The present disclosure relates to a device to accomplish the surgical task of grasping tissue inside hollow viscera and other hollow organs. Additionally, the grasping of tissue provides the counter traction for operations such as clip application, biopsy, and the like. Finally, the grasping of tissue can be used to provide traversal of the small intestine.
Natural orifice surgery is a common method of treating diseases of the hollow organs where we have a natural opening into the body. Currently, endoscopes are inserted into these natural orifices and used to navigate to the site of interest. They commonly have a single tool hole with which to insert a wide range of tools such as, but not limited to, electrocautery, clips, or biopsy needles. However, the current state of endoscopes doesn't offer a way to fix the tissue in place while performing these actions.
Additionally, without countertraction, it is extremely difficult to pass a suture through an organ wall and thus all endoscopic clips clamp the tissue rather than passing through the tissue in a loop like a regular suture; this leaves the clipped tissue protruding from the organ wall and can act as an obstruction to flow through the organ.
Finally, access to the small intestine is difficult and requires a device to pull the small intestine over the endoscope; this is known as enteroscopy. Currently, balloon enteroscopy is used where a balloon is inflated around the scope to fix the small intestine, the scope is advanced, the balloon is deflated and advanced, the balloon is re-inflated, both the endoscope and balloon are pulled back, and then the process repeats thereby advancing the scope down the small intestine. Unfortunately, this is a very slow process and the small intestine is long, resulting in long surgeries.
A system was disclosed in U.S. Pat. No. 8,206,295, herein referred to as the suction pad that uses suction applied to holes on the side of the tool to grasp and manipulate tissue in the digestive tract. However this system is different from embodiments of the present disclosure in many respects. The suction pad was designed to enter the body through a laparoscopic port where as our system can enter through both a laparoscopic port and a natural orifice such as, but not limited to, the mouth. The suction pad does not attach or integrate into an existing endoscope which necessitates additional or larger entries into the body. The suction pad must be rolled up to enter the body and does not disclose a method of removal from the body using the same port size where as our system enters and exits from a natural orifice or port by itself or attached or integrated into an endoscope with or without collapsing. The suction pad cannot translate, rotate, or pitch axially without the aid or external graspers which requires additional entries into the body and additional tools. The suction pad grasping surface is flexible and deformable where as ours is rigid when in use; although, the surface may be soft or the grasping head may be expandable. A fixed shape face allows faster grasping since the tool does not need to be deformed to the tissue surface. The suction pad does not operate in small tubular organs such as, but not limited to, the esophagus or small intestine. The suction pad is a singular entity with two and only two suction chambers whereas our system can act with many head each with one or more suction chambers where each chamber can be individually or synchronously pressurized and each head can be translated, rotated, or pitch which respect to one another or an endoscope. Our suction system is designed to provide counter traction for a tool hole by surrounding set tool hole with suction holes. This allows, but is not limited to, placement of surgical clips or precision biopsy or injection. Our suction system facilitates viewing through the device and many different sensors and imaging types. Our system can use the suction to form a seal around a tissue for local application of collapsed mesh structures, fluid, gel, gas, plasma, drugs, growth factors, cells or any combination thereof. The suction pad only rolls up and still occupies the same volume whereas our system can collapse and occupies less volume.
Additionally, a patent U.S. Pat. No. 7,507,235 discloses a suction tissue stabilization device for the heart which also differs from our device as follows. A tool channel, surgical clip, or surgical clip applier are not disclosed; only a cannula for drug delivery and energy delivery electrodes. They specify a rigid face that is specially shaped to the target tissue but they don't talk about anatomy-specific, age-specific, or patient-specific and never discuss using pre-operative imaging to select sizes. A mixture of hole sizes or a special arrangement of holes is never disclosed; although they try to claim “any suitable arrangement” but our arrangements are for special purposes which are non-obvious. Use of an expandable bladder for either grasping or expansion/contraction is not disclosed. They refer to microgrooves but don't specify soft microgroove which are required to achieve the instance where the pillars flatten to increase surface area which is non-obvious. Finally, the support structure is not integrated with the functional channels (suction, irrigation, etc.) and the functional channels are not used for actuation.
