Patent Grant
10363061
1. Field of the Invention
This invention relates to nozzle assemblies for liquid jet-forming surgical instruments, surgical instruments employing the nozzle assemblies, and methods of fabricating such surgical instruments.
2. Description of the Related Art
Traditionally, many surgical procedures for both open surgery and minimally invasive surgery (i.e., endoscopic, laparoscopic, or arthroscopic surgical procedures) have utilized surgical tools such as scalpels, scrapers, blunt dissectors, lasers, electrosurgical devices, etc., which can have poor tissue differentiating capability, which may easily cause inadvertent damage to tissue surrounding a surgical treatment site, and which do not typically provide for an ability to precisely control a depth of cutting and/or tissue ablation with the instrument and/or effectively provide for evacuation from the treatment site of cut/ablated tissue. Many such surgical procedures can entail more extensive trauma to the patient and/or require longer operating procedures, with associated problems of long recovery periods and potential complication, than is desirable.
Instruments that employ liquid jets have also been utilized in surgical procedures for cutting and ablating tissue. Such instruments can have certain advantages over the above-mentioned traditional surgical instruments for performing surgical and medical procedures. For example, the cutting or ablating power of the liquid jet may be adjusted or controlled by an operator of the instrument, for example by varying the pressure of the liquid supplied to form the jet, to allow for improved tissue differentiation and to reduce inadvertent damage to surrounding tissues when cutting or ablating the target tissue. When operated at lower liquid pressures, the instruments can be utilized for lavage and/or debridement of tissue, without substantial cutting. A variety of such liquid jet surgical instruments for performing open surgical procedures, minimally invasive surgical procedures, and surgical procedures performed on an external portion of the body of a patient (e.g., wound cleansing or skin debridement) are known in the art. Several such instruments are described in commonly-owned U.S. Pat. No. 5,944,686, issued Aug. 31, 1999, U.S. Pat. No. 6,375,635, issued Apr. 23, 2002, and U.S. Pat. No. 6,511,493, issued Sep. 17, 2002, each incorporated herein by reference, and in commonly-owned published U.S. Patent Publication No. 2003/0125660 A1, published Jul. 3, 2003, which is incorporated herein by reference.
Typically, many of the above-described surgical instruments are designed an supplied to be disposable after a single use. As described in the above-identified patents and published application, many liquid jet-forming surgical instruments utilize liquid pressures in excess of 1,000 psig, often in the range of between about 5,000 to 20,000 psig, and in some cases up to 50,000 psig or more. Typical nozzle internal diameters can range from about 0.001 to 0.02 inch. In forming such instruments, the ability to fabricate liquid jet-forming nozzles able to withstand such pressures while forming collimated jets is difficult. Moreover, because, as mentioned above, many such instruments are disposable after a single use, the ability to form nozzles in expensively and reproducibly in quantity adds to the difficulty. Typical nozzle assemblies for forming collimated jets for liquid jet-forming devices can tend to be expensive to fabricate and/or difficult to fabricate in bulk quantities reproducibly and/or can have relatively large ratios of nozzle length to diameter, which can lead to undesirably large pressure drops. Many conventional methods for making such small nozzle openings, such as electric discharge machining, microdrilling, and the like, tend to be expensive, relatively slow, and difficult to automate. In addition, facilitating alignment between liquid jet nozzles and jet receivers in such instruments during fabrication, especially for instruments having relatively long jet lengths, e.g. greater than 5 mm can be difficult.
While many of the above-mentioned surgical instruments, and especially liquid jet-based surgical instruments have utility for performing such surgical and medical procedures, there for improved nozzles and nozzle assemblies for liquid jet-based surgical instruments and for improved techniques and components for aligning liquid jet-forming nozzles in such instruments. The present invention provides, in certain embodiments, such improved nozzles, nozzle assemblies, and surgical liquid jet instruments, and further provides methods for their construction and use in a variety of surgical procedures.
Disclosed are nozzles and nozzle assemblies of liquid jet-forming surgical instruments, surgical instruments employing such nozzles and/or nozzle assemblies, and methods of fabricating the nozzle assemblies in forming surgical instruments. Also, disclosed are liquid jet-forming surgical instruments including both liquid jet-forming nozzles and optional evacuation lumens, which when provided can be configured to receive the liquid jet and evacuate the liquid forming the liquid jet. Certain embodiments of such surgical instruments include inventive nozzle alignment component(s) to facilitate alignment of the nozzles and evacuation lumen upon assembly. In certain embodiments, surgical instruments are provided that include a nozzle that is shaped to form a liquid jet, which has surfaces that are optically smooth. In certain embodiments, the nozzle has a configuration enabling the nozzle to form a liquid jet that has the ability to remain collimated over longer distances than is typically achievable with conventional liquid jet surgical instrument nozzles having the same ratio of nozzle length to minimum inner diameter of the jet opening. In certain embodiments, nozzle assemblies comprising an operative assembly of at least two sub-components, which together provide a nozzle are provided. In certain embodiments, the at least two sub-components may comprise a nozzle-providing component, such as a nozzle ring, and a holder that is configured to retain and position the nozzle-providing component in the nozzle assembly. In certain embodiments, the nozzle-providing component can comprise a liquid flow passage having a diameter that continuously decreases along at least a portion of its length.
