阅读说明：本技术 活检装置及方法 (Biopsy device and method ) 是由 S·沃什伯恩 E·德雷尔 A·L·布朗 D·鲁滨逊 B·雅各布斯 于 2018-11-13 设计创作，主要内容包括：提供被构造为能够从体腔活检组织的各种活检装置及使用方法。在示例性实施方式中,活检套管设有细长轴,细长轴具有远端和近端。细长轴被构造为能够在其中接收成像装置的至少一部分,接合构件设置在近端上并且被构造为能够与成像装置接合。活检收集器能够与细长轴接合并且被构造为能够收集用于活检样本的组织。细长轴的远端的至少部分被构造为能够允许使用成像装置透过其可视化,使得用户能够可见正被收集的组织。(Various biopsy devices configured to enable biopsy of tissue from a body cavity and methods of use are provided. In an exemplary embodiment, a biopsy cannula is provided with an elongate shaft having a distal end and a proximal end. The elongate shaft is configured to receive at least a portion of an imaging device therein, and an engagement member is disposed on the proximal end and configured to be engageable with the imaging device. A biopsy collector is engageable with the elongate shaft and is configured to collect tissue for a biopsy sample. At least a portion of the distal end of the elongate shaft is configured to allow visualization therethrough using an imaging device such that a user can visualize tissue being collected.)

1. A biopsy cannula, comprising:

an elongate shaft having a distal end and a proximal end, at least one lumen extending between the distal end and the proximal end, and a longitudinal axis extending along the elongate shaft, the at least one lumen configured to be capable of receiving at least a portion of an imaging device therein;

an engagement member positioned on the proximal end of the elongate shaft and configured to be engageable with an imaging device;

a biopsy collector positioned adjacent the distal end of the elongate shaft and configured to collect tissue for a biopsy sample,

wherein at least a portion of the distal end of the elongate shaft is configured to allow imaging through the at least a portion of the distal end of the elongate shaft using an imaging device such that a user can visualize tissue being collected.

2. The biopsy cannula of claim 1, wherein at least a portion of the distal end of the elongate shaft is made of an optically transparent material such that imaging by the imaging device is performed directly through the elongate shaft.

3. The biopsy cannula of claim 1, further comprising an opening in the distal end of the elongate shaft such that imaging by the imaging device occurs through the opening.

4. The biopsy cannula of claim 1, further comprising a suction port configured to apply suction and fluid to the biopsy collector through the lumen of the elongate shaft.

5. The biopsy cannula of claim 1, wherein the biopsy collector comprises an opening into the lumen of the elongate shaft, the opening configured to receive a tissue sample therethrough, and the opening having at least one cutting surface thereon configured to cut the tissue sample.

6. The biopsy cannula of claim 1, wherein the engagement member is configured to inhibit relative movement between the biopsy cannula and the imaging device.

7. The biopsy cannula of claim 1, wherein the imaging device comprises a complementary metal oxide semiconductor fiberscope.

8. The biopsy cannula of claim 1, wherein the elongated sheath has a diameter of 5mm or less.

9. A biopsy system, comprising:

a biopsy cannula including an elongate shaft having a distal end and a proximal end and at least one lumen extending therebetween, the biopsy cannula having an engagement member positioned on the proximal end of the elongate shaft, and the biopsy cannula having a biopsy collector positioned adjacent the distal end of the elongate shaft and configured to collect tissue for a biopsy sample; and

an imaging device including a handle and an elongate imaging member extending distally from the handle, the elongate imaging member configured to be insertable into and configured to acquire images from a lumen of an elongate shaft of a biopsy cannula, the handle configured to be engageable with an engagement member of the biopsy cannula.

10. The biopsy system of claim 9, wherein at least a portion of the biopsy cannula is made of a transparent material configured to allow imaging therethrough by an imaging device.

11. The biopsy system of claim 9, wherein the biopsy cannula comprises a suction port configured to apply suction to tissue collected by the biopsy collector.

12. The biopsy system of claim 9, wherein the engagement member is configured to resist relative movement between the biopsy cannula and the imaging device.

13. The biopsy system of claim 9, wherein the biopsy collector comprises an opening into the lumen of the elongate shaft, the opening configured to receive a tissue sample therethrough, wherein the opening has at least one tissue cutting member therein.

14. The biopsy system of claim 9, wherein the imaging device comprises a complementary metal oxide semiconductor fiberscope.

15. The biopsy system of claim 9, wherein the elongate imaging member comprises an optical fiber extending therethrough, the optical fiber configured to provide light for viewing.

16. The biopsy system of claim 15, wherein the imaging device comprises an internal light source configured to transmit light along an optical fiber located within the elongated imaging member.

17. A method of collecting a biopsy sample, comprising:

positioning a biopsy cannula adjacent tissue to be sampled using an image acquired by an imaging device at least partially disposed in the biopsy cannula;

the tissue sample is collected with a biopsy collector positioned at or adjacent to the distal end of the biopsy cannula.

18. The method of claim 17, further comprising engaging the biopsy cannula with the imaging device by inserting an elongate imaging member of the imaging device into the elongate shaft of the biopsy cannula until a distal end of the elongate imaging member is positioned proximate the biopsy collector and an engagement member of the biopsy cannula is fixedly engaged with the handle of the imaging device.

