expanding the circumferential opening, by way of the spreading force; from the closed configuration to an open configuration sized for placement of the cuff on to the target anatomic feature; positioning the cuff such that the central channel at least partially encircles the target anatomic feature; and articulating the placement tool to release the spreading force on the engagement surface; wherein the cuff is self-closing such that upon release of the spreading force, the circumferential opening automatically closes toward the closed configuration to affect contact between the one or more electrodes and curved surface of the target anatomic feature.
19. The implant, system or method of any of the preceding or subsequent embodiments: the cuff further including a retainer.
20. The implant, system or method of any of the preceding or subsequent embodiments: wherein the retainer includes a retainer disposed around the cuff; and wherein the retainer is sized, shaped and composed of a material structured to enhance self-closing of the cuff.
21. The implant, system or method of any of the preceding or subsequent embodiments: wherein the retainer includes a suture channel disposed on an outer surface of the cuff; the channel running at least partially along the outer surface in a direction substantially normal to circumferential opening, the method further including: inserting a suture into the suture channel; and tying the suture to secure closure of the circumferential opening after installation of the cuff to the target anatomic feature at the treatment location.
22. The implant, system or method of any of the preceding or subsequent embodiments: wherein the cuff includes a pair of apertures running through the cuff at locations proximal to the circumferential opening of the cuff, the method further including: inserting a suture through the pair of apertures; and tying the suture to secure closure of the circumferential opening after installation of the cuff to the target anatomic feature at the treatment location
23. The implant, system or method of any of the preceding or subsequent embodiments: wherein the engagement surface includes a pair of longitudinal apertures running along at least a portion of a length of the cuff, the pair of longitudinal apertures being disposed at opposite sides of the circumferential opening, wherein coupling a placement tool to an engagement surface of the cuff includes: slideably receiving a pair of articulating pins into the pair of longitudinal apertures.
24. The implant, system or method of any of the preceding or subsequent embodiments: wherein the pair of pins are disposed on an articulating pair of arms, the pair of arms when in a closed configuration forming a profile substantially matching the c-shaped profile of the cuff.
25. The implant, system or method of any of the preceding or subsequent embodiments: wherein the one or more electrodes include a pair of axially spaced-apart electrodes housed within or on the inner surface of the cuff at axially spaced-apart locations of the cuff to form a bi-polar electrode configuration.
26. The implant, system or method of any of the preceding or subsequent embodiments: wherein the one or more electrodes include a first electrode having a first pole and second and third electrodes having a second pole, the first, second and third electrodes being housed at axially spaced-apart locations within or on the inner surface of the cuff to form a tri-polar electrode configuration.
27. The implant, system or method of any of the preceding or subsequent embodiments: wherein the central channel includes an inner circumferential surface sized and shaped to couple to a target anatomic feature including a nerve, the method further including: contacting the one or more electrodes to an outer surface of the nerve at spaced apart locations; sending at least one electrical signal through the one or more electrodes for stimulation or conduction-block of the nerve.
28. The implant, system or method of any of the preceding or subsequent embodiments: wherein the nerve includes a pudendal nerve or a branch thereof, and wherein the stimulation or conduction-block of the pudendal nerve is to cause at least a first and second physiological action involved in control of the bladder.
29. A cuff provides for medical treatment to a treatment location of a target anatomic feature within the body, where the target anatomic feature includes a curved outer surface. The cuff includes: a band defining a circumferential opening extending along a length of the band; a pair of engagement surfaces defined by or affixed to the cuff, the engagement surfaces structured for application of a spreading force to be distributed continuously along a portion of the circumferential opening, thereby increasing the circumferential opening and accordingly expanding the cuff from a closed configuration to an open configuration sized for placement of the cuff at the target anatomic feature. The cuff is structured to remain in the closed configuration in the absence of the spreading force, and structured to automatically return to the closed configuration after removal of the spreading force.
30. The cuff may include a retainer disposed along at least a portion of the circumference of the cuff, the retainer and the cuff being structured to move in concert with respect to each other during expansion of the circumferential opening upon application of the spreading force. The engagement surfaces may be defined by or affixed to the retainer, or the engagement surfaces may be defined by or affixed to the band. The cuff may be structured to apply a compressive force of less than 150 mmHg of pressure to the target anatomic feature in the closed configuration of the cuff. The cuff may have one or more electrodes disposed on an inner surface of the cuff. The engagement surfaces may be a pair of longitudinal apertures extending along a length of the cuff, or opposing protrusions or channels extending along a length of the cuff. The cuff may be structured in the closed configuration to ensure contact between the one or more electrodes and the curved surface of the target anatomic feature. The target anatomic feature may be a nerve, an inner surface of the cuff defines a central channel sized and shaped to couple to the nerve, and the cuff further includes one or more electrodes structured to contact an outer surface of the nerve to deliver an electrical signal to the nerve.
31. A system is provided for installing a cuff to a treatment location of a target anatomic feature within the body, where the target anatomic feature includes a curved outer surface. The system includes: a cuff defining a circumferential opening spanning longitudinally along a length of the cuff, the cuff being in a closed configuration in a relaxed state, the cuff including a pair of opposing engagement surfaces; and a placement tool structured to interface with the engagement surfaces of the cuff. The placement tool is structured to: be articulated to apply a spreading force to the engagement surfaces while the cuff is in the closed configuration to increase the circumferential opening such that the cuff expands from the closed configuration to an open configuration sized for placement of the cuff on the target anatomic feature; be positioned while the cuff is in the open configuration such that the cuff at least partially encircles the target anatomic feature; and be articulated to release the spreading force on the engagement surfaces while the cuff at least partially encircles the target anatomic feature. The cuff is self-closing such that upon release of the spreading force, the cuff automatically returns to the closed configuration.