In one aspect, the invention is directed to surgical instruments. In one series of embodiments, surgical instruments comprising a nozzle assembly comprising a nozzle-providing component that is shaped to form a liquid jet; and a pressure lumen configured and positioned to convey a flow of liquid to the nozzle assembly; wherein the nozzle assembly comprises a holder that is configured to retain and position the nozzle-providing component, and wherein the nozzle-providing component comprises a liquid flow passage having a diameter that continuously decreases along at least a portion of a liquid flow path through the liquid flow passage are disclosed.
In another series of embodiments, surgical instruments comprising a nozzle assembly comprising a nozzle-providing component that is shaped to form a liquid jet; and a pressure lumen configured and positioned to convey a flow of liquid to the nozzle assembly; wherein the nozzle assembly comprises a holder that is configured to retain and position the nozzle-providing component; and wherein the holder comprises a recessed well having a seating surface comprising a hole, which hole is in fluid communication with the pressure lumen, the hole having an inner diameter less than an outer diameter of the nozzle-providing component when the nozzle-providing component is contained within the recessed well of the holder, and wherein the recessed well of the holder has an inner diameter at least as great as the outer diameter of the nozzle-providing component when the nozzle-providing component is contained within the recessed well of the holder are disclosed.
In another series of embodiments, surgical instruments comprising a nozzle assembly comprising a nozzle-providing component that is shaped to form a liquid jet; and a pressure lumen configured and positioned to convey a flow of liquid to the nozzle assembly; wherein the nozzle assembly comprises a holder that is configured to retain and position the nozzle-providing component, the holder comprising a recessed well formed in the distal tip of the pressure lumen are disclosed.
In another series of embodiments, surgical instruments comprising a nozzle assembly comprising a nozzle-providing component that is shaped to form a liquid jet; and a pressure lumen configured and positioned to convey a flow of liquid to the nozzle assembly; wherein the nozzle-providing component comprises a ring having an outer diameter not greater than 0.1 inch and a height, as measured in a direction parallel to the longitudinal axis of a hole defining a liquid flow path through the ring, less than the outer diameter are disclosed.
In another series of embodiments, surgical instruments comprising a nozzle that is shaped to form a liquid jet; and a pressure lumen configured and positioned to convey a flow of liquid to the nozzle; wherein the nozzle comprises a hole, defining a liquid flow path through the nozzle, which has surfaces that are optically smooth are disclosed.
In another series of embodiments, surgical instruments comprising a nozzle that is shaped to form a liquid jet; and a pressure lumen configured and positioned to convey a flow of liquid to the nozzle; wherein a ratio of a liquid flow path length through the nozzle to a minimum inner diameter of a jet-forming orifice of the nozzle does not exceed 4; and wherein the liquid jet formed by the instrument when in operation has a cone angle not exceeding 10 degrees are disclosed.
In another series of embodiments, surgical instruments comprising a pressure lumen configured and positioned to convey a flow of liquid comprising at or near its distal end a nozzle that is shaped to form a liquid jet; an evacuation lumen comprising a jet-receiving opening locatable opposite the nozzle to receive at least a portion of the liquid jet emitted from the nozzle, when the instrument is in operation, and which is configured and positioned to convey a flow of liquid away from the jet-receiving opening; and a nozzle alignment component located at or near, the distal end of the instrument that is configured and positioned to connect to the pressure lumen and, upon connection to the pressure lumen, to align the nozzle with respect to the evacuation lumen so that the liquid jet enters the jet-receiving opening along a selected trajectory, when the instrument is in operation are disclosed.
In another aspect, the invention is directed to nozzle assemblies of liquid jet-forming surgical instruments. In one series of embodiments, nozzle assemblies of liquid jet-forming surgical instruments comprising a nozzle providing component that is shaped to form a liquid jet; and a holder that is configured to retain and position the nozzle-providing component within the nozzle assembly, wherein the nozzle-providing component comprises a liquid flow passage having a diameter that continuously decreases along at least a portion of a liquid flow path through the liquid flow passage are disclosed.
In another series of embodiments, nozzle assemblies of liquid jet-forming surgical instruments comprising a nozzle-providing component that is shaped to form a liquid jet; and a holder that is configured to retain and position the nozzle-providing component within the nozzle assembly, wherein the holder comprises a recessed well having a seating surface comprising a hole, which hole is connectable in fluid communication with a source of pressurized liquid, the hole having an inner diameter less than an outer diameter of the nozzle-providing component when the nozzle-providing component is contained within the recessed well of the holder, and wherein the recessed well of the holder has an inner diameter at least as great as the outer diameter of the nozzle-providing component when the nozzle-providing component is contained within the recessed well of the holder are disclosed.
In another series of embodiments, nozzle assemblies of liquid jet-forming surgical instruments comprising a nozzle that is shaped to form a liquid jet; wherein the nozzle comprises a hole, defining a liquid flow path through the nozzle, which has surfaces that are optically smooth are disclosed.