19. The method of claim 17, further comprising applying suction to the biopsy collector by connecting a suction device to a suction port of the biopsy cannula.

20. The method of claim 17, further comprising removing the biopsy cannula from the body cavity after collecting the tissue sample by the biopsy collector using an image from the imaging device to guide the removing.

Technical Field

Devices, methods, and systems for performing tissue biopsies are provided herein.

Background

In view of improved healing times and less invasive procedures, patients and physicians are increasingly favored for minimally invasive surgical procedures, diagnostic procedures, exploratory procedures, and other medical procedures. Various medical devices and instruments have been developed for performing these procedures, such as medical introducers, imaging devices such as fiber optic microscopes, and other related endoscopic devices.

Minimally invasive surgery can also include tissue biopsy. However, accurately and efficiently performing tissue biopsies with minimally invasive procedures, such as by using a curette, can be challenging for various factors, such as accessibility of the tissue to be biopsied and lack of visibility of the biopsy site. For example, curettes are commonly used to biopsy tissue. However, the use of curettes requires that the physician operate without any visualization means. In an exemplary procedure, the curette can be inserted into a body cavity (such as the uterus) of a patient by the feel and experience of the physician. The distal tip of the curette can be scraped along tissue, such as uterine tissue, to collect a biopsy sample. The procedure is typically completed without visualization or with inappropriate and invasive visualization components that can add complexity to the procedure.

Accordingly, there remains a need for improved devices, methods, and systems for performing tissue biopsies.

Disclosure of Invention

Devices, methods, and systems for performing tissue biopsies are provided herein. In one embodiment, a biopsy cannula is provided that includes an elongate shaft having distal and proximal ends, a lumen extending between the distal and proximal ends, and a longitudinal axis extending therealong. The lumen is configured to be capable of receiving at least a portion of an imaging device therein. An engagement member is positioned on the proximal end of the elongate shaft and is configured to be engageable with an imaging device. A biopsy collector is positioned adjacent the distal end of the elongate shaft, and the biopsy collector is configured to collect tissue for biopsy samples. At least a portion of the distal end of the elongate shaft is configured to allow imaging therethrough with an imaging device such that a user can visualize tissue being collected.

The biopsy cannula can be varied in numerous ways. For example, the biopsy cannula can also include a suction port configured to apply suction through the lumen of the elongate shaft to the biopsy collector. The distal end of the elongate shaft can also be sealed, and the proximal end of the elongate shaft can be open and configured to receive at least a portion of an imaging device therethrough. In another example, the biopsy collector can include an opening into the lumen of the elongate shaft, the opening configured to receive a tissue sample therethrough. The biopsy collector can also have at least one cutting surface thereon, the at least one cutting surface configured to cut a tissue sample. In other embodiments, the elongate shaft can have an angled distal region that is at a non-zero angle relative to a longitudinal axis of the elongate shaft. For example, the angled distal region can be angled at about 15 degrees relative to the longitudinal axis of the elongate shaft. In another example, the engagement member can be configured to prevent relative movement between the biopsy cannula and the imaging device. The engagement member can also have a plurality of engagement features extending proximally therefrom that are configured to be grippable onto an imaging device.

In another aspect, a biopsy system is provided that includes a biopsy cannula having an elongate shaft with distal and proximal ends and a lumen extending therebetween. The biopsy cannula has an engagement member positioned on a proximal end of the elongate shaft, and the biopsy cannula has a biopsy collector positioned adjacent a distal end of the elongate shaft, the biopsy collector configured to collect tissue for a biopsy sample. The biopsy system also includes an imaging device having a handle and an elongate imaging member extending distally from the handle. The elongate imaging member is configured to be insertable into a lumen of the elongate shaft of the biopsy cannula and configured to acquire images therefrom, and the handle is configured to be engageable with an engagement member of the biopsy cannula.

In various embodiments, at least a portion of the biopsy cannula can be configured to allow imaging therethrough by an imaging device. The biopsy cannula can also include a suction port configured to apply suction to tissue collected by the biopsy collector. The biopsy cannula can also have a fluid port configured to deliver a fluid through the lumen of the elongate shaft. In another example, the elongate imaging member can have a distal-most position within the lumen of the biopsy cannula that is proximal to the biopsy collector when the biopsy cannula and imaging device are engaged by the engaging member. In another embodiment, the engagement member can be configured to prevent relative movement between the biopsy cannula and the imaging device. In one example, the engagement member can have a plurality of engagement features extending proximally therefrom that are configured to be grippable onto the imaging device. The biopsy collector can include an opening into the lumen of the elongate shaft, the opening configured to receive a tissue sample therethrough. In another embodiment, the elongate shaft of the biopsy cannula can have an angled distal region that is at a non-zero angle relative to a longitudinal axis of the elongate shaft. The imaging device can also be a complementary metal oxide semiconductor fiberscope.

In another aspect, a method of collecting a biopsy sample is provided that includes positioning a biopsy cannula adjacent tissue to be sampled using an image acquired by an imaging device, wherein the imaging device is at least partially disposed within the biopsy cannula such that the imaging device visualizes the tissue through the biopsy cannula. The method also includes collecting a tissue sample using a biopsy collector positioned at or adjacent to a distal end of the biopsy cannula.

