阅读说明：本技术 活检布置 (Biopsy arrangement ) 是由 K-U·莎斯伯格 M·奥尔森 A·福格林 J·弗伦宁 A·埃里克苏鲁德 R·斯塔尔 L- 于 2019-08-30 设计创作，主要内容包括：一种用于在人或动物组织中进行活检的活检布置(1),所述活检布置包括：-驱动器单元(3)；和-至少两种不同类型的探头(5a,5b,5c,5d),其可能够释放地连接到驱动器单元(3),所述至少两种不同类型的探头至少包括第一探头类型(5a)和第二探头类型(5b),其中,所述驱动器单元(3)包括控制连接的探头(5a,5b,5c,5d)中的不同探头模块(201,202,203,204,205,206,207,208,209)的至少两个不同的探头控制装置(101,2,103,104),所述至少两个不同的探头控制装置(101,102,103,104)包括吸力产生装置(101)和针移动装置(102),并且其中,第一探头类型(5a)的探头模块(201,202)包括吸力传递模块(201)和至少一个针操纵模块(202),其中,所述吸力传递模块(201)构造成用于将吸力从驱动器单元(3)的吸力产生装置(101)传递到第一探头类型(5a)的针(25a),并且其中,所述至少一个针操纵模块(202)是第一探头类型针操纵模块(202),其构造成用于向第一探头类型(5a)的针(25a)的至少部分提供纵向和/或旋转移动,并且其中,第二探头类型(5b)的探头模块(204)包括至少一个针操纵模块(204),其为第二探头类型弹簧加载针操纵模块(204),第二探头类型弹簧加载针操纵模块(204)构造成用于向第二探头类型(5b)的针(25b)的至少部分提供弹簧加载的纵向移动。(A biopsy arrangement (1) for taking a biopsy in human or animal tissue, the biopsy arrangement comprising: -a driver unit (3); and-at least two different types of probes (5a,5b,5c,5d) which may be releasably connected to the driver unit (3), the at least two different types of probes comprising at least a first probe type (5a) and a second probe type (5b), wherein the driver unit (3) comprises at least two different probe control devices (101,2,103,104) controlling different probe modules (201,202,203,204,205,206,207,208,209) in the connected probes (5a,5b,5c,5d), the at least two different probe control devices (101,102,103,104) comprising a suction generating device (101) and a needle moving device (102), and wherein a probe module (201,202) of the first probe type (5a) comprises a suction transfer module (201) and at least one needle manipulation module (202), wherein the suction transfer module (201) is configured for transferring suction from the suction generating device (101) of the driver unit (3) to the first probe type (101) A needle (25a) of type (5a), and wherein the at least one needle manipulation module (202) is a first probe type needle manipulation module (202) configured for providing longitudinal and/or rotational movement to at least part of the needle (25a) of the first probe type (5a), and wherein the probe module (204) of the second probe type (5b) comprises at least one needle manipulation module (204) which is a second probe type spring loaded needle manipulation module (204), the second probe type spring loaded needle manipulation module (204) being configured for providing spring loaded longitudinal movement to at least part of the needle (25b) of the second probe type (5 b).)

1. A biopsy arrangement (1) for taking a biopsy in human or animal tissue, the biopsy arrangement comprising:

-a driver unit (3); and

-at least two different types of probes (5a,5b,5c,5d), which may be releasably connected to the driver unit (3), the at least two different types of probes comprising at least a first probe type (5a) and a second probe type (5b),

wherein the driver unit (3) comprises at least two different probe control devices (101,102,103,104) controlling different probe modules (201,202,203,204,205,206,207,208,209) in connected probes (5a,5b,5c,5d), the at least two different probe control devices (101,102,103,104) comprising a suction force generating device (101) and a needle moving device (102), and

wherein the probe modules (201,202) of the first probe type (5a) comprise a suction transfer module (201) and at least one needle manipulation module (202), wherein the suction transfer module (201) is configured for transferring suction from the suction generating device (101) of the driver unit (3) to a needle (25a) of the first probe type (5a), and wherein the at least one needle manipulation module (202) is a first probe type needle manipulation module (202), the first probe type needle manipulation module (202) being configured for providing longitudinal and/or rotational movement to at least part of the needle (25a) of the first probe type (5a), and

wherein the probe module (204) of the second probe type (5b) comprises at least one needle manipulation module (204), the at least one needle manipulation module (204) being a second probe type spring loaded needle manipulation module (204), the second probe type spring loaded needle manipulation module (204) being configured for providing spring loaded longitudinal movement to at least part of a needle (25b) of the second probe type (5b),

wherein the different types of probes (5a,5b,5c,5d) use different sampling techniques.

2. The biopsy arrangement (1) according to claim 1, characterized in that the suction generating device (101) of the driver unit (3) is configured for connection to a suction transfer module (201, 206) of a connected probe (5a,5b,5c,5d) and the needle moving device (102) of the driver unit (3) is configured for connection to one or more needle manipulation modules (202, 204, 207) of a connected probe (5a,5b,5c,5d) for controlling at least partial longitudinal and/or rotational movement of a needle (25a, 25b, 25c, 25d) of a probe (5a,5b,5c,5d) connected to the driver unit (3).

3. Biopsy arrangement according to any of the preceding claims, wherein the probe control means (101,102,103,104) of the driver unit (3) further comprises a pulse means (103), the pulse means (103) being adapted to transmit reciprocating pulses to the needles (25a, 25b, 25c, 25d) of the connected probes (5a,5b,5c,5 d).

4. The biopsy arrangement according to claim 3, wherein the further probe modules (203, 205) of both the first probe type (5a) and the second probe type (5b) are pulse transfer modules (203, 205), the pulse transfer modules (203, 205) being configured for transferring reciprocating pulses provided from the pulse device (103) of the driver unit (3) to at least parts of the needles (25a, 25b) of the first probe type (5a) and the second probe type (5b) when connected to the driver unit (3).