In another series of embodiments, nozzle assemblies of liquid jet-forming surgical instruments comprising a nozzle that is shaped to form a liquid jet; wherein a ratio of a liquid flow path length through the nozzle to a minimum inner diameter of a jet-forming orifice of the nozzle does not exceed 4; and wherein the liquid jet formed by the nozzle assembly when in operation has a cone angle not exceeding 10 degrees are disclosed.
In another aspect, the invention is directed to methods for fabricating a nozzle assembly of a liquid jet-forming surgical instrument. In one series of embodiments, methods for fabricating a nozzle assembly of a liquid jet-forming surgical instrument comprising affixing a nozzle-providing component in the shape of a ring, the nozzle-providing component having an outer diameter and a liquid flow passage through the nozzle-providing component wherein the flow passage has a diameter that continuously decreases along at least a portion of a liquid flow path through the liquid flow passage, to or within a holder, the holder being connectable in fluid communication with a source of pressurized liquid, thereby forming the nozzle assembly, such that the nozzle assembly is able to withstand an internal liquid pressure of at least about 1,000 psig without failure are disclosed.
In another series of embodiments, methods assembling at least a portion of a liquid jet-forming surgical instrument, comprising connecting at least a distal portion of a pressure lumen, the pressure lumen comprising at or near its distal end a nozzle that is shaped to form a liquid jet, and at least a distal portion of an evacuation lumen, the evacuation lumen comprising a jet-receiving opening locatable opposite the nozzle, to a nozzle alignment component located at or near the distal end of the instrument, such that upon connection of the pressure lumen and the evacuation lumen to the nozzle alignment component without further alignment steps, the nozzle is aligned with respect to the evacuation lumen so that a liquid jet formed by the nozzle enters the jet-receiving opening along a selected trajectory, when the instrument is in operation are disclosed.
In another aspect, the present invention is directed to a method of making one or more of the embodiments described herein, for example, a liquid jet surgical instrument or a nozzle or a nozzle assembly of a surgical instrument. In yet another aspect, the present invention is directed to a method of using one or more of the embodiments described herein, for example, a liquid jet surgical instrument or a nozzle or a nozzle assembly of a surgical instrument. In still another aspect, the present invention is directed to a method of promoting one or more of the embodiments described herein, for example, a liquid jet surgical instrument or a nozzle or a nozzle assembly of a surgical instrument.
The accompanying drawings are schematic are not intended to be drawn to scale. In the figures, each identical, or substantially similar component that is illustrated in various figures is typically represented by a single numeral or notation. For purposes of clarity, not every component is labeled in every figure, nor is every component of each embodiment of the invention shown where illustration is not necessary to allow those of ordinary skill in the art to understand the invention. In the drawings:
Disclosed are nozzles and nozzle assemblies of liquid jet-forming surgical instruments, surgical instruments employing such nozzles and/or nozzle assemblies, and methods of fabricating the nozzle assemblies in forming surgical instruments. Also, disclosed are liquid jet-forming surgical instruments including both liquid jet-forming nozzles and optional evacuation lumens, which when provided can be configured to receive the liquid jet and evacuate the liquid forming the liquid jet. Certain embodiments of such surgical instruments include inventive nozzle alignment component(s) to facilitate alignment of the nozzles and evacuation lumen upon assembly.
The surgical instruments provided according to certain embodiments of the invention and/or utilizing certain embodiments of the nozzles and/or nozzle assemblies of the invention, can take on many configurations, depending on the particular application. For example, as described in further detail in the context of
The invention also provides, in certain embodiments, kits including an inventive surgical instrument, or component thereof in combination with instructions directing an operator to dispose of at least the portion, and in some instances of the entire instruments, after a single use. “Instructions” can and often do define a component of promotion, and typically involve written instructions on or associated with packaging of instruments or components of the invention. Instructions also can include any oral or electronic instructions provided in any manner. The “kit” typically, and preferably, defines a package including both any one or a combination of the components and/or instruments of the invention and the instructions, but can also include the components and/or instruments of the invention and instructions of any form that are provided in connection with the components and/or instruments in a manner such that a clinical professional will clearly recognize that the instructions are to be associated with the specific components and/or instruments.
In one aspect, the invention provides a series of nozzles and/or nozzle assemblies for liquid jet-forming surgical instruments, as well liquid jet-forming surgical instruments employing such nozzles and/or nozzle assemblies. As described in greater detail below, certain embodiments of the inventive nozzles and nozzle assemblies can provide improved performance over conventional nozzles in that the nozzles and/or nozzle assemblies can improve one or more of the following performance characteristics: the degree of collimation of liquid jets formed by the nozzle, the ease and economy of manufacturing the nozzles and/or nozzle assemblies reproducibility and/or case of fabrication and/or alignment of the nozzles along a desired, the ability to form relatively collimated liquid jets over relatively long jet lengths with lower pressure drops through the nozzle than in conventional nozzle designs, etc. Various embodiments of the nozzle assemblies, nozzles, and surgical instruments described below can achieve one or more of the above-described advantageous performance characteristics and, in certain embodiments, all of the above-described performance characteristics.
