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WO2025090358A1 - Appareil de cryo-aiguille et procédés d'utilisation - Google Patents

Appareil de cryo-aiguille et procédés d'utilisation Download PDF

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Publication number
WO2025090358A1
WO2025090358A1 PCT/US2024/051802 US2024051802W WO2025090358A1 WO 2025090358 A1 WO2025090358 A1 WO 2025090358A1 US 2024051802 W US2024051802 W US 2024051802W WO 2025090358 A1 WO2025090358 A1 WO 2025090358A1
Authority
WO
WIPO (PCT)
Prior art keywords
handle
cryoneedle
needle attachment
inner lumen
outer sheath
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2024/051802
Other languages
English (en)
Inventor
Miles GRAIVER
Brian G. Hill
David A. Hill
Z. Paul LORENC
Brian K PILCHER
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Cryocure LLC
Original Assignee
Cryocure LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Cryocure LLC filed Critical Cryocure LLC
Publication of WO2025090358A1 publication Critical patent/WO2025090358A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/0046—Surgical instruments, devices or methods with a releasable handle; with handle and operating part separable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00477—Coupling
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00452—Skin
    • A61B2018/0047—Upper parts of the skin, e.g. skin peeling or treatment of wrinkles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • A61B2018/0231—Characteristics of handpieces or probes
    • A61B2018/0262—Characteristics of handpieces or probes using a circulating cryogenic fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • A61B2018/0293—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques using an instrument interstitially inserted into the body, e.g. needle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like

Definitions

  • the invention relates to needles used in connection with cryosurgical procedures, and to systems and methods for effecting the same. More specifically, the invention relates to various specially designed needle apparatuses that are usable to perform intralesional cryotherapy procedures for treatment of keloids and hypertrophic scarring, and to systems and methods employing the same.
  • Keloids and hypertrophic scars are representative of abnormally healing skin that is resistant to multiple surgical and non-surgical treatments. These abnormal, fibroproliferative scars exhibit aggressive dermal growth which can be painful and may cause undesirable cosmetic appearance of the skin, physical deformities, restriction of joint mobility, or other undesirable effects.
  • Intralesional cryotherapy has emerged as an effective treatment method for reducing the size of keloids and hypertrophic scars.
  • Earlier treatment options involved topical application of a cryogen to the keloid mass, exposing only the surface of the keloid mass. These treatments did not reach the core of the keloid mass, were minimally effective, and required many rounds of treatments.
  • intralesional cryotherapy involves passing a very low temperature cryogen fluid, typically liquid nitrogen, through a specially designed needle assembly (referred to herein as a cryoneedle) that has been injected into or through the core of the scar tissue mass.
  • Intralesional techniques treat the keloid mass from the inside out, exposing a much larger, internal volume of the mass to the freezing effect of the cryogen.
  • cryoneedle assemblies implement certain design features making them suitable for use for intralesional cryotherapy. More specifically, cryoneedles comprise a component configuration that creates a flow path along the length of the cryoneedle for the cryogen fluid to pass through. Received cryogen is routed through the cryoneedle assembly while it is inserted within the keloid mass, then is expelled from the cryoneedle via an exhaust port of the cryoneedle disposed at a location that is kept external to the patient’s body.
  • the first tube is an inner lumen comprising an open-ended channel through which cryogen fluid from a cryogen source is received and routed.
  • the inner lumen tube is encapsulated within an outer sheath comprising a longer and diametrically wider tube than that of the inner lumen.
  • the outer sheath is closed at its far end to form a sharp tip used to insert the cryoneedle assemble into and through the keloid mass.
  • the outer sheath has an exhaust port at the end opposite the sharp tip through which spent cryogen is expelled into the surrounding environment.
  • cryoneedles are devoid of safeguards to prevent their re-use by physicians to perform multiple cryotherapy procedures, in violation of FDA single-use guidelines. Cryoneedle re-use creates a risk of infection to patients that would not exist otherwise.
  • Improvements are presented in the various embodiments disclosed herein to address one or more of these problems.
  • improvements are implemented with the objective of preventing re-use of the cryoneedle to perform more than one intralesional cryotherapy procedure.
  • improvements are implemented with the further objective of causing uniform cryogen temperature exposure and freezing effect along the working length of the outer sheath surface of the cryoneedle.
  • improvements are implemented for improved ergonomics and/or to reduce or eliminate the risk of unwanted exposure to exhausted cryogen fluid as it leaves the cryoneedle.
