JP2003500084A - Needle and sensor adapter for medical devices - Google Patents

Abstract

A needle adapter is provided having a first member having a head portion and a tail portion, the first portion having a bore at least substantially through the head portion. Is done. The head portion is shaped to receive a segment of the second member and is shaped to receive a needle. The second member comprises a segment and a tail portion, wherein the segment is mounted on the tail portion and within the head portion of the first member to mount the first and second members in a hinge-like manner. I am ready to accept. This mounting allows movement of the first and second members between the open and closed positions. The tail portions of the first and second members are shaped such that when in the closed position, a volume is formed to hold the sensor. A pin is also provided that is removably attachable from the head of the first member. The pin secures the needle when inserted into the needle adapter.

Description

Detailed Description of the Invention

[0001]

FIELD OF THE INVENTION

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a guidance device related to an imaging device such as an ultrasonic wave and CT, and more particularly, to a needle holder to which a sensor is attached and an adapter thereon, and an imaging device such as an ultrasonic transducer and a CT imaging device. To an adapter for attaching a sensor to the.

[0002]

BACKGROUND OF THE INVENTION

Imaging methods such as ultrasound, CT, MRI, x-ray are used to guide the insertion of surgical instruments for diagnosis and therapy. For example, ultrasound imaging and related procedures are routinely performed in connection with fetal monitoring and development, chest biopsy, other biopsies, aspiration and other interrupted insertions.

An apparatus for performing an interruption (penetration) procedure using an image forming apparatus is referred to as US Pat. No. 5,647,373 of the present applicant, and is referred to as “free-guide aiming of needle guide”. It is disclosed in the specification of PCT International Application Publication Number WO-97 / 03609 (International Publication Number PTC / IL96 / 00050). In the device disclosed therein, an imaging device, such as an ultrasonic transducer, cooperates with a guidance device to monitor the relative position of the needle (or any other similar penetrating device) with respect to the imaging device. And function. This produces an image on the screen or monitor showing the internal surgical position and the position of the needle in the body with respect to the imager. PCT International Application Publication No. WO-97 / 03609 also discloses a needle and / or an imager, here a sensor on an ultrasonic transducer, to further assist in guiding the needle on a screen or monitor. Disclosure.

[0004]

[Outline of the Invention]

The present invention improves on the state-of-the-art medical interruption procedure by providing a needle holding device that includes a sensor mounting adapter and an adapter (sensor mounting) for imaging devices such as ultrasonic transducers.

Needle adapters and needle guides are suitable for use with needles of various standards. Throughout this specification the term "needle" refers to, for example, standard medical needles, biopsy needles,
Ablation equipment (such as in cryogenic equipment), (Biopsys Ethicon
A biopsy gun, such as a "MAMMOTOME" (registered trademark) type biopsy gun available as part of a "MAMMOTOME" (registered trademark) vacuum biopsy device available from Endo-Surgery, an introducer, Or, refer to a needle including other similar medical interrupt devices.

The design of the needle adapter and guide minimizes the risk of incorrect insertion of the needle and position sensor into the adapter, thus making the opportunity for incorrect insertion of the sensor extremely difficult.

The needle adapter and guide provide a housing for the sensor (s) that substantially restrains the movement of the sensor so as to substantially cancel any movement.

The structure of the needle adapter and needle guide allows for quick and easy release of the sensor from the adapter after opening the adapter. The adapter design allows configuration of single-use adapters or multiple-use adapters, depending on choice.

The design and construction of the first needle adapter and needle guide allows for correct recognition of the position of the needle and needle tip with respect to the position sensor without the need to calibrate the position sensor for the needle. The design and construction of the second needle adapter allows for correct recognition of the needle orientation and trajectory with respect to the position sensor without having to calibrate the position sensor for the needle.

The first needle adapter and needle guide ensure a firm lock on the needle after closing the adapter and therefore a constant needle positioning with respect to the sensor during the procedure.

The first needle adapter allows attachment of the needle to the needle adapter without the risk of foreign particles contacting the needle tip or other parts of the needle that have entered the body. The second needle adapter and in particular the needle guide minimizes bending of the needle during the entry procedure.

The device adapter allows attachment of the position sensor to any type of ultrasonic transducer or other imaging device. The device adapter allows for reliable and consistent positioning of the sensor for large penetration devices such as biopsy guns.

The structure of the device adapter is such that after the sensor is calibrated to the transducer,
Without storing calibration parameters (as described in PCT International Application Publication No. WO-97 / 03609, supra) and additional calibration (until the adapter is moved or removed). , To ensure that we know the exact location of the sensor with respect to the ultrasonic transducer for each subsequent procedure. This also allows multiple insertions and removals of the sensor from the adapter.

