News Column

Patent Application Titled "Biopsy Needle with a Laterally Expandable Distal Portion" Published Online

July 3, 2014



By a News Reporter-Staff News Editor at Politics & Government Week -- According to news reporting originating from Washington, D.C., by VerticalNews journalists, a patent application by the inventor GIGI, Igal (Givataim, IL), filed on February 12, 2014, was made available online on June 19, 2014.

The assignee for this patent application is Arch Medical Devices Ltd.

Reporters obtained the following quote from the background information supplied by the inventors: "The present invention, in some embodiments thereof, relates to a device and method for collecting tissue samples, and, more particularly, but not exclusively, to biopsy needles introduced into the body within a sheath.

"Sampling of body tissues is often required to help in diagnosis and disease staging of patients. Numerous tools and devices for such purpose have been disclosed. Many comprise a narrow elongated guide or sheath through which a sampling needle or blade is advanced to take a sample, and then retracted.

"On Mar. 24, 2010 the Applicant of the current application filed a PCT application published under International Publication Number WO 2010/113080. That application is referred to as 'PCT '080' herein.

"PCT '080 presents inter alia a variety of configurations of blades (generally labeled blade 10 in the application) which comprise a sharp anterior portion 12 designed for penetrating into tissue, and one or more recesses or notches which comprise sharp or pointed edges capable of cutting and ripping-off some of the tissue into which blade 10 penetrates, which notches or recesses are generally labeled recesses 16 or notches 16 in PCT '080. These notches or recesses are shown as positioned on the sharp edges of blade 10 as shown in FIGS. 1A, 1B, 1C, and 1G, and on an otherwise flat side of blade 10 in FIGS. 1D, 1E, and 1F of PCT '080."

In addition to obtaining background information on this patent application, VerticalNews editors also obtained the inventor's summary information for this patent application: "The present invention, in some embodiments thereof, relates to a biopsy needle for removing tissue samples from within a body, e.g. samples to be used for pathological examinations or other examinations of the tissue. The present invention, in some embodiments thereof, relates particularly to biopsy needles having a laterally expandable distal portion which comprises a plurality of longitudinal elements (called 'spines' herein) operable to laterally expand away from each other into an 'open' configuration when unconstrained, and to approach each other to form a 'closed' configuration when constrained to do so. In some embodiments, spines laterally expand away from each other into an 'open' configuration when unconstrained, and approach each other to form a 'closed' configuration when constrained to do so.

"A configuration is considered 'open' when spines move away from each other to a distance which allows at least body tissue adjacent to the needle to penetrate into a volume defined between (or among) the laterally expanded spines. A configuration is considered closed when the spines and/or teeth on the spines are close enough to each other to catch and hold tissue between them while the needle is moved within the body.

"In some embodiments at least some of these longitudinal elements comprise 'teeth' which grasp (and/or cut and/or tear) tissue samples when the needle is advanced and/or retracted and/or changed from open to closed configuration. In some embodiments the teeth are oriented to point towards each other and/or towards other teeth-supporting elements (called 'spines' herein), rather than pointing outwards from the needle as was taught in PCT '080. Teeth which point towards other teeth and/or spines of the device are referred to as 'inward-pointing teeth' herein.

"In some embodiments a containing sheath constrains a needle such as the needle described in the preceding paragraph, forcing the needle into a closed configuration when the needle is contained or partially contained within the sheath.

"In some embodiments a needle in a sheath and in what is called herein a 'closed configuration' is advanced towards a sampling site, and then a distal portion of the needle is extended from the sheath into body tissues. Advancing the expandable portion of the needle beyond a distal end of the sheath causes the expandable portion to expand, putting the needle into what is called herein an 'open configuration.' When the distal portion of the needle is then retracted into the sheath (and/or when the sheath is advanced over that distal portion), forcing the needle back into closed configuration, body tissue may be captured between the spines and/or between the teeth of the needle. With the needle again in closed configuration within the sheath, captured tissue is held and protected both by interior surfaces of the spines and surfaces of the teeth and by the sheath. The needle and sheath (or only the needle) can then be extracted from the body and the captured tissue garnered for pathological or other examination.

