The present disclosure, in some embodiments thereof, relates to devices and methods for passing artifacts (e.g., wires or sutures) around target tissues within a body of a subject, and more particularly, but not exclusively, to devices and methods for encompassing a tissue mass (e.g., tumor) with a tension member applicable for causing ischemia and/or necrosis thereto.
A uterine fibroid (also referred to as a “myoma”) is a benign tumor that is fed by the uterine artery and grows within the muscle tissue of the uterus. Myomas are solid fibrous tissue growing as a single nodule or in clusters and may range in size from about 1 mm to more than 20 cm in diameter. Myomas are the most frequently diagnosed tumor in the female pelvis and the most common reason for a woman to undergo hysterectomy. The prevailing symptoms of myomas include heavy menstrual bleeding, prolonged menstrual periods, pelvic pressure or pain and lower urinary tract symptoms (LUTS).
The present disclosure, in some embodiments thereof, relates to devices and methods for passing artifacts (e.g., wires or sutures) around target tissues within a body of a subject, and more particularly, but not exclusively, to devices and methods for encompassing a tissue mass (e.g., tumor) with a tension member applicable for causing ischemia and/or necrosis thereto.
In certain embodiments, there is provided an apparatus for passing a tension member around a volumetric region of an organ. The apparatus may include at least one of:
(a) a rigid outer tube comprising a sharp outer tube tip and an outer tube lumen with an outer tube opening in proximity to the outer tube tip;
(b) an inner needle comprising an elastic needle body curved at least in part thereof, the inner needle ending with a sharp needle tip and enclosing an inner needle lumen with an inner needle opening being in proximity to the needle tip, the inner needle body being configured to pass straightened through the outer tube lumen and to partially protrude via the outer tube opening, such that a protruding portion of the inner needle body is allowed to voluntarily flex to a curved form having diameter equal to or greater than diameter of the volumetric region; and
(c) a tension member passer comprising a tension member passer body, sized for passing through the inner needle lumen, and a tension member pulling portion configured for engaging with a portion of the tension member and for continuously applying a pulling force to the engaged portion of the tension member when the tension member is withdrawn with the tension member passer;
In some embodiments, the apparatus is configured for forming a passage through the organ, the passage extending along a plane crossing the volumetric region from an entry point at a surface of the organ, located in front of a first side of the volumetric region, to an exit point at the surface of the organ, located in front of a second side of the volumetric portion opposite to the first side, and the apparatus is further configured for passing the tension member around the volumetric region by pulling the tension member from the exit point to the entry point through the passage.
In some embodiments, the volumetric region of the organ includes a tissue mass comprising at least a portion of a tumor.
In some embodiments, the outer tube is movable relative to a covering portion of the apparatus until the outer tube tip extends a chosen uncovered length from a distal edge of the covering portion, the distal edge is configured to resist penetration into soft tissue to inhibit insertion of the outer tube to a depth greater than the uncovered length.
In some embodiments, the needle body includes a first segment having a first centerline, and a second segment having a second centerline, the second segment adjoins with a proximal end thereof to a distal end of the first segment and with a distal end thereof to a proximal end of a tip segment, wherein, when the needle body is in an unstressed relaxed form, the first centerline has a first radius of curvature, at least along a portion thereof being adjacent to the first segment distal end, and the second centerline has a second radius of curvature, at least along a portion thereof being adjacent to the second segment proximal end, the second radius of curvature is smaller than the first radius of curvature.
In some embodiments, a ratio between the second radius of curvature and the first radius of curvature is within a range of 1/10 to ⅓.
In some embodiments, when the needle body is in the unstressed relaxed form, the first segment subtends a first subtended angle and/or the second segment subtends a second subtended angle, wherein the second subtended angle is smaller than the first subtended angle.
In some embodiments, the first subtended angle is within a range of 200° to 300°, and/or the second subtended angle is within a range of 10° to 80°.
In some embodiments, the first radius of curvature is within a range of 15 mm to 45 mm when the needle body is in the unstressed relaxed state.
In some embodiments, the elastic needle body is configured with elastic resistance to straightening within a range of 2 N to 20 N.
In some embodiments, the apparatus is configured such that the protruding portion exits the outer tube opening with a needle exit angle δ within a range of 10° to 80°, relative to the outer tube.
In some embodiments, the tension member passer body is flexible and elastic.
In some embodiments, the tension member pulling portion includes a securing member forming a loop with the tension member passer body.
In some embodiments, the tension member passer body has a curved or bent portion forming a deviated distal end portion inclined relative to remainder of the tension member passer body.
In some embodiments, the deviated tension member passer distal end portion forms with rest of the tension member passer body a deviation angle within a range of 15° to 55°.
In some embodiments, the tension member pulling portion includes a securing wire portion extending from a first location on the tension member passer body, distally to the curved or bent portion, to a second location on the tension member passer body, proximally to the curved or bent portion.
In some embodiments, the securing wire portion is similar in length to length of a segment of the tension member passer body extending from the first location to the second location.
In some embodiments, the securing wire portion is configured to undergo increased tension when the deviated tension member passer distal end portion is forced to align with rest of the tension member passer body.
In some embodiments, the deviated tension member passer distal end originates at the first location and extends in a straight form at least 10 mm in length.
In some embodiments, the curved or bent portion of the tension member passer body is configured with elastic resistance to straightening within a range of 0.1 N to 1 N.
In some embodiments, the apparatus further comprising a console, optionally formed as a handheld device.
In some embodiments, the apparatus further comprising an inner needle protrusion controller configured to operatively control advancement of the inner needle within the outer tube.
In some embodiments, the apparatus further comprising a tension member passer protrusion controller configured to operatively control advancement of the tension member passer body within the inner needle.
In some embodiments, the apparatus further comprising a forceps head fixedly positioned distally to the console and activatable via the console, configured for selective grasping of the organ adjacent to the entry point and/or the exit point, for holding the grasped organ at a fixed distance relative to the console.
In some embodiments, the forceps head is configured in a form of tenaculum having two hinged tenaculum arms, each tenaculum arm includes a slender sharp-pointed hook configured to penetrate through the organ surface into the organ when the forceps head is operated to grasp the organ surface.
In some embodiments, the outer tube is slidable distally relative to the forceps head such that the outer tube tip is extendable distally beyond the forceps head, wherein the apparatus is configured to prevent extension of the outer tube tip distally beyond the forceps head over a predetermined maximal penetration depth.
In certain embodiments, there is provided a method for passing a tension member around a volumetric region of an organ. The method may include at least one of the following steps (not necessarily in the listed order):
In some embodiments, the drawing includes extending the tension member around the volumetric region such that one end of the tension member projects from the entry point and another end of the tension member projects from the exit point.
In some embodiments, the organ is an internal organ located within a body of a live subject, and the method further comprising forming a surgical route from outside the body of the subject and delivering the outer tube through the surgical route until the outer tube tip reaches the organ.
In some embodiments, the organ is a uterus.
In some embodiments, the volumetric region of the organ includes a tissue mass comprising at least a portion of a tumor.
In some embodiments, the method comprising ending the piercing with positioning the needle tip at a chosen distance from the surface of the organ, so as to form a needle tip angle between the needle tip and the surface of the internal body region.
In some embodiments, the distance is smaller than 3 cm, and/or the needle tip angle is within a range of 10° to 60°.
In some embodiments, the defining includes defining a penetration angle between the outer tube and a perpendicular line to the surface of the internal body region at the entry point, wherein the protrusion length subtends a subtended angle is at least 270° minus the penetration angle.
In some embodiments, the penetrating, the passing, the piercing, the advancing and/or the securing is repeated, each repetition is performed using a different implanted tension member, a different entry point and a different exit point.
In some embodiments, the method comprising:
In some embodiments, the outer tube is slidably connected to a console and the forceps head is fixedly positioned distally to the console, wherein the outer tube is slidable distally relative to the forceps head such that the outer tube tip is extendable distally beyond the forceps head up to a predetermined maximal penetration depth.
