This invention generally relates to an adaptor for elongate medical devices that are insertable into an endoscope, and in particular to an adaptor for orienting the medical device relative to the endoscope.
Endoscopic devices and procedures may be used to diagnose, monitor and treat various conditions by close examination of the internal organs. By way of background, a conventional endoscope generally is an instrument having a device for visualizing the interior of an internal region of a body and a lumen for inserting one or more treatment devices therethrough. A wide range of applications have been developed for the general field of endoscopes including by way of example the following: arthroscope, angioscope, bronchoscope, choledochoscope, colonoscope, cytoscope, duodenoscope, enteroscope, esophagogastro-duodenoscope (gastroscope), laparoscope, laryngoscope, nasopharyngo-neproscope, sigmoidoscope, thoracoscope, and utererscope (individually and collectively, “endoscope”).
In some endoscopic devices, visualization of the internal regions may be obtained using a video camera. The video camera provides a viewing field to observe the surgical instrumentation or procedure within the viewing field. Medical ultrasound has also been used to monitor a surgical procedure within a viewing field. Endoscopic ultrasound (EUS) utilizes high frequency sound waves to create an image of living tissue or an echogenic surface. Ultrasound waves are emitted from transducers located at the distal end of an endoscope. Surgical instruments having an echogenic surface reflect the ultrasound waves and enable an endoscopist to monitor the location of the device within the patient.
In some procedures, medical devices are inserted through the endoscope to access the internal organs. For example, an elongate device, such as a needle, may be inserted through an accessory channel of the endoscope for removing tissue or cell samples, or injecting a medication or diagnostic fluid. Fine needle aspiration (FNA) has been a well accepted method for obtaining tissue samples for pathologic or histological analysis in diagnosing a lesion, tumor neoplasm or other abnormality in internal organs. EUS and EUS-guided fine needle aspiration (EUS-FNA) have become important tools in the evaluation of tissue and cell abnormalities.
Surgical techniques for obtaining tissue samples accessible through an endoscopic device such as an ultrasound-endoscope using a fine needle usually require repeated needle sampling at a tissue site to ensure an adequate sample for analysis. Typically in a biopsy procedure, a distal tip of the elongate medical device is extended distally from a port of the endoscope channel to reach the sample site. A sample is removed from the patient through the distal tip, the distal tip is retracted back through the channel and the sample is collected. The elongate medical device is reinserted into the channel of the endoscope and the distal tip of the device is subsequently re-extended distally through the endoscope to collect another sample. When an EUS system is used, it is important for the endoscopist to be able to re-extend the distal tip of the medical device at the correct angle so that the tip is visible in the EUS plane where the ultrasound waves are emitted. With the tip extended in the EUS plane, a subsequent sample may be obtained.
One problem with repeated sampling using an elongate device viewed with an EUS system, such as a needle, is that the distal tip of the device may curve or bend upon exiting a port of the endoscope. The deformation of the device may be such that the bend or curve formed during the previous extension remains in the distal tip when the distal tip is distally re-extended from the endoscope for the subsequent sampling procedure. The curved distal end of the sampling device will impair the endoscopist's ability to view the distal tip if the bend causes the tip of the device to project at an angle that is out of the EUS viewing plane. Simply reinserting the elongate device through the accessory channel and distally extending the tip may not allow the endoscopist to view the re-extended tip in the EUS viewing plane once the bend or curve has been introduced into the distal tip of the medical device. Similarly, other devices having an orientatable distal end extending from an endoscope may need to be oriented upon reinsertion through a channel of the endoscope so that the distal end of the medical device extends in the desired viewing plane. Viewing devices such as an imaging camera may also have requirements for a medical device to be re-extended into the viewing plane.
For the foregoing reasons, it is desirable to have an adaptor for an endoscope, as taught herein, that orients the distal tip of an elongate medical device that extends distally from the endoscope relative to the endoscope.
Accordingly, it is an object of the present invention to provide an adaptor for an endoscope having features that resolve or improve on one or more of the above-described drawbacks.
The foregoing object is obtained in one aspect of the present invention by providing an adaptor to orient an elongate medical device in relation to an endoscope. The adaptor includes a first portion having a distal end connectable and rotationally securable to an endoscope and a proximal end. The first portion further includes a first lumen defined longitudinally therethrough and one of an orienting key or a keyway extending longitudinally at least partially along the first portion. The adaptor further includes a second portion connectable to the first portion and having a second lumen extending longitudinally through the second portion and operably connectable to the first lumen. The second portion has the other of the key or the keyway extending longitudinally at least partially along the second portion. The keyway is configured to releasably mate with the key to orient and rotationally secure the second portion relative to the first portion. The second portion is configured to receive an elongate medical device longitudinally movable in relation to the second portion and rotationally secured relative to the second portion, the elongate medical device adapted to extend distally through the endoscope and having a tip that is orientable in relation to a distal portion of the endoscope portion. The adaptor is configured to orient the tip portion relative to the endoscope.
