WO2015077421A1 - System and method for depositing a hook at a target within a soft tissue - Google Patents

System and method for depositing a hook at a target within a soft tissue Download PDF

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Publication number
WO2015077421A1
WO2015077421A1 PCT/US2014/066558 US2014066558W WO2015077421A1 WO 2015077421 A1 WO2015077421 A1 WO 2015077421A1 US 2014066558 W US2014066558 W US 2014066558W WO 2015077421 A1 WO2015077421 A1 WO 2015077421A1
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WIPO (PCT)
Prior art keywords
hook
end
needle
system
plunger
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PCT/US2014/066558
Other languages
French (fr)
Inventor
David HSIANG
Joel GONZALEZ
Sharon KURUVILLA
Joycelin LUC
Aleksander METULEV
Nazneen PASHUTANIZADEH
Hana YAMATE-MORGAN
Xiaoxuan Zhang
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The Regents Of The University Of California
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Priority to US201361906555P priority Critical
Priority to US61/906,555 priority
Application filed by The Regents Of The University Of California filed Critical The Regents Of The University Of California
Publication of WO2015077421A1 publication Critical patent/WO2015077421A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39Markers, e.g. radio-opaque or breast lesions markers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0409Instruments for applying suture anchors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0427Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors having anchoring barbs or pins extending outwardly from the anchor body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0464Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors for soft tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B2017/06052Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3904Markers, e.g. radio-opaque or breast lesions markers specially adapted for marking specified tissue
    • A61B2090/3908Soft tissue, e.g. breast tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3925Markers, e.g. radio-opaque or breast lesions markers ultrasonic
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3966Radiopaque markers visible in an X-ray image

Abstract

A system for depositing a hook at a target within a soft tissue system features a hook having a distal hook end and a proximal hook end. The proximal hook end attaches to a string. The system features a needle having a distal needle end and a proximal needle end. The hook is embedded within the needle. The distal needle end is pierced into soft tissue of a patient at a needle depth. The distal hook end is expelled into the soft tissue of a patient at a target. The needle is extracted from the soft tissue of the patient leaving the hook lodged at the target. The string remains attached to the hook extending from the proximal hook end out and away from an external surface of the soft tissue of the patient.

Description

SYSTEM AND METHOD FOR DEPOSITING A HOOK AT A TARGET WITHIN A SOFT TISSUE

CROSS REFERENCE

[0001] This application ciairns priority to U.S. Provisional Patent Application No. 61/906,555, filed November 20, 2013, the specification(s) of which is/are incorporated herein in their entirety by reference.

FIELD OF THE INVENTION

[0002] The present invention relates to equipment and methods for depositing a hook at a target within a soft tissue, commonly used in needle-localized biopsies.

BACKGROUND OF THE INVENTION

[0003] A common surgical biopsy procedure involves the extraction of a sample of suspicious tissue or tumor through the use of a thin metal surgical tool known as a guidewire. For example, in the case of breast tumors, guidewires are inserted by radiologists to the site of nonpalpable breast lesions, where they secure the nearby tissues and or tumors. This helps surgeons to locate and remove tumors while disturbing healthy breast tissues as little as possible.

[0004] A problem with these wire localization procedures is that complications may occur due to the type of guidewire being used. Wire fracturing, melting, or dislocation after insertion may occur in up to twenty percent of these common biopsy procedures. The rigid metal wire protruding from the body can move away from its original location by a simple bump or movement exerted on the wire, which will eventually lead to inadequate or inaccurate tissue removal. A puncture danger also exists from protruding wire that can enter into other soft tissue. In addition, when in contact with the electric cauterizer, the metal wire and the tissue altogether form a closed circuit loop, which generates heat that can cause the wire to melt or fracture. Wire fragments resulting from melting and breakage might be left in the body for months or even years.

[0005] In response to this unfortunate reality, a need exists for an innovative surgical tool to facilitate safer, more stable, and more accurate biopsy procedures. The present invention features a nonconductive and flexible string tail to eliminate the incidence of fracture and melting, and along with its unique insertion support system it will promote accurate string placement without dislocation of the hook via disarticulation by the string,

[0006] Any feature or combination of features described herein are included within the scope of the present invention provided that the features included in any such combination are not mutually inconsistent as will be apparent from the context, this specification, and the knowledge of one of ordinary skill in the art. Additional advantages and aspects of the present invention are apparent in the following detailed description and claims.