The method can have numerous variations. For example, the method can also include engaging the biopsy cannula with the imaging device by inserting an elongate imaging member of the imaging device into an elongate shaft of the biopsy cannula until a distal end of the elongate imaging member is positioned proximate the biopsy collector and an engagement member of the biopsy cannula is fixedly engaged with a handle of the imaging device. The method can also include applying suction to the biopsy collector by connecting a suction device to a suction port of the biopsy cannula. In another example, the method can also include removing the biopsy cannula from the body cavity after collecting the tissue sample by the biopsy collector using an image from the imaging device to guide the removal.

In another aspect, a biopsy cannula is provided that includes an elongate shaft having a distal end and a proximal end, at least one lumen extending between the distal end and the proximal end, and a longitudinal axis extending therealong. The lumen is configured to be capable of receiving at least a portion of an imaging device therein. An engagement member is positioned on the proximal end of the elongate shaft and is configured to be engageable with an imaging device. A biopsy collector is movably disposed within the elongate shaft and is configured to extend from a distal end of the elongate shaft and collect tissue therefrom for biopsy samples. At least a portion of the distal end of the elongate shaft is configured to allow imaging therethrough with an imaging device such that a user can visualize tissue being collected.

The biopsy cannula can be modified in various ways. For example, the biopsy collector can comprise a brush. The brush can include a brush head at a distal end thereof, a handle at a proximal end thereof, and a brush shaft configured to be longer than the elongate shaft. The biopsy cannula can also include a port configured to allow insertion and removal of a biopsy collector from the elongate shaft. In another example, the distal end of the elongate shaft can be open and configured to allow a biopsy collector to extend therefrom to collect tissue. The biopsy cannula can also include an opening in the elongate shaft configured to allow a biopsy collector to extend therefrom to collect tissue. In an embodiment, the biopsy cannula can include a plurality of lumens extending through the elongate shaft. At least one lumen of the plurality of lumens can be configured to receive a biopsy collector therethrough, and at least one other lumen of the plurality of lumens can be configured to receive an imaging device therein. The biopsy cannula can also include a suction port configured to apply suction through the lumen of the elongate shaft. The biopsy cannula can also have a fluid port configured to transmit fluid through the lumen of the elongate shaft. In one example, a biopsy cannula can include an opening in an elongate shaft having at least one cutting surface thereon configured to cut a tissue sample. In another example, the elongate shaft can have an angled distal region that is at a non-zero angle relative to a longitudinal axis of the elongate shaft. The engagement member can also be configured to prevent relative movement between the biopsy cannula and the imaging device. The imaging device can also include a complementary metal oxide semiconductor fiberscope. In another example, the elongate shaft can be flexible, and in another example, the elongate shaft can be rigid. At least a portion of the distal end of the elongate shaft can be made of an optically transparent material such that imaging by the imaging device is performed directly through the elongate shaft. In one example, the biopsy cannula can include an opening in the distal end of the elongate shaft such that imaging of the imaging device occurs through the opening.

In another aspect, a biopsy system includes a biopsy cannula having an elongate shaft with a distal end and a proximal end and at least one lumen extending therebetween. The biopsy cannula has an engagement member positioned on the proximal end of the elongate shaft, and the biopsy cannula has a biopsy collector having a first position and a second position. In the first position, the distal end of the biopsy collector is fully received within the elongate shaft, and in the second position, the distal end of the biopsy collector extends distally from the elongate shaft to collect tissue for biopsy sampling. The biopsy collector is movable between a first position and a second position. The system includes an imaging device having a handle and an elongate imaging member extending distally from the handle. The elongate imaging member is configured to be insertable into a lumen of an elongate shaft of the biopsy cannula and configured to acquire images therefrom. The handle is configured to be engageable with an engagement member of the biopsy cannula.

In an embodiment, a biopsy collector of the system is slidably and removably positionable within the elongate shaft. In another example, the biopsy collector can include a brush. The brush can include a brush head at a distal end thereof, a handle at a proximal end thereof, and a brush shaft configured to be longer than the elongate shaft. The biopsy system can include a port configured to allow insertion and removal of the biopsy collector from the elongate shaft. The distal end of the elongate shaft can be open and configured to allow a biopsy collector to extend therefrom to collect tissue. The biopsy system can include an opening in the elongate shaft configured to allow a biopsy collector to extend therefrom to collect tissue. In one example, the biopsy system can include a plurality of lumens extending through the elongate shaft. At least one of the plurality of lumens can be configured to receive a biopsy collector therethrough, and at least one of the plurality of lumens can be configured to receive an imaging device therein. At least a portion of the biopsy cannula can be configured to allow imaging therethrough by an imaging device. The biopsy cannula can also include a suction port configured to apply suction to the biopsy cannula. In another example, the engagement member can be configured to prevent relative movement between the biopsy cannula and the imaging device. In one example, the imaging device can include a complementary metal oxide semiconductor fiberscope. The imaging device can include an elongated member having optical fibers extending therethrough to provide light for viewing. The imaging device can also include an internal light source configured to transmit light along an optical fiber located within the elongated member.