In another aspect, an system is provided to orient an elongate medical device relative to an endoscope. The system includes an endoscope, an adaptor connected to the endoscope and an elongate medical device rotationally secured to a second portion of the adaptor. The adaptor includes a first portion and a second portion. The first portion includes a connecting portion to rotationally secure a distal end of the first portion to the endoscope, a first lumen extending longitudinally through the first portion and operably connectable to a working channel of the endoscope, and one of an orienting key or a keyway extending longitudinally at least partially along the first portion. The second portion is releasably connectable to the first portion and includes the other of the key or the keyway extending longitudinally along at least a portion of the second portion and a second lumen operably connectable to the first lumen and configured to receive an elongate medical device rotationally secured in relation to the second portion therethrough. The other of the key or the keyway is configured to engage the key or the keyway on the first portion to rotationally fix the second portion in relation to the first portion.
In another aspect, a method of orienting an elongate medical device extending through a working channel of an endoscope and having a distal tip portion extending distally through the endoscope. The method employs an adaptor including a first portion and a second portion, the second portion having an elongate medical device rotationally secured thereto. The method includes connecting a first portion of the adaptor to the endoscope so as to rotationally secure the first portion in relation to the endoscope and operably connect a first lumen of the first portion with the working channel of the endoscope. The method further includes extending a distal portion of an elongate medical device longitudinally through the first lumen and into the working channel of the endoscope and connecting the second portion to the first portion and rotationally securing the second portion to the first portion by engaging one of a key or a keyway on the second portion to the other of the key or the key way on the first portion.
Advantages of the present invention will become more apparent to those skilled in the art from the following description of the preferred embodiments of the invention which have been shown and described by way of illustration. As will be realized, the invention is capable of other and different embodiments, and its details are capable of modification in various respects. Accordingly, the drawings and description are to be regarded as illustrative in nature and not as restrictive.
c illustrate an exemplary handle of a needle device that may be oriented with the adaptor;
The invention is described with reference to the drawings in which like elements are referred to by like numerals. The relationship and functioning of the various elements of this invention are better understood by the following detailed description. However, the embodiments of this invention are not limited to the embodiments illustrated in the drawings. It should be understood that the drawings are not to scale, and in certain instances details have been omitted which are not necessary for an understanding of the present invention, such as conventional fabrication and assembly.
As used in the specification, the terms proximal and distal should be understood as being in the terms of a physician operating an endoscope and an elongate medical device for insertion into a patient. Hence the term distal means the portion of the device that is farthest from the physician and the term proximal means the portion of the device that is nearest to the physician.
As shown in
The second portion 24 of the adaptor 10 includes a lumen 38 extending longitudinally therethough. The second portion 24 is configured to be removably connected to the first portion 22. When the first portion 22 is connected with the second portion 24, the lumens 32 and 38 are operably connected. The second portion 24 further includes an exterior surface 42 having a keyway 44 for engaging the key 34 of the first portion 22. As shown in
The key and keyway configuration described above for the adaptor 10 may have any size and shape known to one skilled in the art. By way of non-limiting example, the shape may be rectangular, circular, oval, triangular, and the like. Any releasably mating configuration may be used to rotationally secure the second portion with respect to the first portion of the adaptors described herein. Two or more key/keyway pairs may be used to orient the first and second portions and rotationally secure the second portion with respect to the first portion. Additional example of exemplary key and keyway configurations are shown in
The connection between the first portion 22 and the second portion 24 may be friction fit so that the second portion 24 remains connected to the first portion 22 until the physician disengages the first portion 22 from the second portion 24. The first portion 22 may also include a releasable locking mechanism, such as a thumb screw 51, to hold the second portion 24 in a longitudinally secured position during a sampling procedure. The thumb screw 51 may also be used to limit or adjust the axial position of the second portion relative to the first portion. The connection between the first portion 22 and the second portion 24 is configured to be repeatedly removed and reconnected to reinsert the second portion 24 in an oriented direction in relation to the first portion 22 and the endoscope 20. One skilled in the art will understand that other connections between the first portion 22 and the second portion 24 are possible.
