Endoluminal surgical device

Abstract

The invention provides a surgical device useful in minimally invasive endoluminal devices. It comprises a flexible and independently manipulated surgical stapler and a multi-degree-of-freedom (multi-DOF) grasper that is configured to work in conjunction with an endoscope or a bronchoscope. The surgical stapler is provided at a proximal end of a flexible compound rotational drive cable while the multi-DOF grasper is provided at a proximal end of a flexible control cable. The distal ends of the flexible cables include suitable accessories and control units as required by the procedure.

Description

ENDOLUMINAL SURGICAL DEVICETECHNICAL FIELD OF THE INVENTION

[0001] The invention relates generally to a surgical device used in minimally invasive endoluminal surgeries and more specifically to a surgical device that comprises two flexible endoscopic surgical instruments acting in conjunction with a colonoscope or bronchoscope.BACKGROUND OF THE INVENTION

[0002] Endoscopic thoracic sympathectomy (ETS), endoscopic lumbar sympathectomy (ELS), and natural orifice transluminal endoscopic surgery (NOTES) are examples of surgical techniques involving minimally invasive surgical techniques intended to minimize the post-surgical impact on the patient during surgical procedures. These procedures generally entail the use of small flexible instruments and camera systems introduced through natural orifices (e.g. oral, urethra, vaginal, anal, etc.) and directed to the surgical sites through the endoluminal anatomy of a patient.

[0003] Typically, these surgical procedures are performed using simple retraction and resection devices including single-degree-of-freedom graspers, flexible monopolar knives, and snares.

[0004] Endoluminal surgical clips have also been developed to handle procedures that require closure. This enables openings in the lumen to be closed. However, their surgical implementation is not ideal, requiring numerous devices to be deployed to complete a closure.

[0005] There have been further developments in surgical devices to advance the procedure capabilities. One exemplary advancement in closure is the OTSC® device from Ovesco Endoscopy. This closure clip has the advantage of closing the potential endoluminal opening before resecting the target tissue. This is particularly advantageous to maintain insufflation during the procedure. This OTSC® clip can perform full thickness closure in endoluminal procedures without opening a hole in the anatomy wall. However, this device islimited in terms of the tissue size that can be drawn into the tube for resection (<20mm), thus limiting its applicability.

[0006] Another exemplary device that has become prevalent is the Overstitch™ endoluminal suturing device developed by Appollo Endosurgery Inc. This device enables surgeons to use sutures for closure in endoluminal surgical spaces. Although suturing is a significant improvement for these surgeries, the complex nature of the device usage has limited the commercial implementation of the device.

[0007] Alternate suturing devices have been developed. One example is the device developed by Nitinotes Ltd., which automates the suturing implementation. Although this solves the ease-of-use issues with the Overstitch™, the non-specific suture placement inherent to the device limits its usage to endoscopic sleeve gastroplasty procedures.

[0008] Thus, it is evident that there are still unmet needs in closure techniques in the current state of the art in endoluminal surgery.SUMMARY OF THE INVENTION

[0009] An ideal surgical device would have the following features:Surgical closure is performed prior to resection;The device should be easy to use despite working in a tight endoluminal surgical space;The device should account for larger tissue resection; andIt needs to be directed by the surgeon for precise tissue resection.

[0010] In one aspect, the invention provides a surgical device that comprises a surgical stapler provided on a proximal end of a flexible compound rotational drive cable and a multi-degree-of-freedom (multi-DOF) grasper provided at a proximal end of a flexible control cable. The surgical stapler comprises a compound drive shaft that is configured to be manipulated axially and rotationally to position the surgical stapler. The flexible compoundrotational drive cable and the flexible control cable have distal ends that include suitable control units and accessories required for a particular endoluminal surgical procedure.BRIEF DESCRIPTION OF THE DRAWINGS

[0011] The detailed description is set forth with reference to the accompanying drawings. The use of the same reference numerals may indicate similar or identical items. Various embodiments may utilize elements and / or components other than those illustrated in the drawings, and some elements and / or components may not be present in various embodiments. Elements and / or components in the figures are not necessarily drawn to scale. Throughout this disclosure, depending on the context, singular and plural terminology may be used interchangeably.

[0012] Figure 1 is a schematic of the surgical device in accordance with at least one embodiment of the invention.

[0013] Figure 2 shows an exemplary embodiment of a flexible OTS device of the invention.