In another aspect, a method of collecting a biopsy sample can be provided that includes positioning a biopsy cannula adjacent tissue to be sampled using an image acquired by an imaging device at least partially disposed in the biopsy cannula. The imaging device visualizes the tissue through the biopsy cannula. The method also includes collecting a tissue sample using a biopsy collector extending beyond a distal end of the biopsy cannula.

The method can include a variety of different embodiments. In one example, the method can also include inserting a biopsy collector through a port in the biopsy cannula, sliding the biopsy collector through the biopsy cannula, and extending the biopsy collector distally beyond a distal end of the biopsy cannula prior to collecting the tissue sample. In another example, the method can include proximally retracting the biopsy collector into the biopsy cannula after collecting the tissue sample such that at least a distal end of the biopsy collector is entirely within the biopsy cannula. The method can further include removing the biopsy cannula from the body cavity after collecting the tissue sample by the biopsy collector using an image from the imaging device to guide the removing. In an embodiment, the method can include engaging the biopsy cannula with the imaging device by inserting an elongate imaging member of the imaging device into an elongate shaft of the biopsy cannula until at least a distal end of the elongate imaging member is positioned within the biopsy cannula and an engagement member of the biopsy cannula is fixedly engaged with a handle of the imaging device.

Drawings

The present invention will become more fully understood from the detailed description given herein below, taken in conjunction with the accompanying drawings, wherein:

FIG. 1 is a perspective view of one embodiment of a biopsy cannula having an imaging device;

FIG. 2 is a perspective view of a biopsy cannula on the imaging device of FIG. 1;

FIG. 3 is a perspective view of the distal end of the biopsy cannula on the imaging device of FIG. 1;

FIG. 4 is a perspective view of the distal tip of the biopsy cannula of FIG. 1;

FIG. 5 is a perspective view of another embodiment of a biopsy cannula having an imaging device;

FIG. 6 is a line drawing of a biopsy cannula on the imaging device of FIG. 5;

FIG. 7 is a transparency line drawing of the distal end of the biopsy cannula and imaging device of FIG. 5;

FIG. 8 is a transparency line drawing of another embodiment of a biopsy cannula on the imaging device of FIG. 5;

FIG. 9 is a transparency line drawing of the biopsy cannula of FIG. 8 and the distal end of the imaging device of FIG. 5; and

FIG. 10 is a transparency line drawing of the distal end of another embodiment of a biopsy cannula on the imaging device of FIG. 5.

Detailed Description

Certain exemplary embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those of ordinary skill in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments and that the scope of the present invention is defined solely by the claims. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present invention.

When attempting to biopsy tissue, particularly in a non-invasive manner, physicians often need to remove tissue that is difficult to access and accurately extract. This problem is exacerbated in the absence of any simple visualization component, where biopsies must be taken inside the body cavity of the patient, such as extracting uterine tissue. Accordingly, various biopsy cannulas are provided herein that are configured to be engageable with various medical imaging devices that can be advanced into a patient and perform a biopsy with concomitant imaging from the imaging device, providing a user with a way to quickly extract tissue for biopsy that is minimally invasive and accurate. Although the biopsy cannula is described herein in connection with a fiberscope and uterine tissue, the biopsy cannula can be used with various types of imaging devices and can be used to biopsy various types of tissue, or in other surgical applications.

In an exemplary embodiment, a biopsy cannula is provided with an elongate shaft having a distal end and a proximal end. The elongate shaft is configured to receive at least a portion of an imaging device therein, and an engagement member is disposed on the proximal end and configured to be engageable with the imaging device. At least a portion of the distal end of the elongate shaft is configured to allow visualization therethrough with an imaging device such that a user can visualize tissue being collected. A biopsy collector may be engaged with the elongate shaft and configured to collect tissue for a biopsy sample. For example, in one embodiment, a biopsy collector can be disposed adjacent the distal end and can be configured to collect tissue for biopsy samples. In another embodiment, a biopsy collector can be removably and/or movably disposed within the elongate shaft and can be configured to extend from a distal end of the elongate shaft to collect tissue therefrom for a biopsy sample.