  • a cryoneedle assembly for performing intralesional cryotherapy which comprises a handle and a needle attachment.
  • the handle may comprise internal channels and connection ports for coupling to supply and exhaust lines for introducing and expelling cryogen fluid from the cryoneedle assembly during use.
  • the needle attachment may comprise a detachable assembly configured to couple to the handle.
  • the needle attachment may comprise an inner lumen operatively coupled to the supply line to receive cryogen fluid during use which may then be routed through the inner lumen to an outer sheath surrounding the inner lumen.
  • the outer sheath may comprise a closed end formed into a sharp point usable for penetrating hypertrophic scar tissue.
  • Cryogen fluid may be routed to the interior of the outer sheath during use to effect freezing of the surrounding tissue, before the cryogen fluid is expelled from the cryoneedle through the exhaust line.
  • a cryoneedle assembly may comprise a handle to which a detachable needle attachment may be affixed.
  • the needle attachment may comprise a configuration causing it to transition from an unused state to a used state.
  • the needle attachment may be rendered unusable for continued use to perform intralesional cryotherapy or become incapable of re-attaching to the handle upon transitioning to its used state.
  • the cryoneedle housing may comprise one or more posts extending outwardly and toward the needle attachment.
  • a needle attachment When in its unused state, a needle attachment may comprise one or more openings for receiving the one or more posts when the handle and needle attachment are coupled to one another.
  • the needle attachment may additionally comprise movable sleeve insert that may be moved from a first to second orientation by a spring when not held in place by a latch protrusion engaging a flange. An end of the latch protrusion may extend into an opening for receiving the one or more posts upon assembly of the cryoneedle components.
  • interference from the post may cause the latch protrusion to deform and disengage, permitting the movable sleeve insert to move to its second orientation. While in its second orientation, portions of the movable sleeve insert may fdl the one or more openings of the needle attachment to prevent reattachment of the needle attachment to the handle, once removed.
  • a cryoneedle may be implemented with an inner lumen comprising an elongated tube having plurality of apertures through the surface of the inner lumen along some or all its length for venting cryogen fluid into the outer sheath.
  • the apertures may comprise a circular cross section, an oval cross section, an elongated, substantially rectangular cross section, or other shape. The apertures may be disposed at various orientations around the circumference of the tube structure comprising the inner lumen.
  • a cryoneedle may be implemented with an outer sheath comprising an elongated tube comprising a sharpened, trocar tip usable to penetrate into and through keloid tissue.
  • the trocar tip may comprise a hollow body or a solid body, and may be affixed to the outer sheath at its distal end.
  • the trocar tip may form a block at the distal end of the outer sheath to limit cryogen fluid flow and insulate the distal portion of the trocar tip from freezing during use.
  • the outer sheath may be implemented with one or more ridge features disposed along its outer surface near its closed, distal end. The one or more ridges may trap excised tissue during use of the cryoneedle and thereby militate against the likelihood of re-use of at least a needle attachment comprising the outer sheath.
  • a cryoneedle is assembled by coupling a housing assembly to a needle attachment.
  • a portion of the cryoneedle assembly comprising an outer sheath surrounding an inner lumen is inserted into the affected tissue of a patient.
  • a supply of cryogen fluid is connected to the cryoneedle along with an exhaust line.
  • Cryogen fluid is routed through the cryoneedle for sufficient time to cause freezing of the affected tissue in contact with and proximal to the outer sheath, at which time the cryogen fluid flow is stopped and the supply is removed.
  • the needle attachment may be removed from the patient’s body, detached from the handle, and discarded.
  • Alternative methods of use may involve performance of additional or different steps for performing interlesional cryotherapy procedures using cryoneedles according to the many novel embodiments disclosed herein.