All technical or/and scientific words, terms, or/and phrases, used herein have the same or similar meaning as commonly understood by one of ordinary skill in the art to which the invention pertains, unless otherwise specifically defined or stated herein. Exemplary embodiments of methods (steps, procedures), apparatuses (devices, systems, components thereof), equipment, and materials, illustratively described herein are exemplary and illustrative only and are not intended to be necessarily limiting. Although methods, apparatuses, equipment, and materials, equivalent or similar to those described herein can be used in practicing or/and testing embodiments of the invention, exemplary methods, apparatuses, equipment, and materials, are illustratively described below. In case of conflict, the patent specification, including definitions, will control.
Some embodiments are herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative description of some embodiments of some embodiments. In this regard, the description taken together with the accompanying drawings make apparent to those skilled in the art how some embodiments may be practiced.
In the drawings:
Certain embodiments relate to devices and methods for passing artifacts (e.g., wires or sutures) around target tissues within a body of a subject, and more particularly, but not exclusively, to devices and methods for surrounding or encompassing a tissue mass (e.g., tumor) with a tension member applicable for causing ischemia and/or necrosis thereto. One or more tension members are applied, according to methods described herein, around or through a target tumor, and are put under tensioning force in a manner that triggers, supports and/or induces tumor suppression.
A “tension member”, as referred to in current disclosure, relates to any flexible slender member that can withstand tension forces of at least 0.1 Kg, optionally at least 0.5 Kg, optionally at least 1 Kg, without failure (e.g., plastic deformation, tear, or breaking). In some embodiments in this disclosure, tension members cannot withstand significant compression and/or lateral forces without, breaking, collapsing or altering shape. Exemplary tension members may include medical or surgical grade wires, filaments or cables, such as sutures (e.g., biodegradable sutures) and cable ties.
In embodiments, tension members are deployed and directly affect (cause) a continuous pressure within the tumor (interstitial pressure), optionally above 22.5 mmHg, thus inhibiting blood flow into the tumor. Optionally, additionally or alternatively, tension members are deployed to path over blood vessels nourishing the tumor and are configured and taut sufficiently so as to impinge the blood vessels and block blood flowing therethrough. Blocking blood supply to the tumor for several hours leads to fibroid ischemia and eventually to necrosis of the tumor cells.
As described, the tension members can be placed around entire volume of the tumor (fibroid), optionally including portions of other tissues surrounding it, or around one or more smaller volumetric portions thereof. It may be advantageous to prefer the first option of surrounding the entire tumor (fibroid) and/or avoid passing a tension member across tumor volume especially due to sharp increase in density when entering the fibroid or the possibility the tumor is cancerous, so that puncturing therethrough increases risk of cancer spreading to surrounding tissues and blood system. Nevertheless, in some procedures it may be found advantageous to pass a tension member through the tumor such as in anatomies imposing difficulties to fully encompass the tumor.
Since that apparatus 50 is configured to pass tension members around a tissue mass such as fibroids, which can be of different sizes, shapes and/or depth (relative to surface of an internal body organ, for example), it may be advantageous in some scenarios to preset a penetration length, from within a range of allowed selectively fixable lengths, which is deriving from, and equal to, the uncovered length UL. This measured penetration of outer tube 51 will allow outer tube opening 54 to be positioned near the outer periphery of the target tissue mass, such that the protruding portion 66 of inner needle 55 can be curved beyond and around the distal boundaries of the tissue mass in proximity thereto. In some embodiments, uncovered length UL is determined in accordance with positioning outer tube opening 54 in proximity to a chosen part of the tissue mass, for example near its middle. Predetermining uncovered length UL may be performed in advance using analysis of invasive or noninvasive imagery.
The volumetric region VR is optionally circumscribed with at least one device of foreign origin relative to the patient, for example a tension member such as a surgical wire, wherein the volumetrically compressing the volumetric region VR and maintaining the elevated internal pressure are achieved via the at least one device. The treated tissue mass TM is optionally a uterine fibroid, and may be one of intramural, subserous or submucosal with respect to the organ it resides in. Optionally, at least a portion of the tissue mass TM is situated intramurally within the organ, and wherein passing the tension member within the organ comprises passing the tension member through an intramural portion of the organ. Passing the tension member through the intramural portion of the organ may comprise passing the tension member around the at least a portion of the tissue mass TM that is situated intramurally within the organ. In some such scenarios, passing the tension member within the organ may comprise passing the tension member exclusively through the intramural portion of the organ and/or the tissue mass TM between the entry point/opening and the exit point/opening.
In order to reach the surface of the organ and treat the tissue mass TM, a surgical access to the organ may be first created from outside the body, which may be formed using minimally invasive techniques or by way of open surgery, for example. At least one of the basic method steps can be performed via the surgical access. The entry point to the organ can be located at a first location on or adjacent to the tissue mass and the exit point can be located at a second location on or adjacent to the tissue mass spaced from the first location, such that the tissue mass TM is located between the entry and exit openings.
Prior to passing the tension member, a passage can be formed around the volumetric region VR and tissue mass TM between the entry and exit points, optionally also forming the entry and exit points (openings), such that the passing can be performed mostly or entirely within the passage, optionally by way of pulling the tension member via the exit point towards the entry point. The passage may be formed using apparatus 50 or any other applicable apparatus or mechanism. For example, an outer tube can be used to create the entry point and positioned through the entry point (opening) into the organ, in proximity to the tissue mass. A curved needle can then be advanced through a lumen of the outer tube around the volumetric region VR.
The volumetric region may be predetermined by a user (practitioner, physician, surgeon, etc.) and passing the tension member may be performed in close fit to and around the tissue mass. Determining the volumetric region may include determining entry and exit points to and from the organ in relation to the tissue mass, and possibly also a particular plane crossing the volumetric region VR and/or tissue mass TM. Passing the tension member may be along a predetermined passage line between the entry point and the exit point. The passage is configured to extend along a plane crossing the volumetric region from an entry point at a surface of the organ, located in front of a first side of the volumetric region, to an exit point at the surface of the organ, located in front of a second side of the volumetric portion opposite to the first side of the organ. The passage line optionally projects across one or more blood vessels feeding the tumor, such that the tightening of the tension member directly causes occlusion of the blood vessels, such as previously discussed.
Passing the tension member may include encompassing more than half a circumference of the tumor with the tension member, and/or it may include winding the tension member or a plurality of additional tension members along separate paths and/or planes around the volumetric region. In case of an additional volumetric region encompasses at least another portion of the tumor, passing the tension member may also include deploying a plurality of windings around the additional volumetric region. The volumetric region optionally encompasses most of a volume of the tissue mass, or its entirety.
The tension member optionally comprises a flexible strip or a wire, such as a suture wire, and may be formed of at least one of implant-grade metal alloy, implant-grade polymer, implant-grade textile, and biodegradable material. In certain embodiments, the tension member is configured with a yield strength or a maximal tension force of at least 25 N (newtons) in order not to prevent failing during tumor compression. Optionally the tension member is configured to yield above about 80 newton or about 100 N (newton) before it can cause cutting in organ tissues resulting from tumor compression by the tension member. Optionally, the tension member is formed as a biodegradable suture wire and is configured to yield under tensioning forces below 25 N (newtons) after the tumor tissues are ischemic or necrotic, for example after a few weeks or months.
With further reference to
In an optional preliminary step, the user (surgeon, practitioner, etc.) may determine a desired orientation for a tension member to pass within body region BR with respect to tissue mass TM. Such a calculated, selected, and/or predetermined orientation may be spatial or two-dimensional. The user may determine an at least one volumetric region VR which encompasses at least a portion of tissue mass TM. Optionally, alternatively or additionally, the user determines a plane crossing or passing through tissue mass TM on which points of entry and exit to and from the body region BR will be made. Optionally, a penetration depth D is defined, taken from an entry point P1 at surface OS relative to boundaries of tissue mass TM.