Fig. 1-4 illustrate one embodiment of a biopsy cannula 100 having an imaging device 500. The biopsy cannula 100 includes an elongate shaft 102, the elongate shaft 102 having an engagement member 120 and a biopsy collector 140. The elongate shaft 102 has a proximal end 104, a distal end 106, and a lumen extending therebetween. The proximal end 104 is open and the lumen is configured to be able to receive at least a portion of the imaging device 500 therealong. The lumen has an inner diameter D1, the inner diameter D1 being larger than a diameter of at least a portion of the imaging device 500. In one embodiment, the inner diameter D1 of the elongate shaft 102 can be configured to be larger than a diameter of at least a portion of the imaging device 500 such that a biopsy sample can be advanced along a lumen of the elongate shaft 102 while the imaging device 500 is still disposed in the elongate shaft 102. The elongate shaft 102 is configured to allow imaging and/or visualization therethrough via the imaging device 500. For example, at least a portion of the elongate shaft 102 can be at least partially transparent, e.g., it can have a transparent distal end 106. While the elongate shaft 102 illustrated herein utilizes transparency to allow imaging therethrough, imaging can be accomplished in a variety of different ways. In other embodiments, an opening can be formed in the elongate shaft 102 to allow imaging directly through the opening, such as the opening at the distal-most end of the elongate shaft. In some embodiments, the imaging device 500 can extend to the opening to provide imaging therethrough. Alternatively, various through-penetrating and/or transparent slides, lenses, members, etc. can be positioned, embedded, formed, etc. in an outer surface of the elongate shaft 102 to allow imaging therethrough without forming additional openings. Depending on the desired use of the cannula 100, the elongate shaft 102 can be flexible or rigid, and the distal end 106 of the elongate shaft 102 can be sealed or open. The elongate shaft 102 can be made from a variety of materials, such as Polyetheretherketone (PEEK), High Density Polyethylene (HDPE), Polytetrafluoroethylene (PTFE), polyether block amide (PEBA) such as PEBAX, other thermoplastic elastomers (TPE), and/or any combination of stainless steel and polymers. The elongate shaft 102 also has an engagement member 120 disposed on the proximal end 104 thereof.

The engagement member 120 is configured to engage the elongate shaft 102 on its distal end 122 and is configured to engage the imaging device 500 on its proximal end 124. The engagement member 120 is configured to receive at least a portion of the imaging device 500 therethrough such that at least a portion of the imaging device 500 can pass completely therethrough and into the lumen of the elongate shaft 102. In some embodiments, the engagement member 120 is configured to secure the imaging device 500 relative to the elongate shaft 102 such that the imaging device 500 can be fixedly disposed within the elongate shaft 102 in a distal position, as shown in fig. 3, and the imaging device 500 is non-slidable within the elongate shaft 102 relative to its longitudinal axis L1 and non-rotatable about the longitudinal axis L1. As shown, the engagement member 102 includes one or more engagement fingers 126, the engagement fingers 126 being configured to engage corresponding features on the imaging device 500, such as in a snap or friction fit engagement. Fingers 126 are configured to be engaged or disengaged by a user such that biopsy cannula 100 is removably, non-rotatably, and non-slidably secured to imaging device 500. Although fingers 126 are illustrated, various engagement features, such as seals, clips, posts, locks, etc., can be used. While the sleeve 100 as illustrated is not rotatable relative to the imaging device 500 when the engagement members are engaged, other embodiments can be provided with a rotational component configured to enable the sleeve 100 to rotate relative to the imaging device 500 without disengaging the sleeve 100 from the imaging device 500, for example, by utilizing a rotational knob around the engagement members 120.

In addition, a suction port 130 is additionally associated with the engagement member 120. The suction port 130 is configured to be coupled to a lumen of the elongate shaft 102 and configured to provide suction thereto, e.g., to draw tissue through the biopsy collector 140 into the elongate shaft. Although the suction port 130 is illustrated as extending from the engagement member 120, the suction port 130 can be attached anywhere on the elongate shaft 102 such that the suction port 130 can apply suction thereto. The aspiration port 130 is shown with a luer fitting, but any fitting that provides a sealable opening for aspiration can be used. The aspiration port 130 can also be configured to allow fluid to flow therethrough to provide irrigation to the target site. However, other embodiments can provide additional ports for fluid inflow. The ports described herein can take the form of various seals, ports, couplings, luer devices, and the like, and can be connected to various fluid lines, aspiration tubing, IV lines, syringes, and the like.

As illustrated in fig. 4, the biopsy collector 140 is opposite the engagement member 120 and adjacent the distal end 106 of the elongate shaft 102. The biopsy collector 140 is configured to engage tissue thereon and sever a tissue sample such that a suction force can draw the tissue sample through the biopsy collector 140 and into the elongate shaft 102. The biopsy collector 140 can take various forms, such as a generally rectangular-shaped opening 142 through the elongate shaft 102. One or more cutting surfaces 144, such as the triangular teeth illustrated in fig. 4, are disposed thereon and are configured to engage and cut tissue to collect a biopsy tissue sample. The triangular teeth of the cutting surface 144 are positioned in the opening 142 and face proximally and are configured to cut tissue as the elongate shaft 102 moves proximally along the tissue. Although a different opening for the biopsy collector 140 is illustrated here, in other embodiments, the biopsy collector 140 can be incorporated into the distal end 106 of the elongate shaft 102. For example, the distal end 106 of the elongate shaft 102 can include a biopsy collector 140 such that the distal end 106 can be open and have one or more cutting surfaces therearound. As suction is applied to the elongate shaft 102, the combined distal end 106 and biopsy collector 140 can be configured to draw tissue therein with the suction and cut one or more tissue samples due to the cutting surface. Additionally, the biopsy collector 140 is not limited to an opening in the elongate shaft 102, and can be a grasper, cutter, scissors, needle, curette, or the like in other embodiments. The cannula 100 can be configured to be disposed of after a single use or after repeated use.

The sleeve 100 is capable of engaging an imaging device 500, similar to the device illustrated in U.S. patent application publication No.2017/0055813 to London Brown et al, filed 2016, 10, 5, and U.S. provisional patent application No.62/585221 to London Brown et al, filed 2017, 11, 13, both of which are incorporated herein by reference in their entirety. The imaging device 500 has a handle 502 and an elongate imaging member 520 extending distally from the handle 502. The handle 502 includes a light source disposed within the handle 502.