SUMMARY OF THE INVENTION

[0007] The present invention features a system for depositing a hook at a target within a soft tissue. In some embodiments, the system comprises a hook having a distal hook end and a proximal hook end. In some embodiments, the proximal hook end attaches to a string. The system comprises a needle having a distal needle end and a proximal needle end. In some embodiments, the hook is embedded within the needle.

[0008] In some embodiments, the distal needle end is pierced into soft tissue of a patient at a needle depth. In some embodiments, the distal hook end is expelled into the soft tissue of a patient at a target. In some embodiments, the needle is extracted from the soft tissue of the patient leaving the hook lodged at the target. In some embodiments, the string remains attached to the hook extending from the proximal hook end out and away from an external surface of the soft tissue of the patient.

[0ΘΘ9] Without wishing to limit the invention to any particular design or mechanism, it is believed that some of the advantages of the present invention are that: (1 ) non- conductive thread (or suture) does not heat up, melt and/or break like that of the traditional wire-hook system; and (2) the collapsible thread of the thread-hook system is not susceptible to an accidental co-axial force along the length of the thread that could unintentionally impel the hook deeper into the soft tissue and remove it from the original target.

BRIEF DESCRIPTION OF THE DRAWINGS

[0010] FIG. 1 shows a cross-sectional view of the present invention featuring a progression of expelling the hook.

[0011] FIG. 2 shows a perspective view of the present invention.

[0012] FIG. 3 shows a side view of the present invention while expelling the hook at the target.

[0013] FIG. 4 shows a side view of the present invention while extracting the needle and leaving the hook at the target.

[0014] FIG. 5 shows an alternate embodiment of the present invention featuring a three-barb hook and a plunger having an opening to accommodate the third barb.

[0015] FIG. 6 shows an alternate embodiment of the present invention featuring a modified hook with a perpendicular block wire and a plunger having a conical tip.

[0016] FIG. 7 shows an alternate embodiment of the present invention featuring a plunger having a conical tip and an external stop near a proximal end.

[0017] FIG. 8 shows an alternate embodiment of the present invention featuring a plunger that is partially open along the length of the plunger.

DESCRIPTION OF PREFERRED EMBODIMENTS

[0018] Following is a list of elements corresponding to a particular element referred to i herein:

[0019] 100 System

[0020] 1 10 Hook

[0021] 1 1 1 Distal hook end

[0022] 1 12 Proximal hook end

[0023] 1 13 Hook ledge

[0024] 1 14 Hook shank

[0025] 120 String

[0026] 130 Needle

[0027] 131 Distal needle end

[0028] 132 Proximal needle end

[0029] 140 Plunger

[0030] 141 Distal plunger end

[0031] 150 Barb

[0032] 151 Distal barb end

[0033] 152 Proximal barb end

[0034] 180 Base [0035] 170 Stopper

[0036] Referring now to F!Gs. 1-8, the present invention features a system (100) for depositing a hook (1 10) at a target within a soft tissue. In some embodiments, the system (100) comprises a hook (1 10) having a distal hook end (11 1 ) and a proximal hook end (1 12). The proximal hook end (1 12) attaches directly or indirectly to a string (120). In other embodiments, the proximal hook end (1 12) attaches to a string (120) via an epoxy mixture. In one embodiment, the proximal hook end (1 12) attaches to a string (120) via an epoxy mixture that includes titanium dioxide. In another embodiment, the proximal hook end (1 12) attaches to a string (120) via an epoxy mixture that includes titanium dioxide in a polyimide sheath.

[0037] As used herein, a "string" may include a braided wire, a nylon coated wire. In preferred embodiments, the "string" may be a highly durable synthetic fiber such as an aramid synthetic fiber. Non-limiting examples of aramid synthetic fibers include KEVLAR, TWARON, TECHNORA, or NOMEX. In one embodiment, KEVLAR may be used as a core material for a suture with a different material coated on the surface of the "core" for added protection. Strong surgical sutures comprise composite materials. Non-limiting alternatives of suture materials may include Polygiactin 910 (Vicryl), Polig!ecaprone 25 (Monocryl), Nylon, silk or Teflon (PTFE). Other suture materials may include materials having aromatic polyamide groups or materials having a strong polyoiefin group, such as polyethylene or polypropylene. Any string having the coilapsibility characteristics the same as that mentioned herein may be used in accordance with the present invention.