  • Figure 1 is an isometric view of an exemplary embodiment of a cryoneedle 10
  • Figure 2A is a partial section view of exemplary cryoneedle 10 showing handle 100, along section A-A of Fig. 1;
  • Figure 2B is a partial section view of exemplary cryoneedle 10, along section A-A of Fig. 1;
  • Figure 2C is a section view of exemplary cryoneedle 10, along section B-B of Fig. 1;
  • Figure 3 is an isometric view of a manifold 110 within the exemplary cryoneedle 10;
  • Figure 5A is a section view of needle attachment 200 of exemplary cryoneedle 10, along section A-A of Fig. 4;
  • Figure 5B is a section view of needle attachment 200 of exemplary cryoneedle 10, along section B-B of Fig. 4;
  • Figure 6 is an exploded view of needle attachment 200 of exemplary cryoneedle 10;
  • Figure 7A is an isometric view of needle attachment 200 of exemplary cryoneedle 10, according to its unused configuration
  • Figure 7B is an isometric view of needle attachment 200 of exemplary cryoneedle 10, according to its configuration after use;
  • Figure 8 is a partial section view of exemplary cryoneedle 10, at detachment of the needle attachment 200 from handle 100, along section A-A of Fig. 1;
  • Figure 9A is a side view of an inner lumen 280 of exemplary cryoneedle 10;
  • Figure 9B is a section view of inner lumen 280 of exemplary cryoneedle 10, along section A-A of Fig. 9A;
  • Figure 9C is a detail view ‘A’ of inner lumen 280 of Fig. 9A;
  • Figure 10A is a view of an outer sheath 220 of exemplary cryoneedle 10;
  • Figure 10B is a section view of outer sheath 220 of exemplary cryoneedle 10, along section A-A of Fig. 10A;
  • Figure 10C is detail view ‘A’ of outer sheath 220 of Fig. 10A;
  • Figure 10D is detail view of outer sheath 220 of Fig. 10B.
  • Figure 11 is a flowchart of an exemplary method of using exemplary cryoneedle 10 to perform intralesional cryotherapy on a keloid.
  • FIG. 1 presents an isometric view of an exemplary embodiment of a cryoneedle 10 which may implement one or more of the innovations disclosed herein.
  • cryoneedle 10 may comprise a handle 100 and a needle attachment 200.
  • the handle 100 may comprise a generally L-shaped outer housing, as shown, to facilitate ease of handling, use, and manipulation of the cryoneedle 10 by a physician to perform intralesional cryotherapy.
  • a person of ordinary skill in the art will appreciate that alternative ergonomic outer housing shapes and configurations of the handle 100 could be implemented.
  • handle 100 may be implemented with connections for receiving and coupling to one or more conduits for fluid flow. Such connections may comprise one or both of a cryogen supply line and an exhaust line. Further, such connections may be disposed internal or external to the body of handle 100. According to the present embodiment, as best shown in Figures 2A-2C, the handle 100 may comprise internal connection ports 112, 114 for coupling to each of a supply line 102 and an exhaust line 104, respectively, disposed within an outer housing 106 of the handle 100.
  • Supply line 102 may connect to a source of cryogen fluid and route the cryogen fluid to cryoneedle 10 for use in performance of intralesional cryotherapy. Spent cryogen fluid may be expelled from the cryoneedle 10 via the exhaust line 104 may be used to vent spent cryogen fluid from cryoneedle 10 following its use.
  • connection ports 112, 114 for supply line 102 and exhaust line 104 may comprise barbed fittings for press-on tube connections. Connection ports 112, 114 may accommodate detachable coupling to the supply line 102 and/or exhaust line 104.
  • different connection means may be utilized, including interference fittings, threaded fittings, quick disconnects, compression fittings, or other known connection types suitable for use with cryogen fluids.
  • the connection ports may comprise a circular crosssection. Alternatively, different cross-sectional geometries may be implemented.
  • handle 100 further comprises a housing 106 which may define a volume and overall shape of the handle 100 to be substantially “L” shaped.
  • connection ports 112, 114 are internal to the handle 100 and disposed within the substantially horizontally extending portion of the housing 100.
  • the connection ports 112, 114 may be disposed at different locations within the handle 100, such as in substantially vertically extended section comprising its “L” shape.
  • connection ports 112, 114 comprise integral features of a manifold 110 within handle 100, best shown in Figure 2A and Figure 3.
  • manifold 110 may be substantially vertically oriented, may abut one or more internal walls or support structures of housing 106, and may comprise a cross-sectional shape substantially coincident with that of housing 106, which may be substantially circular or disk-shaped.
  • manifold 110 may comprise any structure, position, orientation, and/or surface features suitable to accommodate connecting a supply and/or exhaust line, such as supply line 102 and exhaust line 104, to internal components of the cryoneedle 10.
  • manifold 110 may comprise a barbed connection port 112, extending outward and away from the main body of manifold 110 toward the rear of handle 100.
  • Connection port 112 may be centrally located with respect to the substantially circular cross-section of manifold 110.