5. Biopsy arrangement according to claim 4, wherein the pulse delivery module (205, 208) of at least one of the different types of probes (5b) is configured for delivering reciprocating pulses provided from the pulse device (103) of the driver unit (3) to both an inner needle portion (29b, 29c) and an outer needle portion (31b, 31c) of a needle (25b) of the probe (5b), and wherein the pulse delivery module (203) of another one of the different types of probes (5a) is configured for delivering reciprocating pulses provided from the pulse device (103) of the driver unit (3) to only one of the inner needle portion (29a) and the outer needle portion (31a) of the needle (25 a).

6. Biopsy arrangement according to any of the preceding claims, wherein the biopsy arrangement (1) comprises a third probe type (5c) which may be releasably connected to the driver unit (3), the third probe type being a different type of probe than the first probe type (5a) and the second probe type (5b), wherein a probe module (206, 207,208,209) of the third probe type (5c) comprises a suction force transfer module (206) and a needle manipulation module (207), wherein the suction force transfer module (206) is configured for transferring suction force from the suction force generating device (101) of the driver unit (3) to a needle (25c) of the third probe type (5c), and wherein the needle manipulation module (207) is a third probe type needle manipulation module (207), the third probe type needle manipulation module (207) is configured for providing longitudinal movement to an inner needle portion (29c) of the needle (25c) of the third probe type (5c) for positioning the inner needle portion (29c) in a forward or rearward position relative to an outer needle portion (31c) of the needle (25c) and for providing rotational movement to the outer needle portion (31c) of the needle (25 c).

7. Biopsy arrangement according to claim 6, wherein the third probe type (5c) further comprises a sample separation module (209), the sample separation module (209) being configured for cooperating with a sample separation device (104) provided in the driver unit (3), the sample separation device (104) comprising or being connected to a motor, wherein the sample separation module (209) is connected to an outer needle portion (31c) of the needle (25c) such that a rotational movement can be provided from the sample separation device (104) to the outer needle portion (31c) by the sample separation module (209).

8. The biopsy arrangement according to claim 6 or 7, wherein the third probe type (5c) further comprises a pulse transfer module (208), the pulse transfer module (208) being configured for transferring a reciprocating pulse provided from the pulse device (103) of the driver unit (3) to an inner needle portion (29c) and/or an outer needle portion (31c) of a needle (25c) of the third probe type (5 c).

9. Biopsy arrangement according to any of the preceding claims, wherein the biopsy arrangement (1) further comprises a fourth probe type (5d) releasably connected to the driver unit (3), wherein the fourth probe type is a marker probe (5d) configured for leaving a marker in human or animal tissue, the marker probe (5d) being controllable by one or more of the probe control devices (101,102,103,104) provided in the driver unit (3).

10. The biopsy arrangement according to any one of the preceding claims, wherein at least one (5c) of the at least two different types of probes comprises a distal tip loading needle (25c) and at least one (5a, 5b) of the at least two different types of probes comprises a side port needle (25a, 25 b).

11. Biopsy arrangement according to any of the preceding claims, wherein each of the at least two different types of probes (5a,5b,5c,5d) comprises a unique probe identification (41a, 41b, 41c, 41d) and the driver unit (3) comprises a probe identification recognition device (43), which probe identification recognition device (43) is connected to the at least two different probe control devices (101,102,103,104) and comprises control logic, such that the probe identification recognition device (43) may activate certain probe control devices (101,102,103,104) depending on which type of probe (5a,5b,5c,5d) has been identified by the probe identification recognition device (43).

12. Biopsy arrangement according to any of the preceding claims, wherein the first probe type (5a) comprises a sample collection device (29a) connected to the needle (25 a).

13. Driver unit (3) for use with at least two different types of probes (5a,5b,5c,5d) for biopsy in human or animal tissue, the driver unit (3) comprising first connecting means (11) for releasably connecting the probes (5a,5b,5c,5d), wherein the driver unit (3) comprises at least two different probe control means (101,102,103,104), which at least two different probe control means (101,102,103,104) can control different probe modules (201,202,203,204,205,206,207,208,209) in a connected probe (5a,5b,5c,5d), wherein the different types of probes (5a,5b,5c,5d) use different sampling techniques.

14. Driver unit according to claim 13, wherein the at least two different probe control means (101,102,103,104) of the driver unit (3) comprise suction generating means (101) and at least one needle moving means (102) for controlling the longitudinal and/or rotational movement of the needle (25a, 25b, 25c, 25d) of the connected probe (5a,5b,5c,5 d).

15. Driver unit as claimed in any of claims 13 to 14, characterized in that the probe control means (101,102,103,104) of the driver unit (3) comprise a pulse means (103), which pulse means (103) can transmit reciprocating pulses to the needles (25a, 25b, 25c, 25d) of the connected probes (5a,5b,5c,5 d).

16. Driver unit as claimed in any one of claims 13 to 15, characterized in that it further comprises a probe identity recognition device (43) configured for recognizing a probe identity (41a, 41b, 41c, 41d) of a connected probe (5a,5b,5c,5d), said probe identity recognition device (43) being connected to said at least two different probe control devices (101,102,103,104) and comprising control logic such that said probe identity recognition device (43) can activate certain probe control devices (101,102,103,104) depending on which type of probe (5a,5b,5c,5d) has been identified by said probe identity recognition device (43).

17. A probe (5a,5b,5c,5d) for taking biopsies or leaving markers in human or animal tissue, the probe (5a,5b,5c,5d) comprising a second connecting device (23a, 23b, 23c, 23d), the second connecting device (23a, 23b, 23c, 23d) being configured for releasable connection to a first connecting device (11) of a driver unit (3) according to any of claims 13 to 16, wherein the probe (5a,5b,5c,5d) comprises at least one needle handling module (202, 204, 207, 204').

18. The probe according to claim 17, further comprising a pulse delivery module (203, 205, 208, 205 '), said pulse delivery module (203, 205, 208, 205') being configured for delivering a reciprocating pulse provided from a pulse device (103) of the driver unit (3) to at least part of a needle (25a, 25b, 25c, 25d) of the probe (5a,5b,5c,5 d).