[0038] In some embodiments, the system (100) comprises a needle (130) having a distal needle end (131 ) and a proximal needle end (132). In one embodiment, the needle (130) is a hollow needle. In another embodiment, the distal needle end (131 ) is pointed.

[0039] In some embodiments, the hook (1 10) is slidabiy embedded within the needle (130). In other embodiments, the hook (1 10) is retracted within the needle (130). As examples only, a hook comprising more or less barbs than a double-barb hook may be used in the present invention. [0040] In some embodiments, the distal needle end (131 ) is pierced into soft tissue of a patient at a desired needle depth. Then, the distal hook end (11 1 ) is expelled into the soft tissue of the patient a desired hook depth at a target. In some embodiments, the needle (130) is extracted from the soft tissue of the patient leaving the hook (1 10) lodged at the target. Preferably, the string (120) remains attached to the hook (110) extending from the proximal hook end (1 12) out and away from an external surface of the soft tissue of the patient. The string may be collapsible, which inhibits the transfer of co-axial force along the length of the string to the distal needle head. As used herein, the term "collapsible" is defined as not having sufficient rigidity for transmitting a co-axial force down the length of the string to affect a dislocation of the hook. Such coliapsibility is critical in that it prevents an accidental pushing of the hook deeper or away from the target, when an unintentional co-axial force is applied to the string.

[0041] Table 1 below provides non-limiting examples of suture materials and their bending stiffness:

TABLE 1

Figure imgf000006_0001

[0042] In one preferred embodiment, the suture should not be too pliant since the markers along the suture should remain straight during the imaging process and tissue removal. An extra stiff suture may be utilized since it would still be much softer than a metal wire. A stiff suture is usually hard to knot, but since the sutured-hook does not need to be knotted, extra stiffness in the suture would not affect the user performance.

[0043] In some embodiments, a bending stiffness coefficient of a suture is between about 2.0x102 to 1.5x107 kg/cm2. Sn some embodiments, the bending stiffness coefficient of a suture is between about 2.5x102 to 1.0x10'7 kg/cm2. In a preferred embodiment, the bending stiffness of a suture is at least about 2,0x1 kg/cm2. In another embodiment, the minimum bending stiffness of a suture is between about 2.0x10" to 3.0x105 kg/cm2. Compared to the stiffness of the suture materials in Table 1 , the stiffness of steel may be greater by a factor of two. A bending stiffness value in a range between that of the materials in Table 1 and that of steel could significantly reduce the forward directional force on the hook. The bending stiffness of a suture material may range between about 2.0x102 to 5x10b kg/cm2. In another embodiment, the bending stiffness of a suture material may range between about 3.0x10ΰ to 8x105 kg/cm2. In a preferred embodiment, the maximum bending stiffness of a suture is between about 5x10b to 8x1 Qb kg/cm2. In one embodiment, the bending stiffness is at most 8x105 kg/cm2.

[0044] In alternative embodiments, the bending stiffness may range between about 1.0x102 to 1.0x103 kg/cm2. In some embodiments, the bending stiffness may range between about 1 .0x103 to 1 .0x104 kg/cm2, in other embodiments, the bending stiffness may range between about 1 .0x104 to 1 .0x10b kg/cm2. In some embodiments, the bending stiffness may range between about 1 .0x105 to 1.0x10¾ kg/cm2. In other embodiments, the bending stiffness may range between about 1.0x106 to 1 .0x107 kg/cm2.

[0045] The stiffness of a suture may further depend on its material of construction. For example, monofilament sutures typically have a higher stiffness than the braided sutures. Coated sutures are slightly stiffer than the non-coated sutures.