[0014] Figure 3 is a schematic of the surgical stapler used in the surgical device in accordance with at least one embodiment of the invention.

[0015] Figure 4 is a schematic showing the directions of manipulation of the surgical stapler in accordance with at least one embodiment of the invention.

[0016] Figure 5 is a schematic showing representative components of the surgical stapler in accordance with at least one embodiment of the invention.

[0017] Figure 6 is a schematic that shows an exemplary embodiment of jaw clamping and staple firing functions of the surgical stapler.

[0018] Figure 7 is a schematic of the multi -DOF grasper used in the surgical device in accordance with at least one embodiment of the invention.

[0019] Figure 8 is a schematic showing exemplary positioning of the wrists on the multiDOF grasper that allows appropriate manipulation in accordance with at least one embodiment of the invention.

[0020] Figure 9 is a schematic showing the multi-DOF grasper comprising a rotationally actuated screw meant auger in accordance with at least one embodiment of the invention.

[0021] Figure 10 is a schematic of the multi -DOF grasper retracting a tissue through stapler jaws in accordance with at least one embodiment of the invention.

[0022] Figure 11 is a schematic of an OTS device in accordance with at least one embodiment of the invention.

[0023] Figures 12a-h show the various steps involved in the resection of tissue using the surgical device in accordance with at least one embodiment of the invention.DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS OF THE INVENTION

[0024] The disclosure will be described more fully hereinafter with reference to the accompanying drawings, in which example embodiments of the disclosure are shown, and not intended to be limiting.

[0025] The definitions provided herein are to facilitate understanding of certain terms used frequently herein and are not meant to limit the scope of the present disclosure.

[0026] As used in this specification and the appended claims, the singular forms "a", "an", and "the" encompass embodiments having plural referents, unless the content clearly dictates otherwise.

[0027] Unless otherwise indicated, all numbers expressing feature sizes, amounts, and physical properties used in the specification and claims are to be understood as being modified in all instances by the term "about." Accordingly, unless indicated to the contrary, the numerical parameters set forth in the foregoing specification and attached claims are approximations that can vary depending upon the desired properties sought to be obtained by those skilled in the art utilizing the teachings disclosed herein.

[0028] As used in this specification and the appended claims, the term "or" is generally employed in its sense including "and / or" unless the content clearly dictates otherwise.

[0029] As noted herein, in one aspect, the invention provides a surgical device as shown in Figure 1 and depicted by numeral 10 that comprises a surgical stapler 12 and a multi-degree of freedom (DOF) grasper 14. The surgical device is configured to include aflexible endoscopic camera, thus acting as a stand-alone device. Alternately, the surgical device is an Over-The-Scope (OTS) device that is configured to work with existing commercially available endoscopes.

[0030] The device may utilize known steering mechanisms of standard flexible colonoscopes or bronchoscopes. Alternatively, the device could be designed to incorporate the endoluminal steering means into the OTS device and utilize smaller form factor endoscopes for vision. Figure 2 is an exemplary embodiment of a flexible OTS device of the invention that comprises steering mechanisms used to steer the surgical device of the invention.Surgical Stapler:

[0031] The surgical device comprises a small form factor surgical stapler as seen in Figure 3 and depicted by numeral 30 that is designed appropriately for endoluminal surgeries. The surgical stapler is provided on a proximal end of a flexible compound rotational drive cable 32.

[0032] The overall orientation of the surgical stapler utilizes the articulation in the endoscope or OTS device. Further, positioning of the surgical stapler is achieved by manipulating the compound drive shaft axially and rotationally. For clarity, the axial and rotation motions are shown in Figure 4 and represented by numerals 40 and 42 respectively. The surgical stapler could incorporate another DOF, such as, but not limited to articulation.

[0033] Figure 5 shows representative components in an exploded view of one exemplary embodiment of the surgical stapler 50 in accordance with at least one embodiment of the invention. The surgical stapler 50 comprises flexible drive shafts 52 that are linked to a jaw clamp leadscrew 54, which in turn is fitted into a jaw clamp actuator 56 that engages clamping jaw 1062, which then allows closing the jaw. The jaw clamp actuator 56 is snugly fit into a cartridge jaw 1052 and held in place with a pivot pin 1054. The staple firing lead screw 1050 is allowed to fire along a staple guide 1056 on which staples 1058 are provided. A staple drive ramp 58 is provided on the cartridge jaw 1052 to guide one or more lines of staples. This whole unit is provided in a staple cartridge housing 1060 that is held in place with a clamp jaw 1062. The surgical stapler may incorporate one or more lines of staples with or without a resection knife 1064 depending on clinical application.