An elongate imaging member 520 extends from the handle 502 and is configured to be insertable through the engagement member 120 and into the elongate shaft 102. While the distal portion 522 of the elongate imaging member 520 terminates proximal of the biopsy collector 140, in other embodiments the elongate imaging member 520 can extend through the biopsy collector 140 and terminate distal of the biopsy collector 140 or anywhere between the distal end 106 and the proximal end 104 of the elongate shaft 102. For example, the elongate imaging member 520 can extend to substantially the distal end 106 of the elongate shaft 102 and provide imaging therefrom, such as through an opening formed in the elongate shaft 102. The elongate imaging member 520 includes an imaging unit 524 engaged on a distal portion 522 of the elongate imaging member 520. The imaging unit 524 can take various forms, such as an active pixel sensor array or a Complementary Metal Oxide Semiconductor (CMOS) sensor, as provided in more detail in U.S. patent application publication No. 2017/0055813. The imaging unit 524 is configured to be able to communicate with the handle 502 and to acquire images of an area adjacent thereto with the aid of a plurality of light transmission devices.

A plurality of light transmission devices extend from the light source in the handle 502, extend through the lumen defined by the elongate imaging member 520, and terminate at their respective distal ends disposed about the distal portion 522 of the elongate imaging member 520. The light transmission device is disposed around the imaging unit 524. The light delivery device is configured to receive light from the light source and deliver the light to a distal end thereof to provide light to an area adjacent the imaging unit 524 so that images can be acquired within a body cavity of a patient. The light transmission device can include a fiber optic element or light transmission fiber, and can be rigid or flexible to allow bending or flexing within the elongate shaft 102.

The imaging device 500 is also configured to be connected to a power source. For example, the power source can be disposed in the handle 502, or the power source can be external to the device and connected to the handle 502. The power source is disposed in electrical communication with the light source in the handle 502. The communication element 550 is also operably engageable with the handle 502 such that the communication element 550 is in signal communication with the imaging unit 524 and is configured to receive image signals therefrom associated with images acquired by the imaging unit 524 or communicate electrical power to the imaging unit 524. In addition, a display device for displaying the images, or a calculator device for storing or analyzing the images, can communicate with the communication element 550 via a wired communication arrangement or a wireless communication arrangement. All connections provided herein can be wired or wireless connections.

In use, a user engages the cannula 100 with the imaging device 500 by inserting the elongate imaging member 520 into the elongate shaft 102 until the imaging unit 524 is positioned at a distal-most position proximal of the biopsy collector 140 and the engagement member 120 of the cannula 100 engages the handle 502 of the imaging device 500. The user then inserts the distal end 106 of the cannula 100 into a body cavity of a patient and positions the biopsy collector 140 adjacent the tissue to be biopsied using images acquired by the imaging device 500 to ensure proper placement of the cannula 100. The user can actuate suction by connecting a suction device (not shown) to the suction port 130. However, the suction devices can be connected at different times, for example, before the cannula 100 is inserted into the patient. When suction has been activated and the biopsy collector 140 is positioned based on imaging from the imaging device 500, the user draws tissue into the biopsy collector 140 with suction and the user moves the cutting surface 144 back and forth across the tissue to sever and pull a tissue sample into the elongate shaft 102. For example, the user can move the biopsy collector 140 distally, engage suction, and then pull the biopsy collector 140 proximally to pull tissue against the cutting surface 144 and biopsy the tissue. When a tissue sample has been collected, the user removes the cannula 100 from the body cavity, guided by images taken from the imaging device 500 if necessary.

Various embodiments of the sleeve 100 are possible. For example, fig. 5-7 illustrate another embodiment of a cannula 200 having a curved shaft 202 instead of a straight shaft, such as the elongate shaft 102 of the cannula 100. However, the sleeve 200 is otherwise similar to the sleeve 100. Cannula 200 includes a curved shaft 202, curved shaft 202 having an engagement member 220, an aspiration port 230, and a biopsy collector 240. The curved shaft 202 has a proximal end 204, a distal end 206, and a lumen extending therebetween. The proximal end 204 is open and the lumen is configured to be capable of receiving at least a portion of an imaging device therein, such as the imaging device 500 or other imaging device. The curved shaft 202 has a straight proximal region 250 and an angled distal region 260, and the straight proximal region 250 is configured to receive at least a portion of an imaging device therein.

The angled distal region 260 can be angled between 0 and 30 degrees, such as between 15 and 20 degrees, relative to a longitudinal axis L2 extending through the straight proximal region 250. The angled distal region 260 includes the biopsy collector 240 and is configured to provide a greater range of motion when a user manipulates the biopsy collector 240 to collect a tissue sample. The distal-most end of the angled distal region 260 can be open or closed, similar to the cannula 100. The curved shaft 202 is configured to allow imaging therethrough by the imaging device 500. For example, at least a portion of the curved shaft 202 can be at least partially transparent, such as the angled distal region 260. The curved shaft 202 is configured to receive an elongate imaging member 520 therein, with an imaging unit 524 terminating proximal of the angled distal region 260. However, in other embodiments, an imaging device can be received that extends into the angled distal region 260.

