Patent Grant
11717275
Some applications of the present invention relate in general to tissue sampling. More specifically, some applications of the present invention relate to tissue-sampling using Fine Needle Aspiration (FNA).
Tissue/fluid sampling (e.g., biopsying) is used in many medical fields, e.g., to help in diagnosing of conditions. Physicians (e.g., gastroenterologists) sometimes use an endoscope when performing a biopsy, e.g., in order to sample tissue that cannot easily be reached percutaneously, or to which the physician does not have line-of-sight. Fine-needle aspiration biopsy (FNAB, FNA or NAB), or fine-needle aspiration cytology (FNAC), is a common diagnostic procedure used to investigate superficial lumps or masses. A fine needle is used to obtain a small sample of tissue; sufficient for cytology examination. EUS-FNA is fine needle aspiration during endoscopic ultrasound, using an ultrasound equipped endoscope to navigate to and identify the tissue (e.g., a lesion), and to guide a needle into the tissue. It is often necessary to take multiple samples in order to increase diagnostic accuracy, since a single sample may not represent the entirety of the tissue or lesion from which the sample is extracted.
A device is provided for facilitating tissue sampling using Fine Needle Aspiration (FNA). At a distal end of the device, multiple needles are extendible, and are disposed such that a first needle is surrounded by a plurality of other needles. At a proximal end of the device, the first needle is spatially separated from the plurality of other needles, facilitating independent movement of the first needle (e.g., using a separate handle), and/or independent application of suction to the first needle (e.g., via a separate port).
For some applications, handles used to independently move (i) the first needle, and (ii) the plurality of other needles, are lockable, so as to facilitate linked movement of the first and other needles.
There is therefore provided, in accordance with an application of the present invention, apparatus, for use with an endoscope, the apparatus including: a flexible sheath, shaped to be advanced through a working channel of the endoscope, and shaped to define a plurality of openings at a distal end of the flexible sheath, the plurality of openings including a first opening, and a plurality of second openings surrounding the first opening; a housing, coupled to a proximal portion of the sheath; an elongate first needle, extending distally through the housing and through the sheath toward the first opening; a plurality of elongate second needles, each extending distally through the housing and through the sheath toward a respective second opening of the plurality of second openings; a first needle-control handle, attached to the first needle, slidably coupled to the housing along a first axis, and slidable with respect to the housing such that sliding of the first needle-control handle slides the first needle through the sheath such that a distal tip of the first needle moves with respect to the first opening; and a second needle-control handle, attached to the plurality of second needles, slidably coupled to the housing along a second different axis, and slidable with respect to the housing such that sliding of the second needle-control handle slides the plurality of second needles through the sheath such that a distal tip of each second needle moves with respect to a respective second opening of the plurality of second openings.
In an application, the apparatus is configured such that: a distance slid by the first needle-control handle with respect to the housing is equal to a distance moved by the tip of the first needle with respect to the first opening, and a distance slid by the second needle-control handle with respect to the housing is equal to a distance moved, by the tip of each second needle of the plurality of second needles, with respect to the respective second opening of the plurality of second openings.
In an application: the sheath is shaped to define (i) a first needle channel that extends through the sheath and opens to the first opening, and (ii) a plurality of second needle channels that extends through the sheath and surrounds the first needle channel, each second needle channel of the plurality of second needle channels opening to a respective second opening of the plurality of second openings, the first needle is disposed in the first needle channel, and each second needle of the plurality of second needles is disposed in a respective second needle channel of the plurality of second needle channels.
In an application, the first axis is parallel to the second axis.
In an application, the first and second axes are parallel, and are 1-10 cm apart.
In an application, the first needle-control handle is slidable along the first axis into the housing at a first site of the housing, and the second needle-control handle is slidable along the second axis into the housing at a second site of the housing that is at least 2 cm from the first site.
In an application, the first needle-control handle is slidably coupled to the housing such that sliding of the first needle-control handle distally with respect to the housing slides the first needle distally out of the first opening, and the second needle-control handle is slidably coupled to the housing such that sliding of the second needle-control handle distally with respect to the housing slides each needle of the plurality of second needles distally out of a respective opening of the plurality of second openings.
There is further provided, in accordance with an application of the present invention, apparatus, including: a sheath, shaped to define a plurality of openings at a distal end of the sheath, the plurality of openings including a first opening, and a plurality of second openings surrounding the first opening; an elongate first needle, extending through the sheath toward the first opening; a plurality of elongate second needles, extending through the sheath toward the plurality of second openings; a first aspirator port, in fluid communication with the first needle; and a second aspirator port, in fluid communication with at least one of the second needles, a center of the second aspirator port being spaced by at least 1 cm from a center of the first aspirator port.