The present invention provides a needle adapter having a first member with a head portion and a tail portion,
The head portion has a bore that extends at least substantially therethrough. The head portion is shaped to receive the segment of the second member and is also shaped to receive the needle. The second member comprises a segment and a tail portion, the segment attached to the tail portion and adapted to be received within the head portion of the first member, the first member and the second member being hinged. Attach in such a manner. The mounting allows movement of the first and second members between the open and closed positions.
The tail portions of the first member and the second member are shaped such that when in the closed position, a volume is formed to hold the sensor. Also, a pin is provided that can be detachably attached from the bore of the head portion of the first member. This pin is for fixing the needle when mounted in the needle adapter.

The present invention also provides a needle adapter having a first portion for communicating with a second portion containing a sensor and for holding a needle. The second portion includes a first member having a head portion and a tail portion, the head portion shaped to receive a segment of the second member. The second member comprises a segment and a tail portion, the segment adapted to be received by the head portion of the first member, the first member being attached to the second member in a hinge-like manner, Allowing movement of the first and second members between the open and closed positions. The tail portions of the first member and the second member are shaped such that when in the closed position, a volume is formed to hold the sensor.

The present invention also provides an apparatus for mounting a sensor including a base member having an upper surface and a lower surface and a platform on the upper surface of the base member, the platform including opposed rails. . There are also wings mounted on opposite sides of the sensor housing, the wings being shaped to be received and retained by the rails. A hook is provided on the platform in the middle of the rail that holds the sensor housing when the wings are held in the rail.

The present invention additionally provides a needle guide having a needle lock and a needle holder located below the needle lock and aligned with the needle lock. Also, a sensor housing communicating with the needle locking device is provided.

[Brief Description of Drawings] FIG. 1 shows an interrupt image forming apparatus as described in PCT International Application Publication No. WO-97 / 03609 (International Publication No. PTC / IL96 / 05050). 1 shows a device of the present invention for use in. The illustrated interrupt imager uses ultrasonic transducers to generate the required image. This interrupt image forming device is merely an example, and for the device of the present invention, an interrupt image forming device other than the one disclosed in the above-mentioned PCT International Application Publication No. WO-97 / 03609. Can be used with

The device of the present invention is shown in the actuated state, and the surgeon may use the sensor 110 (FIGS. 4, 6B).
, 6C) (typically said PC which can be linked to a position sensing controller by wired or wireless communication according to said PCT International Application Publication No. WO-97 / 03609).
A needle adapter 20 having a position sensor as described in International Publication No. WO-97 / 03609. This adapter 20 is housed in the surgeon's first hand 21a. An ultrasonic transducer 23 having a device adapter 26 for housing a sensor 110 (FIGS. 7, 8) is typically a position sensing controller by wire or wireless communication according to PCT International Application Publication No. WO-97 / 03609. PCT International Application Publication Number WO-97 / 03609, which can be linked
Position sensor as described in the specification. Surgeon operates at surgery site 27 (
For example, during a biopsy of the chest of a woman), the ultrasonic transducer 23 is in the second hand 21b.

FIG. 2A shows the needle adapter 20 divided into three pieces: a main body 32, a housing member 34 and a pin 36. These pieces 32, 34, 36 are shaped to provide a self-fixing (and locking) structure without any additional adhesive or fasteners when assembled, but if desired, Additional adhesives or fasteners are possible. Three pieces are preferred, but any number of other pieces are also suitable. The three pieces 32, 34, 36 are preferably made of plastic, elastomer or the like by a technique such as injection molding.

Returning to FIG. 2B, the main body 32 has a head portion 40 formed by a cylinder 42 intermediate the platforms 44, 45. The cylinder 42 has a bore 46 extending from an opening 48 in the platform 44. The bore 46 preferably extends substantially through the cylinder 42 to the platform 45. However, the platform 45 can have openings such that the head 40 has openings (bores) extending therethrough.

Aperture 48 and bore 46 are preferably coaxial and of the same shape, such as a keyhole rounded to accommodate pin 36. The platforms 44, 45 extend beyond the cylinder 42 and the portion of the platform extending beyond the cylinder 42 is adapted to support the pawl 70 of the housing member 34. Platforms 44, 45 include outer surfaces 44a, 45a, preferably needle 114 (FIGS. 5A, 6A).
A, 6B) have cutouts 44b, 45b associated with the preferably flat wall 42a of the cylinder. The cylinder 42 also has a slot 49 (which extends the length of the bore (and other lengths are suitable) to accommodate the arm 94 of the pin 36.
(Shown in phantom), the arm 94 is designed to extend through the slot 49 when the pin 36 is placed in the bore 46 (as shown in FIG. 5B).