Disclosed herein is a tissue gripping device for use in association with a clip having a distal end and a suction device, comprising a hollow member having a distal end and a proximal end; a head, having a contact face and an inlet, the inlet being attachable to the distal end of the hollow member; a tool channel having a distal end and a proximal end; the contact face having at least one opening, the at least one opening being in flow communication with a suction device through the hollow member; a generally elongate tool housing formed in the head and configured to receive the clip wherein the tool housing is attachable to and in flow communication with the distal end of the tool channel; a tool trench formed in the head configured to receive therein the distal end of the clip; and a control device attachable to the proximal end of the hollow member and operably attachable to the proximal end of the tool channel, whereby the clip is ejected responsive to actuation by the control device from the tool channel and into the tool trench.
In addition, the clip may be loaded into the tool housing through the proximal end of the tool channel. The clip may have a loop shape in stable equilibrium position. The clip may be composed of elastic, super-elastic, or shape memory material. The clip may be composed of self-closing, super-elastic nitinol. The tool housing may have an embedded ejection mechanism which may be actuated hydraulically, electro-dynamically or pneumatically from the control device.
Another embodiment disclosed herein is a tissue gripping device for use in association with a suction device and a bladder pump, comprising: a hollow member having a distal end and a proximal end; a head having a contact face and an inlet, wherein the inlet is attachable to the distal end of the hollow member; an inflatable bladder, formed in the head, in flow communication with the bladder pump; the contact face having at least one opening wherein the at least one opening is in flow communication with the suction device through the hollow member; and a control device attachable to the proximal end of the hollow member.
In addition, the dimensions of the head may be increased or decreased responsive to the bladder pump. Furthermore, the dimensions of the openings may be increased or decreased by a similar mechanism. The inflatable bladder may be inflated or deflated hydraulically or pneumatically.
Another embodiment disclosed herein is a tissue gripping device for use in association with a suction device, comprising: at least two members each having a distal end and a proximal end, wherein one of the at least two members is a flexible member and wherein one of the at least two members is a hollow member; a head, having a contact face and an inlet, where the inlet is attachable to the distal end of the hollow member; the contact face having at least one opening wherein the at least one opening is in flow communication with the suction device through the hollow member; and a control device attachable to the proximal end of the at least two members.
In addition, the hollow members described above may be flexible such that translation or rotation of the members may achieve translation or rotation of the head. The hollow members may be reinforced with a spring core or a super-elastic tube. The head may further comprise one or more attachable chords, ropes, strings or wires such that applied tension may translate or rotate the head. The contact face may have a convex shape.
Furthermore the contact shape may be chosen to match the radius of concavity of an organ, an orifice or a lumen. The hollow member may act as a conduit for flow communication between the openings in the face and the suction device. The suction device may be a pump or a vacuum. The surface of the contact face may be treated with microgrooves. The microgrooves may be stiff micro-pillars or soft micro-pillars that deform under sheering or normal force. The surface may be treated with a hydrophilic, hydrophobic, knurled or abraded coating. The head may be rigid. A lens, window or fiber optic cable may be built into the head or the head may be constructed out of transparent or translucent material to aid in viewing the operation site. Different sized openings may be used such that smaller openings are located closer to the perimeter of the contact face. The device may be attachable a tool selected from the list including but not limited to: an endoscope, a drug administering device, an electrode or a medical retractor. The device may be attachable to a sensor selected from the list including but not limited to: a force sensor, a pressure sensor, a capacitance sensor, a temperature sensor or a pH sensor. The sensor may also be an ultrasonic transducer, a magnetic resonance imaging coil, an optical sensor or lens, an optical coherence tomography sensor or a mechanical excitation and force transducer for elastography imaging. The device may be used to grasp and deliver a patch or film into an orifice or a lumen. The patch may contain tissue, drugs, growth factor, cells or any combination thereof. The openings may be used to form a seal around an area of tissue.