19. The probe according to claim 17 or 18, wherein the needle manipulation module (202) is a first probe type needle manipulation module (202), the first probe type needle manipulation module (202) being configured for providing a longitudinal and/or rotational movement to at least part of a needle (25a) of the probe (5a), and wherein the probe (5a) further comprises a suction force transfer module (201), the suction force transfer module (201) being configured for transferring a suction force from a suction force generating device (101) of the driver unit (3) to the needle (25a) of the probe (5 a).

20. The probe of claim 18 or 19, wherein the needle manipulation module (204) is a second probe type spring loaded needle manipulation module (204), the second probe type spring loaded needle manipulation module (204) being configured for providing spring loaded longitudinal movement to at least part of a needle (25b) of the probe (5 b).

21. The probe according to claim 18 or 19, wherein the needle manipulation module (207) is a third probe type needle manipulation module (207), the third probe type needle manipulation module (207) being configured for providing a longitudinal movement to an inner needle portion (29c) of a needle (25c) of the probe (5c) for positioning the inner needle portion (29c) in a forward or rearward position with respect to an outer needle portion (31c) of the needle (25c), and wherein the probe (5c) further comprises a suction force transfer module (206), the suction force transfer module (206) being configured for transferring a suction force from a suction force generating device (101) of the driver unit (3) to the needle (25c) of the probe (5 c).

22. Probe according to claim 21, characterized in that the probe further comprises a sample separation module (209), the sample separation module (209) being configured for cooperating with a sample separation device (104) provided in the driver unit (3), the sample separation device (104) comprising or being connected to a motor, wherein the sample separation module (209) is connected to an outer needle portion (31c) of the needle (25c) such that a rotational movement can be provided from the sample separation device (104) to the outer needle portion (31c) by the sample separation module (209).

23. The probe according to any one of claims 17 to 22, further comprising a unique probe identification (41a, 41b, 41c, 41d), by means of which unique probe identification (41a, 41b, 41c, 41d) the type of probe (5a,5b,5c,5d) can be identified by a probe identification identifying means (43) of the driver unit (3) when the probe (5a,5b,5c,5d) is connected to the driver unit (3).

Technical Field

The present invention relates to a biopsy arrangement for taking a biopsy in human or animal tissue, a driver unit and a probe.

Background

It is now generally accepted that the final diagnosis of malignant suspicious lesions must be confirmed using biopsy techniques. The most commonly performed cell and tissue sampling techniques are Fine Needle Aspiration (FNA) using primarily 22G and 23G needles (0.6-0.7 mm in diameter) and Core Needle Biopsy (CNB) or Vacuum Assisted Biopsy (VAB) using all needles between 8G and 18G needles (1.3-4.2 mm in diameter), with the latter two techniques being globally dominant. The number of open surgical biopsies is steadily decreasing, due to the significant improvement in sensitivity and minimally invasive properties when combining needle biopsy techniques with imaging guidance.

In contrast to FNA, CNB and VAB allow for large volume tissue sampling, which allows for differentiation between in situ and invasive lesions, histological diagnosis of microcalcifications, and analysis of several relevant biomarkers.

There is a significant advance in the visualization technology that is constantly driving the possible boundaries in terms of locating suspicious lesions. In addition, many developments, such as the use of advanced biomarkers for subsequent and personalized adjuvant therapy, are defining new requirements regarding very precise and minimally invasive tissue sampling.

The distal end of the biopsy needle used in most CNB and VAB devices is a sharp solid tip that is required for penetrating tissue towards the location where the biopsy is to be taken. To penetrate a suspicious lesion, the needle must be inserted manually or by advancing the needle into a lesion of a predetermined length using a commonly used spring loaded mechanism. Thereafter, a tissue sampling procedure is initiated, typically incorporating the opening of the remaining space filled with surrounding tissue and then closed, whereby the tissue inside the remaining space is severed from the surrounding tissue.

The opening and possible closing of the remaining space is typically achieved by a relative movement of two separate elements of the needle biopsy assembly (e.g. an inner sampling needle with respect to an outer cutting needle, an inner trocar with respect to an outer sampling needle, or a distal cutting blade with respect to a distal tip sampling needle).

Different types of biopsy devices are well known in the art. Some documents describing biopsy devices with hollow needles and elongate rods are WO 0056220, EP 2520237, US 2012/0029354, US 5188118, US 5348022, US 5121751, US 6120463, US 8282573, US 7828748, WO 2014/007380, DE 20211934U, US 8313444 and US 5392790. The present applicant has described in EP 2323563 a core biopsy arrangement in which a reciprocating longitudinal movement is applied to a biopsy needle. In EP 3206587 and WO 2016/058845, the applicant discloses a biopsy arrangement with such a reciprocating longitudinal movement of the biopsy needle, wherein specific details are described around a specific configuration of the needle comprising an internal trocar and a distal tip of the needle for cutting a sample. Furthermore, the following documents describe biopsy arrangements comprising a blade or a severing arrangement: WO 2012015801, EP 1832234, WO 0010465, US 5615690, RU 2212848, US 2009012423, WO 2008115526.

In addition, manual insertion of a large diameter needle through healthy tissue toward a target lesion can be cumbersome, especially if the tissue is dense or fibrotic. The physician must apply manual force to guide the needle towards the lesion while maintaining flexibility and control so as not to damage the vessels and organs. The insertion process is a source of anxiety for the patient and should therefore be as short and efficient as possible.

The cases indicated for biopsy vary greatly in technical complexity with respect to the location and size of the lesion and the tissue volume requirements. Different devices with different needle insertion and sample collection mechanisms are used depending on the needs of the case at hand.

This requires the physician to be trained in the use of several different biopsy platforms. Ultrasound guided biopsy is highly dependent on the experience of the physician. The need for multiple biopsy platforms limits the experience available to physicians on each individual platform. Healthcare facilities need to purchase, store and maintain multiple biopsy platforms, which has significant economic disadvantages.