A suture passing mechanism, optionally part of apparatus 50, is then put into use. In some instances, a chosen uncovered length UL of outer tube 51 is first set or fixated, which uncovered length UL can be substantially equal to penetration depth D, by adequately withdrawing tube cover 409 (as described above). Alternatively, uncovered length UL is fixed and predetermined. Apparatus 50 is then passed via first laparoscopic opening O1 and then pressed with sharp outer tube tip 52 at a chosen direction against surface OS until penetrating the soft tissue of the body region BR in proximity to tissue mass TM (
Stated otherwise, in some instances, a plurality of inner needles 55 may be provided. Each needle 55 may have has a pre-curved region with a length and/or radius of curvature that differs from the lengths and/or radii of curvature of the remaining options. A user may choose one inner needle 55 out of the available plurality that will form a passageway of a desired shape, size, and/or orientation around the tumor. In some instances, the outer needle 55 is provided separately from one or more of the inner needles 55. In other instances, the outer needle or tube 51 and a plurality of inner needles 55 are provided together (e.g., are provided in a unitary kit).
As shown in
Inner needle 55 protrudes from outer tube opening 54 at predetermined distance proximally to penetration depth D (e.g., equal to about the size of tissue mass TM radius). Therefore, since outer tube opening 54 is configured as lateral opening, soft tissue penetrated with outer tube 51 is prevented from entering outer tube lumen 53; the inclined exit of inner needle 55 immediately at boundary of outer tube opening 54 increases the initial piercing power of inner needle 55 into soft tissue surrounding outer tube opening 54, relative to tangential exit; and the portion of outer tube 51 between outer tube opening 54 and outer tube tip 52 increases resistance of outer tube 51 to motions in reaction to inner needle 55 engagement with soft tissue laterally thereto.
Once the penetration depth D is determined, and optionally after outer tube 51 is accordingly positioned in internal body region BR along tissue mass TM, the chosen positioning of inner needle tip 57 and protrusion length of inner needle protruding portion 66 can be determined. In some embodiments, inner needle protruding portion 66 is required to surround a chosen portion of tissue mass TM perimeter (measured in an angle γ subtended by inner needle protruding portion 66), and needle tip 57 is required to be positioned at a chosen distance X from internal body region surface OS and/or at a chosen needle tip angle α formed between tangent projection of inner needle 55 at needle tip 57 and internal body region surface OS. In some embodiments, all dimensions are configured relative to largest cross section of tissue mass TM in a certain direction.
In some embodiments, needle tip angle α is equal to or smaller than 90°, optionally taken within a range of about 10° to about 60°, optionally about 30° to about 45°, so that further penetration by tension member passer 60 until emerging into abdominal cavity AC with tension member passer securing member 62 (as shown in
Subtended angle γ of inner needle protruding portion 66 is determined according to the target positioning of needle tip 57 relative to entry point P1 and tissue mass TM, as described, and it is also dependent on the magnitude of outer tube 51 penetration angle β (measured relative to perpendicular line to internal body region surface OS at entry point P1). Optionally, Subtended angle γ is greater than 180°−β, optionally particularly at least 225°−β, optionally particularly at least 270°−β.
After formation of the curved portion of the path via the inner needle 55, the tension member passer 60, which may optionally be pre-loaded within inner needle 55, is advanced through inner needle lumen 58 and out of inner needle opening 59 until securing member 62 portion exits internal body region BR at an exit point P2, which can be spaced from (e.g., opposingly located relative to) entry point P1, relative to tissue mass TM (
in certain embodiments, tension member S is inserted into abdominal cavity AC through first or second surgical opening O1, O2 (in this example, first opening O1, alongside, through or with apparatus 50) as shown in
Apparatus 50 is then pulled out from inner body region BR while drawing the captured tension member S, and then removed from patient's body. As a result, tension member S can be left extended around volumetric region and/or tissue mass TM such that one portion or end 67 of tension member S extends from entry point P1 through abdominal cavity AC and out of patient's body, and another portion or end 68 of tension member S extends from exit point P2 through abdominal cavity AC and out of patient's body (
Some or all steps can repeated, each repetition performed using a different implanted suture, a different entry point and a different exit point.
Apparatus 100 includes an inner needle 105 (shown in detail in
Apparatus 100 also includes a tension member passer 110 (shown in detail in
Apparatus 100 further includes a console 113 in a form of a handheld device, and is equipped with a first control 114 formed as a knob for activating an outer tube uncovering mechanism 115 (shown in detail in
First control 114 is operatively connected to outer tube cover sheath 120 using an uncovering mechanism rack and pinion actuator 121 connected to a push rod 122 (for transmitting knob rotation motions to push rod linear motions). The knob constructed control 114 is finger-operated by forward or backward rotation to force corresponding linear motion of push rod 122 that is fixedly connected to cover sheath 120 and transmits thereto the motions applied via first control 114. Cover sheath 120 is slidable over outer tube 101 between a proximal-most position (shown in
A distal segment 125, which ends with needle tip 106, adjoins curved segment 124 with a bending 129 (optionally an inward bending, inclined towards center of curvature of curved segment 124) having a bending angle θ within a range of 5° to 25° relative to a tangent projection to curved segment 124 at bending 129. Distal segment 125 includes an outer curved side 148 and an inner straight side 149, adjoining with the sharp needle tip 106. Inner straight side 149 encloses the inner needle opening, such that the opening is positioned laterally to needle tip 106, and inwardly (at least partially towards center of curved segment 124), when inner needle 105 is pushed through soft tissue via outer tube 101. Inner needle 105, with distal segment 125 thereof, is configured such that protruding portion 109 of inner needle 105 exits outer tube opening 104 with a needle exit angle δ within a range of 10° to 80°, optionally within a range of 20° to 50°, relative to outer tube 101 (as shown in
Tension member passer 110 is configured to exit the inner needle lumen in a straight form, and optionally tangent thereto, and to keep straight when it is further advanced until a curved or bending point provided along its length reaches the inner needle opening, allowing it to incline relative to inner needle 105. Tension member passer body 111 has a curved or bent portion 135 forming a deviated tension member passer distal end portion 136, which is substantially straight and extends along a length DL which is optionally at least 10 mm, or optionally particularly between about 15 mm and about 30 mm. If, prior to tension member passer protrusion, inner needle tip 106 is distanced less than length DL from outer surface of the treated internal body region (e.g., outer surface OS), then tension member passer 110 will advance in a straight path until reaching or crossing the outer surface of the treated body region. Contrarily, if needle tip 106 is distanced substantially more than length DL, then tension member passer 110 will begin its progress in a straight form but eventually will curve and continue its advancing in a curved path. The deviated tension member passer distal end portion 136 forms with remainder of tension member passer body 111 a deviation angle £ within a range of 15° to 55°, optionally about 35°. Curved or bent portion 135 is configured with elastic resistance to straightening within a range of 0.1 N to 1 N.
Tension member passer securing member 112 includes a securing wire portion 137 extending from a first location 138 at distal end portion 136 to a second location 139 on the tension member passer body 111 proximally to curved or bent portion 135. Securing wire portion 137 is similar in length to length of a segment of tension member passer body 111 extending from first location 138 to second location 139, and form together a symmetric, elastic, normally-opened, loop 147, optionally shaped in a ‘diamond’, ‘oval’ or ‘vesica piscis’ (pointed oval) contour. Optionally, loop 147 is sized to allow passing therethrough of a grasper holding a suture, optionally having a width within a range of 2 mm to 10 mm, optionally about 5 mm. When deviated tension member passer distal end portion 136 is forced to align with rest of tension member passer body 111, securing wire portion 137 is configured to undergo increased tension, so that loop 147 compresses and can therefore hold a tension member (e.g., suture) passing therethrough. When tension member passer securing member 112 extends fully within a space of sufficient size, such as within abdominal cavity AC, loop 147 can elastically (voluntarily) expand to an open form. Optionally, securing member 112 is formed of a super elastic material, optionally Ni—Ti alloy, and/or optionally of same material as tension member passer body 111 yet in smaller width and/or different thermal conditioning. Tension member passer 110 ends with a sharp tension member passer tip 140 configured to cut through soft tissue when pressed therethrough in sufficient force.
