Patent Application
20120191075
i. Field of the Invention
The present application relates to methods and devices for use in minimally invasive diagnostic, therapeutic, or surgical procedures and, more particularly, to devices for withdrawing a tether from a patient's body.
ii. Description of the Related Art
In minimally invasive diagnostic, therapeutic, and surgical procedures, such as laparoscopic surgery, a clinician may place one or more small ports into a patient's abdomen to gain access into the abdominal cavity of the patient. The clinician may use, for example, a port for insufflating the abdominal cavity to create space, a port for introducing a laparoscope for viewing, and a number of other ports for introducing diagnostic, therapeutic, or surgical instruments for viewing, sampling, treating, or operating on tissue. Other minimally invasive surgical procedures include natural orifice transluminal endoscopic surgery (NOTES™) wherein surgical instruments and viewing devices are introduced into a patient's body through, for example, the mouth, nose, vagina, or rectum. The benefits of minimally invasive procedures compared to open surgery procedures for treating certain types of wounds and diseases are now well-known to include faster recovery time and less pain for the patient, better outcomes, and lower overall costs.
In minimally invasive surgery, it is desirable to deliver devices that can be used for surgery into the patient's body via one of the access ports without occupying the port so that other devices may use the space. Some of the devices delivered through the port may be electronic in nature and require power or electronic data to be delivered to them to operate, for example to power a light source or to adjust the focus of a lens system. They may also need to deliver electronic information to personnel in the operating room, for example an image stream. Other devices may make use of an electronic connector, such as a motorized stapler, RF ablation device, harmonic scalpel, bi-polar forceps, and the like.
The foregoing discussion is intended only to illustrate various aspects of the related art in the field of the invention at the time, and should not be taken as a disavowal of claim scope.
One way of delivering power or data signals to devices that have been inserted into a patient and for delivering information from such an internal device back to personnel in the operating room is for the delivered device to include an electronic tether having a connecting member on a free end. Once delivered into the patient, a way of bringing the electronic tether and connecting member out of the body must be provided, unless the tether were to occupy port space or exit adjacent to a port. However, for pure NOTES™ procedures, no port may exist. In this case, it would be useful to be able to insert a small device, such as a 2 mm trocar and grasper, suture, a rigid hook, a threaded rod, or the like, through the abdominal wall to pull the tether outside the body.
A device for use in medical procedures with other medical devices and instruments is described herein. In certain embodiments, the device includes a connecting member having a free end, a joined end, and a body portion positioned between the free and joined ends. The joined end is attached to an electronic tether of a first medical device or instrument. The free end has a tip which has a smooth non-piercing leading end and surface contours suitable for engagement with a second medical instrument. The body portion has at least one conducting portion, and may have a plurality of conducting portions, wherein each of the plurality of conducting portions is separated from an adjacent conducting portion by one of a plurality of insulating portions.
In various embodiments, the smooth leading end of the tip may be in the form of a truncated cone having a flattened end. The body portion may define a longitudinal axis.
In at least one embodiment, the surface contours of the tip form a shoulder portion adjacent the body portion of the connecting member, a neck portion, and a head portion. The shoulder portion is beveled inwardly toward the neck portion, which is sized, in cross section, to be smaller than the size in cross-section of the body and head portions.
In another embodiment, the surface contours form a notch cut into the tip. In a further embodiment, the surface contours of the tip may form a bore passing in a direction transverse to the longitudinal axis. In another embodiment, the surface contours of the tip form a bore cut into the truncated cone in a direction coaxial to the longitudinal axis.
In certain embodiments, a medical device having an electronic tether attached thereto may be provided, wherein the tether includes a connecting member, as described in any of the foregoing embodiments, attached to the free end of the tether.
Certain embodiments of the connector may be characterized as a small diameter, multi-conductor connector that has a low profile and a smooth exterior surface, and that includes surface contours in the tip of the connector to aid a grasper in securely engaging the connector to pull it through the abdominal wall.