Disclosure of Invention

It is an object of the present invention to provide a biopsy arrangement which can be used for taking biopsies from many different types of lesions at different locations.

It is a further object of the present invention to provide a biopsy arrangement with improved flexibility and unprecedented ease of use.

This is achieved by a biopsy arrangement, a driver unit and a probe according to the independent claims.

According to one aspect of the present invention, a biopsy arrangement for taking a biopsy in human or animal tissue is provided. The biopsy arrangement comprises:

-a driver unit; and

at least two different types of probes, which may be releasably connected to the driver unit, the at least two different types of probes comprising at least a first probe type and a second probe type,

wherein the driver unit comprises at least two different probe control devices controlling different probe modules in a connected probe, the at least two different probe control devices comprising a suction force generating device and a needle moving device, and

wherein the probe module of the first probe type comprises a suction transfer module and at least one needle manipulation module, wherein the suction transfer module is configured for transferring suction from a suction generating device of the driver unit to the needle of the first probe type, and wherein the at least one needle manipulation module is a first probe type needle manipulation module configured for providing longitudinal and/or rotational movement to at least part of the needle of the first probe type, and

wherein the probe module of the second probe type comprises at least one needle manipulation module, the at least one needle manipulation module being a second probe type spring loaded needle manipulation module configured for providing spring loaded longitudinal movement to at least part of a needle of the second probe type,

wherein different types of probes use different sampling techniques.

According to another aspect of the invention, there is provided a driver unit for use with at least two different types of probes for biopsy in human or animal tissue. The driver unit comprises a first connecting means for releasably connecting the probe, wherein the driver unit comprises at least two different probe control means which can control different probe modules in the connected probe, wherein different types of probes use different sampling techniques.

According to another aspect of the present invention, there is provided a probe for taking a biopsy or leaving a marker in human or animal tissue, the probe comprising second connecting means configured for releasable connection to the first connecting means of a driver unit as described above, wherein the probe comprises at least one needle manipulation module.

Thereby, a biopsy arrangement is provided, wherein the driver unit can be used for a plurality of different types of probes. The driver unit may thus be reusable, and the probe may suitably be a single use probe. In the present invention, different types of probes are not only biopsy needles of different sizes, but also comprise different means for sampling tissue, which also requires different functions for controlling the probe. At least one of the probe types connectable to and controlled by the driver unit comprises a suction delivery module and at least one of the probe types comprises a spring-loaded needle manipulation module. Thus, both core needle biopsy and vacuum assisted biopsy may be provided by the same biopsy arrangement. The driver unit comprises at least two different probe control means comprising suction generating means and needle moving means. When the probes are connected to the driver unit, the probe modules in the different probes may be controlled by the probe control means in the driver unit. Thereby, the physician can easily change between different probe types and still use the same driver unit. A user-friendly device is provided because the interface is extremely simple and the doctor only needs to operate one driver unit. The most appropriate probe type can be chosen for each patient and for each lesion, which is greatly facilitated in view of the heterogeneity (small, large, soft, hard, difficult to locate, etc.) of the lesions sampled today. Modern visualization techniques enable the localization of smaller and smaller lesions, and changes in treatment protocols increase the need for repeated biopsies during new adjuvant therapy and preoperative sampling of lymph nodes. The simplified procedure and flexibility of biopsy placement results in higher quality tissue samples that can be taken, which supports an important development in personalized medicine. Furthermore, with the biopsy arrangement according to the invention the situation for the physician (typically a radiologist) will be improved, and the arrangement will facilitate easy management of complex cases for more inexperienced users. This will improve the efficiency of the operation of the healthcare facility. With the biopsy arrangement according to the invention, the clinic will only need one biopsy platform instead of a plurality of different platforms for different types and locations of tumors. The high quality tissue sample provided by the biopsy arrangement according to the present invention will improve the likelihood of correct diagnosis and treatment.

In one embodiment of the invention, said suction generating means of the driver unit is configured for connection to a suction delivery module of a connected probe, and said needle moving means of the driver unit is configured for connection to one or more needle handling modules of the connected probe for controlling a longitudinal and/or rotational movement of at least part of a needle of the probe connected to the driver unit.

In one embodiment of the invention said probe control means of the driver unit further comprises a pulse means which can deliver a reciprocating pulse to the needle of the connected probe. Thereby, a longitudinally reciprocating pulse may be transmitted to the biopsy needle of the attached probe. Such reciprocating oscillating movement of the needle or part of the needle (inner and/or outer needle part, such as a cannula or trocar) is particularly suitable when penetration of dense or fibrotic tissue is required on the way to the tumour. Also, when penetrating a tumor for biopsy, preferably an oscillating movement may be used in order to improve the filling of the needle with tissue with inertial stabilization caused by a fast acceleration pulse applied to the needle.

In one embodiment of the invention, the further probe modules of both the first and second probe types are pulse delivery modules configured for delivering reciprocating pulses provided from the pulse arrangement of the driver unit to at least part of the needles of the first and second probe types when connected to the driver unit.

In one embodiment of the invention, the pulse delivery module of at least one of the different types of probes is configured for delivering the reciprocating pulses provided from the pulse arrangement of the driver unit to both the inner and outer needle portions of the needle of the probe, and the pulse delivery module of another of the different types of probes is configured for delivering the reciprocating pulses provided from the pulse arrangement of the driver unit to only one of the inner and outer needle portions of the needle.

In one embodiment of the invention, the biopsy arrangement comprises a third probe type releasably connectable to the driver unit, the third probe type being a different type of probe than the first probe type and the second probe type, wherein a probe module of the third probe type comprises a suction transfer module and a needle manipulation module, wherein the suction transfer module is configured for transferring suction from a suction generating device of the driver unit to a needle of the third probe type, and wherein the needle manipulation module is a third probe type needle manipulation module configured for providing longitudinal movement to an inner needle portion of a needle of the third probe type for positioning the inner needle portion in a forward or rearward position relative to an outer needle portion of the needle and for providing rotational movement to the outer needle portion of the needle. Thus, three different probe types using different sampling techniques can be used with the same reusable driver unit.

