DEBRIDEMENT DEVICE AND METHOD
Devices, systems and methods for cutting and sealing of tissue such as bone and soft tissue. Devices, systems and methods include delivery of energy including bipolar radiofrequency energy for sealing tissue which may be concurrent with delivery of fluid to a targeted tissue site. Devices include debridement devices which may include a fluid source. Devices include inner and outer shafts coaxially maintained and having cutters for debridement of tissue. An inner shaft may include electrodes apart from the cutter to minimize trauma to tissue during sealing or hemostasis. Devices may include a single, thin liner or sheath for electrically isolating the inner and outer shafts.
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This application is a continuation of U.S. application Ser. No. 13/916,127, filed on Jun. 12, 2013, which claims the benefit of U.S. provisional application 61/658,724, filed Jun. 12, 2012 and of U.S. Provisional Application 61/704,904, filed Sep. 24, 2012, the entire disclosures of which are hereby incorporated by reference in their respective entireties.
BACKGROUNDThe present invention is generally directed to devices, systems and methods for cutting and sealing tissue such as bone and soft tissue. The present invention may be particularly suitable for sinus applications and nasopharyngeal/laryngeal procedures and may combine or provide Transcollation® technology with a microdebrider device.
Devices, systems and methods according to the present disclosure may be suitable for a variety of procedures including ear, nose and throat (ENT) procedures, head and neck procedures, otology procedures, including otoneurologic procedures. The present disclosure may be suitable for a varient of other surgical procedures including mastoidectomies and mastoidotomies; nasopharyngeal and laryngeal procedures such as tonsillectomies, trachael procedures, adenoidectomies, laryngeal lesion removal, and polypectomies; for sinus procedures such as polypectomies, septoplasties, removals of septal spurs, anstrostomies, frontal sinus trephination and irrigation, frontal sinus opening, endoscopic DCR, correction of deviated septums and trans-sphenoidal procedures; rhinoplasty and removal of fatty tissue in the maxillary and mandibular regions of the face.
Sinus surgery is challenging due to its location to sensitive organs such as the eyes and brain, the relatively small size of the anatomy of interest to the surgeon, and the complexity of the typical procedures. Examples of debriders with mechanical cutting components are described in U.S. Pat. Nos. 5,685,838; 5,957,881 and 6,293,957. These devices are particularly successful for powered tissue cutting and removal during sinus surgery, but do not include any mechanism for sealing tissue to reduce the amount of bleeding from the procedure. Sealing tissue is especially desirable during sinus surgery which tends to be a complex and precision oriented practice.
Electrosurgical technology was introduced in the 1920's. In the late 1960's, isolated generator technology was introduced. In the late 1980's, the effect of RF lesion generation was well known. See e.g., Cosman et al., Radiofrequency lesion generation and its effect on tissue impedance, Applied Neurophysiology (1988) 51: 230-242. Radiofrequency ablation is successfully used in the treatment of unresectable solid tumors in the liver, lung, breast, kidney, adrenal glands, bone, and brain tissue. See e.g., Thanos et al., Image-Guided Radiofrequency Ablation of a Pancreatic Tumor with a New Triple Spiral-Shaped Electrode, Cardiovasc. Intervent. Radiol. (2010) 33:215-218.
The use of RF energy to ablate tumors or other tissue is known. See e.g., McGahan J P, Brock J M, Tesluk H et al., Hepatic ablation with use of radio-frequency electrocautery in the animal model. J Vasc Intery Radiol 1992; 3:291-297. Products capable of aggressive ablation can sometimes leave undesirable charring on tissue or stick to the tissue during a surgical procedure. Medical devices that combine mechanical cutting and an electrical component for cutting, ablating or coagulating tissue are described, for example, in U.S. Pat. Nos. 4,651,734 and 5,364,395.
Commercial medical devices that include monopolar ablation systems include the Invatec MIRAS RC, MIRAS TX and MIRAS LC systems previously available from Invatec of Italy. These systems included a probe, a grounding pad on the patient and a generator that provides energy in the range of 450 to 500 kHz. Other examples of RF bipolar ablation components for medical devices are disclosed in U.S. Pat. Nos. 5,366,446 and 5,697,536.