The biopsy collector 240 is disposed entirely on the angled distal region 260 and can take various forms, such as an opening 242 through the curved shaft 202, with one or more cutting surfaces 244 formed by triangular teeth, as shown in fig. 7. However, as with biopsy collector 140, biopsy collector 240 is not limited to the illustrated opening. The cannula 200 can be configured to be disposed of after a single use or after a reusable use.

In use, the cannula 200 is manipulated in the same manner as the cannula 100, wherein a user engages the cannula 200 with the imaging device 500, inserts the distal end 206 of the cannula 200 into a body cavity of a patient and positions the biopsy collector 240 adjacent tissue to be sampled using images from the imaging device 500, and collects one or more biopsy samples using the suction and cutting surface 244 at a precise location due to the images taken by the imaging device 500. However, the cannulas disclosed herein are not limited to including aspiration ports and/or one or more cutting surfaces.

While the use of suction and one or more cutting surfaces indicate one way of collecting a biopsy sample, a variety of different ways are possible. For example, fig. 8-9 illustrate another embodiment of a cannula 300 having a curved shaft 302. The cannula 300 is similar to the cannulas 100, 200 discussed above. The curved shaft 302 has a proximal end 304, a distal end 306, and a lumen extending between the proximal and distal ends. The proximal end 304 is open and the lumen is configured to be capable of receiving at least a portion of an imaging device, such as the imaging device 500 or other imaging device, therein. The curved shaft 302 has a straight proximal region 350 and an angled distal region 360, and the straight proximal region 350 is configured to receive at least a portion of an imaging device therein.

The angled distal region 360 can be angled between 0 and 30 degrees, such as between 15 and 20 degrees. The angled distal region 360 includes an opening 340, and a distal-most end 364 of the angled distal region 360 is open. However, in other embodiments, the distal-most end can be closed. The curved shaft 302 is configured to allow imaging therethrough by the imaging device 500, either through the material itself, or through an opening therethrough and/or a viewing window embedded therein, using an optically transparent material. For example, at least a portion of the curved shaft 302 can be at least partially transparent, such as the angled distal region 360. The curved shaft 302 is configured to receive an elongated imaging member 520 therein, with an imaging unit 524 terminating proximal of the angled distal region 360. However, in other embodiments, an imaging device can be received that extends into the angled distal region 360.

Similar to cannula 200, cannula 300 includes a curved shaft 302 having an engagement member 320, a hub or port 330, and an opening 340. However, a port 330 on cannula 300 is configured to receive a biopsy collector, such as an elongated brush 1000, therein. Opening 340 is configured to allow brush 1000 to pass therethrough to access a target site distal to cannula 300. The port 330 is not a suction port, but some embodiments can combine both a suction port and a brush port to provide suction to the cannula and a path for the brush to the target site. Other embodiments can incorporate both suction and brush paths to one engagement hub or port, and one or more ports can be additionally configured to allow fluid flow therethrough to provide irrigation to a target site. Still other embodiments can provide a separate port for fluid inflow. The ports described herein can take the form of various seals, ports, couplings, luer devices, and the like, and can be connected to various fluid lines, aspiration tubing, IV lines, syringes, and the like. Additionally, opening 340 does not have any cutting surfaces thereon, but some embodiments can incorporate both openings with one or more cutting surfaces and brushes to allow tissue samples to be severed by the cutting surfaces and/or collected by the brushes.

The elongated brush 1000 includes a handle 1002 on a proximal end, an elongated shaft 1004, and a brush head 1006 including a plurality of bristles on a distal end thereof. The brush 1000 is long enough that it can be inserted into the port 330, travel entirely through the cannula 300, and protrude from the distal end 306 of the cannula 300, with the handle 1002 still protruding proximally from the port 330. The brush head 1006 is configured to rub along or contact a target tissue region. As the brush head 1006 contacts the target tissue area, the brush head 1006 is configured to collect a tissue sample thereon and retract into the cannula 300. The brush head 1006 has bristles thereon, but various heads can be used, such as protrusions, hooks, scrubbing members, and the like. The brush 1000 can be made from a variety of materials, such as Polyetheretherketone (PEEK), High Density Polyethylene (HDPE), Polytetrafluoroethylene (PTFE), polyether block amide (PEBA) such as PEBAX, other thermoplastic elastomers (TPE), and/or any combination of various metals and polymers such as stainless steel. The handle 1002, the elongate shaft 1004, and the brush head 1006 can each be made of one or more of different materials or the same material. Each component of brush 1000 can be separately manufactured or can be of unitary construction.

As shown in fig. 8 and 9, the brush 1000 can exit the cannula 300 on its distal end from either the opening 340 or the distal-most end 364 of the angled distal region 360, the opening 340 and the distal-most end 364 of the angled distal region 360 being open and configured to allow the brush head 1006 to pass therethrough. However, in other embodiments, the distal-most end of the angled distal region can be closed or the opening can be removed, thereby allowing the brush 1000 to exit through only one distal opening. Cannula 300 can be configured to be disposed of after a single use or after a reusable use. The brush 1000 can also be used with a cannula having a straight axis instead of an angled axis.