[0046] Since the bending stiffness may depend on the cross-sectionai area of the suture, another measurement of a material's stiffness would be the modulus of elasticity (E), which is simply a material specific property. The modulus of elasticity for sutures may range from about 0.5 GPa to 20 GPa. Sn a one embodiment, E may range from about 0.5 to 3.0 GPa. Sn a preferred embodiment, E may range from about 1.0 to 2.0 GPa. The bending stiffness is the product of E and the area moment of inertia (I) of the suture. Assuming that a suture can be considered as a general cylinder, then I is equal to (ir/2)*(r4) and is perpendicular to a surface of the cylinder. Assuming that the hook end and the suture tip share the same configuration and thus have the same !, and knowing the modulus of elasticity of the hook and the suture material, then the difference of the bending stiffness of the two components may be calculated. Therefore, E and the bending stiffness essentially describe the suture stiffness in the same manner.

[0047] Another property that may be used to quantify the suture would be the knot tenacity (knot strength), which is the strength of the material when a knot is present. A common range for the knot tenacity is between about 1 to 20 grams per denier.

[0048] In some embodiments, the system (100) further comprises a plunger (140). The plunger may be located within the needle (130). In one embodiment, the plunger (140) may be pushed through the needle (130) to expel the hook (1 10). In another embodiment, the plunger (140) is manually pushed through the needle (130) to expel the hook (1 10). In some embodiments, the plunger (140) is hollow. The hook (110) and string (120) may be located within the plunger (140). As shown in Figure 8, a plunger may be at least partially or entirely open along its length. The plunger may facilitate the expulsion of the hook from the needle by pushing on the hook directly or indirectly.

[0Θ49] In some embodiments, the hook (1 10) comprises a hook ledge (1 13) disposed on the proximal hook end (1 12) thereon. A distal plunger end (141 ) may interface directly or indirectly with hook ledge (1 13) to expel the hook (1 10) into the soft tissue at or near the target.

[0050] In some embodiments, the hook (1 10) is constructed from stainless steel. In alternative embodiments, the hook (110) may be constructed from memory metals such as Nickel Titanium. In some embodiments, the hook (1 10) is constructed from an electrically non-conductive material. In other embodiments, the hook (1 10) is constructed from a thermally non-conductive material, in another embodiment, the hook (1 10) is constructed from a material electrically and thermally less conductive than metal. [0051] In some embodiments, the hook (1 10) is barbed. The hook (1 10) may comprise a first barb (150) disposed thereon and a second barb (150) disposed thereon opposed to the first barb (150). In some embodiments, the first barb (150) and the second barb (150) may retract.

[0052] In some embodiments, the barb (150) is linear. A distal barb end (151 ) may be disposed on the distal hook end (11 1 ). The distal barb end (151 ) may be angularly disposed on the distal hook end (1 1 1 ). In some embodiments, the angle is between 15 degrees and 75 degrees, for example 30, 45, or 60 degrees. In another embodiment, a distal barb end (151 ) is disposed on a hook shank (1 14). A proximal barb end (152) may be disposed at a distance offset from the hook shank (1 14). In one embodiment, the barb (150) on the hook (1 10) resembles a "J" shape. In another embodiment, the first barb (150) and the second barb (150) on the hook (1 10) resembles two "J" shapes, back to back.

[0053] In some embodiments, the barb (150) is spring biased with respect to the hook shank (1 14). The barb (150) may spring into an extended position upon expulsion from the needle (130).

[0054] In some embodiments, the string (120) is constructed from an electrically non- conductive material. In other embodiments, the string (120) is constructed from a thermally non-conductive material. The string (120) may be constructed from a material electrically and thermally less conductive than metal. In another embodiment, the string (120) is constructed from polyester. In one embodiment, the string (120) is a suture. In another embodiment, the string is a thread. The string may be constructed from a material that allows for the string to collapse upon itself if it is co-axialiy pushed from along the length of the string. This effectuates a disarticulation between an accidental force and the hook such that a direct forward force on the string does not impel the hook deeper into the tissue and away from the target.

[0055] In some embodiments, the string (120) is incrementally marked for visibility. The string (120) may be aitematingiy marked for visibility. In one embodiment, the string (120) is marked via echogenic markers. In another embodiment, the string (120) is marked via radiopaque markers. The string (120) may be incrementally marked via gold. In another embodiment, the string (120) is incrementally marked via sputter coating with gold in alternating bands, for example, a gold band followed by an unmarked band, followed by another gold band. The bands may be about 1 cm wide.