  • Manifold 110 may further be implemented with an additional coupling along its opposite, forward-facing surface that may align with the location of connection port 112. As shown, this forwardly extending coupling may comprise a cylindrically shaped, open- ended collar 116. Collar 116 may be configured to receive within it, and thereby connect to, an internal structure of the cryoneedle, such as the connector port 262 of needle attachment 200, shown in Figs. 2B, 2C, and Fig. 6.
  • collar 116 may accommodate a sealed, interference fit between its circular, inner wall surface and the connection port 262 and gasket 264.
  • connection port 112 and collar 116 of manifold 110 operate as an intermediary for placing the needle attachment 200 components of the cryoneedle 10 in fluid communication with supply line 102 for receipt of cryogen fluid during use.
  • manifold 110 additionally comprises a second rearward facing connection port 114 for coupling to the exhaust line 104.
  • Connection port 114 may comprise a barbed connection extending outward and away from the main body of manifold 110 toward the rear of handle 100.
  • Connection port 114 may be disposed vertically adjacent to connection port 112 with respect to the substantially circular cross-section of manifold 110.
  • cryogen fluid source is sufficiently cooled such that it is supplied in its liquid state.
  • the cryogen fluid warms and evaporates during cryotherapy whereby expelled cryogen is typically in a completely gaseous state.
  • manifold 110 may not be implemented with a separate coupling opposite the connection port 114 on its forward-facing surface for directing a flow of spent cryogen from the system. Instead, the cryogen fluid will expand as it warms in ambient conditions. This expansion induces free-flow egress of cryogen from the outer sheath 220 to within the internal volume created by the coupled cap 210 and housing 106, before exiting through the opening provided at connection port 114 into exhaust line 104.
  • Connection port 114 may provide the only opening for venting cryogen fluid from the coupled cap 210 and housing 106 due to the presence of annular interference fit between outer surface 120 of the manifold 110 and the inner surface of housing 106 creating an otherwise sealed internal volume.
  • manifold 110 may comprise one or more posts, for example the two posts 118 shown in Fig. 3, extending outward from the surface of manifold 110 opposite from connection ports 112, 114.
  • posts 118 may comprise raised structures disposed adjacent to collar 116 and protruding outward from the disk-shaped, vertically oriented body of manifold 110.
  • Posts 118 may protrude out farther from the body of manifold 110 than the circular wall structure forming collar 116.
  • post 118 may comprise a crescent-like cross-section.
  • additional or fewer posts, or other structures may be present.
  • such structures may comprise sizes, shapes, and locations differing from that shown, to include, for example, protrusions having square, oval, circular, or other shapes that may have greater or less depth than posts 118.
  • at least one such alignment feature may be configured with a suitable size, shape, and location to cause it to engage a corresponding feature of the needle attachment 200 when the handle 100 and needle attachment 200 are coupled to one another.
  • post 118 may be configured to engage a latch 238 of sleeve insert 230 (best shown in Figures 6 and 7) when cryoneedle 10 is assembled.
  • housing 106 and manifold 110 are permanently affixed to one another via adhesives, fasteners, welding, or any known coupling means suitable for withstanding exposure to cryogen fluids.
  • housing 106 and manifold 110 are integrally formed as a one-piece assembly.
  • housing 106 and manifold 110 are detachably coupled to one another via an interference fit, removable fasteners, or other suitable coupling method.
  • housing 106 may be implemented with one or more couplings disposed at or near its forwardmost edge which may provide means for coupling handle 100 to needle attachment 200. As shown in the embodiment of Figs. 2A and 2B, housing 106 may comprise hook-shaped retaining lips 122, 124 protruding outward from the forwardmost edge of housing 106. In alternative embodiments, additional, fewer, or different couplings may be implemented and may have different sizes, shapes, or locations than those shown.
  • cryoneedle 10 may comprise a needle attachment 200 which may be configured to permit detachable coupling to and subsequent removal from handle 100.
  • needle attachment 200 may comprise a cover 210 which may comprise one or more couplings 214; an outer sheath 220 comprising an elongated, hollow tube structure with a closed, sharp end 226; a sleeve insert 230 configured to rotate from a first to a second orientation; an internal frame 250; and, tube gland 260 affixed to an inner lumen 280 comprising an elongated, hollow tube structure having one or more openings through it.
  • Alternative embodiments may comprise additional, fewer, or different components than those shown.
  • one or more components shown may be integrated with one or more other components to form a single, combined structure.