Another embodiment disclosed herein is a tissue gripping device for use in association with a suction device, comprising: a hollow member having a distal end and a proximal end; a head, having a substantially convex contact face and an inlet, the inlet being attachable to the distal end of the hollow member; the substantially convex contact face having at least one opening, the at least one opening being in flow communication with a suction device through the hollow member; and a control device attachable to the proximal end of the hollow member.
Another embodiment disclosed herein is a clip for use in association with a clip applying apparatus, wherein the clip is flexible, substantially bent or curved in stable equilibrium position and can be loaded into a substantially elongate clip cartridge such that the clip's shape in loaded configuration is substantially more elongate than the clip's shape in stable equilibrium position. The clip may have a sharpened tip, and may be rigid, elastic or super elastic. The clip may be composed of shape memory alloy, shape memory polymer, biodegradable polymer, nitinol, stainless steel, titanium or cross-linked polyurethane. The cross sectional shape of the clip may be circular, rectangular or flat.
A further understanding of the functional and advantageous aspects of the present disclosure can be realized by reference to the following detailed description and drawings.
Embodiments of the present disclosure will now be described, by way of example only, with reference to the drawings, in which:
As required, embodiments of the present disclosure are disclosed herein. However, the disclosed embodiments are merely exemplary, and it should be understood that the present disclosure may be embodied in many various and alternative forms.
The Figures are not to scale and some features may be exaggerated or minimized to show details of particular elements while related elements may have been eliminated to prevent obscuring novel aspects. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting but merely as a basis for the claims and as a representative basis for teaching one skilled in the art. For purposes of teaching and not limitation, the illustrated embodiments are directed to a tissue gripping device.
As disclosed herein, the term ‘rigid members’ means a member that does not deform significantly under normal loading for its operation. ‘flexible members’ means that the member deforms significantly in bending but not axial; it may or may not deform significantly in torsional loading. ‘cables’ deform significantly in all loading except axial extension. Finally, ‘cords’ deform significantly in all loadings (axial, bending, torsion).
As disclosed herein the ‘clip’ is any device which joins tissue by use of normal force or the frictional force derived from application of normal force.
As disclosed herein, “superelasticity” is a process where the elastic energy is stored in a solid-to-solid phase change in addition to standard elastic effect where elastic energy is stored in the bonds of the material.
As disclosed herein, “shape memory” is a process where a material can be deformed in a non-elastic, but non-permanent, fashion thereby giving the illusion of permanent deformation. The material may then regain its original form by an application of another stimulus such as, but not limited to, heat, cold, chemical, electrical, or magnetism but excluding deforming into the original shape.
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These attachments 1 can facilitate the aforementioned motions over a flexible path with any number of bends by providing a short enough distance between attachments 1, stiff enough tubing 4, and smooth enough motion such that the tubes do not buckle when translated. In this example, there are many attachments 1 placed along the length of the endoscope 5. The attachments have a high friction, elastic strap 13, such as silicone, to hold the attachments 1 in place on the endoscope and a low friction rigid body 12, such as PTFE or UHMWPE, to allow smooth translation of the tubes.
The suction can be derived from any source such as, but not limited to, medical wall suction, hand pump, or pump.
The members 2 are hollow and provide the negative pressure and the tool channel to the head 6 and can be flexible or rigid. In addition to negative pressure and tools, any other fluid, gas, or plasma can be delivered through the channels to perform operation such as, but not limited to, intubation, irrigation, insufflation, or anesthesia. The members 2 may also be made transparent to provide less obstruction of view.