The tail portion 50 extends from the head 40. The tongue 52 is preferably formed within this tail portion 50 and behaves elastically (due to the nature of the material from which the main body 32 is made) in a spring-like manner. When the sensor 110 is placed in the assembled adapter 20 (as shown in Figures 4-6B), the tongue can move into the opening. Tail portion 50 preferably has an outwardly extending end 58 which is a rib 59 which can be easily grasped by a surgeon.
Have on it. The flange 60 extends from the tail portion 50 (preferably from the outwardly extending end 58) to hold the adapter 20 in place in a secure manner such that the sensor 110 (FIG. 6B) can be properly held therein. Wall 74 of housing member 34
Of teeth 62 shaped to engage an edge 78a (see FIG. 6b) of the.

As shown in FIG. 3A, the tooth 62 has a tapered portion 63 and a substantially flat platform 64 so that it can be biased in one direction. (Housing member 34
This one-way bias occurs when the adapter is assembled to the closed position (by relative relative movement of the respective tail portions 50, 72 as the pawl 70 of the main body 32 pivots about the cylinder 42). , The flange 60 supporting the teeth 62 flexes inwardly against the recess 80 in the wall 74, allowing the platform 64 to snap into place in the track 78 when it crosses the upper edge 78a of the wall 74. . This tooth design (of FIG. 3A) limits the needle adapter 20 to single use or single use. The reason for this is that when the adapter 20 is disassembled (to the open position), by separating the main body 32 from the housing member 34 and by moving their respective tail portions 50, 72 apart, the teeth 62 are moved to the housing. This is because a part of the housing member 34 is broken when pulling a part of the member 34. If a reusable device is desired, the teeth 62 'can have tapered platforms 64' as shown in Figure 3B, or they can be rounded.

The housing member 34 includes platforms 44, 45 (as shown in FIG. 6A).
Of the cylinder 42 to receive the needle 114 within the cutouts 44b, 45b of the cylinder. This winding is the main body 3
2 and a hinge-like attachment for the housing member 34. Preferably, the pawl 70 has a radius of curvature equal to or slightly less than the radius of curvature of the cylinder 42 so that the pawl 70 is attached to the cylinder 42 by frictional engagement and the main body 32 and the housing member 34 include the cylinder 42. Allows relative movement around. The claw 70 is sufficiently flexible to accommodate some standard needles. For example, the adapter 20 can be made to accommodate typically 14-18 and 18-23 gauges.

The pawl 70 also has a shoulder 71 with a knurl therein, the shoulder 71 having an inner wall 71.
Along a, along its upper portion, along substantially the entire circumference. This shoulder 71 terminates in a stop surface 71b extending inwardly beyond the shoulder 71.

The tail portion 72 has a stop wall 73 near the pawl 70 and a laterally located wall 74, the walls 73, 74 defining a cavity 76. The cavity 76 is formed by the sensor 110 (FIGS. 4-6).
It has a sufficient volume to accommodate C). Wall 74 platform 44
, 45 to accommodate the curvature of the main body 32 and thus the housing member 3
It has a curved segment 77 near the head 72 to absorb the pivoting movement of the four.

Track 78 is preferably cut into wall 74 to divide the wall into two parts. The track 78 defines edges 78a, 78b of the wall 74. The track 78 preferably extends a substantial length along the wall 74 (in the direction from the pawl 70 to the tail portion 72) and the bridge portion 79 connects portions of the wall 74. If a single use adapter (as described above) is desired, the track 78 associated with the bridge portion 79 facilitates breakage of this housing member 34. But if you want a multi-use adapter,
The length of the track can be varied as required and the track 78 is only needed at the end of the tail portion 72 to accommodate the teeth 62 for locking the adapter 20, as will be described later.

A recess 80 at the end of the tail portion 72 is cut into the wall 74 and positioned so that the teeth 62 ride into the recess when the adapter 20 moves to the closed position. The closed position is reached when the tooth 62 flexes outwardly beyond the edge 78a. The platform 64 of the teeth 62 eventually engages the corresponding edges 78a and provides a snap fit between the main body 32 and the housing member 34.

