This disclosure relates to devices and methods for disrupting blood clots, such as, for example, blood clots in a bladder.
Severe hematuria due to surgery, bladder tumors, or other disease entities can result in the formation of blood clots within the bladder. These can result in blockage of the bladder outlet with subsequent obstruction. In most cases, the clots are large and can fill the entire bladder. Current management involves suctioning the clot through a 28 French (0.93 cm) cystoscope sheath. With the patient under anesthesia, the cystoscope is advanced through the urethra in a sheath and into the bladder. The cystoscope is removed and a manual suction bulb is then attached to the sheath. Extensive saline instillation and suctioning is then conducted. Fluid turbulence and suction forces act to fragment the clot, and the small pieces are removed piecemeal from the bladder. Clots that have been in the bladder for more than 24 hours are more resistant to fragmentation due to fibrinization. Cystoscopic suction-based clot evacuation can require over an hour for large clots and conveys the risk of bladder injury, systemic fluid overload and bladder perforation.
Thus, a need exists for a minimally invasive way to remove blood clots within the bladder.
Disclosed herein, in one aspect, is an apparatus having an outer sleeve having a longitudinal axis and a wire having opposed first and second ends. A portion of the wire forms a wire loop that extends from the opposed first and second ends in a first direction along the longitudinal axis. The wire loop surrounds an operational area. Retraction of at least one of the first and second ends of the wire in a second direction opposite the first direction along the longitudinal axis decreases the operational area of the wire loop.
Additional advantages of the disclosed system and method will be set forth in part in the description which follows, and in part will be understood from the description, or may be learned by practice of the disclosed system and method. The advantages of the disclosed system and method will be realized and attained by means of the elements and combinations particularly pointed out in the appended claims. It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention as claimed.
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate several embodiments of the disclosed apparatus, system, and method and together with the description, serve to explain the principles of the disclosed apparatus, system, and method.
The disclosed system and method may be understood more readily by reference to the following detailed description of particular embodiments and the examples included therein and to the Figures and their previous and following description.
It is to be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the scope of the present invention which will be limited only by the appended claims.
It must be noted that as used herein and in the appended claims, the singular forms “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise. Thus, for example, reference to a “fragment” can include one or more of such fragments, and so forth.
“Optional” or “optionally” means that the subsequently described event, circumstance, or material may or may not occur or be present, and that the description includes instances where the event, circumstance, or material occurs or is present and instances where it does not occur or is not present.
Ranges may be expressed herein as from “about” one particular value, and/or to “about” another particular value. When such a range is expressed, also specifically contemplated and considered disclosed is the range from the one particular value and/or to the other particular value unless the context specifically indicates otherwise. Similarly, when values are expressed as approximations, by use of the antecedent “about,” it will be understood that the particular value forms another, specifically contemplated embodiment that should be considered disclosed unless the context specifically indicates otherwise. It will be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independently of the other endpoint unless the context specifically indicates otherwise. Finally, it should be understood that all of the individual values and sub-ranges of values contained within an explicitly disclosed range are also specifically contemplated and should be considered disclosed unless the context specifically indicates otherwise. The foregoing applies regardless of whether in particular cases some or all of these embodiments are explicitly disclosed.
Optionally, in some aspects, when values or characteristics are approximated by use of the antecedents “about,” “substantially,” or “generally,” it is contemplated that values within up to 15%, up to 10%, up to 5%, or up to 1% (above or below) of the particularly stated value or characteristic can be included within the scope of those aspects.
Optionally, in some aspects, when values or characteristics are approximated by use of the antecedents “about,” “substantially,” or “generally,” in modifying geometric relationships such as perpendicular and parallel (e.g., “generally parallel”) it is contemplated that values within up to 15 degrees, or within 10 degrees, or within 5 degrees, or within 1 degree of the particularly stated geometric relationship can be included within the scope of those aspects.
Unless defined otherwise, all technical and scientific terms used herein have the same meanings as commonly understood by one of skill in the art to which the disclosed apparatus, system, and method belong. Although any apparatus, systems, and methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present apparatus, system, and method, the particularly useful methods, devices, systems, and materials are as described.
Throughout the description and claims of this specification, the word “comprise” and variations of the word, such as “comprising” and “comprises,” means “including but not limited to,” and is not intended to exclude, for example, other additives, components, integers or steps. In particular, in methods stated as comprising one or more steps or operations it is specifically contemplated that each step comprises what is listed (unless that step includes a limiting term such as “consisting of”), meaning that each step is not intended to exclude, for example, other additives, components, integers or steps that are not listed in the step.
As used herein, “insertional” can be understood to refer to an end or portion of a structure that, during use of the structure, is positioned away from or in a direction away from the clinician or the clinician's control device. Optionally, “insertional” can refer to a leading end or leading portion of a structure that is inserted into a patient.