In an application, the second aspirator port is in fluid communication with all the second needles of the plurality of second needles.
In an application, the apparatus is for use with an endoscope, and the sheath is flexible and shaped to be advanced through a working channel of the endoscope.
There is further provided, in accordance with an application of the present invention, apparatus, including: a sheath; a housing, coupled to a proximal portion of the sheath; an elongate first needle, extending through the housing and through the sheath; a plurality of elongate second needles, extending through the housing and through the sheath; a first needle-control handle: attached to the first needle, having a first hand-grip, and slidably coupled to the housing, such that sliding of the first needle-control handle slides the first needle through the sheath; and a second needle-control handle: attached to the plurality of second needles, having a second hand-grip, slidably coupled to the housing, such that sliding of the second needle-control handle slides the plurality of second needles through the sheath, and rotatable with respect to the housing such that: in a first rotational position, the first and second hand-grips are graspable independently and simultaneously by separate hands of a human operator, and in a second rotational position, the first and second hand-grips (i) are closer together than in the first rotational position, and are graspable simultaneously by a single hand of the human operator.
In an application, in the second rotational position, the first and second hand-grips mate to define a single unified hand-grip.
In an application, the apparatus is for use with an endoscope, and the sheath is flexible and shaped to be advanced through a working channel of the endoscope.
There is further provided, in accordance with an application of the present invention, apparatus, including: a sheath; a housing, coupled to a proximal portion of the sheath; an elongate first needle, extending through the housing and through the sheath; a plurality of elongate second needles, extending through the housing and through the sheath; a first needle-control handle: attached to the first needle, having a first hand-grip, and slidably coupled to the housing, such that sliding of the first needle-control handle slides the first needle through the sheath; and a second needle-control handle: attached to the plurality of second needles, having a second hand-grip, slidably coupled to the housing, such that sliding of the second needle-control handle slides the plurality of second needles through the sheath, having a first state in which the first needle-control handle is slidable to slide the first needle through the sheath without causing the plurality of second needles to slide through the sheath, and having a second state in which sliding of the first needle-control handle causes the plurality of second needles to slide through the sheath.
In an application, the apparatus includes a lock, and locking of the lock moves the apparatus from the first state into the second state.
In an application, the apparatus is for use with an endoscope, and the sheath is flexible and shaped to be advanced through a working channel of the endoscope.
In an application, a needle-control handle selected from the group consisting of: the first needle-control handle and the second needle-control handle is rotatable with respect to the housing such that: in a first rotational position of the selected needle-control handle, the apparatus is in the first state, and in a second rotational position of the selected needle-control handle, the apparatus is in the second state.
In an application, the first and second needle-control handles define respective mating surfaces that mate when the selected needle-control handle is in the second rotational position.
The present invention will be more fully understood from the following detailed description of applications thereof, taken together with the drawings, in which:
Reference is made to
Device 20 comprises a sheath 22, a housing 24 coupled to a proximal portion of the sheath, a first needle-control handle 26a, and a second needle control handle 26b.
Sheath 22 defines a plurality of openings 30 at a distal end thereof. The plurality of openings 30 comprises a first opening 30a, and a plurality of second openings 30b surrounding opening 30a. It is to be noted that, in this context, the term “surrounding” (including the specification and the claims) means that if one were to draw straight lines between the center of each opening 30b and the centers of its nearest neighbors, the center of opening 30a would be disposed within the resulting polygon (e.g., the quadrilateral shape drawn in broken lines in
It is to be noted that, for clarity, the distal portion of tool 10 is not shown in
Handle 26a is slidably coupled to housing 24 along a first axis ax1, and handle 26b is slidably coupled to housing 24 along a second axis ax2. Handle 26a is attached to a first elongate needle 28a, such that sliding of handle 26a with respect to housing 24 (along axis ax1) slides needle 28a through sheath 22, such that a distal tip of the needle moves with respect to opening 30a (e.g., the tip moves through the opening, such as out of the opening). Handle 26b is attached to a plurality of second elongate needles 28b, such that sliding of handle 26b with respect to housing 24 (along axis ax2) slides needles 28b through sheath 22, such that a distal tip of each needle 28b moves with respect to a respective opening 30b (e.g., the tip moves through the respective opening, such as out of the respective opening).
Although needle 28a is described and shown as being a single needle, for some applications needle 28 is a plurality of needles, mutatis mutandis.