Various features of the embodiments described herein are set forth with particularity in the appended claims. The various embodiments, however, both as to organization and methods of operation, together with advantages thereof, may be understood in accordance with the following description taken in conjunction with the accompanying drawings as follows.
Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set out herein illustrate various embodiments of the invention, in one form, and such exemplifications are not to be construed as limiting the scope of the invention in any manner.
Numerous specific details are set forth to provide a thorough understanding of the overall structure, function, manufacture, and use of the embodiments as described in the specification and illustrated in the accompanying drawings. It will be understood by those skilled in the art, however, that the embodiments may be practiced without such specific details. In other instances, well-known operations, components, and elements have not been described in detail so as not to obscure the embodiments described in the specification. Those of ordinary skill in the art will understand that the embodiments described and illustrated herein are non-limiting examples, and thus it can be appreciated that the specific structural and functional details disclosed herein may be representative and do not necessarily limit the scope of the embodiments, the scope of which is defined solely by the appended claims.
Reference throughout the specification to “various embodiments,” “some embodiments,” “one embodiment,” or “an embodiment”, or the like, means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, appearances of the phrases “in various embodiments,” “in some embodiments,” “in one embodiment,” or “in an embodiment”, or the like, in places throughout the specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments. Thus, the particular features, structures, or characteristics illustrated or described in connection with one embodiment may be combined, in whole or in part, with the features structures, or characteristics of one or more other embodiments without limitation.
It will be appreciated that the terms “proximal” and “distal” may be used throughout the specification with reference to a clinician manipulating one end of an instrument used to treat a patient. The term “proximal” refers to the portion of the instrument closest to the clinician and the term “distal” refers to the portion located farthest from the clinician. It will be further appreciated that for conciseness and clarity, spatial terms such as “vertical,” “horizontal,” “up,” and “down” may be used herein with respect to the illustrated embodiments. However, surgical instruments may be used in many orientations and positions, and these terms are not intended to be limiting and absolute.
“Small diameter” as used herein means about 2.5 mm or less. “Low profile” as used herein means that the features and contours on the surface of the devices are smooth and radiused to avoid becoming caught in tissue and to avoid causing any drag or resistance when being pulled through a wall of tissue.
One embodiment of a tip 20 is shown in
Another embodiment of tip 20 is shown in
It will be understood by those normally skilled in the art that numerous other geometries of tips 20 and grasping devices that aid in attachment to devices that are capable of pulling the connector tip 20 through an organ or body wall may be developed. For example, a collet-like grasping device which uses diametrical pressure to impress shaped fingers around the exterior surface of a connector tip formed in the negative of the grasping tip interior shape.
The joining member 80 may be releasably attached to the electronic tether, or may form an integral part thereof. The connecting barrel 30 may be releasable attached to the joining member 80 or may form an integral part thereof. The releasable attachment may be by any suitable known means that will securely attached the various components during use, but permit detachment upon removal for disposal or sterilization prior to re-use, as appropriate.
A method is provided for using the connecting member described herein in minimally invasive procedures to electrically connect an internal medical device to an external device. The external device may operatively connect the connecting member, and thereby the internal medical device to a power source, by a direct connection to an electric outlet or indirectly through another device, or may provide power by means of a battery. The external device may have one or both of electrical connectors for delivering power or data signals to the internal medical device and receivers for receiving signals from the internal device. The method may include in general, the step of equipping the internal medical device with an electronic tether having a free end, wherein the free end of the electronic tether has a connecting member. The connecting member may have, as described herein, a free end and a body portion positioned between the free end and the electronic tether. The free end of the connecting member has a tip which has a smooth non-piercing leading end and surface contours suitable for engagement with a medical instrument. The body portion of the connecting member has at least one conducting portion. Equipping the medical device may include any one or more of the following steps: attaching a non-releasable tether having a tip, attaching a releasably attachable electronic tether to the medical device, attaching a releasably attachable connecting member to the electronic tether, or attaching a releasably attachable tip to the body portion of the connecting member.