Disclosed herein, in various aspects, and with reference to
Accordingly, as illustrated in
Referring also to
At least a portion of the insertional tip 30 can be disposed within the operational area of the wire loop. When in a fully retracted configuration, the wire loop can be configured to bias against the outer surface of the insertional tip. In this way, the insertional tip 30 can prevent the wire loop 26 from being pulled into the outer sleeve 12, thereby preventing the wire 20 from getting wrapped around itself, kinked, or otherwise caught in the outer sleeve. The insertional tip 30 can therefore promote cycling of the wire loop between extended and contracted configurations.
In further aspects, and as shown in
In further aspects, the insertional tip 30 can be integral to the outer sleeve 12. For example, the outer sleeve 12 can define two holes through which respective portions of the wire can extend, and the portion of the outer sleeve itself between the two holes can serve as a stop to prevent an entirety of the wire loop from being pulled into the outer sleeve 12.
The insertional tip 30 can further comprise side slots 36 that extend along the length of the apparatus 10 and permit the wire to extend therethrough. As shown in
In some aspects, and with reference to
The inner body 40 can optionally comprise stainless steel. The inner body 40 can be sufficiently rigid to endure cyclic and/or repeated movement through the outer sleeve 12. In some aspects, the inner body 40 can be cylindrical. The first and second ends 22, 24 of the wire 20 can be coupled to the inner body 40 via, for example, one or more fasteners and/or deformation of the inner body (e.g., crimping of the inner body) in a configuration in which the first and second ends are secured to the inner body.
Referring also to
Optionally, the apparatus 10 can comprise a handle 50 that is coupled to the inner body 40. The handle 50 can have a gripping surface 52. Optionally, the gripping surface 52 can be a textured surface that is configured to promote grip. The textured surface can comprise ridges, knurls, a rough profile, finger grooves, combinations thereof, or any feature that promotes grip. Optionally, the handle 50 can define a radial flange 54 that is in the first direction 18 relative to the gripping surface. A user can push against the radial flange 54 to effect axial movement of the inner body 40 and opening of the wire loop 26.
In some aspects, the inner body 40 can be movable along the longitudinal axis 14 of the outer sleeve 12 from a first position in which the wire loop is in a fully retracted position within the outer sleeve (
The outer sleeve 12 can have a major transverse dimension (e.g., a diameter) in cross sectional planes perpendicular to the longitudinal axis 14. In some aspects, the major transverse dimension is ⅛ inch or less. In various optional aspects, the outer sleeve 14 can have a major transverse dimension (e.g., major diameter) from about 1/16 inch to about ⅛ inch, or from about 4 mm to about 5 mm. Accordingly, the outer sleeve 14 can be configured for receipt into a cystoscope 100, as illustrated in
In some optional aspects, the outer sleeve 12 can have a length from about 14 inches to about 18 inches along the longitudinal axis 12. In other aspects, the outer sleeve 12 can have a length from about 10 to about 20 inches, or about 15.7 inches (40 mm).
In some optional aspects, the wire 20 can comprise a nickel titanium alloy (e.g., nitinol). In further aspects, it is contemplated that the wire 20 can comprise a high-memory biocompatible material having sufficient rigidity for operation. For example, the wire can have sufficient rigidity to remain generally in the same position when the wire loop 26 fully extends from the outer sleeve, regardless of the orientation of the apparatus 10. In various aspects, the wire 20 can have has a thickness from about 0.01 inches to about 0.02 inches (e.g., 0.015 inches). In further aspects, the wire can have a thickness from about 0.03 inches to about 0.10 inches, or from about 0.04 inches to 0.07 inches, or about 0.059 inches. Such a thickness can make the wire suitable for maintaining its rigidity as it is manipulated within a portion of the body (e.g., within a bladder) and around a clot.
In exemplary aspects, the outer sleeve 12 can comprise polymer (e.g., polyoxymethylene, such as DELRIN polymer). It should be understood that materials described herein are provided as exemplary materials that can be suitable, while other materials may be substituted based on factors such as availability and cost.
Each of the outer sleeve 12 and the inner body 40 can be rigid or sufficiently rigid such that they do not significantly bend. In this way, the outer sleeve and the inner body can be easily advanced into the cystoscope 100 and can be robust for repeated actuation during use.
In some aspects, the apparatus 10 can have only one single wire loop 26. It is contemplated that the single wire loop 26 can be optimal for selected placement of said loop around the clot. However, in further aspects, the apparatus 10 can comprise two or more wire loops. For example, the apparatus 10 can comprise from one to six wire loops (e.g., four wire loops). Optionally, in some aspects, each of the wire loops can extend from respective first and second ends of a corresponding wire, with the first and second ends of each of said corresponding wires being coupled to the inner body 40.
As illustrated, it is contemplated that when the wire loop 26 is opened (
In some optional aspects, the apparatus 10, or components thereof, can be sterilizable or autoclavable. In other aspects, the apparatus 10, or components thereof, can be disposable (for example, as a single-use apparatus and/or component).