"According to an aspect of some embodiments of the present invention, there is provided a biopsy needle comprising a laterally expandable distal portion.

"According to an aspect of some embodiments of the present invention, there is provided a biopsy needle comprising a laterally self-expanding distal portion.

"According to some embodiments of the invention, the needle comprises a sharp distal end capable of penetrating tissue.

"According to some embodiments of the invention, the laterally expandable distal portion, once laterally expanded to an open configuration, is laterally contractible to a closed configuration.

"According to some embodiments of the invention, the laterally expandable portion in an open configuration is shaped to allow at least some tissue located in a vicinity of the expandable portion to move into the expandable portion.

"According to some embodiments of the invention, the expandable portion is laterally contractible from the open configuration to trap and hold the tissue.

"According to some embodiments of the invention, the expandable portion contracts when the needle is retracted from tissue into which it had penetrated.

"According to some embodiments of the invention, the expandable portion contracts when the relative position of the needle and a sheath changes, covering a portion of the needle with a distal portion of the sheath.

"According to some embodiments of the invention, the needle comprises a base end with a releasable catch configured for tool-free mounting and unmounting to a receiving part.

"According to some embodiments of the invention, the base end is flattened.

"According to some embodiments of the invention, the expandable portion comprises a plurality of spines moveable toward and away from each other along at least a portion of their length.

"According to some embodiments of the invention, the spines are joined at their distal end and at their proximal end.

"According to some embodiments of the invention, the spines distance themselves from each other when the expandable portion is laterally unconstrained, and approach each other when the expandable portion is laterally constrained.

"According to some embodiments of the invention, the needle comprises teeth along at least one of the spines.

"According to some embodiments of the invention, at least some of the teeth along the at least one spine protrude into an interior volume defined by the spines when the spines are distanced from each other in an open configuration.

"According to some embodiments of the invention, at least some of the teeth are so oriented as to have a sharp edge facing in a proximal direction, so as to catch and hold tissue when a distal portion of the needle is retracted from tissue into which it has been inserted.

"According to some embodiments of the invention, the spines are operable to trap and hold tissue when the needle is inserted into tissue and is constrained to change from open to closed configuration.

"According to some embodiments of the invention, the needle comprises more than two spines.

"According to some embodiments of the invention, the needle comprises a longitudinal passageway extending from a distal end of the spines and ending in a distal orifice.

"According to some embodiments of the invention, the needle has a bendable distal portion.

"According to some embodiments of the invention, the expandable portion contracts when the needle is retracted into a distal portion of a sheath.

"According to some embodiments of the invention, the expandable portion contracts when a distal portion of a sheath is advanced over the expandable portion.

"According to some embodiments of the invention, the spines approach each other when constrained to do so by a sheath advancing along the needle until it at least partially encloses at least a part of the laterally expandable portion of the needle.

"According to some embodiments of the invention, the spines approach each other when constrained to do so by a sheath when at least a part of the distally expandable portion of the needle is retracted into the sheath, thereby enclosing at least a part of the laterally expandable portion of the needle within the sheath.

"According to some embodiments of the invention, the spines, when constrained to approach each other, define a volume capable of holding a tissue sample.

"According to some embodiments of the invention, at least some of the teeth are backward-pointing teeth which catch tissue when the needle is retracted from tissue into which it is inserted.

"According to some embodiments of the invention, all teeth along the spines are backward-pointing and catch tissue only during retraction of the needle from the tissue.

"According to some embodiments of the invention, the teeth along the first one of the spines have sharp portions facing another of the spines.

"According to some embodiments of the invention, at least some of the teeth are backward-pointing teeth which catch tissue during retraction of the needle, and at least some of the teeth are inward-pointing teeth having sharp portions which face an internal volume of the needle defined by the spines when the expandable distal portion of the needle is in open configuration.