In certain embodiments, surgical instruments are provided that include a nozzle that is shaped to form a liquid jet, which has surfaces that are optically smooth. The term “optically smooth” as used herein refers to a surface that is smooth on the scale of the wavelength of visible light. As discussed further below, the ability to provide nozzles having such smooth surfaces can reduce the degree of induced turbulence in the liquid forming the jet, thereby improving the degree of collimation of the jet and reducing pressure drop across the nozzle during formation of the jet. As discussed in more detail below, one method of forming nozzles having optically smooth surfaces involves forming such surfaces using techniques involving the electrodeposition of conductive materials, such as metals.
The term “nozzle” as used herein refers to a lumen or conduit having a reduced inner diameter with respect to the inner diameter of a region of a conduit or container, with which the nozzle is in fluid communication, upstream of the nozzle. It should be noted that the reduced inner diameter of the nozzle may be constant, in certain embodiments, or may be stepped or tapered along the flow path through the nozzle. Moreover, the cross-sectional shape of the flow path through the nozzle can be any suitable shape. In certain embodiments, illustrated herein, the cross sectional shape is a circle. A “jet-forming orifice” or “jet opening” of a nozzle, as used herein refers to the smallest diameter orifice in the nozzle from which a liquid jet formed by the nozzle is emitted. The initial diameter of the liquid jet typically corresponds to the cross sectional diameter of the jet-forming orifice/jet opening. In certain embodiments, the invention provides a surgical instrument including a nozzle having a configuration enabling the nozzle to form a liquid jet that has the ability to remain collimated over longer distances than is typically achievable with conventional nozzles having the same ratio of liquid flow path length through the nozzle to minimum inner diameter of the jet forming orifice of the nozzle. In certain embodiments, discussed in more detail below, such inventive nozzles have the ability to form liquid jets characterized by a cone angle that is less than would be the cone angle formed by a typical nozzle of conventional design for a surgical liquid jet instrument and having the same ratio of liquid flow path length to minimum inner diameter of the jet forming orifice. A “liquid flow path length” through the nozzle or, equivalently, “nozzle length” as used herein refers to the length of the nozzle (see above definition of nozzle) as measured along a central axis of the hole comprising the flow path of the nozzle. A “cone angle” of a liquid jet is given its ordinary meaning and is illustrated and discussed in more detail in the context of
In certain embodiments of the invention nozzle assemblies comprising nozzle-providing components and surgical instruments employing such nozzle assemblies are provided. A “nozzle assembly” as used herein refers to an operative assembly of at least two sub-components, which together provide a nozzle that is shaped to form a liquid jet. In certain embodiments, the at least two sub-components may comprise the above-mentioned nozzle-providing component and a holder that is configured to retain and position a nozzle-providing component in the nozzle assembly. A “nozzle assembly” as used herein would not apply to a nozzle structure that is integrally formed in a container or lumen, such as a hole in a wall of such container/lumen or a necked-down region of an outlet end of such a lumen. A “nozzle-providing component” as used herein refers to a sub-component of a nozzle assembly that includes as part of its structure a nozzle.
As discussed and illustrated in more detail below, in certain embodiments of the invention, in order to improve the efficiency of the inventive nozzles and nozzle-providing components and provide a vena contracta effect, the nozzle-providing component can comprise a liquid flow passage having a diameter that continuously decreases along at least a portion of its length, and in certain embodiments continuously decreases along essentially the entirety of its length. As discussed and illustrated in more detail below, in one series of embodiments, such a liquid flow passage through the nozzle-providing component is provided by fabricating the nozzle-providing component so that it has a curved cross-sectional profile, and in one embodiment a semicircular profile. The provision of a liquid flow path through the nozzle-providing component having a continuously decreasing diameter along the direction of liquid flow, according to certain embodiments of the invention—especially for those embodiments wherein the cross-sectional shape of the nozzle-providing component is semicircular and/or the surfaces of the liquid flow path are optically smooth—can enable the inventive nozzle-providing components to produce liquid jets having a desirable degree of collimation while also having a liquid flow path that is relatively short, which can lead to a reduced pressure drop for the nozzle compared with many conventional surgical liquid jet instrument nozzle designs. For example, in certain embodiments, the nozzle-providing component comprises a ring that has an outer diameter not greater than 0.1 inch and height, as measured in a direction parallel to the longitudinal axis of the hole defining the liquid flow path through the ring, that is less than the outer diameter of the ring. A “ring” as used in the above-context in describing certain nozzle-providing components of the invention refers to such a component having the shape of a torus, wherein the cross-sectional shape of the torus, taken in a plain containing the central axis of the hole of the torus, can be any closed plane curve, e.g. a circle, rectangle, triangle, semicircle, etc. As mentioned above, in one particular embodiment, which is illustrated in
In another aspect, the invention also provides surgical instruments. The surgical instruments include a pressure lumen that is configured and positioned to convey a flow of liquid to a nozzle shaped to form a liquid jet positioned at or near the distal end of the pressure lumen. Certain surgical instruments also include an optional evacuation lumen comprising a jet-receiving opening locatable opposite the nozzle to receive at least the portion of the liquid jet that is emitted from the nozzle, when the instrument is in operation, and which is configured and positioned within the instrument to convey a flow of liquid away from the jet-receiving opening toward the proximal end of the instrument. Certain embodiments of such surgical instruments include an inventive nozzle alignment component located at or near the distal end of the instrument that is configured and positioned, as described in more detail below in the context of
