Patent Application
20080228202
The present invention relates to methods and devices for approximating tissue.
Gastroesophageal reflux disease (GERD) is a common upper gastrointestinal disorder. GERD is a condition in which acidic contents of the stomach flow inappropriately from the stomach into the esophagus. Chronic irritation of the esophagus leads to inflammation of the esophagus, known as esophagitis. In addition to esophagitis, complications of GERD include Barrett's esophagus, esophageal stricture, intractable vomiting, asthma, chronic bronchitis, and aspiration pneumonia. Pharmacological therapy is available and commonly used. However, this therapy does address the fundamental problem of stomach content flowing in the inappropriate retrograde and into the esophagus.
Normally, the lower esophageal sphincter (LES) allows food to pass from the esophagus to the stomach, while otherwise remaining closed, thus preventing reflux. Closure of the LES is an active process, requiring a combination of proper mechanics and intact innervation. Additionally, the diaphragm may act on the esophagus normally to keep it closed at the LES. Backflow of gastric contents into the esophagus results when gastric pressure is sufficient to overcome the pressure gradient that normally exists at the gastroesophageal junction (GEJ) or when gravity acting on the contents is sufficient to cause flow, retrograde through the GEJ. This situation arises when the gastric pressure is elevated or when the competence of the LES is comprised. Gastric pressure is elevated in association with eating, bending at the waist, squatting, constriction of the waist by clothing, obesity, pregnancy, partial or complete bowel obstruction, etc. Gravitational effects occur when a patient with this condition becomes recumbent. Incompetence of the LES can be functional or anatomic in origin. Function incompetence is associated with hiatus hernia, denervation, myopathy, sclerodertna, and chemical or pharmacological influences (smoking, smooth muscle relaxants, caffeine, fatty foods, and peppermint). Anatomic incompetence is associated with congenital malformation, surgical disruption (myotomy, balloon dilatation or bouginage), neoplasm, etc.
The principal types of operations that address the issues with GERD have included some type of reconstruction of the antireflux barrier, which may include a gastric wrap, as in classic Nissen fundoplication, Toupet fundoplication, a nongastric wrap, e.g., the Angelchik prothesis, a ligamentum teres cardiopexy, and fixation of a part of the stomach to an immobile structure, e.g., the preaortic fascia, as in the Hill repair or the anterior rectus sheath. Several of these operations also include a crural repair of the esophageal hiatus in the diaphragm.
Other clinical studies have shown that tightening the LES helps reduce GERD. The requirement is to gather tissue from various locations forming a serosa-to-serosa plication, and securing the tissue position until the tissue unites. The resulting tightening in the LES will increase competency in preventing acid reflux.
Typically, these procedures are performed surgically through an open incision or with traditional laparoscopic and laparotomy techniques. Accordingly, a need exists for methods and devices for approximating tissue using an endoscopic approach.
The present invention generally provides devices and methods for approximating tissue. In one embodiment, a device for applying an implantable tissue fastener is provided having an elongate sheath, a handle that can be disposed at a proximal end of the elongate sheath, and a hollow needle that can be disposed within the elongate sheath and be adapted to move independent of the sheath. The elongate sheath can be flexible or it can be rigid. The device can also include a first actuator mechanism that is disposed on the handle and can be operatively associated with the needle such that actuation of the first actuator mechanism is effective to extend the needle from the elongate sheath. A second actuator mechanism can be disposed on the handle and be adapted to deploy a tissue fastener that is disposed within the needle. In one embodiment, the device can further include a tissue backstop that is associated with the hollow needle. A third actuator mechanism can be provided to deploy the tissue backstop. In another embodiment, the device can also include a tissue grasping member that is associated with the elongate sheath and is adapted to engage and manipulate a target region of tissue.
A variety of implantable tissue fasteners are also provided. In one exemplary embodiment, an implantable tissue fastener is provided having an anchor member that includes a continuous body with proximal and distal ends and a longitudinal axis extending therebetween. At least one proximal extension member can be disposed at the proximal end of the anchor member and can extend at an angle with respect to the longitudinal axis of the anchor member. The one-piece fastener can also include at least one distal extension member that is disposed at the distal end of the anchor member and can extend at an angle with respect to the longitudinal axis of the anchor member. The proximal and distal extension members can be configured such that they extend away from the anchor member. In one embodiment, the anchor member can include at least two proximal extension members and at least two distal extension members to form an I-shaped fastener.