[0056] In some embodiments, the system (100) further comprises a base (160) disposed on the needle (130) thereon. The base (180) comprises a distal end, and a proximal end. The base (180) may comprise a shape of a loop having a cross support located thereon. In some embodiments, the base (160) is constructed from silicone rubber.

[0057] In some embodiments, the base (180) is pivotally disposed on the needle (130) thereon. The distal end of the base (180) may be pivotally disposed on the needle (130) thereon. The proximal end of the base (160) may be detachably disposed on the plunger (140) thereon. A distance between the distal end and the proximal end of the base (180) may be fixed.

[0058] In some embodiments, the system (100) further comprises a plunger (140). The plunger (140) may be a cannula. The plunger (140) may be pushed through the needle (130) to expel the hook (1 10). In some embodiments, the system (100) further comprises a stopper (170) adjustably disposed on the plunger (140) for interfacing with the base (160) to control the hook depth when expelling the hook (1 10) into the soft tissue of the patient. The stopper (170) may interface with the proximal end of the base (160) to secure the hook before expelling the hook (1 10) into the soft tissue of the patient. In another embodiment, the stopper (170) interfaces with the distal end of the base (160) to control the hook depth when expelling the hook (1 10) into the soft tissue of the patient. The stopper (170) may be constructed from silicone rubber.

[0059] In some embodiments, the hook (1 10) may be constructed from stainless steel. The needle (130) may be constructed from stainless steel. In some embodiments, the plunger (140) may be constructed from stainless steel or polyimide.

[0060] In an alternate embodiment, heat-shrink materials may be utilized for bonding the hook (1 10) to a suture. The heat-shrink material may be used with a suture constructed from TEFLON (PTFE) material. [0061] In some embodiments, the present invention features a method of depositing a hook (1 10) at a target within a soft tissue. As a non-limiting example, the method may comprise the steps of providing a hook (1 10) having a distal hook end (1 1 1 ) and a proximal hook end (1 12), providing a needle comprising a distal needle end (131 ) and a proximal needle end (132), embedding the hook (1 10) in the needle (130), piercing the distal needle end (131 ) into the soft tissue, expelling the hook (110) at the target, and extracting the needle (130) and leaving the hook (1 10) at the target. In some embodiment, the proximal hook end (1 12) attaches to a string (120).

[0062] In some embodiments, the method may further comprise providing a plunger (140) and pushing the plunger (140) through the needle (130) to expel the hook (1 10). In one embodiment, the plunger (140) is hollow. The string (120) may reside within the hollow plunger (140).

[0063] In addition to the above disclosed features, the present invention may also have double-barb hook tip to properly secure the tissue surrounding the abnormality; a nonconductive polyester string tail marked at 1 cm increments with gold bands, and a secure attachment piece. The multi-hook tip will reduce incidences of dislocation following insertion, the elimination of the metal tail will prevent tail fracture, the gold bands will precisely specify the lesion's spatial location, and the epoxy attachment with titanium dioxide will ensure visibility under ultrasound. Finally, the present invention with the insertion cannula and the needle may be packaged altogether with the aid of a bendable clamp.

[0Θ64] The present invention may include a multi-pronged needle with a flexible suture like tail (e.g., string). The needle is not conductive and the suture portion essentially disarticulates the needle from moving once it is placed. Bands are located on the suture to help judge distance from tumor as well as titanium dioxide used ultrasound enhancement. One significant feature of the present invention is that it is conducive to being a single hand insertion device.

[0065] In an alternate embodiment as shown in Fig. 5, the present invention features a three-barb branched hook at the tip of the string. The first two barbs mimic the spring-like quality of a single barb J-hook, while the third barb is located about 2 cm distal to a tip of the string. The third barb is used to secure the string inside of the plunger. The plunger is manufactured with a circular opening (-0.25 cm in radius), located 1 cm away from a proximal end. To assemble the device, the three barbs can be pinched against the string to form a linear string, and then the string can be threaded down through the plunger until the first two barbs are released from the other end, and the third barb can be fitted through the hole out the side of the plunger to latch the hook and plunger together.