The invention also provides methods of fabricating the above-described surgical instruments and nozzle assemblies. In one such method of fabrication of a nozzle assembly according to the invention, described in more detail below, the nozzle assembly is fabricated by combining a nozzle-providing component, such as a nozzle ring, with a holder that secures and positions the nozzle-providing component and is connectable to a source of pressurized fluid. In a first step of an embodiment of such a method, a nozzle ring is fabricated by a technique that is preferably able to produce desirable quantities of such nozzle rings economically and reproducibly. Any suitable technique may potentially be used to fabricate nozzle rings that will provide a desirable level of reproducibility, uniformity, smoothness, and fabrication economy. In one preferred embodiment, the nozzle rings are obtained that are made by a photolithographic technique coupled with subsequent electrodeposition, as described in more detail below in the context of
A subsequent step of the exemplary fabrication method can involve forming or providing a nozzle-providing component holder, into which the nozzle-providing component is installed, and to which a source of high-pressure liquid is in fluid communication or can be connected in fluid communication. A variety of configurations and materials can be utilized in forming the holder of the nozzle assembly. In certain embodiments, a structure in which the holder is formed comprises high pressure tubing forming a pressure lumen of the surgical instrument. Such tubing can be selected to be suitable for connection to a source of liquid having a pressure desirable for operation of the instrument, e.g. in excess of 1,000 psig, 3,000 psig, 5,000 psig, 10,000 psig, 15,000 psig, 30,000 psig, 50,000 psig, or more. The tubing also, desirably, is configured to facilitate bending as required to form desired configurations of the distal portion of the pressure lumen of the surgical instrument (e.g. see
In certain embodiments, the holder is formed, for example in thin-walled tubing comprising the pressure lumen, by creating a recessed well in the tubing or other holder structure, wherein the recessed well has a seating surface having a bore therethrough that is in fluid communication with the pressure lumen of the instrument. In order to retain and position the nozzle ring or other nozzle-providing component, the inner diameter of the bore through the seating surface should be less than the outer diameter of the nozzle-providing component. As described in more detail below, depending on the technique utilized for 1.5 affixing the nozzle-providing component within the recessed well, the inner diameter of the recessed well may be at least as great as the outer diameter of the nozzle-providing component, when it is in a relaxed configuration prior to insertion in the recessed well, or, in other embodiments, may be somewhat smaller in diameter, so that the nozzle-providing component can be press fit and somewhat deformed upon insertion in to the recessed well.
In certain preferred embodiments, the shape and size of the recessed well is selected such that, upon insertion of the nozzle-providing component into the well, the nozzle-providing component becomes automatically positioned, via mating interaction with contacting surfaces of the recessed well of the holder, such that a liquid jet formed by the nozzle of the nozzle-providing component will be directed along a desired trajectory within the surgical instrument. In certain embodiments, the recessed well is formed in tubing comprising the pressure lumen at a distal tip of the pressure lumen. A “distal tip” of the pressure lumen as used herein refers to the distal-most end and outlet of the pressure lumen, e.g. as illustrated in
The nozzle-providing component, such as a nozzle ring, can be affixed and secured to or within the holder, such that the nozzle assembly thus formed is able to withstand an internal liquid pressure at least as great as that expected to be utilized for forming the liquid jet of the surgical instrument, for example at least about, without failure of the nozzle assembly, e.g., by mechanical failure or undesirable leakage or misdirection of liquid. As described in greater detail below, a variety of ways of affixing and securing the nozzle-providing component within the nozzle assembly may be utilized. In certain embodiments, the nozzle-providing component is secured alter its insertion into a recessed well positioned at a distal tip of high pressure tubing by crimping the end of the tubing, so that the nozzle-providing component is prevented from moving. In other embodiments, separate structures may be utilized for retaining and securing the nozzle-providing component, such as retaining rings, caps, plates, etc. Other means of retention within the scope of the invention can include, without limitations, the use of adhesive, welding, brazing, soldering, or any other suitable means of retention, know to those skilled in the art.
In certain embodiments, wherein the seating surface of the holder is positioned downstream of the nozzle-providing component, because the fluid pressure exerted on the nozzle-providing component forming the liquid jet tends to force the nozzle-providing component against the seating surface, the securing means utilized to hold the nozzle-providing component in place need not be able to provide a high level of retention force, and can include securing components such as elastomer O-rings, adhesives, deformable lightweight metal or plastic retainers (e.g. locking washers, etc), disks or rings of paper or other fibrous materials, screens, etc. Such restraints need only prevent the nozzle-providing component from becoming incorrectly positioned in the absence of water pressure. In certain such embodiments, a disk or plug of filter paper or other material permeable to liquid flow, and lacking any central hole, is used both to retain the nozzle-providing component and to prevent its plugging by debris (see, e.g.