"According to some embodiments of the invention, the spines define an internal volume of the needle when the needle is in closed configuration, and the volume is sufficiently large to contain tissue samples useful for tissue pathology examinations.

"According to some embodiments of the invention, at least most teeth of the needle have sharp portions which face and point towards other portions of the needle.

"According to some embodiments of the invention, at least some of the teeth are designed to catch tissue during retraction of the needle from tissue into which it is inserted.

"According to some embodiments of the invention, at least some of the teeth comprise a recessed portion capable of holding tissue when the needle is in closed configuration.

"According to some embodiments of the invention, the needle comprises two spines attached at their proximal and distal ends and comprising medial portions capable of moving away from each other into an open configuration and also capable of being positioned near each other in a closed configuration.

"According to some embodiments of the invention, the medial portions of the spines move away from each other when unconstrained, but which may be constrained to approach each other to form a closed configuration.

"According to some embodiments of the invention, the more than two spines define a volume capable of holding body tissue when the spines are in closed configuration, the spines then being near each other along their length.

"According to some embodiments of the invention, the more than two spines define a volume capable of holding body tissue when the spines are in closed configuration, the spines then touching each other along at least a part of their length.

"According to some embodiments of the invention, the needle comprises three spines.

"According to some embodiments of the invention, the needle comprises four spines.

"According to some embodiments of the invention, the needle comprises at least 3 spines and further comprises a longitudinal passageway ending in a distal orifice.

"According to some embodiments of the invention, the needle comprises two spines.

"According to an aspect of some embodiments of the present invention, there is provided a tissue sampling apparatus which comprises: (a) a biopsy needle which comprises a laterally expandable distal portion; and (b) a sheath sized to contain at least a distal portion of the needle; such that the needle is slideable distally and proximally within the sheath; and (d) the needle tends to assume an open or closed configuration depending on where the expandable distal portion of the needle is positioned within the sheath.

"According to some embodiments of the invention, the needle tends to assume an open configuration when the expandable distal portion extends beyond the sheath, and the expandable distal portion is constrained to assume a closed configuration when the expandable distal portion of the needle is positioned within the sheath.

"According to some embodiments of the invention, the sheath comprises an elongated sheath body having an interior lumen with an arcuate slot forming a continuum between an interior lumen of the sheath and an exterior aperture disposed laterally on the sheath body.

"According to some embodiments of the invention, one or more walls of the lumenal surface of the sheath are formed with protrusions having heights sufficient to lift at least a portion of the needle away from adjacent portions of the lumenal surface.

"According to some embodiments of the invention, protrusions of facing walls of the lumenal surface are arranged in staggered alternation along the length of the lumenal surface.

"According to some embodiments of the invention, the apparatus comprises: a sheath head at a distal end of the sheath; the sheath head comprising a substantially tubular body; wherein the wall of the body comprises at least one flap cut from the body of the sheath head, and formed to protrude into a lumen defined by the body, such that the at least one flap comprises at least one guide protrusion contacted by the needle upon passage of a portion of the needle through the body.

"According to some embodiments of the invention, the guide protrusion comprises a bearing surface having a polymer resin coating.

"According to some embodiments of the invention, the at least one guide protrusion comprises at least two guide protrusions protruding into the lumen from opposite sides of the lumen.

"According to some embodiments of the invention, the sheath head comprises an angle guide positioned at a distal end thereof; and the needle is constrained by contact with the angle guide to exit the sheath head at an angle oblique to the longitudinal axis of the sheath head.

"According to some embodiments of the invention, the oblique exit angle is also determined by contact with a guide protrusion on a side of the needle opposite the angle guide.

"According to some embodiments of the invention, the angle guide comprises a flap cut from the body of the sheath head.

"According to some embodiments of the invention, the needle comprises a bendable distal portion.

"According to some embodiments of the invention, the lumenal surface of the sheath is undulated, forming protrusions.

"According to some embodiments of the invention, at least one of any protrusions in the form of the lumenal surface falls away along a steeper grade on the side opposite the side first approached by the tip of the needle during extension of the needle than on the first-approached side.