FNA needles are known in the art. An FNA needle is a fine hollow needle (e.g., 19 gauge or smaller, and typically 22-25 gauge), used to obtain a sample from a tissue. Typically, an FNA needle has a sharpened tip. Typically, needles 28a and 28b are long (e.g., 100-200 cm long, such as 145-190 cm long) and flexible. Typically, sheath 22 is also flexible, and is shaped to be advanced through a working channel of guiding tool 10. For example, tool 10 may be a steerable ultrasonic endoscope, and sheath 22 may be advanceable through a working channel of the endoscope. For example, tool 10 and device 20 may be advanced into the gastrointestinal tract, and used to obtain a sample of a tissue of the gastrointestinal tract, or tissue proximal to the gastrointestinal tract.
Alternatively, sheath 22 may be rigid, and/or tool 10 may be a rigid trocar. For some applications, sheath 22 may be used without tool 10.
Needle 28a (or at least a distal portion thereof) is typically biased to be straight. That is, in the absence of an external force, the distal portion of needle 28a is typically straight. Therefore when disposed outside of opening 30a, the distal portion of needle 28a typically extends straight out of sheath 22. Each needles 28b (or at least a distal portion thereof) is typically biased to be bent. That is, in the absence of an external force, the distal portion of each needle 28b is typically bent. Therefore when disposed outside of opening 30b, the distal portion of each needle 28b curves. Needles 28b are typically rotationally oriented such that when exposed from the distal end of sheath 22, the distal ends of needles 28b diverge outward from needle 28. It is hypothesized that this arrangement (i) results in needles 28b entering the tissue at a nonzero angle with respect to needle 28a, and therefore (ii) facilitates sampling of tissue over a wider area compared to using a single needle. Each needle 28b is hypothesized to reach a different part of the tissue from that reached by the other needles 28b, and from that reached by needle 28a. Device 20 facilitates control of the position of, and suction through, needles 28b independently of that of needle 28a (as described in more detail hereinbelow). If the physician desires (e.g., in a particular case), needle 28a may be used without using (e.g., without advancing) needles 28b (or vice versa). For some applications, needles 28b are of higher gauge than is needle 28a.
Typically, sheath 22 defines a plurality of needle channels 32 that extend through (i.e., along) the sheath. A first needle channel 32a opens to opening 30a, and a plurality of second needle channels 32b open to respective openings 30b. Needle 28a is disposed in channel 32a, and needles 28b are disposed in respective channels 32b. Typically, channels 32b surround channel 32a along at least the distal half of sheath 22 (e.g., along at least the distal 75 percent of sheath 22, such as along at least the distal 90 percent of sheath 22). For some applications, channels 32b surround channel 32a along the entire of sheath 22.
Typically, sheath 22 has an external diameter of 2.5-3 mm (e.g., 2.7 mm), needle 28a is 22 gauge, and needles 28b are 25 gauge.
For some applications, handle 26a is slidable along axis ax1 into housing 24 at a first site 34a, and handle 26b is slidable along axis ax2 into housing 24 at a second site 34b that is at least 1 cm and/or less than 10 cm (e.g., 1-10 cm, e.g., 2-8 cm, e.g., 4-6 cm, such as about 5 cm) from site 34a. For some applications, axes ax1 and ax2 are parallel. For some such applications, axes ax1 and ax2 are at least 1 cm and/or less than 10 cm (e.g., 1-10 cm, e.g., 2-8 cm, e.g., 4-6 cm, such as about 5 cm) apart.
Typically, device 20 comprises a plurality of aspirator ports 46. A first aspirator port 46a is in fluid communication with needle 28a, and a second aspirator port 46b is in fluid communication with at least one of needles 28b (e.g., with all of needles 28b). When device 20 is used to obtain a biopsy sample, suction is typically applied via the ports, e.g., similarly to the use of suction in existing FNA biopsy procedures. Port 46a is typically coupled to handle 26a, and port 46b is typically coupled to handle 26b. Ports 46a and 46b (i.e., the centers thereof) are spatially separated (e.g., laterally), e.g., by at least 0.5 cm and/or less than 20 cm (e.g., 0.5-20 cm, such as 1-10 cm, such as 1-5 cm).
For some applications, each port 46 comprises a standard medical fitting, such as a Luer-type lock.
The distances between handles 26, ports 46 and axes ax1 and ax2 are typically (i) sufficiently large that ports 46 are independently accessible by separate suction devices (e.g., syringes), and (ii) sufficiently small that the handles may placed together and/or locked together, as described hereinbelow.