Fabrication of exemplary nozzle assemblies, according to the invention, including a specific embodiment of a nozzle-providing component in the form of a nozzle ring is described below in the context of
Referring to
While a variety of known electroplating/electrodeposition techniques can potentially be utilized for forming the nozzle rings 21, in the illustrated embodiment, referring to
The utilization of electrodeposition of metal in the above-described exemplary embodiment for forming the nozzle ring is one way to enable the curved surfaces 42 of nozzle ring 21 to be extremely smooth, for example to be optically smooth as defined previously. As indicated in
Finished nozzle rings 21 can be detached from plate 20, by conventional means, and, if required, cleaned in preparation for inserting them into holders for forming the inventive nozzle assemblies, as described in further detail in
In particular embodiments, nozzle ring 21 will have an outer diameter OD not greater than about 0.1 inch and a height H that is less than the outer diameter. In certain such embodiments, the outer diameter OD of nozzle ring 21 is between 0.02 inch and 0.1 inch. In certain other embodiments, outer diameter OD of nozzle ring 21 is between 0.03 inch and 0.04 inch and the height H of the ring is between 0.005 inch and 0.01 inch. In one exemplary embodiment, where the nozzle ring is used for forming a nozzle assembly in a distal tip of a pressure lumen, which pressure lumen has an inner diameter of 0.03 inch and an outer diameter of 0.05 inch, the outer diameter OD of ring 21 is about 0.034 inch and the height H of the ring is about 0.007 inch. In certain exemplary embodiments, the minimum diameter ND of jet opening 28, which defines the initial diameter of the liquid jet emitted from nozzle ring 21 in operation, is between about 0.001 and about 0.02 inch, in certain embodiments is between about 0.002 inch and about 0.01 inch, and in certain embodiments is between about 0.003 and about 0.007 inch. In one exemplary embodiment, inner diameter ND is about 0.005 inch.
As mentioned above and as described in further detail below, because nozzle ring 21 can have extremely smooth liquid contacting surfaces 42 on the upstream side of the nozzle ring and a gradually decreasing inner diameter of nozzle 30, the nozzle ring can have the ability to form highly collimated liquid jets even for relatively low ratios of nozzle length H to jet opening diameter ND. For example, it has been found in the context of the present invention that a liquid jet formed by a nozzle ring, such as nozzle ring 21 can have a cone angle not exceeding 10 degrees, when the ratio of nozzle length H to jet opening diameter ND does not exceed 4, in certain embodiments when the ratio does not exceed 2, and in certain other embodiments where the ratio does not exceed 1.5. In certain such embodiments, the liquid jet formed can have a cone angle between 3 degrees and 6 degrees. The cone angle refers to the angle formed at the apex of the liquid jet (see
As explained in more detail below in the context of
Holder 50, as illustrated, is configured to retain and position a nozzle-providing component in a configuration in which a liquid jet formed by a nozzle of the nozzle-providing component is directed along a desired trajectory. For example, referring to FIG. 2A, if it is desirable that a liquid jet formed by the nozzle-providing component, when assembled into a nozzle assembly comprising holder 50, is oriented co-linear with longitudinal axis 60 of pressure lumen 56, then seating surface 58 should provide a seat co-planar to or geometrically centered about a plane perpendicular to longitudinal axis 60, as is illustrated in
The inner diameter LD of hole 62 through seating surface 58 is selected, in certain embodiments, to be less than the outer diameter OD of nozzle ring 21. For example, in an exemplary embodiment where OD of nozzle ring 21 is about 0.034 inch, LD of hole 62 may be in the range of between about 0.02 and about 0.03 inch. The specific dimension selected for LD is, typically, not critical. In certain embodiments, however, it is preferred that LD be greater than the inner diameter ND of jet opening 28 of nozzle ring 21 by at least a factor of about 2, and certain embodiments by at least a factor of about 4, and certain embodiments by at least a factor of about 6. Conveniently, LD can be selected to be equal to the inner diameter of lumen 56 of tubing 52 comprising holder 50.
In the exemplary embodiment illustrated in
As mentioned above in the context of
As mentioned above, it is desirable that the nozzle assemblies formed according to the invention be able to withstand desirable operating pressures for forming liquid jets without failure, undesirable leakage, or undesirable misorientation of a liquid jet due to displacement of the nozzle-providing component within the holder. For example, in certain embodiments, it is desirable for a nozzle-providing component to be secured and retained by the holder sufficiently such that the nozzle assembly is able to withstand an internal liquid pressure of at least about 1,000 psig without failure, in certain embodiments, at least about 2,000 psig without failure, in certain embodiments, at least about 3,000 psig without failure, in certain embodiments, at least about 5,000 psig without failure, in certain embodiments, at least about 10,000 psig without failure, in certain embodiments, at least about 15,000 psig without failure, in certain embodiments, at least about 30,000 psig without failure, and yet in other embodiments, at least about 50,000 psig or more without failure.