In one embodiment of the invention, the third probe type further comprises a sample separation module configured for cooperation with a sample separation device provided in the driver unit, the sample separation device comprising or being connected to the motor, wherein the sample separation module is connected to the outer needle portion of the needle such that a rotational movement can be provided from the sample separation device to the outer needle portion by the sample separation module.

In one embodiment of the invention, said third probe type further comprises a pulse delivery module configured for delivering a reciprocating pulse provided from the pulse device of the driver unit to the inner and/or outer needle portion of the needle of the third probe type.

In one embodiment of the invention, the biopsy arrangement further comprises a fourth probe type, which may be releasably connected to the driver unit, wherein the fourth probe type is a marker probe configured for leaving a marker in human or animal tissue, the marker probe being controllable by one or more of the probe control means provided in the driver unit. Thereby, the biopsy arrangement according to the invention may also be used for leaving markers in tissue, i.e. the same driver unit may also be used for a marker probe. This will provide an efficient and easy to operate system.

In one embodiment of the invention, at least one of the at least two different types of probes comprises a distal tip loading needle and at least one of the at least two different types of probes comprises a side port needle. Thus, different probes comprising different needle types using different sampling techniques may be used with the same driver unit.

In one embodiment of the invention, each of the at least two different types of probes comprises a unique probe identity, and the driver unit comprises a probe identity recognition device connected to the at least two different probe control devices and comprising control logic, such that the probe identity recognition device may activate certain probe control devices depending on which type of probe has been identified by the probe identity recognition device. Thereby, one and the same driver unit may be used for different probe types, and different functions in the driver unit may be activated depending on the type of connected probe.

Further embodiments of the invention are described in the dependent claims.

Drawings

Fig. 1a is a perspective side view and fig. 1b is a perspective bottom view of a biopsy arrangement according to an embodiment of the invention.

Fig. 2a is a perspective top view and fig. 2b is a perspective bottom view of a driver unit according to an embodiment of the invention.

FIG. 3a is a side view and FIG. 3b is a bottom view of a first probe type according to one embodiment of the invention.

FIG. 4a is a side view and FIG. 4b is a bottom view of a second probe type according to one embodiment of the present invention.

FIG. 5a is a side view and FIG. 5b is a bottom view of a third probe type according to one embodiment of the present invention.

FIG. 6a is a side view and FIG. 6b is a bottom view of a fourth probe type according to one embodiment of the present invention.

Detailed Description

Fig. 1a and 1b show different perspective views of a biopsy arrangement 1 according to an embodiment of the invention. The biopsy arrangement 1 is an arrangement for taking a biopsy in human or animal tissue and comprises according to the invention a driver unit 3 and at least two different types of probes 5a,5b,5c,5d, which probes may be releasably connected to the driver unit 3. The driver unit 3 may suitably be hand-held and it is reusable. The probes 5a,5b,5c,5d are suitably single-use biopsy probes or marker probes. The at least two different types of probes comprise at least a first probe type 5a and a second probe type 5 b. According to the invention, these different types of probes are not only biopsy needles of different sizes, but also comprise different functions for controlling the probe. At least one of the single-use probe types connectable to and controlled by the driver unit comprises a suction delivery module and at least one of the single-use probe types comprises a spring-loaded needle manipulation module. Thus, both core needle biopsy and vacuum assisted biopsy may be provided by the same biopsy arrangement. Thus, different types of probes use different sampling techniques.

Fig. 2a and 2b show different perspective views of the driver unit 3 of the biopsy arrangement 1 as shown in fig. 1a and 1 b. In fig. 2b, the driver connection surface 9 of the driver unit 3 is visible, which driver connection surface 9 can be mated and connected with the probe connection surfaces 21a, 21b, 21c, 21d of the connected probes 5a,5b,5c,5 d. Fig. 3 to 6 show four different types of probes 5a,5b,5c,5d according to embodiments of the invention, which can be used with the driver unit 3 as shown in fig. 2. Fig. 3a and 3b show a first probe type 5a, fig. 4a and 4b show a second probe type 5b, fig. 5a and 5b show a third probe type 5c, and fig. 6a and 6b show a fourth probe type 5 d. According to the invention, at least two different single-use probe types should be provided for connection to the same driver unit. According to the present invention, it is not necessary to provide all four probe types 5a,5b,5c,5d as shown in fig. 3, 4, 5 and 6, and furthermore, the different properties of the different probe types (which will be described in detail below with reference to fig. 3 to 6) may be combined differently in the different probe types and still be within the scope of the present invention.

The driver unit 3 comprises at least two different probe control devices 101,102,103,104, which control different probe modules 201,202,203,204,205,206,207,208,209 in the connected probes 5a,5b,5c,5 d. The at least two different probe control means 101,102,103,104 comprise at least a suction generating means 101 and a needle moving means 102. The needle movement device 102 is a DC motor that is coupled both directly to the cogwheel 102a that produces rotational movement and to the linear screw 102b with an actuator that produces longitudinal movement.

The driver unit 3 may be connected to a base unit (not shown). The base unit may provide power to the driver unit 3 and possibly also vacuum and pressurized air. Alternatively, the driver unit 3 may be directly connected to the power point without an intermediate base unit. Both the suction generating means 101 and the needle moving means 102 require power.

The suction generating device 101 is typically a sealed air connection coupled to a vacuum pump having an integrated backflow valve to ensure that air flows in only one direction.