[0034] The compound rotational drive cables are utilized to enable other functions of the surgical stapler, such as jaw clamping and staple firing. Rotationally driving these functions enables the use in an endoluminal application, because large push-pull forces are challenging to achieve in flexible cable applications. Figure 6 shows an exemplary embodiment of the jaw clamping and staple firing functions of the surgical stapler. An inner shaft 62 rotationally drives staple firing leadscrew 64 while an outer shaft 66 rotationally drives jaw clamping leadscrew 68 which in turn drives the clamping jaw 69. The rotation actuation drives leadscrews which independently activate a jaw clamping mechanism and the staple drive ramp to form the surgical staples for the clinical application.

[0035] Although the inner shaft of the compound flexible drive shaft is shown to be directly driving the staple drive ramp, an alternate version could be deployed to drive a set of gears to adjust the position and force capability of the staple firing leadscrew.

[0036] Typically, the staple guides pilot through the staple cartridge housing during the firing process. To minimize the form factor of the surgical stapler, the design includes incorporation of unique features that utilize the staple cartridge housing, cartridge jaw, as well as the staple drive ramp to guide the staple guides during firing. These features required to guide the staple guide during the firing of staples may be found from the art.Multi-DOF Grasper:

[0037] The surgical device then comprises a small form factor multi-DOF grasper. Figure 7 shows arrangement 70 wherein the multi-DOF grasper 72 is provided on a proximal end of a flexible control cable 74. The distal end of the flexible control cable 74 may include a suitable control unit 76 configured to be used by a suitable healthcare professional during a procedure, such as a mechanical or an electromechanical control unit.

[0038] The multi-DOF grasper incorporates 6 DOF: axial translation, axial rotation, 2 X 2-DOF wrists. Figure 8 shows the multi-DOF grasper 80 with wrist 1 and wrist 2 depicted by numeral 82 and 84 respectively. The wrists could be of articulated joint design or alternatively could utilize steerable catheter technology. DOF could be added or removed depending on clinical implementation. The grasping mechanism could be opposing jaws actuated by a push pull cable. Alternatively, the multi-DOF grasper could incorporate a rotationally actuated screw meant auger into the target tissues to enable secure retraction asshown in Figure 9 and depicted by numeral 90. Figures 8 and 9 also depict the direction of action (longitudinal or rotational) of the wrists or the auger.

[0039] The multi -DOF grasper enables the function of the stapler by retracting the target tissue through the stapler jaws to seal and resect said tissue. Figure 10 shows a schematic of the multi -DOF grasper 100 retracting a tissue (not shown) through stapler jaws 102.Over the Scope (OTS) Device:

[0040] The OTS device is designed to incorporate commercially available endoscopes. The OTS device could be a passive device that utilizes the general capabilities of the endoscope as shown in Figure 11 and depicted by numeral 110 that comprises the surgical stapler 112 and the multi-DOF grasper 114.

[0041] If the OTS device is designed for a small form endoscope, it may be required to add a method to steer the tip of the device in case the steering mechanism of the small form commercial endoscope is insufficient to manipulate the entire surgical device of the invention. Standard hardware for most commercially available endoscopes may be suitably adapted for use in the surgical device of the invention. This option will also require additional working channels to enable standard endoluminal surgical instruments and functions, which include, for example, but are not limited to biopsy, resection, irrigation, and suction. Such additional hardware and features may be available in the art.

[0042] Another potential feature for either option above would be a torque stop incorporated into the surgical stapler or multi-DOF grasper working channel. The torque stop would be enabled or disabled externally. Disabling the torque stop allows axial rotation and translation of each instrument for surgical positioning. Enabling the torque stop retains rotational and translational forces to be supported locally at the tip of the surgical device as opposed to translating externally down the flexible instrument shafts. This may be required to increase the forces required for tissue retraction, clamping, and staple firing. Numerous designs could be employed for this purpose. One such implementation would be a linear collet in the instrument channel at the tip of the OTS which is actuated by a hollow push-pull cable.