For added strength and stability, especially for embodiments in which the outer diameter OD of nozzle ring 21 is the same as or somewhat less than inner diameter Z of recessed well 54 of a holder of a nozzle assembly of the invention, an additional retaining element, such as retaining element 72, can be provided downstream of the nozzle ring 21 to retain and secure it within the nozzle assembly. Such a retaining element can be any suitable retaining means such as one of those previously mentioned. In certain embodiments, retaining element 72 can comprise a rigid ring or disk press-fit into the recessed well, or a weld or solder bead. In another embodiment, as illustrated in
Additionally, because many of die configurations, dimensions, materials, methods of fabrication, geometric and dimensional relationships between components, etc. of surgical liquid jet instrument 100 have been previously described in detail in, for example, commonly-owned U.S. Pat. Nos. 5,944,686; 6,375,635 and 6,511,493, and commonly-owned U.S. Patent Publication 2003/0125660 A1, such details are not repeated herein. The reader is referred to the above-mentioned US patents and patent publication for more details. In general, the various materials, configurations, dimensions, interrelationships, etc. recited in the above-mentioned commonly owned U.S. patents and patent publication are applicable in forming surgical liquid jet instruments, such as liquid jet instrument 100, according to the present invention, except as noted below. For example, surgical jet instruments according to the present invention, in certain embodiments, will include one or more of the above-described inventive nozzles or nozzle assemblies and/or the above- and below-described nozzle alignment components specifically set forth and described herein.
Two tubes emerge from the proximal end 116 of the hand piece body: a low pressure evacuation tube 118 and a flexible high pressure hose 120, each of which can be made of a variety of suitable materials as would be apparent to those of ordinary skill in the art. In one particular embodiment, each of the above-mentioned tubes is made of a suitable polymeric material. Connections within body 110 facilitating fluid communication between high pressure lumen 106 and flexible high pressure hose 120 and between evacuation lumen 108 and low pressure evacuation tube 118 are illustrated in
High pressure hose 120 is connected to a source of pressurized liquid (e.g., a high pressure pump—not shown). Evacuation tube 118 can be connected to a suitable container for containing and storing recovered fluid and debris, and, optionally, containing a filtered outlet for entrained air (not shown). In certain embodiments, the evacuation lumen 108 is shaped and positionable to enable it to remove from a surgical site at least a portion of tissue excised by the liquid jet formed by the nozzle during operation. In certain embodiments, the evacuation lumen is shaped and positionable to enable evacuation of essentially all of the liquid comprising the liquid jet from jet receiving opening 126 of the evacuation lumen 108 to the proximal end 116 of the instrument, without the need for an external source of suction. In other embodiments, wherein the surgical handpiece requires or utilizes a source of external suction to facilitate evacuation, evacuation tube 118 can be connected in fluid communication with a suitable source of suction, such as a vacuum pump, aspirator, house vacuum line, etc.
In certain embodiments, especially those in which the evacuation lumen is shaped and positionable to enable evacuation of liquid and debris without the need for an external source of suction, evacuation efficiency can be enhanced by providing an enlargement in the internal diameter of the evacuation plumbing—for example in evacuation lumen 108 and/or between evacuation lumen 108 and evacuation tube 118—proximally of jet-receiving opening 126 and any optional constriction forming a venturi (not shown). In certain such embodiments, the inner diameter of the evacuation lumen and/or evacuation tube increases from a certain minimum value at a first, distal location to a certain maximum value at a more proximal location. More detail concerning the configuration of the evacuation lumen in such embodiments can be found in commonly-owned U.S. Pat. No. 6,375,635 and the U.S. Patent Publication No. 2003/0125660 A1. Such an expansion advantageously provides a diffuser element able to bring about the above-mentioned enhanced suction effect. In certain embodiments, such a diffuser may be provide by simply expanding the internal diameter of the evacuation lumen at some point along its length downstream of jet-receiving opening 126. In one such embodiment, such a diffuser may be effected by, for example, making the jet-receiving opening inner diameter somewhat smaller than the inner diameter of the evacuation lumen at any point downstream of the jet-receiving opening. In the above and/or other embodiments, an expansion can be provided by interconnecting the evacuation lumen to evacuation tubing 118 having a somewhat larger internal diameter than the evacuation lumen. An exemplary expansion of the evacuation line provided at an interconnection between the evacuation lumen and the evacuation tube could be provided by interconnecting an evacuation lumen having a selected internal diameter, for example of between about 0.1 inch and about 0.6 inch, with evacuation tubing having internal diameter exceeding that internal diameter of the evacuation lumen by about 5% to 150% percent, in certain embodiments between about 20% and 120%, depending on the degree of suction enhancement desired. The configuration of the illustrated embodiment of a nozzle alignment component 104 and the liquid jet-forming components at the distal end 103 of surgical instrument 100 are illustrated in greater detail in
As mentioned above, when utilizing certain nozzle assembly configurations provided according to the invention, such as nozzle assembly 70′ as illustrated in
Although the semicircular cross-sectional profile of nozzle ring 21, described previously, is believed to be particularly efficient, in certain embodiments, significant improvement, over typical conventional surgical liquid jet nozzle designs, can be obtained utilizing other nozzle configurations in which a liquid flow passage through the nozzle has a diameter that continuously decreases along at least a portion of a liquid flow path through the nozzle. Such tapers can at least partially obviate the effects of flow path sharp edges. Such tapered nozzles can be produced by a variety of techniques, such as for example the above-mentioned photolithographic/electrodeposition technique, as well as by techniques such as micro-machining of blanks by various known micro machining methods, etc.