In one embodiment of the invention, the driver unit 3 further comprises a pulse device 103 which can deliver longitudinally reciprocating pulses to a biopsy needle of an attached probe. Such reciprocating oscillating movement of the needle or part of the needle (inner and/or outer needle part, such as a cannula or trocar) is particularly suitable when penetration of dense or fibrotic tissue is required on the way to the tumour. Also, when penetrating a tumor for biopsy, preferably an oscillating movement may be used in order to improve the filling of the needle with tissue with inertial stabilization caused by a fast acceleration pulse applied to the needle. The pulse device 103 may be a piston arrangement. Such a piston arrangement comprises a piston arranged to reciprocate in a piston housing. The piston arrangement is driven by a movement generating source (not shown), for example a weight accelerated by pressurized air generated by a compressor. Such a movement generation source may be provided in the driver unit 3, or in a base unit to which the driver unit is connectable. In the alternative, the piston arrangement is driven by magnetic force, hydraulic force or force generated by a spring. In another alternative, the piston arrangement is driven by a force generated by an electric motor or a piezoelectric device. In EP 2323563, EP 3206587 and WO 2016/058845, the applicant describes details of one type of pulse device which can also be used in the present invention.

Furthermore, the driver unit 3 comprises first connecting means 11 for releasable connection to said probes 5a,5b,5c,5 d. The first connecting means 11 may be provided as one or more recesses and/or protrusions 11 for cooperation with corresponding recesses/protrusions 23a, 23b, 23c, 23d on the probe 5a,5b,5c,5 d. As shown in fig. 2b, these recesses and/or projections 11 may be provided to the driver connection surface 9, i.e. in this example two projections 11 in one end of the driver unit and two recesses in the opposite end. However, different configurations are of course possible. Furthermore, in this example, the first connecting means 11 further comprises front connecting means 11a provided in the front end of the driver unit 3 for mating with the front connecting means 23 a' of the probe. In this example, furthermore, the first connecting means 11 comprise a release button 11 b. By pressing the release button 11b, the probe connected to the driver unit 3 can be released. The release button 11b is thereby connected to locking means provided to the recess and/or projection 11 of the first connecting means 11.

At least one activation button 13a, 13b is provided on the outer surface of the driver unit 3. The activation buttons 13a, 13b are connected to at least two different probe control means 101,102,103,104 of the driver unit 3. The physician using the biopsy arrangement 1 may activate the different probe controls by pressing the at least one activation button 13a, 13 b. In some embodiments, a single press on the activation button may initiate the entire sampling sequence, and/or multiple presses on the activation button may activate different steps in the sampling sequence. More than one activation button 13a, 13b may also be provided for initiating different steps of the sampling sequence. In this embodiment two activation buttons 13a, 13b are provided, wherein a first activation button 13a is provided for activating the sampling sequence and/or different steps of the sampling sequence, and a second activation button 13b is provided for controlling the pulsing means of the driver unit as described above.

The first probe type 5a is shown in fig. 3a and 3 b. Fig. 3a is a side view and fig. 3b is a top view of the first probe type 5a, showing a probe connection surface 21a of the first probe type 5a, which probe connection surface 21a is mateable and connectable with the driver connection surface 9 of the driver unit 3. The first probe type 5a comprises second connecting means 23a for releasable connection to the first connecting means 11 of the driver unit 3. The second connecting means 23a may be provided as one or more recesses and/or protrusions for cooperation with corresponding recesses/protrusions 11 on the driver unit 3. As shown in fig. 3b, recesses and/or protruding portions 23a may be provided to the probe connection surface 21a, i.e. in this example two protruding portions 23a in one end of the probe and two recesses 23a in the opposite end. However, different configurations are of course possible. Furthermore, in this example, the second connection means 23a further comprises front connection means 23 a' provided in the front end of the probe 5a for mating with the front connection means 11a of the driver unit 3. The first probe type 5a comprises at least two different probe modules 201, 202. These probe modules include a suction delivery module 201 and at least one needle manipulation module 202. The suction transfer module 201 is configured to transfer suction from the suction generating device 101 of the driver unit 3 to the needle 25a of the first probe 5 a. By providing suction to needle 25a, a biopsy sample may be drawn into sample receiving opening 27a of the needle, and the biopsy sample may also be transferred within needle 25 to sample collection device 28a, which may be disposed in single-use probe 5 a. Thus, multiple biopsy samples may be taken and transferred through the needle to the sample collection device 28a without removing the needle from the tumor/lesion. However, sample collection device 28a is not essential to the present invention. The at least one needle manipulation module 202 for the first probe type 5a is referred to as a first probe type needle manipulation module 202 and may be configured for providing longitudinal and/or rotational movement to at least a portion of the needle 25a of the first probe type 5 a. In one embodiment of the invention, as shown in fig. 5a and 5b, both longitudinal and rotational movement is provided to the needle 25. If the needle 25a comprises an inner needle portion 29a and an outer needle portion 31a (both being cannulas in this embodiment), i.e. the inner cannula is arranged inside the outer cannula, the first probe-type needle manipulation module 202 may be configured to provide only a longitudinal movement of the inner needle portion 29a relative to the outer needle portion 31a, thereby providing an opening and closing of the sample receiving opening 27 a. Furthermore, the first probe type needle manipulation module 202 may be configured for providing rotational movement only to the inner needle portion 29a in order to sever a biopsy sample. However, another alternative would be to provide only longitudinal and rotational movement to the outer needle portion 31a for severing the biopsy sample. In this embodiment, the first probe-type needle manipulation module 202 includes a rotational movement generation portion 202a (e.g., a cogwheel) and a longitudinal movement generation portion 202b (e.g., a linear screw with an actuator). The first probe type needle manipulation module 202 is configured for connection to the needle moving device 102 of the driver unit 3. In this embodiment of the invention, the first probe type 5a further comprises a pulse delivery module 203, which pulse delivery module 203 is configured for delivering reciprocating pulses provided from the pulse arrangement 103 of the driver unit 3 to the biopsy needle 25a of the first probe type 5a when connected to the driver unit 3. This first probe-type pulse delivery module 203 may be configured for delivering a reciprocating pulse to only one of the inner needle portion 29a or the outer needle portion 31a of the needle 25a, or to both the inner needle portion 29a and the outer needle portion 31 a. In this first probe type 5a, it may be advantageous to transmit the reciprocating pulses only to the outer needle portion 31a of the needle 25 a.