Like the tail portion 50 of the main body 32, the tail portion 72 is preferably an outwardly extending end portion 8.
6 and this end may have ribs 87 thereon for the surgeon to easily grasp. The tail portion 72 also extends through the bottom fin 111 of the sensor 110 (as shown in FIG. 6C) to properly position the sensor 110 within the adapter 20.
Has an opening 88 for receiving

The pin 36 has a head 90 mounted on a shaft 92, which has an arm 94. The head 90 typically has a cutout 96 shaped to correspond to the shape of the cutouts 44b, 45b of the platforms 44, 45.

Shaft 92 and arm 94 are shaped to fit through opening 48 in first platform 44 and bore 46 in cylinder 42. Arm 94
The shaft 92 preferably pivots integrally with the shaft in a spring-like manner.
Is formed at the end of. The arm 94 has an outer extension 9 extending in the direction of the head 90.
Have 5. The extension portion 95 is provided after the pin 36 has been inserted into the bore 46.
It has a width such that it can extend through the slot 49. The extension portion 95 contacts the platform 44 to lock the pin 36 inside the cylinder 42.

Continuing to refer to FIGS. 2A and 2B, and returning now to FIGS. 4, 5A and 5B, needle adapter 2
An exemplary actuation of 0 is shown. As shown in FIGS. 2B and 4, the pawl 70 (FIG. 2A) of the housing member 34 is placed in engagement with the cylinder 42 of the main body 32. The device 20 thus formed is in the open state, with the respective main body 32 and tail portions 50, 72 of the housing member 34 spaced apart. The pin 36 is inserted into the platform opening 48 and bore 46 such that the head 90 is located above the outer surface 44a of the platform 44. At this time, the extension portion 95 of the arm 94 is located in or above the shoulder portion 71 of the pawl 70 and extends through the slot 49 of the cylinder 42.

At this time, the sensor 110 (described in detail) has its bottom fin 111 fitted into the opening 88 (shown in FIG. 6C) and its rear side located near or in contact with the stop wall 73. And is disposed within the housing member 34 within the cavity 76. Cavity 76 preferably has only a slightly larger dimension than sensor 110 to accommodate the sensor in a snug (preferably frictionally snug) manner.

In FIG. 5A, a needle 114 having a head 116, a shaft 118, and a tip 119 is shown such that the shaft 118 is located within the cutouts 96, 44b, 45b of the pin 36 and platforms 44, 45. Will be placed. When the needle is inserted into the adapter 20, the needle 114 can be positioned from the side of the adapter 20 to avoid the risk of foreign particles contacting the needle tip 119.

Returning to FIG. 5B, the main body 32 and the tail portions 50, 72 of the housing member 34 are
Rotation of the pawl 70 of the housing member 34 about the cylinder 42 of the main body 32 brings it together to the semi-closed position. This rotation depends on the extension 95 of the arm 94.
Continues until it contacts the stop surface 71b of the pawl 70. In this semi-closed motion, the pawl 70 moves on the needle shaft 118 surrounding it.

To achieve the closed position and lock the needle 114 and sensor 110, FIG. 6A-
It is necessary to push pin 36 further into bore 46 by pushing needle head 116 to rotate pawl 70 around cylinder 42, as shown at 6C. To the point where the pin 36 disengages the extension 95 and the stop surface 71b,
After being pushed further into the bore 46, further rotation of the pawl 70 about the cylinder 42 occurs, allowing the adapter 20 to move to the closed position. Upon movement to the closed position, the teeth 62 ride in the corresponding indentations 80 and flex outwardly as they pass within the track 78 so that the platform 64 extends beyond the edge 78a of the wall 74,
It flexes outward and locks the adapter 20. In this position, the arm 9 of the pin 36
4 is firmly held to the inner wall 71a of the claw 70 and locks the pin 36. At this time, the adapter 20 is fully assembled (accommodating the sensor 110) and the needle 114 is in the operable position.

As a result of this locking configuration, the needle 114 has its head 116 with the head 90 of the pin 36.
The claw 70 and the cylinder 42 (flat portion 42a) are engaged with each other in a state of being on the top. Upon insertion of each needle, needle 114 is in the same position with respect to sensor 110, eliminating the need for sensor calibration for needle 114 prior to performing the entry procedure. Also,
When the adapter 20 is locked, the upper fin 120 of the sensor 110 presses the tongue 52, causing the tongue 52 and the fin 120 to fit within the opening 54.

To open the adapter 20 (move it to the open position) and release the sensor 110, the tail portions 50, 72 are spaced apart from each other. In the case of a single-use or single-use adapter, the teeth 62 pull a portion of the wall 74 and break at least a portion of the housing member 34. At the same time, the tongue 52 is spring-displaced inward, and the sensor 110
The upper fin 120 of the sensor is pressed to push the sensor 110 out of the adapter 20. This ensures a quick and easy release of the sensor 110 from the adapter 20 after opening the adapter 20.