Apparatus 200 is optionally an exemplary implementation or variation of apparatus 50 and/or apparatus 100 described above, and it may include some or all embodiments and features of apparatus 50 and/or apparatus 100. Similarly, apparatus 200 is configured for forming a passage through an organ surrounding the volumetric region and/or tissue mass, from an entry point at a surface of the organ to an opposingly located exit point at the surface of the organ, relative to the tissue mass, and for passing the tension member around the volumetric region and/or tissue mass by pulling the tension member from the exit point to the entry point through the passage. In addition to features described with respect to apparatus 100, for example, apparatus 200 also employs a forceps head 216 and mechanism for using it to hold a portion of the treated organ in a chosen distance, relative to a fixed portion of apparatus 200, while forming a surgical passage in the organ and/or passing the tension member through the surgical passage.
Apparatus 200 is optionally a handheld device, although it can—as a whole or in part—be integrated in a robotic system; and it includes a plurality of members, devices and/or mechanisms housed in, connected to, and/or operational via, a console 215. Apparatus 200 includes a substantially straight rigid outer tube 201 comprising a sharp outer tube tip 202 and an outer tube lumen 203 with an outer tube opening 204 in proximity (e.g., adjacent) to the outer tube tip 202. Apparatus 200 also includes an inner needle 205 which comprises an elastic needle body 206, curved at least in part thereof and configured with elastic resistance to straightening within a range of 2 N to 20 N. Needle body 206 ends with a sharp needle tip 207 and encloses an inner needle lumen 208 with an inner needle opening 209 in proximity (e.g., adjacent) to the needle tip 207. Inner needle body 206 is configured to pass straightened through outer tube lumen 203 and to partially protrude via the outer tube opening, such that a protruding portion thereof is allowed to voluntarily flex to a curved form having diameter equal to or greater than diameter of the target tissue mass.
Apparatus 200 also includes a tension member passer 210 which is similar or identical to tension member passer 110 shown in
In the illustrated embodiment, securing member 212 comprises a resiliently deformable member that forms a loop with the tension member passer body 211. Securing member 212 is configured for securing a portion of the tension member to apparatus 200 when tension member passer body 211 is withdrawn into inner needle body 206 in a way that the loop surrounding the tension member gradually withdrawn into inner needle lumen 208 while its remainder portion outside inner needle lumen 208 increases embracing and tightening around the held portion of the tension member. As such, the securing member 212 secures the portion of the tension member to tension member passer body 211 and/or to inner needle body 206. Some or all other structural and/or functional features of tension member passer 110 described above are also applicable to tension member passer 210.
Forceps head 216 is fixedly connected to console 215 with a forceps shaft 217. Forceps shaft 217 extends distally from the console, adjacent and aligned parallel to the outer tube 201. Forceps head 216 is fixedly positioned distally to the console 215 and is activatable via the console and configured for selective grasping of the treated organ adjacent to the entry point and/or the exit point, for holding the grasped organ at a fixed distance relative to console 215. Forceps head 216 is configured in a form of tenaculum having two hinged tenaculum arms 218, each tenaculum arm includes a slender sharp-pointed hook configured to penetrate through the organ surface into the organ when forceps head 216 is operated to grasp the organ surface. After the organ is grasped with forceps head 216, outer tube 201 is allowed to slide distally relative forceps head 216 such that outer tube tip 202 can extend distally beyond forceps head 216 and penetrate into the organ (and form the entry point thereinto). In some embodiments, apparatus 200 includes a safety mechanism that prevents forward extension of outer tube 201 before forces head 216 is operated and/or grasps the organ, and this safety mechanism operates either manually or automatically. Optionally, apparatus 200 is configured to prevent extension of outer tube tip 202 over a predetermined maximal penetration depth beyond forceps head 216.
Apparatus 200 can be applied for passing one or more tension members around a tissue mass such as a tumor (e.g., fibroid), as described above. A plurality of tension members (e.g., in a form of wire or suture), distributed along spaced paths around the tissue mass, for example, can be applied with controlled and/or continuous tension therethrough, thereby collectively apply spatial inward compression of the tissue mass with the taut tension members. This method was found to cause ischemia and/or necrosis to target tissue masses under prolonged spatial compressions. In order to pass a tension member, a surgical passage is first created in a bodily organ (e.g., uterus), around a target tissue mass (e.g., tumor or portion thereof) and then a tension member is passed in reversed travel through the passage. Tension applied to the one or more tension members after implantation thereof, can be performed using apparatus 200, using another device, or performed manually.
A method for passing tension member around tissue mass may include some or all steps of the method shown in
When the needle body 206 is in an unstressed relaxed form (as shown in
Tip segment 228 has a tridimensional beveled shape formed by adjoined curved outer surface 229 and flat inner surface 230 intersecting at the needle tip 207. Inner surface 230 is tilted radially inwardly relative to a forward tangent 233 of first segment distal end 225. A (straight) outline of outer surface 229 extends from second segment distal end 226 above (radially outwardly to) point C of second centerline 223. A (straight) outline of inner surface 230 extends from a mid-portion of second segment 222 below second centerline 223. The outline of outer surface 229 is shorter than the outline of inner surface 230, optionally about half in length thereof. An intersection angle r, defined by intersection of outer surface 229 and inner surface 230 at needle tip 207, is within a range of 10° to 30°, optionally about 20°.
Alternatively, radius of curvature R1′ may be greater than radius of curvature R1, however the integration or merging of first and second curved paths 234 and 235, such that second curved path 235 begins from first curved path 234, forms an integrated or complete path of protruding portion PP at its full extent, optionally having an average or median radius of curvature being similar to or smaller than first radius of curvature R1. In some such embodiments, the introduction of a first curved segment having smaller radius of curvature affects a preliminary curved path intended to diminish and/or compensate for increase of average or median radius of curvature, relative to first radius of curvature R1, as a result of (radial) resistance to penetration from the surrounding organ tissue. Optionally, additionally or alternatively, by causing a preliminary penetration having a substantially smaller radius of curvature, the lateral (side) penetration from outer tube 201 is easier with less resistance by the surrounding organ tissue and/or harm thereto.
As shown in
On the other hand, and as demonstrated in
In some embodiments, needle body 206 is shaped and configured such that the radial force (resisting advancement) applied by surrounding tissue increases during the further advancement of protruding portion PP in the organ such that radius of curvature R1′ of second curved pass 235 reduces per further advancement relative to first radius of curvature R1 of needle body's first centerline 221 when in the unstressed relaxed form.
Following are various illustrative examples, each of which is a separate embodiment. This disclosure further includes all permutations of the “independent” examples below with their “dependent” examples. Moreover, additional embodiments capable of derivation from the independent and dependent examples that follow are also expressly incorporated into the present written description.