[0043] One skilled in the art will understand that the distal ends of the flexible compound rotational drive cable and the flexible control cable would be attached to suitable accessories, such as grippers, eyepiece, electronics, controllers, and connectors.Method of Operation:

[0044] In another aspect, the invention provides a method of using the surgical device. Figures 12a-h depict the various stages of the resection of a tissue in a target region using the surgical device of the invention. As would be obvious to one skilled in the art, the method depicted herein is applicable to either a surgical device with an endoscope or bronchoscope device, or an OTS surgical device used in conjunction with a commercially available endoscope. Figure 12a is a depiction of the first step of the method that comprises navigating the surgical device 120 to surgical space 122. Then, Figure 13 shows the surgical stapler 130 and multi-DOF grasper 132 being extended from the surgical device. Following this, surgical stapler 140 is positioned over a target tissue 142 as shown in Figure 14. Then, target tissue 150 is retracted using the multi-DOF grasper 152 through the surgical stapler jaws 154 as shown in Figure 15. Subsequently, a set of jaws 160 of the surgical stapler 162 is closed in preparation for a stapling fastener (not shown) to be set as shown in Figure 16. Then, the staple fasteners 170 are set and the target tissue 172 is resected, as depicted in Figure 17. Finally, surgical device 180 is retracted from the region with the resected tissue 182 as shown in Figure 18, which is then removed with the target tissue, as depicted in Figure 19.

[0045] The surgical device of the invention offers tremendous convenience of use and simplicity of operation during minimally invasive procedures, such as ETS, ELS, and NOTES. It further enables resecting tissue of any size followed by removal and retraction with ease. Further, the surgical device can also be used as a standalone device with an inbuilt endoscope or a bronchoscope. Alternatively, the surgical device can be configured to be used as an Over-The-Scope device with existing commercially available endoscopes or bronchoscopes.

[0046] While only certain features of the invention have been illustrated and described herein, many modifications and changes will occur to those skilled in the art. It is, therefore, to be understood that the appended claims are intended to cover all such modifications and changes as fall within the true spirit of the invention.

Claims

CLAIMSWhat is claimed is:

1. A surgical device comprising: a flexible compound rotational drive cable having a first distal end and a first proximal end, wherein the first proximal end comprises a surgical stapler comprising a compound drive shaft that is configured to be manipulated axially and rotationally to position the surgical stapler; and a flexible control cable having a second distal end and a second proximal end, wherein the second proximal end comprises a multi-degree of freedom grasper.

2. The surgical device of claim 1 wherein the surgical stapler comprises an inner shaft configured to rotationally drive staple firing leadscrews and an outer shaft configured to rotationally drive jaw clamping leadscrew.

3. The surgical device of claim 1 wherein the surgical stapler is configured for articulation.

4. The surgical device of claim 2 wherein the surgical stapler further comprises a set of gears connected to the inner shaft.

5. The surgical device of claim 1 wherein the grasper comprises opposing jaws actuated by a push-pull cable at the second proximal end of the flexible control cable.

6. The surgical device of claim 1 wherein the grasper comprises a rotationally actuated screw provided at the second proximal end of the flexible control cable.

7. The surgical device of claim 1 wherein the surgical stapler and the grasper are provided within channels in a tube, wherein the tube further comprises channels for at least one of an endoscope and a bronchoscope.

8. The surgical device of claim 7 wherein the tube further comprises working channels for performing one or more functions of biopsy, resection, irrigation, and suction.

9. The surgical device of claim 1 further comprising a torque stop at the first proximal end of the flexible compound rotational drive cable, the second proximal end of theflexible control cable, or both.

10. A method of operating a surgical device, the surgical device comprising: a surgical stapler comprising a compound drive shaft that is configured to be manipulated axially and rotationally to position the surgical stapler; and a flexible control cable having a distal end and a proximal end, wherein the proximal end comprises a multi-degree of freedom grasper; the method comprising: navigating the surgical device to a surgical space; extending the surgical stapler and multi-degree of freedom grasper extended from the surgical device; positioning the surgical stapler over a target tissue; retracting the target tissue using the multi-degree of freedom grasper through the Surgical Stapler jaws; closing a set of jaws of the surgical stapler in preparation for a stapling fastener to be set; setting the staple fasteners and resecting the target tissue; retracting the surgical device; and removing the surgical device with the target tissue.

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