In another embodiment, an implantable tissue fastener is provided that can include a first anchor member and a second anchor member. The first anchor member can have a continuous body with a longitudinal axis extending between proximal and distal ends. The proximal end can have at least one extension member extending at an angle with respect to the longitudinal axis of the first anchor member. The second anchor member can be removably matable to the first anchor member and can include at least one extension member extending therefrom. In one embodiment, the first anchor member can have at least two extension members that extend away from the longitudinal axis of the first anchor member to form a substantially T-shaped anchor member. The second anchor member can also have at least two extension members that extend away from the longitudinal axis of the first anchor member to form a substantially C-shaped anchor member.
In yet another embodiment, an implantable tissue fastener is provided that can include first, second, and third anchor members. The first anchor member can have a continuous body with a longitudinal axis extending between proximal and distal ends. The second and third anchor members can be removably matable to the proximal and distal ends of the first anchor member, respectively, and can include at least one extension member extending at an angle with respect to the longitudinal axis of the first anchor member.
In general, the extension members associated with the implantable tissue fasteners can have an arcuate shape. A variety of configurations are available for the terminal ends of the extension members. For example, in one embodiment, the terminal ends can be blunt or rounded. In another embodiment, the terminal ends can be sharp or pointed such that they are adapted to penetrate tissue. The implantable tissue fastener can be formed from a variety of materials. For example, exemplary fasteners can be formed from materials including, but not limited to, stainless steel, titanium, and superelastic alloys such as a nickel titanium alloy. The fastener can be formed entirely from one material or can be formed from any combination of materials.
In another aspect of the invention, a method for approximating tissue is provided and can generally include inserting a device for applying an implantable tissue fastener, positioning the device adjacent a targeted tissue, actuating the device to extend a hollow needle that is disposed within an elongate sheath of the device to penetrate the targeted tissue, reconfiguring the targeted tissue in a desired orientation, and actuating the device to deploy a tissue fastener to penetrate the reconfigured tissue to secure the reconfigured tissue in the desired orientation. In one embodiment, the device can be used in conjunction with an endoscope to facilitate viewing of at least a portion of the method for approximating and can be inserted translumenally through a working channel of the endoscope or through an accessory channel that is mated to the endoscope. In another embodiment, the device can be used in conjunction with a laparoscope and can be inserted through a trocar that extends from an access port. A variety of configurations are available for the approximating device, but the device can generally include an elongate sheath, a hollow needle that is slidably disposed within the sheath, and at least one selectively deployable tissue fastener.
In one embodiment, actuating the device can include partially deploying the tissue fastener so as to engage the targeted tissue with the tissue fastener in a partially deployed configuration. In this embodiment, reconfiguring the targeted tissue can include manipulating the engaged tissue with the partially deployed tissue fastener. In another embodiment, the method can include actuating the device to deploy a tissue backstop disposed on a distal portion of the hollow needle. Reconfiguring the targeted tissue can include compressing the engaged tissue between a proximal surface of the tissue backstop and a distal surface of the elongate sheath. In general, reconfiguring the targeted tissue can include engaging and manipulating an inner surface of the targeted tissue to change the shape of the targeted tissue. The method can further include repeating the steps of reconfiguring the targeted tissue and actuating the device to deploy the tissue fastener.
The invention will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings, in which:
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 skilled 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.
The present invention generally provides methods and devices for approximating tissue. The methods and devices utilize a device for applying an implantable tissue fastener and a variety of implantable tissue fasteners. The tissue-fastening device can be delivered endoscopically and can be adapted to function along side of or in conjunction with a flexible endoscope. In general, the device can include a flexible shaft having an implantable tissue fastener applier disposed at a distal end thereof and a handle for operating the implantable tissue fastener applier disposed at a proximal end thereof. For example, in an exemplary embodiment, the device can have a flexible elongate sheath, a handle that is disposed at a proximal end of the elongate sheath, and a hollow needle that is disposed within the elongate sheath and is adapted to move independent of the sheath. At least one actuator mechanism can be disposed on the handle for actuating various operations of the device. For example, a first actuator mechanism can be operatively associated with the needle such that actuation of the first actuator mechanism is effective to extend the needle from the elongate sheath. The device can further include a second actuator mechanism that is adapted to deploy a tissue fastener disposed within the needle. Although the device is shown and described for endoscopic use, one skilled in the art will appreciate that device could include a rigid shaft for laproscopic use.