Medical devices are also used to ablate heart tissue with RF energy. See, e.g., Siefert et al. Radiofrequency Maze Ablation for Atrial Fibrillation, Circulation 90(4): I-594. Some patents describing RF ablation of heart tissue include U.S. Pat. Nos. 5,897,553, 6,063,081 and 6,165,174. Devices for RF ablation of cardiac tissue are typically much less aggressive than RF used to cut tissue as in many procedures on cardiac tissue, a surgeon only seeks to kill tissue instead of cutting or removing the tissue. Cardiac ablation of this type seeks to preserve the structural integrity of the cardiac tissue, but destroy the tissue's ability to transfer aberrant electrical signals that can disrupt the normal function of the heart.
Transcollation® technology, for example, the sealing energy supplied by the Aquamantys® System (available from Medtronic Advanced Energy of Portsmouth, N.H.) is a patented technology which stops bleeding and reduces blood loss during and after surgery and is a combination of radiofrequency (RF) energy and saline that provides hemostatic sealing of soft tissue and bone and may lower transfusion rates and reduce the need for other blood management products during or after surgery. Transcollation® technology integrates RF energy and saline to deliver controlled thermal energy to tissue. Coupling of saline and RF energy allows a device temperature to stay in a range which produces a tissue effect without the associated charring found in other ablation methods.
Other ablation devices include both mechanical cutting as well as ablation energy. For example, the PK diego® powered dissector is commercially available from Gyms ENT of Bartlett, Tenn.. This device utilizes two mechanical cutting blade components that are moveable relative to each other, one of which acts as an electrode in a bipolar ablation system. The distal end portion of the device includes six layers to accomplish mechanical cutting and electrical coagulation. The dual use of one of the components as both a mechanical, oscillating cutting element and a portion of the bipolar system of the device is problematic for several reasons. First, the arrangement exposes the sharp mechanical cutting component to tissue just when hemostasis is sought. In addition, the electrode arrangement does not provide for optimal application of energy for hemostasis since the energy is applied essentially at a perimeter or outer edge of a cut tissue area rather than being applied to a central location of the cut tissue. The arrangement of the device also requires more layers than necessary in the construction of a device with both sharp cutters and RF ablation features. The overabundance of layers can make it difficult to design a small or optimally-sized distal end. Generally speaking, the larger the distal end, the more difficult it is for the surgeon to visualize the working surfaces of the device. The use of six layers at the distal end of the system also interferes with close intimate contact between the tissue and the electrodes. Some examples of cutting devices are described in U.S. Pat. Nos. 7,854,736 and 7,674,263.
The Medtronic Straightshot® M4 Microdebrider uses sharp cutters to cut tissue, and suction to withdraw tissue. While tissue debridement with the Medtronic microdebrider system is a simple and safe technique, some bleeding may occur. The Medtronic microdebrider does not include a feature dedicated to promoting hemostasis or bleeding management. Thus, nasal packing is often used.
In the drawings, where like numerals refer to like components throughout several views:
Proximal end region 110 also includes a fluid source connector 150, a power source connector 160 and a suction source connector 170 for connection to a fluid source 152, a power source, 162 and/or a suction source of system 10. One fluid useful with the present disclosure is saline, however, other fluids are contemplated. Power source 162 may be a generator and optionally may be designed for use with bipolar energy or a bipolar energy supply. For example, the Transcollation® sealing energy supplied by the Aquamantys® System (available from Medtronic Advanced Energy of Portsmouth, N.H.) may be used. Both the fluid source 152 and suction source 172 are optional components of system 10. However, use of fluid in conjunction with energy delivery aids in providing optimal tissue effect as will be further explained, thus embodiments of the present invention include specific arrangement of the device 100 for coupling of energy with a fluid. In use, a fluid (e.g., saline) may be emitted from an opening at the distal end region of the device 100. Tissue fragments and fluids can be removed from a surgical site through an opening (not shown in
Rotation of inner shaft 140 may be achieved via manipulation of hub 175 (
As depicted in
With reference between
Electrodes or electrode traces 142a and 142b comprise bipolar electrodes and may comprise wet or dry electrodes. Electrodes 142a and 142b may be used to deliver any suitable energy for purposes of coagulation, hemostasis or sealing of tissue. Electrodes 142a and 142b are particularly useful with fluid such as saline provided by fluid source 152 (
Both
Returning to
With continued reference to
Clip housing 220, shown alone or apart from cell 200 in
When energy is activated or applied to clips 216a, 216b, due to the intimate contact of clips 216a and 216b with electrode rings 300 and 301, electrical communication with bipolar electrodes 142a, 142b is achieved whereby energy is delivered along electrode traces 142a and 142b to the distal end 120 of device 100 and is applied to a targeted area of tissue as described herein above. This aspect of the present disclosure integrates electrodes 142a and 142b to the inner shaft 140 while isolating the inner shaft and electrodes 142a and 142b from other components and while distributing the required power to two separate and distinct electrodes 142a, 142b. This design also minimizes the number of layers required to make the distal end 120 of the device.