An apparatus for passing a tension member around a volumetric portion of an organ can comprise: a rigid outer tube comprising a sharp outer tube tip and an outer tube lumen with an outer tube opening in proximity to the outer tube tip; an inner needle comprising an elastic needle body curved at least in part thereof, the inner needle ending with a sharp needle tip and enclosing an inner needle lumen with an inner needle opening being in proximity to the needle tip, the inner needle body being configured to pass straightened through the outer tube lumen and to partially protrude via the outer tube opening, such that a protruding portion of the inner needle body is allowed to voluntarily flex to a curved form having diameter equal to or greater than diameter of the volumetric portion; and a tension member passer comprising a tension member passer body, sized for passing through the inner needle lumen, and a tension member pulling portion configured for engaging with a portion of the tension and for continuously applying a pulling force to the engaged portion of the tension member when the tension member is withdrawn with the tension member passer; wherein the apparatus is configured for forming a passage through the organ, the passage extending along a plane crossing the volumetric portion from an entry point at a surface of the organ, located in front of a first side of the volumetric portion, to an exit point at the surface of the organ, located in front of a second side of the volumetric portion opposite to the first side, and the apparatus is further configured for passing the tension member around the volumetric portion by pulling the tension member from the exit point to the entry point through the passage.
In various embodiments, the volumetric portion of the organ includes a tissue mass comprising at least a portion of a tumor.
In various embodiments, the outer tube is movable relative to a covering portion of the apparatus until the outer tube tip extends a chosen uncovered length from a distal edge of the covering portion, the distal edge is configured to resist penetration into soft tissue to inhibit insertion of the outer tube to a depth greater than the uncovered length. In various embodiments, the apparatus comprising measurement readings arranged to facilitate visual reading of a dimension indicative of the uncovered length.
In various embodiments, the outer tube opening is located proximally to the outer tube tip at a side of the outer tube.
In various embodiments, the outer tube opening is located adjacent to the outer tube tip.
In various embodiments, the needle body includes a first segment having a first centerline, and a second segment having a second centerline, the second segment adjoins with a proximal end thereof to a distal end of the first segment and with a distal end thereof to a proximal end of a tip segment, wherein, when the needle body is in a relaxed form, the first centerline has a first radius of curvature, at least along a portion thereof being adjacent to the first segment distal end, and the second centerline has a second radius of curvature, at least along a portion thereof being adjacent to the second segment proximal end, the second radius of curvature is smaller than the first radius of curvature.
In various embodiments, a ratio between the second radius of curvature and the first radius of curvature is within a range of 1/10 to ⅓, optionally between about 1/7 and about ⅕. In various embodiments, when the needle body is in the relaxed form, the first segment subtends a first subtended angle and/or the second segment subtends a second subtended angle, wherein the second subtended angle is smaller than the first subtended angle. In various embodiments, the first subtended angle is within a range of 200° to 300°, optionally between 240° and 260°, and/or the second subtended angle is within a range of 10° to 80°, optionally between 30° and 60°.
In various embodiments, the tip segment has a tridimensional beveled shape formed by adjoined curved outer surface and flat inner surface intersecting at the needle tip, wherein outline of the outer surface extends from a point of the second segment distal end located radially outwardly to the second centerline and outline of the inner surface extends from a point between the second segment proximal end and second segment distal end located radially inwardly to the second centerline, relative to the second radius of curvature. In various embodiments, the inner surface surrounds the inner needle opening. In various embodiments, an intersection angle defined by intersection of the outer surface and the inner surface at the needle tip is within a range of 10° to 30°, optionally about 20°. In various embodiments, the outline of the outer surface is straight. In various embodiments, the outline of the outer surface is shorter than the outline of the inner surface, optionally about half in length thereof. In various embodiments, the inner surface is tilted radially inwardly relative to a forward tangent of the first segment distal end.
In various embodiments, the first radius of curvature is within a range of 15 mm to 45 mm when the needle body is in the unstressed relaxed state.
In various embodiments, the elastic needle body is configured with elastic resistance to straightening within a range of 2 N to 20 N.
In various embodiments, the apparatus is configured such that the protruding portion exits the outer tube opening with a needle exit angle δ within a range of 10° to 80°, optionally within a range of 20° to 50°, relative to the outer tube.
In various embodiments, the tension member passer body is flexible and elastic.
In various embodiments, the tension member passer body is solid.
In various embodiments, the tension member pulling portion includes a securing member forming a loop with the tension member passer body.
In various embodiments, the tension member passer body has a curved or bent portion forming a deviated distal end portion inclined relative to remainder of the tension member passer body. In various embodiments, the deviated tension member passer distal end portion forms with rest of the tension member passer body a deviation angle within a range of 15° to 55°, optionally about 35°.
In various embodiments, the tension member pulling portion includes a securing wire portion extending from a first location on the tension member passer body, distally to the curved or bent portion, to a second location on the tension member passer body, proximally to the curved or bent portion. In various embodiments, the securing wire portion is similar in length to length of a segment of the tension member passer body extending from the first location to the second location. In various embodiments, the securing wire portion is configured to undergo increased tension when the deviated tension member passer distal end portion is forced to align with rest of the tension member passer body. In various embodiments, the deviated tension member passer distal end originates at the first location and extends in a straight form at least 10 mm in length. In various embodiments, the curved or bent portion of the tension member passer body is configured with elastic resistance to straightening within a range of 0.1 N to 1 N.
In various embodiments, the apparatus further comprising a console, optionally formed as a handheld device.
In various embodiments, the apparatus further comprising an inner needle protrusion controller configured to operatively control advancement of the inner needle within the outer tube. In various embodiments, the inner needle protrusion controller includes a second control operatively connected to an inner needle motion generator configured to selectively force axial movement of the inner needle within the outer tube. In various embodiments, the needle motion generator includes at least one of a needle motor, a needle gear mechanism and a needle printed circuit board. In various embodiments, the needle motion generator is configured to force by default axial movement of the tension member passer with the inner needle such that both advance and/or withdraw together within the outer tube.
In various embodiments, the apparatus further comprising a tension member passer protrusion controller configured to operatively control advancement of the tension member passer body within the inner needle. In various embodiments, the tension member passer protrusion controller is operable using a third control operatively connected to a tension member passer motion generator configured to selectively force axial movement of the tension member passer within the inner needle. In various embodiments, the tension member passer motion generator includes at least one of a tension member passer motor, and a tension member passer gear mechanism. In various embodiments, the apparatus is configured such that the tension member passer protrusion controller can be activated to advance the tension member passer body only after the needle protrusion controller finishes advancing of the inner needle up to a user defined length of the protruding portion.
In various embodiments, the apparatus further comprising a forceps head fixedly positioned distally to the console and activatable via the console, configured for selective grasping of the organ adjacent to the entry point and/or the exit point, for holding the grasped organ at a fixed distance relative to the console. In various embodiments, the forceps head is configured in a form of tenaculum having two hinged tenaculum arms, each tenaculum arm includes a slender sharp-pointed hook configured to penetrate through the organ surface into the organ when the forceps head is operated to grasp the organ surface. In various embodiments, the outer tube is slidable distally relative to the forceps head such that the outer tube tip is extendable distally beyond the forceps head. In various embodiments, the apparatus is configured to prevent extension of the outer tube tip distally beyond the forceps head over a predetermined maximal penetration depth. In various embodiments, the forces head is connected to the console with a forceps shaft extending from the console adjacent and aligned parallel to the outer tube.
A method for passing a tension member around a volumetric portion of an organ can comprise: using a rigid outer tube, comprising a sharp outer tube tip and an outer tube lumen with an outer tube opening in proximity to the outer tube tip, penetrating into the organ such that the outer tube tip reaches a penetration depth; passing an inner needle in the outer tube lumen, the inner needle includes an elastic needle body curved at least in part thereof, ending with a sharp needle tip and enclosing an inner needle lumen with an inner needle opening in proximity to the needle tip; piercing a curved passage with the needle tip around the volumetric portion with a protrusion length of a protruding portion of the inner needle body, by pushing the inner needle via the outer tube opening and allowing the protruding portion to voluntarily flex to a curved form having diameter equal to or greater than diameter of the volumetric portion; advancing a tension member passer comprising a tension member passer body and a tension member pulling portion, in the inner needle lumen and via the inner needle opening, until the tension member pulling portion exits the organ at an exit point opposing the entry point relative to the volumetric portion; and drawing the tension member into and through the curved passage by pulling the tension member passer with the secured tension member.