The second portion 24 is configured to receive an elongate medical device therethrough as will be described in more detail below. The elongate medical device may be longitudinally movable within the second portion 24, but not radially rotatable in relation to the second portion 24.
The second portion 24 may be connected to a handle 102 at a proximal end 104 of the medical device 100 as shown in
The exemplary handle 102 of the medical device 100 is shown in
An exemplary endoscope is shown in
The endoscope 20 also includes an accessory channel 30 having a lumen 178 extending from the connector 28 to the distal end 176 of the endoscope 20. The accessory channel 30 is configured to receive medical devices, such as the medical device 100, therethrough for performing procedures through the distal end 176 of the endoscope 20 as is known in the art. The adaptor 10 described above is configured to removably connect to the connector 28 to orient the medical device 100 in relation to the endoscope 20.
As shown in
The length of the adaptor 10 may be configured to be sufficient to allow the initial engagement, orientation and rotational securing of the second portion 24 in relation to the first portion 22 before the medical device 100 extends out of the distal end 176 of the endoscope 20. Orienting and rotationally securing the second portion 24 in relation to the first portion 22 using the key 34/keyway 44 before the medical device 100 extends out of the distal end 176 of the endoscope 20 allows the medical device 100 to be oriented before the medical device 100 passes through the portion of the endoscope 20 that induces bending into the medical device 100 as described above. The bend-inducing portion of the endoscope may be at the port 182 of the distal end 176, by way of non-limiting example. However, one skilled in the art will understand that the bend-inducing portion may also be at other positions along the working channel 173 of the endoscope 20.
The relationship between the length of the engagement region where the key 34 and the keyway 44 of the adaptor 10 initially connect and the distal extension of the medical device 100 is illustrated in the following example. If the length of the elongate medical device 100 that extends beyond the bend-inducing portion of the endoscope 20 is about 10 cm, then the length of the engagement region between the key 34 and the keyway 44 is at least about 10 cm so that the orientation of the medical device 100 relative to the endoscope 20 begins with the engagement of the key 34 and the keyway 44 and before the medical device 100 extends through the bend inducing portion.
One or more additional samplings may be completed while the distal end 176 of the endoscope 20 remains optimally positioned near the tissue mass 192. The second portion 24 of the adaptor 10 may be reconnected to the first portion 22 in the same rotational orientation as the original connection using the key/keyway 34, 44 orientation to ensure that the needle 108 will extend in substantially the same position 108a as in the first sampling procedure shown in
In an alternative operation, the second portion 24 may be connected to the first portion 22 by orienting and engaging the key 34 and the keyway 44 and rotationally securing the second portion 24 in relation to the first portion 22 before connecting the first portion 22 to the endoscope 20. The first portion 22 may then be connected to the connector 28 on the accessory channel 30 of the endoscope 20 having the elongate medical device 100 inserted into the endoscope 20 before completing the connection of the first portion 22 to the connector 28. Once the first portion 22 is connected to the connector 28, the first portion 22 remains connected and rotationally secured in relation to the endoscope 20 through out the procedure. A sample may be taken and the second portion 24 may be released from the first portion 22 to remove the medical device 100 from the endoscope 20. The medical device 100 may be reinserted into the endoscope 20 as described above and the second portion 24 reconnected to the first portion 22 so that the medical device 100 is oriented with respect to the endoscope 20 in the same rotational relationship as the first sampling relationship and the needle 108 extends into the viewing plane 180 as described above.
As will be understood by a skilled artisan, the orienting adaptor may also be used with a conventional image system also having a viewing plane where a curved medical device may be re-extended from the distal tip of the endoscope outside of the viewing plane. In addition, many types of elongate medical devices, used for multiple extensions through the endoscope distal end and having an operational direction for the patient procedure may be used with the adaptor of the present invention.
The above Figures and disclosure are intended to be illustrative and not exhaustive. This description will suggest many variations and alternatives to one of ordinary skill in the art. All such variations and alternatives are intended to be encompassed within the scope of the attached claims. Those familiar with the art may recognize other equivalents to the specific embodiments described herein which equivalents are also intended to be encompassed by the attached claims. For example, the invention has been described using an EUS needle for illustrative purposes only. Application of the principles of the invention to any other elongate medical device are within the ordinary skill in the art and are intended to be encompassed within the scope of the attached claims.
This application claims the benefit under 35 U.S.C. § 119(e) of U.S. Provisional Application Ser. No. 61/026,391, filed Feb. 5, 2008, which is incorporated herein by reference in its entirety.
Number | Date | Country | |
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61026391 | Feb 2008 | US |