There may be openings placed on the head(s) in order to facilitate viewing during an operation. Also, as shown in
The surface of the head 6 with holes in it that faces the tissue can be modified to increase or decrease grasping force. This is accomplish by, but not limited to, knurling, abrading, particle embedding, the aforementioned micropillars, hydrophobicity, hydrophilicity, or some combination, mixture, or arrangement thereof. Knurling, abrading, and particle embedding increase the friction when pulling parallel to the suction face. Hydrophobicity can be used to force mucus and bodily fluid away from the surface thereby, but not limited to, keeping the surface clean for viewing through a transparent body, cleaning the esophageal wall when force into it, reducing perpendicular force on tissue due to loss of fluid viscosity, and/or increasing friction. Hydrophilicity can be used to hold bodily fluids to the surface thereby, but not limited to, increasing lubrication, reducing friction, and increasing perpendicular force on tissue by increased fluid viscosity.
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In the embodiment where surgical clips are applied through the tool channel, the surgical clips can be rigid, elastic, or superelastic and these clips may or may not bend back on themselves. In the case of elastic and superelastic clips, the clip is deformed before application and springs back into its relaxed circular shape. In the case of rigid clips, the clip must be permanently deformed into a circular shape as it exits the tool channel. Bending back on themselves prevents tissue for escaping and the wound closure from opening. Clips can be composed of, but not limited to, superelastic metal such as nitinol, stainless steel, titanium, shape memory metal such as nitinol, shape memory polymer such as cross-linked polyurethane, biodegradable polymer, shape memory, biodegradable polymer, ceramic, silicone, or any combination, composite, laminate, coating, embedding, patterning, alloy, polymerization, or arrangement thereof.
The ram rod can be actuated in any way including, but not limited to, manual pushing, hydraulic, pneumatic, piezoelectric, electric motor, heat expansion, or combination thereof.
This method provides a suture-like, protrusion-less closure whereas existing endoscopic surgical clips protrude from the organ surface. The openings 8 may be arranged in such a way that they surround or mostly surround the tool channel 2 exit in order to provide better counter traction. Additionally, smaller holes may be placed around the tool hole to provide a more gradual loss of suction as was elaborated on earlier for suction tissue manipulation.
The clips are generally tipped at the distal end and flat or blunt at the proximal end to allow puncturing and ram rod force respectively. The end of the clip can, however, be of any profile such as, but not limited to, blunt, conical, beveled, diamond, flat. The tip or clip may also be treated or coated with, but not limited to, any combination of drugs, polishing, abrading, oxide, indicator, polymer, carbide, silicone, hydrogel, biologic, or cells. As examples, endothelial cells proliferate best at around a 2400 grit surface, cells differentiate preferentially based on the hardness of their surroundings so a coating matching the hardness of the organ the clip is embedded in is preferable, the titanium oxide coating on nitinol is known to be extremely bioinert, and growth factors can be used to control the wound healing process thereby speeding or improving wound healing. Finally, additional features may be manufactured onto the clip such as, but not limited to, diamond or carbide tipping or rubber or plastic ends.
The clip(s) can be loaded into hypodermic tube cartridges that are then loaded into the tool channel. This allows the clips to be loaded from the proximal end of the tool and allows empty cartridge to be quickly exchanged with loaded ones without removing the tool or endoscope.
Beyond, the aforementioned curved tool channel exit orientation can also be accomplished by partial flattening of the tool channel and/or cartridge to create an elliptical profile. In this embodiment, the elasticity of the clip(s) forces it to align with the longer direction of the ellipse. This method only guarantees alignment along this axis leaving two possible orientations; thus, the channel must be marked to indicate which of these two orientations the clip(s) are in. Additionally, the clip can be manually orientated and then the surgeon can impart orientation manually or by forced orientation of the cartridge such as, but not limited to, keying. Finally, any method which ensures the orientation of the clip(s) may be used.