In various embodiments, the drawing includes extending the tension member around the volumetric portion such that one end of the tension member projects from the entry point and another end of the tension member projects from the exit point.
In various embodiments, the organ is an internal organ located within a body of a live subject, and the method further comprising forming a surgical route from outside the body of the subject and delivering the outer tube through the surgical route until the outer tube tip reaches the organ. In various embodiments, the organ is a uterus.
In various embodiments, the volumetric portion of the organ includes a tissue mass comprising at least a portion of a tumor.
In various embodiments, the method comprising ending the piercing with positioning the needle tip at a chosen distance from the surface of the organ, so as to form a needle tip angle between the needle tip and the surface of the internal body region. In various embodiments, the distance is smaller than 3 cm.
In various embodiments, the needle tip angle is within a range of 10° to 60°.
In various embodiments, the defining includes defining a penetration angle between the outer tube and a perpendicular line to the surface of the internal body region at the entry point, wherein the protrusion length subtends a subtended angle is at least 270° minus the penetration angle.
In various embodiments, the penetrating, the passing, the piercing, the advancing and/or the securing is repeated, each repetition is performed using a different implanted tension member, a different entry point and a different exit point.
In various embodiments, the method can comprise: using a forceps head, grasping the organ adjacent to the entry point and/or the exit point for holding the grasped organ before the penetrating with the outer tube. In various embodiments, the outer tube is slidably connected to a console and the forceps head is fixedly positioned distally to the console, wherein the outer tube is slidable distally relative to the forceps head such that the outer tube tip is extendable distally beyond the forceps head up to a predetermined maximal penetration depth.
An apparatus for passing a tension member around a tissue mass that is positioned below a surface of an organ, the surgical apparatus can comprise: a tube comprising a tube lumen, a tube opening at a distal end of the tube, and a tube tip configured to penetrate through the surface of the organ to form an entry point and a passage into the organ; a needle comprising a needle lumen, a needle tip configured to penetrate tissue of the organ, and a needle body of which at least a distal portion is configured to transition between a straightened orientation and a curved orientation, the distal portion of the needle being configured to: be received within the tube lumen in the straightened orientation, pass through the tube opening and out of the tube lumen as the needle is advanced distally relative to the tube, and automatically transition to the curved orientation upon passing through the outer tube opening so as to extend the passage through the organ along a curved path that extends around at least a portion of the tissue mass; and a tension member passer configured to be advanced distally through the needle lumen and couple with the tension member; wherein at least one of the needle and the tension member passer is configured to be advanced distally relative to the tube to extend the pathway back through the surface of the organ at an exit point from the organ, and wherein the tension member passer is configured to couple to the tension member at a position external to the organ to then pass the tension member through the exit opening, then through the passage, and then through the entry opening.
In various embodiments, the distal portion of the needle is in a stressed state when in the straightened orientation and is in a relaxed state when in the curved orientation.
In various embodiments, the distal portion of the needle is deformed from a natural state into the straightened orientation when received within the tube lumen, and wherein the distal portion of the needle resiliently returns to the natural state when transitioned to the curved orientation.
In various embodiments, when the distal portion of the needle is positioned within the outer tube, the outer tube maintains the distal portion of the needle in the straightened orientation against a resilient bias that tends to return the distal portion of the needle to the curved orientation.
In various embodiments, the distal portion of the needle is further configured to be retracted through the tube opening and back into the tube lumen when the needle is retracted proximally relative to the tube.
In various embodiments, the distal portion of the needle is configured to automatically transition from the curved orientation to the straightened orientation as the needle is retracted proximally relative to the tube.
In various embodiments, the apparatus further comprising an actuator configured to distally advance the needle relative to the tube.
In various embodiments, the actuator is further configured to proximally retract the needle relative to the tube.
In various embodiments, the actuator is configured to remain at an exterior of a patient throughout usage of the apparatus.
In various embodiments, the apparatus further comprising an additional actuator configured to distally advance the tension member passer relative to the needle.
In various embodiments, the actuator and the additional actuator are configured to remain at an exterior of a patient throughout usage of the apparatus.
In various embodiments, the actuator is further configured to proximally retract the needle relative to the tube, and wherein the additional actuator is further configured to retract the tension member passer relative to the needle.
In various embodiments, the apparatus further comprising a covering coupled to the tube so as to be stationary relative to the tube, wherein the covering is configured to be selectively advanced or retracted relative to the tube to define an uncovered length of the tube.
In various embodiments, the covering comprises a blunt distal end that is resistant to passage through the surface of the organ such that the covering resists advancement of the tube into the organ beyond the uncovered length of the tube.
In various embodiments, the apparatus further comprising an actuator configured to adjust a position of the covering relative to the tube.
In various embodiments, the tube comprises a plurality of depth markings that can assist in adjusting the uncovered length of the tube to a desired length.
In various embodiments, the tube comprises a plurality of depth markings.
In various embodiments, the tube opening is at a distalmost tip of the tube.
In various embodiments, the tube opening is at a side of the tube.
In various embodiments, the tube comprises a sidewall, and wherein the tube opening extends through the sidewall.
In various embodiments, the tube further comprises a ramp configured to urge the needle tip laterally through the tube opening at the side of the tube.
In various embodiments, the ramp is at a distal end of the tube lumen.
In various embodiments, the apparatus further comprising the tension member.
In various embodiments, the tension member comprises a suture.
In various embodiments, the tension member comprises a wire.
In various embodiments, the tension member passer comprises a tension member passer body configured to follow a curvature of the needle when the needle is in the curved orientation.
In various embodiments, the distal portion of the tension member passer is configured to define a curve of a larger radius of curvature or to extend substantially rectilinearly when the distal portion of the tension member passer is advanced distally past the needle tip.
In various embodiments, the tension member passer body is resiliently deformable.
In various embodiments, the tension member passer comprises an attachment mechanism configured to couple the tension member to the tension member passer.
In various embodiments, the attachment mechanism defines a loop that is expanded when the attachment mechanism is advanced distally beyond the needle tip and is contracted when the attachment mechanism is retracted proximally into the needle.
In various embodiments, the tension member passer is configured to be advanced distally through the needle lumen to expose the attachment mechanism at an exterior of the needle, and the tension member passer is configured to be attached to the tension member when exposed at the exterior of the needle.
In various embodiments, the tension member passer comprises a tension member passer body of which at least a distal portion is resiliently deformable.
In various embodiments, the tension member passer body comprises a distal tip configured to penetrate tissue of the organ.
In various embodiments, the apparatus further comprising a securing member coupled to the resiliently deformable distal portion of the tension member passer body.
In various embodiments, the resiliently deformable distal portion of the tension member passer body is pre-curved, wherein the securing member comprises a wire attached to the distal portion of the tension member passer body at two distinct points, and wherein the tension member passer body and the securing member cooperate to form a loop when the deformable distal portion is positioned at an exterior of the needle.
In various embodiments, the tension member passer further comprises a distal tip configured to penetrate tissue of the organ.
In various embodiments, the tension member passer is sufficiently stiff to form a tract through the organ when advanced distally through the needle.
In various embodiments, the tension member passer comprises a resiliently deformable loop that is configured to automatically open to an expanded state when the loop is advanced distally past the needle tip and is configured to collapse to a contracted state when the loop is retracted proximally into the needle tip.
In various embodiments, the needle is configured to be advanced distally relative to the tube to a position beneath the surface of the organ, and wherein the tension member passer is configured to be advanced distally relative to the needle by an amount sufficient to penetrate the surface of the organ and thereby extend the pathway back through the surface of the organ at the exit point from the organ.
In various embodiments, the passer comprises a distal tip configured to penetrate tissue of the organ.