"According to some embodiments of the invention, protrusions in the form of the lumenal surface are arranged to avoid mutual reinforcement of the tendency of each protrusion to impede passage of the needle.

"According to some embodiments of the invention, protrusions in the form of the lumenal surface are arranged at non-constant distances from one another.

"According to an aspect of some embodiments of the present invention there is provided a method for capturing tissue samples from within a body, comprising: (a) advancing a sheath containing a biopsy needle having a laterally expandable distal portion to a vicinity of a tissue; (b) extending the distal portion of the needle beyond a distal end of the sheath, thereby causing the laterally expandable distal portion of the needle to assume an open configuration; and causing the sheath to cover at least a part of the laterally expandable distal portion, thereby causing the laterally expandable distal portion to assume a closed configuration, thereby trapping body tissue within the distal portion; (d) retracting all of the distal portion into the sheath; and (e) retracting the needle, containing the tissue samples, from the body.

"According to some embodiments of the invention, the method further comprises causing the sheath to cover at least a part of the laterally expandable distal portion by advancing the sheath over at least a part of the laterally expandable distal portion.

"According to some embodiments of the invention, the method further comprises causing the sheath to cover at least a part of the laterally expandable distal portion by retracting the needle into the sheath, until the sheath covers at least a part of the laterally expandable distal portion.

"According to an aspect of some embodiments of the present invention, there is provided a method for capturing tissue samples from within a body, comprising: (a) advancing a sheath at least partially containing a biopsy needle having a laterally expandable distal portion to a vicinity of a tissue; (b) causing a distal portion of the sheath to change how much of at least a part of the laterally expandable distal portion it covers, thereby constraining the expandable portion to assume a closed configuration, thereby trapping tissue within the distal portion; and retracting the needle, containing the tissue samples, from the body.

"According to some embodiments of the invention, causing a distal portion of the sheath to cover at least a part of the laterally expandable distal portion of the needle thereby constrains the expandable portion to assume a closed configuration, thereby trapping tissue within the distal portion.

"According to some embodiments of the invention, the method comprises extending the distal portion of the needle beyond a distal end of the sheath to cause the laterally expandable distal portion of the needle to assume an open configuration prior to the trapping of tissue.

"According to some embodiments of the invention, the method comprises retracting all of the distal portion of the needle into the sheath.

"Unless otherwise defined, all technical and/or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the invention, exemplary methods and/or materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.

BRIEF DESCRIPTION OF THE DRAWINGS

"Some embodiments of the invention 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 discussion of embodiments of the invention. In this regard, the description taken with the drawings makes apparent to those skilled in the art how embodiments of the invention may be practiced.

"In the drawings:

"FIG. 1 is a simplified schematic of a biopsy needle held within a sheath and constrained to be in closed configuration, according to some exemplary embodiments of the present invention;

"FIG. 2 is a simplified schematic of a biopsy needle extending beyond a distal portion of a sheath, and expanded to open configuration, according to some exemplary embodiments of the present invention;

"FIGS. 3A-3D are simplified illustrations of a method of sampling tissues, according to some exemplary embodiments of the present invention;

"FIG. 4 is a simplified flow chart presenting the method illustrated in FIG. 3, according to some exemplary embodiments of the present invention;

"FIGS. 5A-5D are simplified illustrations of an additional method of sampling tissues, according to some exemplary embodiments of the present invention;

"FIG. 6 is a simplified flow chart presenting the method illustrated in FIG. 5, according to some exemplary embodiments of the present invention;

"FIGS. 7 and 8 are views of flat biopsy needles, according to some exemplary embodiments of the present invention;

"FIG. 9A is a detailed view of a biopsy needle in closed configuration, showing exemplary dimensions and detailed images of several portions of the needle, including inward-pointing teeth, according to some exemplary embodiments of the present invention;

"FIG. 9B is a detailed view of a biopsy needle in open configuration, showing exemplary dimensions and detailed images of several portions of the needle, including inward-pointing teeth, according to some exemplary embodiments of the present invention;