  • needle attachment 200 may accommodate receipt of supply cryogen through one or more connections to supply line 102 via manifold 110, and the flow of cryogen fluid through the inner lumen 280 and outer sheath 220 while coupled to handle 100 during use.
  • cryoneedle 10 may comprise a component configuration suitable for discouraging or preventing re-use of the needle attachment 200 following its first attachment to handle 100 and use to perform an intralesional cryotherapy procedure.
  • the cryoneedle 10 may comprise a two-piece design in which needle attachment 200 may be attachable to, and removable from, handle 100.
  • cap 210 may comprise one or more couplings along its rearward facing edge for this purpose. As shown, these couplings may comprise one or more hookshaped retaining lips 214.
  • retaining lip 214 may comprise a size, shape, location, and orientation suitable for engaging with and affixing to corresponding retaining lip 124 of handle 100 upon the needle attachment 200 being pressed into and received within the handle 100.
  • these components may be disassembled via application of pinching force to the cap 210 on its sides, which will cause outward deflection in the areas proximal to retaining lips 214 and disengagement.
  • additional, fewer, or different couplings than those shown may be implemented.
  • coupling of the needle attachment 200 to handle 100 may cause insertion of connector port 262 (shown in Figs. 2B, 2C, and Fig. 6) into collar 116 to form a sealed connection around gasket 264.
  • Gasket 264 may comprise an O-ring and may be made using rubber, PTFE, Nitrile, Neoprene, and/or Fluorocarbon, or other similar suitable material.
  • This connection may cause inner lumen 280 to be in fluid communication with supply line 102 via sealed connections at connection port 112 and collar 116, whereby cryogen fluid may be routed through the cryoneedle 10 upon assembly to perform intralesional cryotherapy.
  • tube gland 260 is included, and comprises a sleeve 274 along the axial length of tube gland 260.
  • sleeve 274 of tube gland 260 may have a substantially cylindrical shape that may enclose a channel extending through the entire axial length of tube gland 260.
  • An inner lumen 280 comprising an elongated, hollow tube which may be affixed along a portion of its outer surface to the interior channel formed by sleeve 274 of tube gland 260.
  • sleeve 274 may shield the inner lumen 280 and strengthen its resistance to deformation under stress.
  • the sleeve 274 may additionally operate as an alignment aid securing inner lumen 280 in a desired position and orientation.
  • the tube gland 260 and inner lumen 280 may be configured to coterminate at, or adjacent to, the connection port 262. This co-planar termination may facilitate the simultaneous disengagement of the coupling of the inner lumen 280 and tube gland 260 from collar 116 upon disassembly of cryoneedle 10.
  • the placement of gasket 264 may prevent escape of cryogen fluid that may otherwise result from an imperfect coupling of connection port 262 and inner lumen 280 to the collar 116 while cryoneedle 10 is in use.
  • sleeve 274 may be disposed within a circular channel through the entire axial length of sleeve insert 230, which in turn may be disposed within a central channel passing through the entire length of internal frame 250.
  • Internal frame 250 may, in turn, be fixedly restrained in a desired orientation and position within cap 210 via engagement of alignment tabs 218 of cap 210 by groove 258 of internal frame 250, as best shown in Figs. 6-8.
  • each of these needle attachment 200 structures may aid in securing inner lumen 280 in a fixed position within the needle attachment 200.
  • These components may work in concert to secure inner lumen 280 in a preferred position and orientation with respect to outer sheath 220.
  • outer sheath 220 may, likewise, be fixed. As shown in the embodiment of Figure 5B, for example, outer sheath 220 may be fixedly attached to cap 210 at a coupling forming a collar 212 extending into and through the forward-facing surface of cap 210. The size, position, and orientation of collar 212 may be suitable for contacting and tightly encircling outer sheath 220 along the portion of its outer surface disposed within collar 212. The connection may be sealed via overmold inserted along and around the contact area between outer sheath 220 and collar 212. [0037] As shown, outer sheath 220 may comprise an elongated, hollow tube structure.
  • outer sheath 220 may be implemented with an oval-shaped cross-section, a squareshaped cross-section, or other cross-sectional geometry known in the art. Outer sheath 220 may extend outward and away from the handle 100 of cryoneedle 10 and may comprise a closed or otherwise blocked distal end. Outer sheath 220 may be manufactured out of stainless steel, carbon steel, titanium, silicon, polymers, or any other material approved for use to perform intralesional cryotherapy known by those skilled in the art. Similarly, inner lumen 280 may likewise be manufactured from any of the foregoing materials.