The method may, in general, further include the steps of inserting the internal medical device into a body cavity of a patient through a first opening, creating a second opening and a path into the body cavity, inserting a first medical instrument which has an engagement portion through the path into the body cavity, engaging the engagement surfaces of the tip of the connecting member with the engagement portion of the first medical instrument, withdrawing the connecting member and a portion of the electronic tether from the body cavity of the patient through the path with the first medical instrument, and, connecting the connecting member to a device external to the patient. The step of creating a second opening and a path into the body cavity preferably includes making an incision with, and inserting into the body cavity, a combination of a trocar and an obturator. After inserting the combination of the trocar and the obturator through the incision, the obturator is withdrawn prior to inserting the first medical instrument into the body cavity.
In use, with specific reference to the embodiments described herein, a tethered medical device, such as a camera, may be inserted into an internal cavity in a patient 10, such as the abdominal cavity 14, through a small, key-hole incision, with a laparoscope, or through a natural orifice. An open ended tube 92 may be inserted into the abdominal cavity. The tethered medical device is placed into the abdominal cavity 14.
Those skilled in the art will appreciate that the tethered medical device may be a device other than a camera or other imaging devices. The medical device may be a motorized stapler, RF ablation device, harmonic scalpel, bi-polar forceps, electrocautery device, and the like. The electronic tether may be releasably attached to the medical device, or may be integrally attached in any suitable known manner.
A medical instrument selected from the group consisting of a grasper, a suture, a rigid hook, and a threaded rod may be used to withdraw the connector and a portion of the tether from the patient's body cavity.
Referring to
The embodiments of the devices described herein may be introduced inside a patient using minimally invasive or open surgical techniques. In some instances it may be advantageous to introduce the devices inside the patient using a combination of minimally invasive and open surgical techniques. Minimally invasive techniques may provide more accurate and effective access to the treatment region for diagnostic and treatment procedures. To reach internal treatment regions within the patient, the devices described herein may be inserted through natural openings of the body such as the mouth, nose, anus, and/or vagina, for example. Minimally invasive procedures performed by the introduction of various medical devices into the patient through a natural opening of the patient are known in the art as NOTES™ procedures. Some portions of the devices may be introduced to the tissue treatment region percutaneously or through small-keyhole-incisions.
Endoscopic minimally invasive surgical and diagnostic medical procedures are used to evaluate and treat internal organs by inserting a small tube into the body. The endoscope may have a rigid or a flexible tube. A flexible endoscope may be introduced either through a natural body opening (e.g., mouth, anus, and/or vagina) or via a trocar through a relatively small-keyhole-incision incisions (usually 0.5-2.5 cm). The endoscope can be used to observe surface conditions of internal organs, including abnormal or diseased tissue such as lesions and other surface conditions and capture images for visual inspection and photography. The endoscope may be adapted and configured with working channels for introducing medical instruments to the treatment region for taking biopsies, retrieving foreign objects, and/or performing surgical procedures.
Preferably, the various embodiments of the devices described herein will be processed before surgery. First, a new or used instrument is obtained and if necessary cleaned. The instrument can then be sterilized. In one sterilization technique, the instrument is placed in a closed and sealed container, such as a plastic or TYVEK®bag. The container and instrument are then placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation kills bacteria on the instrument and in the container. The sterilized instrument can then be stored in the sterile container. The sealed container keeps the instrument sterile until it is opened in the medical facility. Other sterilization techniques can be done by any number of ways known to those skilled in the art including beta or gamma radiation, ethylene oxide, and/or steam.
Although the various embodiments of the devices have been described herein in connection with certain disclosed embodiments, many modifications and variations to those embodiments may be implemented. For example, different types of end effectors may be employed. Also, where materials are disclosed for certain components, other materials may be used. The foregoing description and following claims are intended to cover all such modification and variations.
Any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated materials does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.