[0066] In an alternate embodiment as shown in Fig. 8, the present invention features a tapered tip at the proximal end of the plunger, resembling a cone-shape. The complementary hook design comprise two barbs mimicking single barbed J-hooks, and a third segment of wire positioned perpendicular to the axis of the hook shank, 1 cm away from the tips of the two barbs. The perpendicular wire segment serves to block the plunger from sliding past the barbs at the tip of the hook, which would interfere with the successful release and attachment of the sutured-hook into the tissue. To assemble the string and plunger, the distal end of the suture must be back threaded through the plunger from cone-tip to distal end.

[0067] In an alternate embodiment as shown in Fig. 7, the present invention features a two-J-hook wire tip, and stemming from the hook is a 3 cm length of string segmented with radiopaque markers at every 0.5 cm interval. The plunger is manufactured with the cone-tip described above and shown in Fig. 6, but with the addition of a stop formed as a bump in the poiyimide material, 6 cm from the proximal tip of the plunger. The purpose of the stop is to facilitate optimal hook penetration with respect to the tip of the needle. The hook is fitted into the plunger by sliding the distal end of the string into the proximal end of the plunger, and folding the suture next to the hooks and out again through the plunger tip. Next, the suture dangling from the cone-tip of the plunger is wrapped up the side of the plunger until it reaches the distal end, where the excess suture will remain outside of the body, coiled and taped with a small square of gauze.

[0068] In an alternate embodiment as shown in Fig. 8, the plunger is constructed such that the plunger is partially open along the length of the plunger. The partially open section of the plunger taken at a co-axial cross-section of the plunger may be an arc having a central angle of between about 5° to 180°.

[0069] As used herein, the term "about" refers to plus or minus 10% of the referenced number. [0070] The disclosures of the following U.S. Patents are incorporated in their entirety by reference herein: U.S. Patent Pub. No. 2013/0228237.

[0071] Various modifications of the invention, in addition to those described herein, will be apparent to those skilled in the art from the foregoing description. Such modifications are also intended to fall within the scope of the appended claims. Each reference cited in the present application is incorporated herein by reference in its entirety.

[0072J Although there has been shown and described the preferred embodiment of the present invention, it will be readily apparent to those skilled in the art that modifications may be made thereto which do not exceed the scope of the appended claims. Therefore, the scope of the invention is only to be limited by the following claims. Reference numbers recited in the claims are exemplary and for ease of review by the patent office only, and are not limiting in any way. In some embodiments, the figures presented in this patent application are drawn to scale, including the angles, ratios of dimensions, etc. In some embodiments, the figures are representative only and the claims are not limited by the dimensions of the figures. In some embodiments, descriptions of the inventions described herein using the phrase "comprising" includes embodiments that could be described as "consisting of", and as such the written description requirement for claiming one or more embodiments of the present invention using the phrase "consisting of" is met.

[0073] The reference numbers recited in the below claims are solely for ease of examination of this patent application, and are exemplary, and are not intended in any way to limit the scope of the claims to the particular features having the corresponding reference numbers in the drawings.