In various embodiments, the needle is configured to be advanced distally relative to the tube by an amount sufficient to penetrate the surface of the organ and thereby extend the pathway back through the surface of the organ at the exit point from the organ.
In various embodiments, the tube is configured to be positioned within the organ at a depth beneath the surface of the organ that is greater than a maximum depth of the tissue mass beneath the surface of the organ.
In various embodiments, the tension member passer is configured to pull the tension member through the exit opening, the passage, and the entry opening prior to retraction of the needle into the tube.
In various embodiments, the tension member passer is configured to pull the tension member through the exit opening, the passage, and the entry opening after retraction of the needle into the tube.
In various embodiments, the tension member passer is configured to pull the tension member through the exit opening, the passage, and the entry opening after retraction of the tube out of the organ.
In various embodiments, the needle comprises an opening at a distal tip of the needle.
In various embodiments, the curved path extends exclusively around an exterior of the tissue mass.
In various embodiments, the curved path extends through a portion of the tissue mass.
In various embodiments, the entry point and the exit point are spaced from each other.
In various embodiments, a distance between the entry point and the exit point is no greater than 2 times a diameter of the tissue mass.
In various embodiments, a distance between the entry point and the exit point is no greater than the diameter of the tissue mass.
In various embodiments, a distance between the entry point and the exit point is smaller than a diameter of the tissue mass.
In various embodiments, the distal portion of the needle comprises a first region defining a first radius of curvature and a second region defining a second radius of curvature, and wherein the first radius of curvature is greater than the second radius of curvature.
In various embodiments, the first radius of curvature is greater than the second radius of curvature by a factor of no less than 3.
In various embodiments, the first radius of curvature is greater than the second radius of curvature by a factor of no less than 4.
In various embodiments, the first radius of curvature is greater than the second radius of curvature by a factor of no less than 5.
In various embodiments, the first radius of curvature is greater than the second radius of curvature by a factor of no less than 6.
In various embodiments, the first radius of curvature is greater than the second radius of curvature by a factor of no less than 7.
In various embodiments, a length of the first region is greater than a length of the second region by a factor of no less than 10.
In various embodiments, a length of the first region is greater than a length of the second region by a factor of no less than 15.
In various embodiments, a length of the first region is greater than a length of the second region by a factor of no less than 20.
In various embodiments, a length of the first region is greater than a length of the second region by a factor of no less than 25.
In various embodiments, a length of the first region is greater than a length of the second region by a factor of no less than 30.
In various embodiments, the first region and the second region are adjacent to one another, and wherein the first region is proximal to the second region.
In various embodiments, the needle tip comprises at least a portion of the second region.
In various embodiments, at least a portion of the needle tip is positioned distally relative to the second region.
In various embodiments, a radially outer surface of the second region is configured to push against tissue as the needle is advanced through the organ in a manner that encourages the needle to form a tighter curved path than would be achieved if the second region were to have the same radius of curvature as the first region.
In various embodiments, the needle tip comprises a primary bevel at which an opening of the needle lumen is positioned, and wherein the second region orients the bevel to be within 10 degrees of a direction of travel of the needle tip as the needle as advanced through the organ to thereby reduce an amount of tissue coring at the opening than would be experienced if the second region were to have the same radius of curvature as the first region.
In various embodiments, the second region orients the bevel to be within 5 degrees of the direction of travel of the needle tip.
In various embodiments, the second region orients the bevel to be colinear with or parallel to the direction of travel of the needle tip.
In various embodiments, the apparatus further comprising a gripping device configured to grip the organ to stabilize the organ as the tube is advanced through the surface of the organ.
In various embodiments, the gripping device comprises a pair of tenaculum arms configured to hold a portion of the organ.
In various embodiments, the apparatus further comprising an elongated member coupled with both the gripping device and the tube, wherein the gripping device is fixedly secured to the elongated member and wherein the tube is configured to translate relative to the elongated member.
In various embodiments, the elongated member defines a lumen, and wherein the tube is configured to pass through the lumen of the elongated member.
In various embodiments, the gripping device comprises an actuator configured to remotely manipulate the gripping device.
In various embodiments, the gripping device comprises a pair of opposable arms, and wherein the actuator is configured to approximate the opposable arms toward each other.
In various embodiments, the actuator comprises a lock configured to maintain the opposable arms in a fixed orientation relative to each other when locked.
In various embodiments, the actuator comprises a lock configured to maintain the gripping device in a gripping orientation relative to the organ when locked.
In various embodiments, the tube is translatable relative to the gripping device.
In various embodiments, the apparatus further comprising a console fixedly coupled to the tube and the gripping device, wherein the console comprises a first actuator configured to control movement of the gripping device when the console is held stationary, and wherein the console comprises a second actuator configured to control translation of the tube relative to the gripping device when the console is held stationary.
A surgical needle can comprise: an elastic needle body ending with a sharp needle tip, the needle body includes a first segment having a first centerline, and a second segment having a second centerline, the second segment adjoins with a proximal end thereof to a distal end of the first segment and with a distal end thereof to a proximal end of a tip segment; wherein, when the needle body is in an unstressed relaxed form, the first centerline has a first radius of curvature and the second centerline has a second radius of curvature smaller than the first radius of curvature.
In various embodiments, a ratio between the second radius of curvature and the first radius of curvature is within a range of 1/10 to ⅓, optionally between about 1/7 and about ⅕.
In various embodiments, when the needle body is in the unstressed relaxed form, the first segment forms a first outer arc subtending a first subtended angle and/or the second segment forms a second outer arc subtending a second subtended angle, wherein the second subtended angle is smaller than the first subtended angle.
In various embodiments, the first subtended angle is within a range of 200° to 300°, optionally between 240° and 260°, and/or the second subtended angle is within a range of 10° to 80°, optionally between 30° and 60°.
In various embodiments, the tip segment has a tridimensional beveled shape formed by adjoined curved outer surface and flat inner surface intersecting at the needle tip, wherein outline of the outer surface extends from a point on second segment distal end located radially outwardly to the second centerline and outline of the inner surface extends from a point provided between second segment proximal end and second segment distal end located radially inwardly to the second centerline, relative to the second radius of curvature.
In various embodiments, the needle body encloses a needle lumen with a needle opening in proximity to the needle tip, wherein the inner surface surrounds the needle opening.
In various embodiments, an intersection angle defined by intersection of the outer surface and the inner surface at the needle tip is within a range of 10° to 30°, optionally about 20°.
In various embodiments, the outline of the outer surface is straight.
In various embodiments, the outline of the outer surface is shorter than the outline of the inner surface, optionally about half in length thereof.
In various embodiments, the inner surface is tilted radially inwardly relative to a forward tangent of the first segment distal end.
In various embodiments, the first radius of curvature is within a range of 15 mm to 45 mm when the needle body is in the unstressed relaxed state.
In various embodiments, the needle body is configured with elastic resistance to straightening within a range of 2 N to 20 N.
A surgical apparatus can comprise: a rigid outer tube comprising a sharp outer tube tip and an outer tube lumen with an outer tube opening in proximity to the outer tube tip; and an inner needle configured as the surgical needle according to Example 4; wherein the inner needle body is configured to pass straightened through the outer tube lumen and to partially protrude via the outer tube opening, such that a protruding portion of the inner needle body is allowed to voluntarily flex to a curved form, whereby the inner needle tip is configured to follow a first curved path having a radius of curvature similar to the second radius of curvature, when the protruding portion excludes the first segment distal end, and to shift into following a second curved path having a radius of curvature similar to or smaller than the first radius of curvature, when the protruding portion includes the first segment distal end.