In use, the cannula 300 is manipulated in the same manner as the cannula 100, wherein a user engages the cannula 300 with the imaging device 500, inserts the distal end 306 of the cannula 300 into a body cavity of a patient, and positions the opening 340 and/or the distal-most end 364 adjacent to tissue to be sampled using images from the imaging device 500. In this embodiment, the brush 1000 is inserted through the port 330 and along the cannula 300 to the tissue to be sampled. The brush 1000 can be inserted at any time before, during, or after insertion of the cannula 300 into the body cavity. The brush head 1006 is rubbed or scraped against the tissue to be sampled by the user manipulating the handle 1002 and cannula 300, as desired. Sample tissue is collected in the brush head 1006 and then the user retracts the brush head 1006 with the sample back into the cannula 300. The user can optionally and additionally apply suction, rinse, and/or cut the sample using one or more cutting surfaces as discussed above.

Thus, the brush, suction, and/or one or more cutting surfaces can all be combined together into one device, allowing the user to select whether to collect a sample using the brush, suction, and/or cutting surfaces. In addition, the sleeve can incorporate the brush in various ways. The cannula 300 discussed above has a single lumen therethrough that is shared between the brush 1000 and the imaging device 500. However, in other embodiments, the cannula can have multiple lumens therein, which can incorporate brushes and/or imaging devices. For example, fig. 10 illustrates another cannula 400 similar to the cannula 300 discussed above. The cannula 400 has a shaft 402, the shaft 402 having a proximal end (not shown) and a distal end 406. The proximal end is open and the shaft 402 is configured to be able to receive at least a portion of an imaging device, such as the imaging device 500 or other imaging device. The shaft 402 has an opening 440 and a distal-most end 464 that is also an opening, but in other embodiments one or more of these openings can be closed. The shaft 402 is configured to allow imaging therethrough by the imaging device 500, either through the material itself using an optically transparent material, or through an opening therethrough and/or a viewing window embedded therein. As with cannula 300, cannula 400 is configured to receive an elongated brush 2000 therein, and opening 440 is configured to allow brush 2000 to pass therethrough to access tissue for biopsy samples distally from cannula 400. The elongated brush 2000 is similar to the brush 1000 and includes a handle on a proximal end, an elongated shaft 2004, and a brush head 2006 including a plurality of bristles on a distal end thereof. The brush head 2006 is configured to collect a biopsy sample at a target tissue region.

However, as illustrated in fig. 10, the shaft 402 has multiple lumens therethrough, such as a brush lumen 450 and an imaging lumen 452. The brush lumen 450 is configured to receive the brush 2000 therein, and the imaging lumen 452 is configured to receive an imaging device, such as the imaging device 500, therein. The brush 2000 thus extends along the dedicated brush lumen 450 and exits the cannula 400 at its distal end from the opening 440 or distal-most end 464 of the shaft 402. The imaging lumen 452 can have an opening therethrough on its distal end or can be completely sealed on its distal end, and the shaft can have one or more additional lumens, e.g., a working channel lumen and one or two fluid lumens such as a fluid inflow lumen and a fluid outflow lumen.

The sleeves discussed above may be removable from any associated imaging device, but embodiments enable the sleeves and imaging device to be incorporated into a fully reusable device such that an imaging device, such as imaging device 500, is fully and permanently incorporated into the design of one or more of the sleeves discussed above. Thus, the imaging device will effectively incorporate a cannula thereabout, with the cannula having one or more lumens therethrough, such as a working channel lumen, a viewing lumen, one or more fluid flow lumens, or the like. One or more lumens of the imaging device may have an open distal end, a closed distal end, or a combination of both.

The cannula disclosed herein can have any of a variety of sizes depending on the patient anatomy, the type of procedure, the imaging device to be used, and various other parameters that will be apparent to those of ordinary skill in the art. The cannula can also have various lengths, for example, about 15cm to 30cm, and can have various diameters, such as about 1mm to 5 mm. The cannulas can also be flexible or rigid, depending on the conditions under which the cannula will be used and the surgical tool, e.g., imaging device, with which the cannula will be used, and they can be made of various materials, such as Polyetheretherketone (PEEK), High Density Polyethylene (HDPE), Polytetrafluoroethylene (PTFE), polyether block amide (PEBA) such as PEBAX, other thermoplastic elastomers (TPE), and/or any combination of various metals and polymers such as stainless steel.

Similarly numbered components of the embodiments generally have similar features in the present disclosure, and thus each feature of each similarly numbered component need not be sufficiently exhaustive within a particular embodiment. The size and shape of the devices and their components described herein can depend at least on the anatomy of the subject in which the device will be used, the size and shape of the components with which the device will be used, and the methods and procedures in which the device will be used. The drawings provided herein are not necessarily to scale. While the devices and methods disclosed herein are generally directed to surgical techniques, they can also be used in applications outside of the surgical field. While the invention has been described with reference to specific embodiments, it should be understood that numerous changes could be made within the spirit and scope of the inventive concepts described. Accordingly, it is intended that the invention not be limited to the described embodiments, but that it have the full scope defined by the language of the following claims.