Claims

WHAT IS CLAIMED IS:
1. A system (100) for depositing a hook (1 10) at a target within a soft tissue, the system (100) comprising:
(a) a hook (1 10) having a distal hook end (1 1 1 ) and a proximal hook end (1 12), wherein the proximal hook end (1 12) attaches to a string (120); and
(b) a needle (130) having a distal needle end (131 ) and a proximal needle end (132); wherein the hook (1 10) is s!idably embedded within the needle (130); wherein the distal needle end (131 ) is pierced into soft tissue of a patient at a needle depth, wherein the distal hook end (1 11 ) is expelled into the soft tissue of the patient a hook depth at a target, wherein the needle (130) is extracted from the soft tissue of the patient leaving the hook (1 10) lodged at the target, wherein the string (120) remains attached to the hook (1 10) extending from the proximal hook end (1 12) out and away from an external surface of the soft tissue of the patient.
2. The system (100) of claim 1 , wherein the system (100) further comprises a plunger (140), wherein the plunger (140) is pushed through the needle (130) to expel the hook (1 10),
3. The system (100) of claim 2, wherein the plunger (140) is hollow.
4. The system (100) of claim 3, wherein the hook (1 10) comprises a hook ledge (1 13) disposed on the proximal hook end (1 12) thereon, wherein a distal plunger end (141 ) interfaces with hook ledge (1 13) to expel the hook (1 10).
5. The system (100) of claim 1 , wherein the hook (1 10) is constructed from stainless steel.
6. The system (100) of claim 1 , wherein the hook (1 10) is barbed, wherein the hook (1 10) comprises a first barb (150) disposed thereon and a second barb (150) disposed thereon opposed to the first barb (150).
7. The system (100) of claim 6, wherein the barb (150) is linear, wherein a distal barb end (151 ) is angularly disposed on the distal hook end (1 1 1 ), wherein a proximal barb end (152) is disposed at a distance offset from a hook shank (1 14).
8. The system (100) of claim 6, wherein the barb (150) is spring biased, wherein the barb (150) springs into an extended position upon expulsion from the needle (130).
9. The system (100) of claim 1 , wherein the string (120) is constructed from an electrically non-conductive material, wherein the string (120) is constructed from a thermally non-conductive material.
10. The system (100) of claim 1 , wherein the string (120) is alternatingiy marked for visibility via a radiopaque or echogenic marker.
1 1 . The system (100) of claim 1 , wherein the system (100) further comprises a base (160) disposed on the needle (130) thereon.
12. The system (100) of claim 1 1 , wherein a distal end of the base (160) is pivotaily disposed on the needle (130) thereon, wherein a proximal end of the base (160) is detachably disposed on the plunger (140) thereon.
13. The system (100) of claim 1 1 , wherein the base (160) is constructed from silicone rubber.
14. The system (100) of claim 1 1 , wherein the system (100) further comprises a plunger (140), wherein the plunger (140) is pushed through the needle (130) to expel the hook (1 10), wherein the system (100) further comprises a stopper (170) adjustably disposed on the plunger (140) for interfacing with the base (160) to control the hook depth when expelling the hook (1 10) into the soft tissue of the patient.
15. A method of depositing a hook (1 10) at a target within a soft tissue, the method comprising:
(a) providing a hook (1 10) having a distai hook end (1 1 1 ) and a proximal hook end (1 12), the proximal hook end (1 12) attaches to a string (120);
(b) embedding the hook (1 10) in a needle (130), the needle (130) having a distal needle end (131 ) and a proximai needie end (132);
(c) piercing the distal needle end (131 ) into the soft tissue:
(d) expelling the hook (1 10) at the target; and
(e) extracting the needle (130) and leaving the hook (1 10) at the target.
16. The method of claim 15, wherein a plunger (140) is pushed through the needie (130) to expel the hook (110).
17. The method of claim 16, wherein the plunger (140) is hollow.
18. The method of claim 17, wherein the string (120) resides within the hollow plunger (140).
PCT/US2014/066558 2013-11-20 2014-11-20 System and method for depositing a hook at a target within a soft tissue WO2015077421A1 (en)

Priority Applications (2)

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US201361906555P true 2013-11-20 2013-11-20
US61/906,555 2013-11-20

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5647874A (en) * 1982-05-20 1997-07-15 John O. Hayhurst Anchoring and manipulating tissue
US6306156B1 (en) * 1997-11-20 2001-10-23 Ron Clark Meniscus repair anchor system
US20070112385A1 (en) * 2005-11-15 2007-05-17 Conlon Sean P Expandable suture anchor
US20100324596A1 (en) * 2002-03-14 2010-12-23 Jeffrey Eric Yeung Method for anchoring suture and approximating tissue
US20110264138A1 (en) * 2008-05-16 2011-10-27 Angiotech Pharmaceuticals, Inc. Coded heterofunctional sutures and methods

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5647874A (en) * 1982-05-20 1997-07-15 John O. Hayhurst Anchoring and manipulating tissue
US6306156B1 (en) * 1997-11-20 2001-10-23 Ron Clark Meniscus repair anchor system
US20100324596A1 (en) * 2002-03-14 2010-12-23 Jeffrey Eric Yeung Method for anchoring suture and approximating tissue
US20070112385A1 (en) * 2005-11-15 2007-05-17 Conlon Sean P Expandable suture anchor
US20110264138A1 (en) * 2008-05-16 2011-10-27 Angiotech Pharmaceuticals, Inc. Coded heterofunctional sutures and methods

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