In the case of a multi-use adapter, separating the tail portions 50, 72 (see FIG. 3B
Tooth 62 'slips along tongue 80. This keeps the adapter 20 untouched.

In another embodiment of the needle adapter described above, main body 32 and housing member 34 are maintained as described above. The pin 36 is omitted and the adapter 20 is moved in a single movement (the tooth 62 is moved into the respective track 78 so that its platform 64 abuts the upper edge 78a of the wall). Is pressed and engaged to engage). Needles 114 cut out 44b, 45b
When inside, the needle 114 is then pushed downward (towards the device 20) until the head 116 rests on the platform 44 of the device 20.

The device adapter 26 is shown in detail in FIGS. 7A and 7B. This adapter 26 has an upper surface 1
It has a base 130 with 32 and a lower surface 133. The upper surface 132 is the sensor 1
It houses the platform 134 for 10, while the lower surface 133 is attached to the device, typically by adhesive attachment to a portion of this lower surface 133. The adhesive portion can be covered by a cover (not shown) of material inert to the adhesive to prevent exposure and possible contamination of the adhesive until use. Alternatively, equivalent fastener configurations are possible. The dimensions of the base 130 can vary depending on the transducer, imaging or scanning device desired.

A safety hook 1 made of an elastic material such as plastic and having a tail portion 139.
38 are mounted on a platform 134 as rails 140 located opposite each other. A nub 141 projects from this safety hook 138. The sensor 110 typically has a housing 142 which is comprised of two parts 142a, 142b.
Wrapped inside. The lower portion 142b fits into a wing 144 that is correspondingly shaped with respect to the rail 140 to engage the rail and has an opening 146 for receiving the small portion 141.

In an exemplary operation, the sensor 110 is placed within the housing 142 and the housing 142 is slid in the direction of arrow 147 to engage the rail 140 with the wings 144. Sliding continues until small portion 141 is received in opening 146 and sensor 110 is over safety hook 138. The adapter 26 is the ultrasonic transducer 2
3 or other image forming or scanning device and then by adhesive fixing or the like, as shown in FIG.
Each insertion of the sensor 110 into the adapter 26 brings the sensor 110 to the same position with respect to the ultrasound beam (or scanning or imager beam), as shown in FIG. Removal of the housing 142 from the adapter 26 is accomplished by pressing the tail portion 139 of the hook 138 and sliding the housing 142 out of the rail 140 and out of the base 130. The housing 142 can now be opened and the sensor 110 removed therefrom.

This design allows for multiple insertions and withdrawals of the sensor within the medical device adapter at precise or near exact locations with respect to the ultrasonic transducer 23. Therefore, the calibration of the sensor for the ultrasonic transducer 23 only needs to be done once and thereafter (after storing the calibration parameters) this calibration need not be repeated unless the position of the adapter 26 changes.

FIG. 8B shows an adapter 26 for use on a biopsy gun. The biopsy gun has a needle 114 designed for rapid (typically spring loaded) advance and retract. Alternatively, the adapter 26 can be used by other devices, as detailed above for the device.

9-11 show a second embodiment of the needle adapter 220. This needle adapter 2
20 has a needle housing 222 attached to a sensor housing 224.
Attachment can be accomplished by a member 226 on the needle housing 222 with a protrusion 228 that extends therefrom to engage a slot 230 formed in a member 232 attached to the sensor housing 224. Alternatively, the positions of the protrusions 228 and slots 230 can be interchanged on the respective members 226, 228. This needle adapter is preferably made of plastic or the like.

The needle housing 222 preferably frictionally contacts the body 2 to allow the desired rotation.
It has a rotatable cylinder 240 which fits within 42. Cylinder 240 has bores 243a-243d that can be shaped to accommodate various standard needles (both fewer or more than four bores are possible). Upon rotation of cylinder 240, each bore 243a-243d can be positioned to align with bore 244 at body end 246 to allow insertion of needle 114 through needle housing 222. The body 242 can also include a window 247 that can display, for example, a needle gauge (gauge) corresponding to the bore that has rotated into place relative to the body bore.