"FIG. 9C is an additional detailed view of a biopsy needle in open configuration, showing exemplary dimensions and detailed images of several portions of the needle, according to some exemplary embodiments of the present invention;

"FIG. 9D is a detailed view of an exemplary sheath head usable with flat biopsy needles, according to some embodiments of the present invention;

"FIGS. 9E-9I are detailed views of embodiments providing dimensional information, according to some exemplary embodiments of the invention;

"FIGS. 9J-9N are detailed views of an exemplary sheath head with a lumenal surface formed with protrusions sufficient to lift at least a portion of a flat biopsy needle away from impeding interactions with adjacent portions of said lumenal surface, according to some exemplary embodiments of the present invention;

"FIGS. 9O-9Q schematically illustrate a lateral-guiding needle sheath head comprising needle guides formed from protrusions bent inward from the sheath head body, according to some exemplary embodiments of the invention;

"FIGS. 9R-9T schematically illustrate a sheath head in relation to a flexible needle passing therethrough, according to some exemplary embodiments of the invention;

"FIG. 10A is a view adapted from a photograph of an embodiment of the present invention showing a proximal handle for a sheath, according to some exemplary embodiments of the present invention;

"FIG. 10B is a view adapted from a photograph of an embodiment of the present invention showing the handle of FIG. 10A connected to a sheath, according to some exemplary embodiments of the present invention;

"FIG. 10C is a photograph of an embodiment of the present invention showing a flat biopsy needle in open configuration extending from a distal portion of the sheath of the embodiment shown in FIG. 10B, according to some exemplary embodiments of the present invention;

"FIG. 10D is a photograph of an embodiment of the present invention showing a proximal handle for a sheath, according to some exemplary embodiments of the present invention;

"FIG. 10E is a photograph of an embodiment of the present invention showing the handle of FIG. 10D connected to a sheath, according to some exemplary embodiments of the present invention;

"FIG. 10F is a view adapted from a photograph of an embodiment of the present invention showing a flat biopsy needle in open configuration extending from a distal portion of the sheath of the embodiment shown in FIG. 10E, according to some exemplary embodiments of the present invention;

"FIG. 11 is a simplified schematic of a multi-aperture flat biopsy needle, according to some exemplary embodiments of the present invention;

"FIGS. 12, 13 and 14 are views of multi-spined biopsy needles in open configurations, according to some exemplary embodiments of the present invention;

"FIG. 15 is a view of the needle of FIG. 12 in closed configuration, according to some exemplary embodiments of the present invention;

"FIGS. 16A-16B schematically illustrate an exemplary biopsy needle including details of a base end attachable to a catheter shaft, according to some exemplary embodiments of the present invention;

"FIGS. 17A-17C schematically illustrate details of the construction of an exemplary biopsy needle, according to some exemplary embodiments of the present invention;

"FIGS. 18A-18D schematically illustrate an assembled biopsy needle catheter shaft, according to some exemplary embodiments of the present invention;

"FIG. 19 schematically illustrates a needle assembled to a needle attachment ferrule, according to some exemplary embodiments of the present invention;

"FIGS. 20A-20E are schematic views of exemplary attachment structures in detail, according to some exemplary embodiments of the present invention;

"FIGS. 21A-21D schematically illustrate details of exemplary proximal (base) regions of a biopsy needle catheter shaft, according to some exemplary embodiments of the present invention; and

"FIG. 22 schematically illustrates an assembly comprising a biopsy needle attached through a ferrule to a push wire near the region where the needle passes out of a sheath head, according to some exemplary embodiments of the present invention."

For more information, see this patent application: GIGI, Igal. Biopsy Needle with a Laterally Expandable Distal Portion. Filed February 12, 2014 and posted June 19, 2014. Patent URL: http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&u=%2Fnetahtml%2FPTO%2Fsearch-adv.html&r=1833&p=37&f=G&l=50&d=PG01&S1=20140612.PD.&OS=PD/20140612&RS=PD/20140612

Keywords for this news article include: Arch Medical Devices Ltd.

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