32. The system may include one or more electrodes disposed on an inner surface of the cuff, the one or more electrodes structured to deliver an electrical signal to the target anatomic feature. The system may include a band and a retainer secured along at least a portion of the band, wherein the retainer and the band are sized, shaped and composed of a material structured to allow for an increase of the circumferential opening upon application of the spreading force. The placement tool may include a pair of opposing spreading surfaces structured to couple to the engagement surfaces of the cuff for distribution of the spreading force along the engagement surfaces; and the spreading surfaces are disposed on respective arms of an articulating pair of arms, the pair of arms when in a closed configuration forming an inner profile substantially matching an outer profile of the cuff. The engagement surfaces may include a pair of longitudinal apertures running along a length of the cuff, the pair of longitudinal apertures being disposed at opposite sides of the circumferential opening; and the spreading surfaces may include a pair of articulating pins structured to be slideably received in the pair of longitudinal apertures and contact the engagement surfaces for application of the spreading force. The engagement surfaces may include a pair of channels or protrusions disposed at opposite sides of the circumferential opening of the cuff; and the spreading surfaces may include a pair of mating surfaces structured to contact the engagement surfaces for application of the spreading force. The spreading surfaces may be structured to be slideably received into the circumferential opening to then be mated with the engagement surfaces. The system may further include one or more electrodes within or on an inner surface of the cuff to form a bi-polar or tri-polar electrode configuration.
33. A method is provided for installing a cuff to a treatment location of a target anatomic feature within a body. The method includes: providing a cuff defining a circumferential opening extending longitudinally along a length of the cuff, the cuff in its natural relaxed state being in a closed configuration, the cuff including a pair of engagement surfaces; coupling a placement tool to the engagement surfaces of the cuff; articulating the placement tool while the cuff is in the closed configuration to increase the circumferential opening by way of a spreading force such that the cuff expands from the closed configuration to an open configuration sized for placement of the cuff on the target anatomic feature; positioning the cuff such that the cuff at least partially encircles the target anatomic feature; articulating the placement tool to release the spreading force on the engagement surfaces. The cuff is self-closing such that upon release of the spreading force, the cuff automatically returns to the closed configuration; and disengaging the placement tool from the cuff.
34. The disengaging of the placement tool from the cuff may include decoupling the placement tool from the engagement surfaces of the cuff, articulating the placement tool to increase a dimension of an inner surface defined by a pair of arms of the placement tool, and extricating the placement tool from a position at least partially encircling the target anatomic feature to a position external to the body. The cuff may further include one or more electrodes disposed on an inner surface of the cuff, the one or more electrodes structured to deliver an electrical signal to the target anatomic feature. The cuff may further include a band and a retainer secured along at least a portion of a circumference of the band; wherein the retainer and the band are sized, shaped and composed of materials structured to allow for the increase in the circumferential opening upon application of the spreading force, and further structured to apply a specified force to the target anatomic feature in the closed configuration. The placement tool may include a pair of opposing spreading surfaces structured to couple to the engagement surfaces of the cuff for contiguous distribution of the spreading force along the engagement surfaces. The spreading surfaces may be disposed on respective arms of an articulating pair of arms, the pair of arms when in a closed configuration having an inner surface profile substantially matching an outer surface profile of the cuff. The engagement surfaces may include a pair of longitudinal apertures running along at least a portion of a length of the cuff and the spreading surfaces may include a pair of pins. Coupling a placement tool to the engagement surfaces of the cuff may include: slideably receiving the pair of pins in respective longitudinal apertures; and applying the spreading force contiguously along a longitudinal length of the engagement surfaces. The engagement surfaces may include a pair of channels or protrusions disposed at opposite sides of the circumferential opening and the spreading surfaces may include a pair of mating surfaces. The method may include slideably receiving the spreading surfaces into the circumferential opening; contacting the engagement surfaces with the spreading surfaces; and applying the spreading force contiguously along a longitudinal length of the engagement surfaces.
In any of the foregoing embodiments, the self-closing cuff may be attached to a housing of an implantable medical treatment device, or may be attached to a catheter or cannula.
The foregoing description of various embodiments of the technology of the present disclosure has been presented for purposes of illustration and description. It is not intended to limit the technology of the present disclosure to the precise forms disclosed. Many modifications, variations and refinements will be apparent to practitioners skilled in the art. For example, embodiments of the device can be sized and otherwise adapted for various pediatric and neonatal applications as well as various veterinary applications. They may also be adapted for the urinary tracts of both males and females. Further, those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, numerous equivalents to the specific devices and methods described herein. Such equivalents are considered to be within the scope of the technology of the present disclosure and are covered by the appended claims below.
Elements, characteristics, or acts from one embodiment can be readily recombined or substituted with one or more elements, characteristics or acts from other embodiments to form numerous additional embodiments within the scope of the technology of the present disclosure. Moreover, elements that are shown or described as being combined with other elements, can, in an embodiment, exist as standalone elements. Hence, the scope of the technology of the present disclosure is not limited to the specifics of the described embodiments, but is instead limited solely by the appended claims.
This application claims priority to, and the benefit of, U.S. Provisional Patent Application No. 62/951,981 filed on Dec. 20, 2019 and titled SELF-CLOSING CUFF ELECTRODE AND METHOD OF INSTALLATION, which is incorporated herein by reference in its entirety for all purposes.
This invention was made with Government support under W81XWH-15-C-0066, awarded by U.S. Department of Defense, U.S. Army Medical Research Acquisition Activity. The Government has certain rights in the invention.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2020/055770 | 10/15/2020 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 62951981 | Dec 2019 | US |