The sensor housing 224 is similar to the corresponding portion of the needle adapter 20 detailed above, and has similar structure and material except where indicated. The sensor housing 224 has a main body 252 designed to be attached to the housing member 254 in a hinge-like manner. The operation of sensor housing 224 is similar to the operation of needle adapter 20 and the alternatives (detailed above). The main body 252 has a head 256 and a tail portion 258. The head 256 includes the sensor housing 22.
4 has a cylinder member 260 adapted to pivot as it moves between open and closed positions (detailed above). Cylinder member 260 has a cylinder (not shown) in the middle of a platform (not shown), similar to that shown and described in detail above with respect to FIGS. 2-6C. The cylinder of cylinder member 260 houses a pawl (not shown) similar to pawl 70 (detailed above). The tail portion 258 is similar to the tail portion of the main body portion 32 illustrated and described above, and structural elements are numbered the same.

The housing member 254 is similar to the housing member 34 illustrated and described above, and structural elements are numbered the same except as otherwise noted. In particular, the lateral wall 74 is shaped to receive the cylinder member 260 of the main body portion 252. These walls 74 include tracks 78 for receiving the teeth 62 of the main body portion 252 if a locking mechanism for the sensor housing 224 is desired, as detailed above.

Alternatively, other sensor housings are used in connection with the needle housing 222, such as the sensor housings similar to those used in conjunction with the adapter 26 illustrated in detail above with respect to FIGS. 7A and 7B. be able to. As another alternative, the needle housing 222 can be replaced with a needle having a member similar to member 226 with a protrusion adapted to be attached to the sensor housing 224.

FIG. 12A details an exemplary operation of the needle adapter 220 in connection with the ultrasonic transducer 23 using the adapter 26 (as detailed and illustrated above for FIG. 8A). The adapter 220 is placed on the human body at the surgical site 27. Needle 114 is guided through adapter 220. The exact length of the needle 114 entering the human body is unknown, but the orientation and needle trajectory can be calculated with this adapter 220. The reason is that the orientation of the bores 243a-243d with respect to the position sensor 110 is known. An additional benefit from this adapter 220 is that the substantial length of the needle shaft 118 is housed within the respective bores 243a-243d, thus minimizing the likelihood of the needle 114 bending during the entry procedure. That is.

FIG. 12B shows another embodiment for the apparatus detailed in FIGS. 9-12A. This device is similar to the one described and illustrated in detail above with respect to FIGS. 9-12A, and instead of needle adapter 220, slot 230 in member 232 of sensor housing 224.
There is provided a member 226 'with a projection 228' adapted to engage with. Figure 9-1
As with the 2A embodiment, the structure providing the protrusions 228 'and slots 230 can also be interchanged.

FIG. 12C shows a sensor housing 224 (detailed above for FIGS. 9-12A) with a biopsy gun 150 (detailed above and detailed in FIG. 8B), eg, 14G with a driver. 9 illustrates another embodiment as attached to a "MAMOTOME" probe, where biopsy gun 150 includes sensor housing 22.
4 has a member 226 ″ with a protrusion 228 ″ adapted to engage the four slots 230. As with the embodiment of FIGS. 9-12B, the structure providing the protrusions 228 ″ and slots 230 can also be interchanged.

13 and 14 show the needle guide 320 in detail. The needle guide 320 has a needle alignment device 324 and a sensor housing 224 (detailed above). The needle alignment device 324 includes an arm 326, a needle housing 222 (detailed above) attached to an arm adapter 327, and a needle lock 328. Needle lock 328 includes elements that are structurally similar to those of main body 32, pawl 70 of housing member 34, and pin 36 detailed above. The needle lock 328 also has an arm adapter 340 connected to the pawl 70. The arm adapter 340 is provided with a groove hole (
It has a projection 341 thereon, which can be received within (not shown). The locking mechanism for the needle 114 is similar to that for the first embodiment of the needle adapter (adapla 20) detailed above. The tail portion 342 is similar to the tail portion 50 of the main body 32 (detailed above) and is attached to the arm adapter 340 by a locking structure such as a male-female engagement.

The locking mechanism of the needle 114 in the needle locking device 328 and the locking mechanism of the sensor housing 224 with respect to the arm adapter 340 ensure that the position of the needle 114 with respect to the sensor is the same when each needle 114 is inserted. Guarantee. This is the needle 1 before performing the procedure
Eliminates the need for sensor calibration for 14. Moreover, sliding the needle along the arm 326 minimizes the likelihood of the needle bending. This effect is due to the needle being held in alignment on the two solid devices (needle lock 328 and needle holder 222) and the needle holder being placed on the surgical site 27 as shown in FIG. Is achieved.

A mark may be provided on the arm 326 to allow estimation of the penetration depth of the needle 114. These indicia are typically visible indicia and can take the form of, for example, inches, millimeters or other scales.