  • the inner lumen 280 and outer sheath 220 may be oriented in a substantially concentric configuration.
  • Outer sheath 220 may comprise inner dimensions sufficiently large to permit it to completely surround and encapsulate the portion of inner lumen 280 extending outward beyond the forward-facing surface of cap 210. It is along this outwardly extended portion of its length that one or more openings through the surface of inner lumen 280 may be present.
  • inner lumen 280 may comprise an open distal end with or without any additional openings along its length.
  • a distal end of the inner lumen 280 terminates near to the distal end of the outer sheath 220.
  • inner lumen 280 and outer sheath 220 may create a cavity between the outer surface of inner lumen 280 and the inner surface of outer sheath 220.
  • Inner lumen 280 is operatively connected to receive supply cryogen fluid and to route it along its length.
  • Cryogen fluid escapes from inner lumen 280 through one or more openings into the cavity formed between the outer surface of inner lumen 280 and the inside of outer sheath 220.
  • the cryogen fluid is sufficiently cooled to effect freezing in the area in contact with and proximal to the external surface of the outer sheath 220. Accordingly, when inserted into a keloid or other afflicted tissue of a patient, cryogen fluid flowing through cryoneedle 10 may induce freezing and necrosis of the surrounding tissue near the outer sheath 220.
  • the efficiency, safety, and therapeutic effect of intralesional cryotherapy can be further improved through adoption of certain innovative features of the inner lumen 280 and the outer sheath 220, in accordance with exemplary embodiments disclosed below.
  • inner lumen 280 may be implemented with one or more apertures 286 disposed along a portion of its length.
  • inner lumen 280 may be implemented with a series of apertures 286 disposed near its distal end 284 and spanning a portion of its length back toward its proximal end 282.
  • Apertures 286 may additionally be disposed at several orientations around the circumference of inner lumen 286, as shown in the embodiment of Fig. 9B.
  • apertures may comprise an elongated slit shape, as shown in Fig. 9C, providing openings for cryogen fluid to exit the inner channel 288 of inner lumen 280.
  • inner lumen 280 may comprise a hollow tube having a circular cross section and a closed distal end 284.
  • Inner lumen 280 may comprise a series of three slit shaped apertures at each of three different orientations, evenly spaced from one another about the circumference of inner lumen 280.
  • the apertures may each comprise approximately 0.012” tall by 0.1” wide slits, separated from one another by 0.25” of linear distance and/or 120 degrees of the cross-sectional circumference.
  • the inner lumen 280 may be implemented with more or less apertures 286 than shown, which may be disposed over a shorter, greater, or different span along the length of inner lumen 280 than shown. Additionally, or alternatively, apertures 286 may comprise a different shape than shown, such as circular, oval, or other geometric shape. Apertures 286 may differ in size or shape from that shown, and may be of uniform or differing sizes along the length of inner lumen 280. In some embodiments, the plurality of apertures 286 may be circular in shape and may increase in diameter for those disposed farther along the length of the inner lumen 286. This gradient may allow for the flow of cryogen fluid to be substantially uniform along the length of the inner lumen 280.
  • the inner lumen 280 may terminate further from the distal end of the outer sheath 220.
  • Inner lumen 280 may terminate having its distal end 284 flatly sealed, resembling the end of a cylinder, but may also terminate by having its distal end 284 come to a point, resembling a needle.
  • the inner lumen 280 may terminate with its distal end 284 open, further allowing cryogen fluid to escape.
  • Additional embodiments may comprise apertures 286 comprising slits that may spiral along the length and around the circumference of inner lumen 280.
  • the inner lumen 280 may permit greater cryogen fluid flow through it into the outer sheath 220.
  • Other improvements include a reduced likelihood of components within the cryoneedle freezing during use, thereby allowing the cryoneedle to achieve a lower temperature and more evenly distributed cooling effect. Both outcomes increase the effectiveness of intralesional cryotherapy treatment. Reducing the likelihood of components within the cryoneedle freezing also reduces the risk of a significant decline in performance or complete failure of the cryoneedle, which may result in directly exposing the patient's skin to cryogen fluid. In addition, cryotherapy may take less time to complete as time is no longer wasted waiting for a frozen cryoneedle to unfreeze to permit removal and reinsertion during ongoing treatment.
  • an improved outer sheath 220 may comprise a proximal end 222 and a closed distal end comprising a solid sharp tip 226.