For the first probe type 5a, in one embodiment, the entire sampling sequence may be initiated by pressing only once on the first activation button 13a of the driver unit 3 when the needle has been placed in a position suitable for tissue sampling. Thereby, the suction generating means 101 are first activated for generating a vacuum to the needle, and then the needle moving means 102 are automatically activated such that the inner needle portion 29a rotates and longitudinally translates with respect to the outer needle portion 31a, first backwards for filling the needle with the sample, and then forwards for cutting off the sample, whereby the sample is transported to the sample collecting means 28a due to the pressure difference. During the needle positioning prior to the sampling process, the second activation button 13b may be pressed for activating the pulse device 103.

The second probe type 5b is shown in fig. 4a and 4 b. Fig. 4a is a side view of the second probe type 5b and fig. 4b is a top view of the second probe type 5b, showing the probe connection surface 21b of the second probe type 5a, which probe connection surface 21b should mate and connect with the driver connection surface 9. The second probe type comprises second connecting means 23b for releasable connection to the first connecting means 11 of the driver unit 3, the second connecting means 23b being provided as protruding portions and/or recesses 23b on the probe connection surface 21b and front connecting means 23 b', for example in the same way as described above for the first probe type 5 a. The second probe type 5b includes at least one probe module, which is a needle manipulation module 204, referred to in this embodiment as a second probe type spring-loaded needle manipulation module 204. The second probe type spring-loaded needle manipulation module 204 is configured for providing spring-loaded longitudinal movement to at least a portion of the needle 25b of the second probe type 5 b. Also, the needle 25b may comprise an inner needle portion 29b and an outer needle portion 31b (both of which may be cannulae in this embodiment), whereby the sample receiving opening 27b may be opened or closed by relative movement between the inner needle portion 29b and the outer needle portion 31 b. In one embodiment, the inner needle portion 29a may be provided with a sample receiving opening 27b at a side surface of the top portion of the needle, and the outer needle portion 31b may be configured for cutting a sample provided into the opening 27b when the outer needle portion 31b is moved relative to the inner needle portion 29b for closing the opening 27 b. In this second probe type 5b, first the inner needle portion 29b is moved longitudinally into the tumour and thereafter the outer needle portion 31b is moved longitudinally to cut the sample provided by the spring-loaded action. This is a procedure commonly referred to as core needle biopsy. The spring loading is provided in a second probe type spring loaded needle manipulation module 204 which is connected to the needle movement means 102 of the driver unit 3 for being activated. Thereby, at least one spring is provided in the second probe type spring-loaded needle manipulation module 204. For example, a spring may be provided for loading only the outer needle portion 31 b. In another example, two springs may be provided for separately loading the inner needle portion 29b and the outer needle portion 31 b. The second probe type spring loaded needle handling module 204 is configured for connection to the needle moving device 102 of the driver unit 3 for loading and releasing the at least one spring. For example, depending on the weight of the needle portion to be accelerated, a coil spring may be used and loaded to, for example, 30-60N. In one example, the outer needle portion should accelerate to a velocity of 7-15 m/s over a distance of between 15-30 mm.

Also, in one embodiment of the invention, the second probe type 5b may comprise a pulse delivery module 205, the pulse delivery module 205 being configured for delivering reciprocating pulses provided from the pulse device 103 of the driver unit 3 to the needle 25b of the second probe type 5b when connected to the driver unit 3. The second probe-type pulse delivery module 205 may be configured to deliver a reciprocating pulse to only one of the inner needle portion 29b or the outer needle portion 31b of the needle 25b, or to both the inner needle portion 29b and the outer needle portion 31 b. In this second probe type 5b, it may be advantageous to transfer the reciprocating pulses to both the inner needle portion 29b and the outer needle portion 31b of the needle 25 b.

For the second probe type 5b, in one embodiment, the sampling sequence may be initiated by a first press on the first activation button 13a of the driver unit 3 when the needle has been placed in a position suitable for tissue sampling. A first press on the first activation button 13a will activate the needle moving means 102 such that the outer needle portion 31b of the needle will be retracted, the spring will be loaded and the tissue will fill the sample receiving opening 27 b. A second press on the first activation button 13a will release the spring, whereby the outer needle part 31b will move forward and thereby close the sample receiving opening 27b of the needle and the sample will be cut off. During the needle positioning prior to the sampling process, the second activation button 13b may be pressed for activating the pulse device 103.

A third probe type 5c is shown in fig. 5a and 5 b. Fig. 5a is a side view and fig. 5b is a top view of a third probe type 5c, showing the probe connection surface 21c of the third probe type 5c, which probe connection surface 21c should mate and connect with the driver connection surface 9. The third probe type comprises second connecting means 23c for releasable connection to the first connecting means 11 of the driver unit 3, the second connecting means 23c being provided as protruding portions and/or recesses 23c on the probe connection surface 21c and front connecting means 23 c', for example in the same way as described above for the first probe type 5 a. The third probe type 5c comprises at least two probe modules.

The third probe type 5c is a type of probe different from the first probe type and the second probe type. The probe modules of the third probe type 5c include a suction delivery module 206, a needle manipulation module 207 (referred to as the third probe type needle manipulation module 207 in this embodiment), and possibly a pulse delivery module 208. The suction transfer module 206 is configured for transferring suction from the suction generating device 101 of the driver unit 3 to the needle 25c of the third probe type 5 c. The third probe type needle manipulation module 207 is configured for providing longitudinal movement to the inner needle portion 29c of the needle 25c of the third probe type 5c for positioning the inner needle portion 29c in a forward or rearward position relative to the outer needle portion 31c of the needle 25 c. The pulse delivery module 208 is configured for delivering the reciprocating pulses provided from the pulse device 103 of the driver unit 3 to the inner needle portion 29c and/or the outer needle portion 31c of the needle 25c of the third probe type 5 c. In one embodiment of the invention, a needle portion connection is provided in connection with the impulse delivery module 208, which is configured for holding the inner and outer needle portions together or separately, such that impulses may be provided to the combined unit of the inner and outer needle portions of the needle, or to one of the inner and outer needle portions separately. One example of such a pulse transmission module and needle portion connection arrangement is described by the applicant in EP 3206587 and WO 2016/058845.