A method can comprise: penetrating a soft tissue with a sharp outer tube tip of a rigid outer tube enclosing an outer tube lumen with an outer tube opening in proximity to the outer tube tip; passing an inner needle through the outer tube lumen, the inner needle comprising an elastic inner needle body ending with a sharp inner needle tip, the inner needle body includes a first segment having a first centerline, and a second segment having a second centerline, the second segment adjoins with a proximal end thereof to a distal end of the first segment and with a distal end thereof to a proximal end of a tip segment, wherein, when the needle body is in an unstressed relaxed form, the first centerline has a first radius of curvature and the second centerline has a second radius of curvature smaller than the first radius of curvature; initially advancing the inner needle tip in the soft tissue via the outer tube opening while increasing length of a protruding portion of the inner needle body until reaching a first penetration depth such that the protruding portion excludes the first segment distal end, thereby allowing the inner needle tip to follow a first curved path having a radius of curvature similar to the second radius of curvature; and further advancing the inner needle tip in the soft tissue via the outer tube opening while increasing length of the protruding portion until reaching a second penetration depth such that the protruding portion includes the first segment distal end, thereby allowing the inner needle tip to follow a second curved path having a radius of curvature similar to or smaller than the first radius of curvature and greater than the second radius of curvature.
In various embodiments, the further advancing the inner needle includes transferring a second force vector through the first segment to the second segment and the tip segment, and from both the second segment and the tip segment to tissue surrounding thereto.
In various embodiments, a tangential force component of the second force vector tangent to the second curved path is smaller than a normal force component of the second force vector perpendicular to the second curved path.
In various embodiments, the initially advancing the inner needle includes transferring a first force vector through the first segment to the second segment and the tip segment, applied from the tip segment to tissue surrounding thereto.
In various embodiments, a tangential force component of the first force vector tangent to the first curved path is greater than a normal force component of the first force vector perpendicular to the first curved path.
In various embodiments, a normal force component of the second force vector is greater than a normal force component of the first force vector.
In various embodiments, the tip segment has a tridimensional beveled shape formed by adjoined curved outer surface and flat inner surface intersecting at the needle tip, wherein outline of the outer surface extends from a point on second segment distal end located radially outwardly to the second centerline and outline of the inner surface extends from a point provided between second segment proximal end and second segment distal end located radially inwardly to the second centerline, relative to the second radius of curvature, the needle body encloses an inner needle lumen with an inner needle opening in proximity to the needle tip, the inner needle opening is surrounded with the inner surface; wherein the further advancing the inner needle includes forming a surgical passage within the organ by forcing the outer surface against the tissue surrounding the second segment and the tip segment in direction of the second force vector, thereby preventing coring of penetrated tissue via the inner needle opening.
Each of the following terms written in singular grammatical form: ‘a’, ‘an’, and ‘the’, as used herein, means ‘at least one’, or ‘one or more’. Use of the phrase ‘one or more’ herein does not alter this intended meaning of ‘a’, ‘an’, or ‘the’. Accordingly, the terms ‘a’, ‘an’, and ‘the’, as used herein, may also refer to, and encompass, a plurality of the stated entity or object, unless otherwise specifically defined or stated herein, or, unless the context clearly dictates otherwise. For example, the phrases: ‘a unit’, ‘a device’, ‘an assembly’, ‘a mechanism’, ‘a component’, ‘an element’, and ‘a step or procedure’, as used herein, may also refer to, and encompass, a plurality of units, a plurality of devices, a plurality of assemblies, a plurality of mechanisms, a plurality of components, a plurality of elements, and, a plurality of steps or procedures, respectively.
Each of the following terms: ‘includes’, ‘including’, ‘has’, ‘having’, ‘comprises’, and ‘comprising’, and, their linguistic/grammatical variants, derivatives, or/and conjugates, as used herein, means ‘including, but not limited to’, and is to be taken as specifying the stated component(s), feature(s), characteristic(s), parameter(s), integer(s), or step(s), and does not preclude addition of one or more additional component(s), feature(s), characteristic(s), parameter(s), integer(s), step(s), or groups thereof. Each of these terms is considered equivalent in meaning to the phrase ‘consisting essentially of’.
The term ‘method’, as used herein, refers to steps, procedures, manners, means, or/and techniques, for accomplishing a given task including, but not limited to, those steps, procedures, manners, means, or/and techniques, either known to, or readily developed from known steps, procedures, manners, means, or/and techniques, by practitioners in the relevant field(s) of the disclosure.
Throughout this disclosure, a numerical value of a parameter, feature, characteristic, object, or dimension, may be stated or described in terms of a numerical range format. Such a numerical range format, as used herein, illustrates implementation of some exemplary embodiments, and does not inflexibly limit the scope of the exemplary embodiments. Accordingly, a stated or described numerical range also refers to, and encompasses, all possible sub-ranges and individual numerical values (where a numerical value may be expressed as a whole, integral, or fractional number) within that stated or described numerical range. For example, a stated or described numerical range ‘from 1 to 6’ also refers to, and encompasses, all possible sub-ranges, such as ‘from 1 to 3’, ‘from 1 to 4’, ‘from 1 to 5’, ‘from 2 to 4’, ‘from 2 to 6’, ‘from 3 to 6’, etc., and individual numerical values, such as ‘1’, ‘1.3’, ‘2’, ‘2.8’, ‘3’, ‘3.5’, ‘4’, ‘4.6’, ‘5’, ‘5.2’, and ‘6’, within the stated or described numerical range of ‘from 1 to 6’. This applies regardless of the numerical breadth, extent, or size, of the stated or described numerical range.
Moreover, for stating or describing a numerical range, the phrase ‘in a range of between about a first numerical value and about a second numerical value’, is considered equivalent to, and meaning the same as, the phrase ‘in a range of from about a first numerical value to about a second numerical value’, and, thus, the two equivalently meaning phrases may be used interchangeably. For example, for stating or describing the numerical range of room temperature, the phrase ‘room temperature refers to a temperature in a range of between about 20° C. and about 25° C.’, and is considered equivalent to, and meaning the same as, the phrase ‘room temperature refers to a temperature in a range of from about 20° C. to about 25° C.’.
The term ‘about’, as used herein, refers to ±10% of the stated numerical value.
It is to be fully understood that certain aspects, characteristics, and features, of the invention, which are, for clarity, illustratively described and presented in the context or format of a plurality of separate embodiments, may also be illustratively described and presented in any suitable combination or sub-combination in the context or format of a single embodiment. Conversely, various aspects, characteristics, and features, of the invention which are illustratively described and presented in combination or sub-combination in the context or format of a single embodiment, may also be illustratively described and presented in the context or format of a plurality of separate embodiments.
Although the invention has been illustratively described and presented by way of specific exemplary embodiments, and examples thereof, it is evident that many alternatives, modifications, or/and variations, thereof, will be apparent to those skilled in the art. Accordingly, it is intended that all such alternatives, modifications, or/and variations, fall within the spirit of, and are encompassed by, the broad scope of the appended claims.
All publications, patents, and or/and patent applications, cited or referred to in this disclosure are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent, or/and patent application, was specifically and individually indicated to be incorporated herein by reference. In addition, citation or identification of any reference in this specification shall not be construed or understood as an admission that such reference represents or corresponds to prior art of the present invention. To the extent that section headings are used, they should not be construed as necessarily limiting.
Number | Date | Country | Kind |
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16539800 | Aug 2019 | US | national |
This application claims the benefit under 35 U.S.C. § 119(e) of U.S. Provisional Patent Application No. 62/774,249, filed on Dec. 2, 2018, titled “APPARATUS FOR PASSING TENSION MEMBER AROUND TISSUE MASS AND METHOD OF USE THEREOF”, and U.S. patent application Ser. No. 16/539,800, filed on Aug. 13, 2019, titled “CAUSING ISCHEMIA IN TUMORS”, the entire contents of which are hereby incorporated by reference herein.
Filing Document | Filing Date | Country | Kind |
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PCT/US2019/064030 | 12/2/2019 | WO | 00 |
Number | Date | Country | |
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62774249 | Dec 2018 | US |