  • Sharp tip 226 may be manufactured from stainless steel, carbon steel, titanium, silicon, polymers, and other materials know by those skilled in the art.
  • Sharp tip 226 may be made using thermally resistant materials, such as nickel-based alloys, and may further comprise thermally resistant coatings known to those skilled in the art.
  • sharp tip 226 may comprise a trocar configuration.
  • a freezing zone 224 may be disposed along a portion of the outer sheath 220 length.
  • the solid body configuration of the trocar tip end 226 may operate to block cryogen fluid flow and effectively insulate the tip 226 to reduce or eliminate the incidence of it freezing during use.
  • Outer sheath 220 may additionally comprise one or more external ridge features 228 near its sharp tip 226. Ridge features 228 may cause tissue build up to collect on the surface of outer sheath 220, rendering outer sheath 220 more difficult to sanitize and therefore less likely to be reused. Avoiding re-use eliminates certain risks to the patient of infection.
  • the outer sheath 220 does not comprise an opening through it for expelling spend cryogen fluid.
  • the outer sheath 220 may be implemented with an exhaust port for this purpose disposed near its proximal end 222.
  • cryoneedle 10 can be further improved by implementing it with a component configuration preventing re-use of needle attachment 200 to perform more than a single intralesional cryotherapy procedure.
  • components comprising needle attachment 200 may be configured such that the needle attachment 200 may transition from a “new” state to a “used” state upon detachment from handle 100. Following this transition, needle attachment 200 may comprise a changed component configuration that physically prevents subsequent re-attachment of needle attachment 200 to a handle 100.
  • latch connector 238 While in the “new” state, latch connector 238 may be visible through one of the cutout sections 268.
  • Latch connector 238 may comprise a deformable protrusion having a hook shape at its end. This is best shown in Figure 6.
  • recesses 234 of sleeve insert 230 Latch connector 238 may be disposed such that it occupies a portion of the volume within one of the recesses 234. Further, as shown, recesses 234 may be in a rotational orientation when needle attachment is in its “new” state such that their positions are substantially coincident with those of cutout sections 268 of flange 266.
  • latch connector 238 may engage a notch 272 disposed along the inward facing surface of flange 266 immediately adjacent to a cutout section 268.
  • the hook connection between these components fixes the orientation of sleeve insert 230 relative to tube gland 260 to maintain the configuration shown in Fig. 7A.
  • a post 118 within handle 100 may engage latch connection 238 at its forward extended surface, which may protrude deep enough into the inner volume of handle 100 to cause latch connection 238 to deform and lose contact with notch 272.
  • a torsion spring 242 may be disposed along an internal surface of sleeve insert 230 and may be configured to cause rotation of sleeve insert 230 by approximately a quarter turn about its longitudinal axis when insert sleeve is not being held in its first position by latch connector 238 engaging notch 272. According to this exemplary embodiment, therefore, upon subsequent detachment of needle attachment 200 from handle 100, sleeve insert 230 will rotate and place needle attachment in its “used” state, shown in Fig. 7B.
  • “used” needle attachment 200 When in its “used” state, access to the internal volume of oval shaped section 254 of internal frame 250 may be physically blocked by portions of the insert sleeve 230. Accordingly, “used” needle attachment 200 may be incapable of being inserted into handle 100 sufficiently far for coupling. Interference between the forward edges of posts 118 with portions of the sleeve insert 230 may prevent coupling and creation of a sealed connection at collar 116 for receipt of cryogen fluid by the needle attachment 200. As such, the “used” needle attachment 200 is rendered unusable and may be discarded and replaced with a “new” needle attachment 200 before any further intralesional cryotherapy can be performed using cryoneedle 10.
  • cryoneedle 10 may be assembled by coupling a needle attachment 200 with a handle 100.
  • an inner lumen 280 and outer sheath 220 may be operatively connected via the handle 100 to receive cryogen fluid from a source 102 upon it being connected to a connection port 112.
  • outer sheath 220 and inner lumen 280 may be partially inserted into or through the keloid tissue.
  • a cryogen fluid supply line may be connected to cryoneedle 10. According to certain exemplary methods of use, including the method shown in Fig.
  • cryoneedle 10 may be used in accordance with a method in which only a cryogen source is connected to cryoneedle 10, or in which one or more of the cryogen supply and exhaust connect! on(s) to cryoneedle 10 are made at connection ports of cryoneedle 10 disposed in locations other than at or within a handle 100.