The hollow needle 20 can further include a tissue backstop 22 to aid in isolating and compressing a target tissue. The backstop 22 can have a variety of configurations, but in one exemplary embodiment, shown in
The handle portion 16 of the device can have a variety of configurations but is generally positioned at a proximal end 12a of the elongate sheath 12 and is configured to operate the implantable tissue applier 14 described above. In one exemplary embodiment, the handle 16 can include one or more actuator mechanisms for actuating various operations of the tissue approximating procedure. As shown in
A variety of implantable tissue fasteners can be used with the tissue fastener applier device described above. For example, in one exemplary embodiment, shown in
The proximal and distal extension members 34a, 34b can extend away from the anchor member 32 to form the one-piece fastener 32. In one embodiment, shown in
In general, the extension members associated with the implantable tissue fasteners 30, 40, 50 can have an arcuate shape. When deployed, the arcuate shape can provide a rounded surface for contacting and applying a fastening load to the tissue. The length of the extension member can vary such that the arcuate extension member can be substantially circular (
The implantable tissue fastener can be formed from a variety of materials. For example, exemplary fasteners can be formed from materials including, but not limited to, stainless steel, titanium, and superelastic alloys such as a nickel titanium alloy. The fastener can be formed entirely from one material or can be formed from any combination of materials. For example, in an exemplary embodiment, the anchor member can be formed from stainless steel and the proximal and distal extension members can be formed from a superelastic alloy. Such a configuration can allow the fastener to be retained within the hollow needle in a constrained position and revert to its unconstrained shape upon deployment or release from the needle. The materials can also be selected such that the fastener can be used as a marker when deployed in a target tissue.
The present invention also provides methods of approximating a target region of tissue. The method can include inserting a device for applying an implantable tissue fastener translumenally. The device can be used in conjunction with an endoscope to facilitate viewing of at least a portion of the method for approximating and can be inserted through a working channel of the endoscope or through an accessory channel that is mated to the endoscope. The approximating device can take the form of any of the embodiments described above but can generally include an elongate sheath, a hollow needle that is slidably disposed within the sheath, and at least one selectively deployable tissue fastener.
The target tissue can then be reconfigured in a desired orientation. Reconfiguring the targeted tissue can include engaging and manipulating an inner surface of the targeted tissue to change the shape of the targeted tissue. The reconfigured tissue can take a variety of shapes including, for example, a fold, a bulge, a mound, a plication, a ridge, a tube, a cone, and a horn.
After manipulating the tissue to reconfigure the tissue in a desired orientation, the device 10 can be actuated to deploy a tissue fastener 64 to the target tissue to penetrate the reconfigured tissue to secure the tissue in the reconfigured orientation. In one embodiment, shown in
The steps of reconfiguring the target tissue and actuating the device to deploy a tissue fastener can be repeated as needed. Once the target tissue is reconfigured and secured as desired, the needle can be retracted within the sheath and the device can be removed from the treatment site.
A person skilled in the art will appreciate that the present invention has application in conventional endoscopic and open surgical instrumentation as well application in robotic-assisted surgery.
The devices disclosed herein can be designed to be disposed of after a single use, or they can be designed to be used multiple times. In either case, however, the device can be reconditioned for reuse after at least one use. Reconditioning can include any combination of the steps of disassembly of the device, followed by cleaning or replacement of particular pieces, and subsequent reassembly. In particular, the device can be disassembled, and any number of the particular pieces or parts of the device can be selectively replaced or removed in any combination. Upon cleaning and/or replacement of particular parts, the device can be reassembled for subsequent use either at a reconditioning facility, or by a surgical team immediately prior to a surgical procedure. Those skilled in the art will appreciate that reconditioning of a device can utilize a variety of techniques for disassembly, cleaning/replacement, and reassembly. Use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.
Preferably, the invention 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.
It is preferred that device is sterilized. This can be done by any number of ways known to those skilled in the art including beta or gamma radiation, ethylene oxide, steam.
One skilled in the art will appreciate further features and advantages of the invention based on the above-described embodiments. Accordingly, the invention is not to be limited by what has been particularly shown and described, except as indicated by the appended claims. All publications and references cited herein are expressly incorporated herein by reference in their entirety.