Further, in this embodiment, the third probe type includes, but does not necessarily include, a sample separation module 209. The sample separation module 209 is configured to be connected to the sample separation device 104 (seen in fig. 2 b) optionally provided in the driver unit 3, when the third probe is connected to the driver unit. However, the sample separation module 209 and the sample separation device 104 are not essential to the present invention. The sample separation means 104 provided in the driver unit 3 may be a cogwheel connected to a motor and the sample separation module 209 provided in the probe may be a cogwheel connected to the outer needle portion 31c of the needle 25c, such that a rotational movement may be provided to the outer needle portion 31c in order to separate the sample, i.e. to cut the sample from the tissue. By providing two separate motors in the driver unit 3, one for providing the longitudinal movement to the needle and one for separating the sample by rotating a part of the needle, it is possible to provide the rotation to the part of the needle independently of the longitudinal movement of the needle, which is advantageous for this type of sample severing method. Furthermore, when different motors are provided for the two separate functions, different motor performances may be used for the different motors, which is suitable. Fast rotation with high starting torque is suitable for the sample severing process. This is also described in more detail in EP 3206587 and WO 2016/058845.

For the third probe type 5c, in one embodiment, the sampling sequence may be initiated by a first press on the first activation button 13a of the driver unit 3 when the needle has been placed in a position suitable for tissue sampling. In one embodiment, a first press will activate the needle moving means 102 such that the inner needle portion 29c is retracted, and the first press will also activate the suction creating means 101. In this position, the second activation button 13b may be used to activate the pulsing device 103. Thereby, the needle may pulsate into the lesion and the sample will fill the needle. Thereafter, a second press of the first activation button 13a will activate the sample separation device 104 and the sample will be cut off as described above. After the needle has been removed from the patient, a third press of the first activation button 13a may then activate the needle moving device 102 again, such that the inner needle portion 29c moves forward and thereby pushes the sample out of the needle. In this embodiment, the inner needle portion may be a solid trocar and the outer needle portion may be a cannula.

A fourth probe type 5d is shown in fig. 6a and 6 b. Fig. 6a is a side view and fig. 6b is a top view of the fourth probe type 5d, showing the probe connection surface 21d of the fourth probe type 5d, which probe connection surface 21d should mate and connect with the driver connection surface 9. The fourth probe type comprises second connecting means 23d for releasable connection to the first connecting means 11 of the driver unit 3, the second connecting means 23d being provided as protruding portions and/or recesses 23d on the probe connection surface 21d and front connecting means 23 d', for example in the same way as described above for the first probe type 5 a. The fourth probe type 5d is similar to the second probe type 5b and includes a needle manipulation module 204 ', the needle manipulation module 204' being spring loaded in the same manner as described above with respect to the second probe type 5 b. The fourth probe type 5d may suitably further comprise a pulse delivery module 205 ', the pulse delivery module 205' being configured for delivering reciprocating pulses provided from the pulse device 103 of the driver unit 3 to the needle 25d of the fourth probe type 5d when connected to the driver unit 3. The needle 25d of the fourth probe type 5d comprises an inner needle portion 29d and an outer needle portion 31d, wherein the inner needle portion 29d is arranged to push out the marker 32 into the tissue when the needle 25d has been correctly positioned in the tissue. The longitudinal movement of the inner needle portion 29d for ejecting the marker 32 is controlled by the needle manipulation module 204'. In this embodiment, the inner needle portion may be a solid trocar and the outer needle portion may be a cannula. The outer needle portion 31d is suitably provided with a sharp beveled end for penetrating tissue.

Additionally or alternatively, any of the first probe type 5a, the second probe type 5b or the third probe type 5c may comprise a further probe module (not shown) for leaving a marker in the human or animal tissue, i.e. the marker functionality may be integrated in the first probe type 5a, the second probe type 5b and/or the third probe type 5 c.

The needles 25a, 25b, 25c, 25d of the different probe types 5a,5b,5c,5d may comprise inner needle portions 29a, 29b, 29c, 29d and outer needle portions 31a, 31b, 31c, 31d as described above. The sampling method may be a distal tip sampling method as shown for the third probe type 5c, or a side port sampling method as shown for the first and second probe types 5a,5 b.

According to one embodiment of the invention, each of the different single-use probe types 5a,5b,5c,5d comprises a unique probe identity 41a, 41b, 41c, 41d, and the reusable driver unit 3 comprises probe identity recognition means 43. The probe identity and the probe identity recognition means may be based on, for example, mechanical activation or electrical or optical reading. In the embodiment as shown in fig. 2 to 6, the probe markings are provided as protrusions arranged in different patterns 41a, 41b, 41c, 41d on the connection surfaces 21a, 21b, 21c, 21d of the probes 5a,5b,5c,5 d. These projections are received in corresponding recesses with sensors 43 (probe identity recognition means) in the connection surface 9 of the driver unit 3. The probe identity recognition means 43 of the driver unit 3 is connected to at least two different probe control means 101,102,103,104 and comprises control logic such that the probe identity recognition means 43 can activate certain probe control means 101,102,103,104 depending on which type of probe 5a,5b,5c,5d has been identified by the probe identity recognition means 43. The control logic may be a microprocessor with software connected to the position indicator. Other identification methods such as, for example, RFID are of course possible and are encompassed by the present invention.

Other types of probes than the probe described above with reference to fig. 3, 4, 5 and 6 may also be provided which are connectable to the driver unit according to the invention. The probe modules may be selected from the modules described above and combined in different ways, and further probe modules may be provided. In addition, the design of the probe's needle may vary, for example, a distal tip or side port sampling method may be provided.