Reference is now made to FIGS. 16A and 16B. Here, "MAMMOTOME" (
Device 40 adapted to accept and engage biopsy guns
Indicates 0. The device preferably has a needle housing 402 adapted to engage a sensor housing 404. Needle housing 402 is sized and shaped to receive needle member 410. The sensor housing 404 has a compartment 405 dimensioned to house the sensor (detailed above), with a resilient flange 4 for fixedly retaining the sensor within the compartment 405.
Has 06.

The needle member 410 includes a needle (needle shaft) 114, a needle extension 412, and a “MAM”.
And members 413a and 413b adapted to be attached to the main body of a MOTOME (registered trademark) biopsy gun (not shown). The needle extension 412 has a shaft holder 416, an upper chamber wall 418, and a lower chamber wall 420.

Needle housing 402 and sensor housing 404 are a single piece (one piece construction)
Alternatively, it can be a detachably attachable piece (as described above). Needle housing 402 is sized and shaped (preferably with a cylindrical bore extending therethrough) to accommodate needle extension 412, rather than being attached directly to needle shaft 114. In particular, the needle housing 402 is suitable for mounting on the shaft holder 416, while the shape of the sensor housing 404 matches the shape of the upper chamber wall 418. All these pieces (except needle 114) can be made of elastic plastic or other elastic material.

Reference is now made to FIGS. 17A and 17B. Here, SENOREX (trade name)
Shown is a device 500 adapted to receive and engage an introducer 114 '. The device 500 preferably has a needle housing 502 adapted to engage the sensor housing 504. Needle housing 502 is a C-shaped member with a cutout inner wall 505 dimensioned to engage and retain the collar portion of SENOREX ™ introducer 114 '. The sensor housing 504 has a compartment 504a dimensioned to house the sensor (detailed above) and has a resilient flange 506 for fixedly retaining the sensor within the compartment 504a. Needle housing 502 is preferably shaped to be attached to sensor housing 504 by any of the attachments detailed above, for example, a protrusion / slot or any other conventional attachment.

The introducer member 114 ′ includes an outer shaft (not shown), a shaft portion 510,
It has an extension 512 that acts as a shaft holder, and an upper portion 514 adapted to connect to the rest of the SENORX ™ opening.

Needle housing 502 is sized and shaped to accommodate extension 512 rather than being directly attached to shaft portion 510. Needle housing 502 and sensor housing 504 can be a single piece (one piece construction). Needle housing 5 similar to device 400 of FIGS. 16A and 16B (detailed above).
02 and the sensor housing can be made of elastic plastic or other material having elasticity.

Although the present invention has been described above, it should be understood that the present invention is not limited to the embodiments described in detail above. The invention covers all modifications and equivalents within the spirit and scope of the invention as defined by the appended claims.

[Brief description of drawings]

The present invention will now be described with reference to the attached figures, wherein like numerals identify corresponding or similar elements.

[Figure 1]   FIG. 3 illustrates the present invention used in a medical procedure.

2A is a partial exploded view of a first embodiment of a needle adapter of the present invention with component elements spaced apart from each other, and FIG. 2B is a first embodiment of the needle adapter in an open position. It is a perspective rear view of FIG.

3A and 3B are detailed views of an embodiment for a tooth of a finger used to lock the adapter of FIGS. 2A and 2B.

FIG. 4 is a perspective view of the device of FIG. 2B with the sensor loaded in the needle adapter in the open position.

5A is a perspective front view of the first embodiment during needle loading, and FIG. 5B is a multi-level top cross-sectional view of the first embodiment during needle loading.

6A and 6B are perspective views of the needle adapter of the present invention in a closed position containing a sensor and a needle, and FIG. 6C is a cross-sectional view taken along line 6C-6C of FIG. 6B.

7A is a perspective view of a device adapter of the present invention, and FIG. 7B is a perspective view of a sensor and housing suitable for use with the device adapter of the present invention.

FIG. 8A is a front view of a sensor device mounted on an ultrasonic transducer,
FIG. 8B is a perspective view of a biopsy gun with the sensor device of the present invention mounted thereon.

FIG. 9 is a perspective view of a second embodiment of the needle adapter of the present invention with the component parts spaced apart from each other.

[Figure 10]   It is a perspective view of the 2nd Embodiment of the needle adapter of this invention.

FIG. 11   FIG. 11 is a perspective view of a needle housing of the needle adapter of FIGS.

12A illustrates the needle adapter of FIGS. 9 and 10 in an exemplary operation, and FIG. 12B illustrates another embodiment of the needle adapter of FIGS. 9 and 10 in an exemplary operation. FIG. 12C is a perspective view of the biopsy gun with the sensor adapter according to the second embodiment of the present invention mounted thereon.