For certain embodiments of surgical instruments utilizing inventive nozzles and/or nozzle assemblies producing highly collimated jets, e.g. those producing a liquid jet having a cone angle less than about 10 degrees, the evacuation lumen 108 can be configured to have a somewhat different relationship of internal diameter to liquid jet dispersed diameter at the inlet to the evacuation lumen than has been described in Applicant's U.S. Pat. No. 6,375,635. Specifically, in such embodiments, when providing an evacuation lumen having a smallest internal diameter at the location of the jet-receiving opening, the jet-receiving opening can be sized so that it has a diameter of about 150% to 300% the diameter of a cross section of the base (e.g. 132) of the dispersed jet 130 as it crosses the plane defining the jet-receiving opening. In other such embodiments, not illustrated, in which an evacuation lumen having a smallest internal diameter at a location of a necked-down constriction at the distal end of the evacuation lumen is provided, the jet-receiving opening can be sized so that it has a diameter between about 150% to about 400%, the diameter of a cross-section of the base of the dispersed jet as it crosses the plane defining the jet-receiving opening, and the minimum opening of the constriction can be sized so that it has a diameter of between about 100% to about 200% the diameter of the cross-section of the base of the dispersed jet as it crosses the plane defining the minimum diameter opening of the constriction.
The configuration and function of an exemplary embodiment of a nozzle alignment component is now explained with reference to
As illustrated, a proximal region of nozzle alignment component 104 comprising a downstream end of the insert, includes a section 142 that is sized and configured to be insertable into the jet receiving opening 126 of evacuation lumen 108. For example, the outer diameter of section 142 of alignment component 104 may be equal to or slightly greater than the inner diameter of the distal end of evacuation lumen 108. If necessary or desired, downstream evacuation lumen connecting component 142 of nozzle alignment component 104 can be secured within the distal end of evacuation tube 108 via any one of wide variety of suitable means that would be apparent to those skilled in the art. In one exemplary embodiment, a compression sleeve, not shown, may be provided to securely interconnect downstream portion 142 of alignment component 104 within the distal end of evacuation lumen 108.
In the particular exemplary embodiment illustrated, nozzle alignment component 104 further comprises therein an elongated jet interacting channel 144, having a depth DC (see
An alternative configuration of a nozzle alignment component is illustrated in
Another alternative configuration for providing a distal end of a surgical liquid jet instrument providing a nozzle alignment component is illustrated in
Nozzle alignment component 170 also illustrates an embodiment utilizing a nozzle assembly 70″, previously illustrated and described in the context of
While several embodiments of the invention have been described and illustrated herein, those of ordinary skill in the art will readily envision a variety of other means and structures for performing the functions and/or obtaining the results or advantages described herein, and each of such variations, modifications and improvements is deemed to be within the scope of the present invention. More generally, those skilled in the art would readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that actual parameters, dimensions, materials, and configurations will depend upon specific applications for which the teachings of the present invention are used. 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 invention described herein. It is, therefore, to be understood that the foregoing embodiments are presented by way of example only and that, within the scope of the appended claims and equivalents thereto, the invention may be practiced otherwise than as specifically described. The present invention is directed to each individual feature, system, material and/or method described herein. In addition, any combination of two or more such features, systems, materials and/or methods, provided that such features, systems, materials and/or methods are not mutually inconsistent, is included within the scope of the present invention. In the claims (as well as in the specification above), all transitional phrases or phrases of inclusion, such as “comprising,” “including,” “carrying,” “having,” “containing,” “composed of,” “made of,” “formed of,” “involving” and the like shall be interpreted to be open-ended, i.e. to mean “including but not limited to” and, therefore, encompassing the items listed thereafter and equivalents thereof as well as additional items. Only the transitional phrases or phrases of inclusion “consisting of” and “consisting essentially of” are to be interpreted as closed or semi-closed phrases, respectively. In cases where the present specification and a document incorporated by reference include conflicting disclosure, the present specification shall control.
This application is a continuation of U.S. patent application Ser. No. 10/544,015, filed on Mar. 31, 2006 and issued as U.S. Pat. No. 9,597,107, which is a continuation-in-part of U.S. patent application Ser. No. 10/695,632, filed on Oct. 27, 2003 and issued as U.S. Pat. No. 8,162,966, which claims the benefit of U.S. Provisional Patent Application No. 60/488,024, filed on Jul. 17, 2003, U.S. Provisional Patent Application No. 60/421,219, filed on Oct. 25, 2002, and U.S. Provisional Patent Application No. 60/444,344, filed on Jan. 31, 2003. The disclosures of these prior applications are incorporated by reference in their entirety.
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| Number | Date | Country | |
|---|---|---|---|
| 20170258484 A1 | Sep 2017 | US |
| Number | Date | Country | |
|---|---|---|---|
| 60488024 | Jul 2003 | US | |
| 60444344 | Jan 2003 | US | |
| 60421219 | Oct 2002 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 10544015 | US | |
| Child | 15444084 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 10695632 | Oct 2003 | US |
| Child | 10544015 | US |