An interesting aspect of device 20 is that (a) at a distal portion of the device (e.g., at the distal end of sheath 22), needles 28a and 28b are disposed together, e.g., with needle 28a surrounded by needles 28b (e.g., see section C-C of
Thus at some point between the proximal end and the distal end of device 20, needle 28a becomes surrounded by needles 28b. Typically, this occurs within housing 24, as is shown in section B-B of
Typically, these described paths of needles 28a and 28b are provided by housing 24, which defines a plurality of ducts 48 through which the needles extend. For example, needle 28a may extend through a first duct 48a, and needles 28b may extend through respective second ducts 48b, and progressively distal portions of duct 48a may become progressively closer to ducts 48b, until duct 48a is surrounded by ducts 48b (as shown in section B-B of
For some applications, at the place in which needle 28a passes between two needles 28b in order to become surrounded by needles 28b (e.g., at the location of section B-B of
The ability to apply suction independently advantageously facilitates the physician deciding, even after having advanced sheath 22 into the body of the subject, whether to use both needle 28a and needles 28b, or just one or the other type of needle. For example, if only a single suction port were provided, if the physician were to decide to use only needle 28a, suction through the single suction port would nevertheless be applied to needles 28b (still within sheath 22). This may adversely affect the suction that reaches needle 28a, may apply suction to undesired tissue sites (e.g., immediately outside of openings 30b), and/or may cause contamination of the sample obtained with needle 28a. For some applications the ability to apply suction independently to needle 28a and needles 28b is also advantageous if the needles are of different gauges, e.g., because different degrees of suction may be needed to draw sample into the needles.
For some applications, ducts 48a and 48b are in fluid communication with and/or are continuous with channels 32a and 32b, respectively. For some applications, proximal portions of channels 32b serve as and/or define respective ducts 48b. For example, a proximal portion of sheath 22 may be disposed inside housing 24.
As described hereinabove, device 20 facilitates control (e.g., distal and proximal sliding) of needles 28b from needle 28a. This is shown in
Typically, the distance slid by handle 26a is equal to the distance moved by the tip of needle 28a, and the distance slid by handle 26b is equal to the distance moved by the tip of each needle 28b. This is typically facilitated by the provision of a separate duct 48 and channel 32 for each needle 28, and by each needle 28 fitting snugly within its respective duct and channel, so as to prevent buckling of the needles.
As is apparent from
As shown in
In the state shown in
Typically, at least one gauge 62 is provided to indicate a distance of advancement of each handle 26 relative to housing 24, thereby indicating a distance of advancement out of sheath 22 of the respective needle(s) 28. Typically, each handle 26 is coupled to a respective handle-advancement limiter 54, which limits the advancement of the respective handle, and thereby limits the distance out of sheath 22 that the respective needle(s) may be advanced. For example, limiter 54 may be lockable at a user-selectable distance along its respective handle 26.
For some applications, device 20 comprises an offset adjuster 56, which is used to compensate for different working-channel lengths of different endoscopes by adjusting the distance through the endoscope that sheath 22 is advanced (e.g., adjusting the effective length of the sheath). Using offset adjuster 56, device 20 may be calibrated for a given endoscope, such that gauge 62 accurately indicates advancement of needle(s) 28 (e.g., the amount of advancement relative to a distal end of the endoscope).
For some applications, device 20 is lockable to endoscope 10, e.g., via a Luer-type lock fitting (not visible in the figures) that mates with a counterpart fitting on the endoscope. Typically, this fitting is coupled to (or defined by) offset adjuster 56.
Typically, device 20 is provided (e.g., packaged) with needles 28 disposed within housing 24 and sheath 22. For some applications, needles 28 are provided separately, and are subsequently introduced into ducts 48 and channels 32, e.g., at the institution in which device 20 will be used, such as by the physician or a technician.
It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description.
The present application is a divisional of U.S. patent application Ser. No. 15/757,622, filed Mar. 5, 2018 and entitled “NEEDLE-HANDLING DEVICE”, which is a National Phase of PCT Patent Application No. PCT/IL2016/050971 to Belsky et al., filed Sep. 4, 2016, and entitled “NEEDLE-HANDLING DEVICE”, which published as WO 2017/037720, and which claims priority to U.S. Provisional Patent Application No. 62/215,003 to Belsky et al., filed Sep. 6, 2015, and entitled “NEEDLE-HANDLING DEVICE”, which is incorporated herein by reference. The present application is related to U.S. patent application Ser. No. 14/772,364 to Belsky et al., which published as US 2016/0000415, and which is the US National Phase of PCT application IB2014/059420 to Belsky et al., filed Mar. 4, 2014, entitled “Multiple-tissue FNA sampling,” which published as WO 2014/136045, both of which are incorporated herein by reference.
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| Number | Date | Country | |
|---|---|---|---|
| 20210145419 A1 | May 2021 | US |
| Number | Date | Country | |
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| 62215003 | Sep 2015 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 15757622 | US | |
| Child | 17113643 | US |