Additionally, these holes 8 can be placed around the tool channel 2 exit and a sealing ring composed of soft material such as, but not limited to, silicone, neoprene, polyurethane, or Buna-N may or may not also be placed to seal around a section of tissue to allow localized delivery of collapsed mesh structures, fluid, gel, gas, plasma, drugs, growth factors, cells or any combination thereof. For example, this facilitates localized drug delivery, plasma ablation, and delivery of cells suspended in hydrogel with growth factors for regenerative medicine.
The device can be used to perform anastomosis by one or more separate heads. As an example, three heads can be used in the following manner: one to grasp one side of the wound, another to gasp the other side of the wound, and the third to provide counter traction for suture placement. Additionally, one or more heads can be used in a fashion such that they can traverse the small intestine. As an example, if two heads are used: negative pressure is applied to head one, head two is advanced, negative pressure is applied to head two and removed from head one, head two is retracted and pulls the small intestine down with it, head two has negative pressure removed, and then the process is repeated.
In a preferred embodiment for performing traversal of the small intestine, two heads are used where both have a single suction chamber and one or both have the ability to translate. As demonstrated in
In another preferred embodiment for anastomosis of the esophagus, two heads are used where the first head is attached to the endoscope by attachments and the second head is coupled to the endoscope but is permitted to freely rotate about the axis of the endoscope. Additionally, the first head has a single chamber attached to all suction holes, a tool channel loaded with the previous disclosed superelastic clip applying apparatus, and the ability to translate, rotate, and pitch by using the two suction tubes and one tool channel and has the ability to roll with the endoscope. The second head has two chambers, no tool channel, and the ability to translate and rotate by use of the two suction tubes. This embodiment operates as follows. Initially, the first head is used to retrieve the distal lumen and pull it back towards the endoscope. Secondly, the distal chamber of the second head grasps the distal lumen, pulls it into the proximal lumen, and then the proximal chamber of the second head grasps the proximal lumen thereby temporarily coupling the organ. Then, the first head is used to clip the lumens together as per the earlier example of clip application. Finally, the endoscope is then rolled by an increment thereby leaving the second hand in place and rolling the first head along the lumen interface. The clip application is then repeated. This process is repeated until the lumens are anastomosed. As a variation in use, the second step may be changed to, “the proximal chamber of the second head grasps the proximal lumen, pushes it towards the distal lumen, and then the distal chamber grasps the distal lumen thereby temporarily coupling the organ”. This alternative is useful where one lumen is fixed in place by connective tissue or other anatomy such as, but not limited to, nerves, blood vessels, bone, or other organs.
In a preferred embodiment for puncture or fistula closure, a single head is used with two suction channels with one suction chamber and one tool channel. The tool channel is used with the superelastic clip applying apparatus that was previously disclosed. The tool is attached to an endoscope and has the ability to translate by use of the suction tubes and tool channel and can translate and rotate by attachment to the endoscope. The tool operates as per the example given for clip application. It can also provide tissue manipulation for finding punctures by pulling on tissue to open up said punctures or fistula for easy detection.
In another embodiment of the present disclosure, the device may be inserted through an incision in the body as opposed to through a natural orifice.
As used herein, the terms “comprises”, “comprising”, “includes” and “including” are to be construed as being inclusive and open ended, and not exclusive. Specifically, when used in this specification including claims, the terms “comprises”, “comprising”, “includes” and “including” and variations thereof mean the specified features, steps or components are included. These terms are not to be interpreted to exclude the presence of other features, steps or components.
The foregoing description of the preferred embodiments of the present disclosure has been presented to illustrate the principles of the disclosure and not to limit the disclosure to the particular embodiment illustrated. It is intended that the scope of the present disclosure be defined by all of the embodiments encompassed within the following claims and their equivalents.
Filing Document | Filing Date | Country | Kind |
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PCT/CA2014/050573 | 6/18/2014 | WO | 00 |
Number | Date | Country | |
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61836478 | Jun 2013 | US |