  • a cryogen fluid flow through cryoneedle 10 may be initiated to cause freezing of the volume of the keloid in contact with or near the portion of the outer sheath inserted into the keloid.
  • the cryoneedle is disassembled by detaching needle attachment 200 from handle 100.
  • detached needle attachment 200 may be discarded and handle 100 sterilized.
  • one or more of the foregoing Steps may be omitted, or may be performed in a different order than shown in Fig. 11.
  • Steps 1102, 1104, and 1106 may be performed in any sequence while remaining within the scope of the present disclosure.
  • Step 1114 may partially or completely omitted, such as, for example, in instances in which the cryoneedle 10 is not implemented with a component configuration preventing re-use of needle attachment 200.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Otolaryngology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne des conceptions de cryo-aiguille améliorées et des procédés d'utilisation de celles-ci. Selon les modes de réalisation divulgués ici, une cryo-aiguille améliorée peut comprendre une poignée configurée pour se raccorder à une ou les deux parmi une ligne d'alimentation en cryogène et une ligne d'échappement. La poignée peut être configurée pour se coupler de manière amovible à une fixation d'aiguille comprenant une lumière interne et une gaine externe fonctionnellement couplées pour recevoir un écoulement de fluide cryogénique provenant de la source de cryogène lorsque la fixation d'aiguille est couplée à la poignée pour être utilisée pour effectuer une cryothérapie intralésionnelle. Dans certains modes de réalisation, l'ensemble aiguille peut être configuré pour être amovible, jetable ou pour empêcher sa réutilisation dans plus d'une procédure de cryothérapie. De plus, ou en variante, une cryo-aiguille améliorée peut comprendre une lumière interne mise en œuvre avec des ouvertures sur sa longueur. En outre, une cryo-aiguille améliorée peut en outre, ou en variante, comprendre une gaine externe ayant une pointe de corps solide.
PCT/US2024/051802 2023-10-23 2024-10-17 Appareil de cryo-aiguille et procédés d'utilisation Pending WO2025090358A1 (fr)

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Application Number Priority Date Filing Date Title
US202363592274P 2023-10-23 2023-10-23
US202363592293P 2023-10-23 2023-10-23
US202363592286P 2023-10-23 2023-10-23
US63/592,293 2023-10-23
US63/592,274 2023-10-23
US63/592,286 2023-10-23

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Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090149846A1 (en) * 2003-10-07 2009-06-11 Tsunami Medtech, Llc Medical system and method of use
US20100256620A1 (en) * 2006-01-12 2010-10-07 Galil Medical Ltd. Thin flexible cryoprobe operated by krypton
US20130090639A1 (en) * 2011-09-24 2013-04-11 Joseph Atias System and methods for destruction of tissue using cryogenic fluid
US20150305722A1 (en) * 2010-02-25 2015-10-29 Robin Medical Inc Cryogenic biopsy system and method
US20180116705A1 (en) * 2016-05-13 2018-05-03 Myoscience, Inc. Methods and Systems for Locating and Treating Nerves with Cold Therapy
US20180303535A1 (en) * 2015-06-03 2018-10-25 Adagio Medical, Inc. Cryoablation catheter having an elliptical-shaped treatment section
US20190142494A1 (en) * 2017-11-15 2019-05-16 Myoscience, Inc. Integrated cold therapy and electrical stimulation systems for locating and treating nerves and associated methods

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090149846A1 (en) * 2003-10-07 2009-06-11 Tsunami Medtech, Llc Medical system and method of use
US20100256620A1 (en) * 2006-01-12 2010-10-07 Galil Medical Ltd. Thin flexible cryoprobe operated by krypton
US20150305722A1 (en) * 2010-02-25 2015-10-29 Robin Medical Inc Cryogenic biopsy system and method
US20130090639A1 (en) * 2011-09-24 2013-04-11 Joseph Atias System and methods for destruction of tissue using cryogenic fluid
US20180303535A1 (en) * 2015-06-03 2018-10-25 Adagio Medical, Inc. Cryoablation catheter having an elliptical-shaped treatment section
US20180116705A1 (en) * 2016-05-13 2018-05-03 Myoscience, Inc. Methods and Systems for Locating and Treating Nerves with Cold Therapy
US20190142494A1 (en) * 2017-11-15 2019-05-16 Myoscience, Inc. Integrated cold therapy and electrical stimulation systems for locating and treating nerves and associated methods

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