[Fig. 13]   It is a perspective view of the 3rd Embodiment of the needle adapter of this invention.

FIG. 14   FIG. 14 is a perspective view of a needle track positioner of the third embodiment of the needle adapter of FIG. 13.

FIG. 15   FIG. 14 illustrates the needle adapter of FIG. 13 in exemplary operation.

16A and 16B are perspective and side views of an embodiment of a needle adapter of the present invention adapted to accept a "MAMMOTOME" biopsy "gun".

17A is a perspective view of an embodiment of a needle adapter of the present invention operating with a Senorex ™ introducer, and FIG. 17B is a perspective view of an embodiment of the needle adapter of FIG. 17A.

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Claims (16)

[Claims] 1. A needle adapter having a first member and a second member, the first member including a first portion and a second portion, the first portion being at least substantially. Having a bore extending therethrough, the first portion being shaped to receive the first portion of the second member, the second portion being shaped to receive the needle, and The member comprises a first portion and a second portion, the first portion being hinge-like to allow movement of the first and second members between an open position and a closed position. In a manner such that the first member and the second member are mounted within the first portion of the first member such that the first member and the second member are received. The second portion of the is formed with a cavity for holding the sensor when in the closed position. Is shaped to, above the bore of the first portion of the first member, a pin for mounting the needle is so may be removably mounted, a needle adapter, characterized in that. 2. The second portion of each of the first and second members share a second member to lock the first member to the second member when in the closed position. The needle adapter according to claim 1, further comprising a dynamic locking structure. 3. The first portion of the first member includes a cylinder with a bore extending therethrough such that the first portion of the second member is attached to the cylinder. The needle adapter according to claim 1, further comprising a claw. 4. The pawl has a second radius of curvature equal to or slightly smaller than the first radius of curvature, the pawl being attached to the cylinder by frictional engagement, and The needle adapter of claim 3, wherein the member and the second member are adapted to move relative to each other about the cylinder. 5. A needle adapter having a first member and a second member, the first member having a first portion for holding a needle and a second portion for receiving a sensor.
And a second portion comprising a first portion and a second portion, the second portion being pivotally received in the first portion of the first member. , The first and second members are allowed to move between an open position and a closed position, the second portion of the first member and the second member being A needle adapter, wherein the needle adapter is shaped to form a cavity for holding the sensor when in the closed position. 6. The second portion of the first member and the second member is adapted to lock the first member to the second member when in the closed position.
The needle adapter of claim 5, including a cooperating locking structure. 7. The first portion of the first member has a cylinder member, and the first portion of the second member has a pawl that is engaged around the cylinder member. The needle adapter according to claim 5. 8. A device for mounting a sensor, comprising: a base member having an upper surface and a lower surface; a platform including opposed rails located on the upper surface of the base member; A sensor housing having a wing shaped to be received and retained by said sensor housing; located on said platform intermediate said rail and said sensor housing when said wing is retained within said rail. A device for holding a hook; 9. The device of claim 8, wherein at least a portion of the lower surface comprises an adhesive. 10. In the needle guide,   Needle lock;   A needle holder located below the needle locking device and aligned with the needle locking device;   A sensor housing communicating with the needle locking device; A needle guide characterized by having. 11. The sensor housing is a first member having a first portion and a second portion, the first portion receiving the first portion of the second member. A first member shaped; a second member having a first portion and a second portion, the first and second members being between an open position and a closed position. Movably, said first portion of said second member having a second member pivotally received within said first portion of said first member; One member and the second portion of the second member are shaped to form a cavity for holding a sensor when in the closed position. Item 10. The needle guide according to Item 10. 12. The needle guide of claim 11, wherein the first portion comprises a cylinder member and the first portion comprises a pawl engaged around the cylinder member. 13. A device for positioning a sensor near a biopsy gun, a needle housing having a substantially cylindrical bore extending therethrough; a sensor housing removably attachable to the needle housing; A needle member adapted to be received in a housing, the needle member including a needle shaft communicating with a chamber, and the needle member accommodating a biopsy gun such that the chamber communicates with the needle shaft. Characterized device. 14. The apparatus according to claim 13, wherein the biopsy gun is a “MMAMOTOME” (registered trademark) biopsy gun. 15. An introducer receiving device, comprising: a collar member comprising a cutout inner wall, shaped as a discontinuous ring, and configured to receive an introducer, the collar member comprising a substantially elastic material; A sensor housing detachably attachable to the collar member; 16. The introducer of claim 15, wherein the collar member is shaped to receive a SENOREX ™ introducer.