Referring to
The process can be repeated to iteratively section the blood clot and its generated fragments into smaller and smaller pieces. For example, the wire loop can be positioned around the first piece of the blood clot, one or both of the first and second ends of the wire can be retracted to draw the wire through the first portion of the blood clot to divide the blood clot into at least a first sub-piece and a separated second sub-piece. The opening and closing of the wire loop 26 (that is, the increasing and decreasing of its operational area 28) can be done manually. That is, the clinician can push and pull the handle relative to the outer sleeve 12 to cause the opening and closing of the wire loop. In this way, the clinician can provide a sufficient but controlled force. Thus, the clinician can use tactile feedback to prevent injury from occurring during cycling the loop about and between extended and contracted configurations.
In this way, the blood clot 200 can be reduced into pieces/fragments that can be removed from the body. For example, the first and second pieces 202, 204 of the blood clot 200, or fragments thereof, can be suctioned out of a bladder 206. In exemplary aspects, a cystoscopic suctioning device such as, but not limited to an ELLIK bladder evacuator, can be used to remove said fragments.
The disclosed apparatus and method have major advantages over current suction-based disruption treatment options for blood clots in the bladder. One advantage is that the disclosed apparatus can disrupt the clot far more rapidly than conventional methods. This can significantly decrease operative time. Other advantages include that the disclosed apparatus can allow for the clot to be disrupted under direct vision and eliminates the requirement for prolonged high-pressure suctioning to remove the clot. This can significantly improve safety of clot evacuation and decreases the risk of bladder injury.
In view of the described products, systems, and methods and variations thereof, herein below are described certain more particularly described aspects of the invention. These particularly recited aspects should not however be interpreted to have any limiting effect on any different claims containing different or more general teachings described herein, or that the “particular” aspects are somehow limited in some way other than the inherent meanings of the language literally used therein.
Aspect 1: An apparatus comprising:
Aspect 2: The apparatus of aspect 1, further comprising an insertional tip that is coupled to the outer sleeve, wherein the insertional tip has an outer surface, wherein at least a portion of the insertional tip is disposed within the operational area of the wire loop, wherein, when in a fully retracted configuration, the wire loop is configured to bias against the outer surface of the insertional tip.
Aspect 3: The apparatus of aspect 2, wherein the outer surface of the insertional tip defines a groove that is configured to receive a portion of the wire therein.
Aspect 4: The apparatus of aspect 2 or aspect 3, wherein a portion of the outer surface of the insertional tip is spherical.
Aspect 5: The apparatus of any one of the preceding aspects, further comprising an inner body that is at least partially received within the outer sleeve, wherein the inner body is slidable relative to the outer sleeve, wherein the first and second ends of the wire are coupled to the inner body so that retraction of the inner body relative to the outer sleeve in the second direction retracts both the first and second ends of the wire.
Aspect 6: The apparatus of aspect 5, wherein the inner body is an inner tube, wherein the first and second ends of the wire are positioned within the inner tube.
Aspect 7: The apparatus of aspect 5 or aspect 6, wherein the apparatus comprises a handle that is coupled to the inner body.
Aspect 8: The apparatus of any one of aspects 5-7, further comprising an insertional tip that is coupled to the outer sleeve, wherein the insertional tip has an outer surface, wherein at least a portion of the insertional tip is disposed within the operational area of the wire loop, wherein, when in a fully retracted configuration, the wire loop is configured to bias against the outer surface of the insertional tip, wherein the inner body is movable along the longitudinal axis of the outer sleeve from a first position in which the wire loop is in a fully retracted position to a second position in which the inner body is at least 10 cm from the first position in an insertional direction relative to the outer sleeve.
Aspect 9: The apparatus of any one of the preceding aspects, wherein the outer sleeve has a major transverse dimension, wherein the major transverse dimension is ⅛ inch or less.
Aspect 10: The apparatus of aspect 9, wherein the major transverse dimension is from about 4 mm to about 5 mm.
Aspect 11: The apparatus of aspect 9 or aspect 10, wherein the major transverse dimension is a diameter.
Aspect 12: The apparatus of any one of the preceding aspects, wherein the outer sleeve has a length from about 14 cm to about 18 inches along the longitudinal axis.
Aspect 13: The apparatus of aspect 12, wherein the length of the outer sleeve is about 40 cm.
Aspect 14: The apparatus of any one of the preceding aspects, wherein the wire comprises a nickel titanium alloy.
Aspect 15: The apparatus of any one of the preceding aspects, wherein the wire has a thickness from about 0.01 inches to about 0.02 inches.
Aspect 16: The apparatus of aspect 15, wherein the wire has a thickness of about 0.015 inches.
Aspect 17: A method of disrupting a blood clot in a patient, the method comprising:
Aspect 18: The method of aspect 17, further comprising:
Aspect 19: The method of aspect 17 or aspect 18, further comprising removing at least one of the first or separated second pieces from the patient.
Aspect 20: The method of aspect 19, wherein the at least one of the first or separated second pieces is removed from the patient via suction.
Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments of the method and compositions described herein. Such equivalents are intended to be encompassed by the following claims.
This application claims priority to and the benefit of the filing date of U.S. Provisional Application No. 63/335,935, filed Apr. 28, 2022, the entirety of which is hereby incorporated by reference herein.
Number | Date | Country | |
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63335953 | Apr 2022 | US |