Various modifications and alterations to this disclosure will become apparent to those skilled in the art without departing from the scope and spirit of this disclosure. It should be understood that this disclosure is not intended to be unduly limited by the illustrative embodiments and examples set forth herein and that such examples and embodiments are presented by way of example only with the scope of the disclosure intended to be limited only by the claims set forth herein as follows.
Claims
1-20. (canceled)
21. A method of surgically cutting and sealing tissue comprising:
- positioning a distal end region of a debridement device at an operative site within a patient, the debridement device having an outer shaft comprising a lumen and a distal end comprising a cutter forming a cutting window, the device further comprising an inner shaft rotatably disposed within the lumen of the outer shaft, the inner shaft having a distal portion comprising a cutter forming a cutting window, the outer shaft and the inner shaft forming a fluid passage therebetween, the device further comprising a bipolar electrode assembly including first and second electrodes that are electrically isolated from one another and positioned at the distal end region, the device further comprising a proximal region opposite the distal end region and including housing maintaining a button, the button being manually transitionable to an activation position;
- grasping the housing by a hand of a user;
- cutting tissue at the operative site with the inner shaft cutter and the outer shaft cutter by moving the inner shaft relative to the outer shaft;
- transitioning the button to the activation position;
- delivering bipolar RF energy to the first and second electrodes in response to the button being held in the activation position to apply RF energy to tissue of the operative site; and
- terminating the delivery of bipolar RF energy to the first and second electrodes upon releasing the button from the activation position.
22. The method of claim 21, wherein the step of transitioning is performed by a finger of the user's hand otherwise simultaneously grasping the housing.
23. The method of claim 21, wherein the step of transitioning includes depressing the button relative to the housing.
24. The method of claim 21, further comprising discontinuing the delivery of bipolar RF energy when the button is manipulated away from the activation position.
25. The method of claim 24, wherein the button is provided as part of a button assembly, the button assembly further including a biasing member biasing the button away from the activation position.
26. The method of claim 21, wherein the bipolar electrode assembly further includes first and second electrical contacts electrically coupled to the first and second electrodes, respectively, and further wherein the step of transitioning the button to the activation position includes delivering energy from an energy source simultaneously to the first and second contacts.
27. The method of claim 21, wherein the bipolar electrode assembly includes first and second electrical contacts electrically coupled to the first and second electrodes, respectively, and further wherein the button is operatively associated with first and second resilient members, and even further wherein the activation position includes the first and second resilient members electrically coupled to the first and second electrical contacts, respectively.
28. The method of claim 27, wherein the first and second resilient members are located within the housing.
29. The method of claim 27, wherein the step of transitioning the button to the activation position includes establishing electrical communication between a source of energy and the first and second electrical contacts.
30. The method of claim 21, wherein the step of delivering bipolar RF energy include effecting hemostasis at the operative site.
31. The method of claim 21, further comprising supplying fluid to the bipolar electrode assembly simultaneously with the step of delivering bipolar RF energy such that the fluid is operatively coupled to the bipolar electrode assembly.
32. The method of claim 21, wherein after the step of cutting tissue and prior to the step of transitioning the button, the method further comprising:
- arranging the debridement device in a home position in which the inner shaft cutter is shielded; and
- enabling an RF energy mode in which the debridement device is maintained in the home position.
33. The method of claim 32, wherein the step of delivering bipolar RF energy includes supply bipolar RF energy while the RF energy mode is enabled.
34. The method of claim 32, wherein the cutter of the inner shaft includes a cutting surface at a perimeter of the inner shaft cutting window, and further wherein the home position includes the cutting surface disposed within the lumen of the outer shaft.
35. The method of claim 32, wherein the home position includes the outer shaft covering the inner shaft cutting window.
36. The method of claim 32, wherein the home position include the cutter of the inner shaft facing a direction opposite the cutter of the outer shaft.
37. The method of claim 32, wherein the home position includes the first and second electrodes being exposed for electrically interfacing with tissue of the operative site.
38. A method of surgically cutting and sealing tissue comprising:
- positioning a distal end region of a debridement device at an operative site within a patient, the debridement device having an outer shaft comprising a lumen and a distal end comprising a cutter forming a cutting window, the device further comprising an inner shaft rotatably disposed within the lumen of the outer shaft, the inner shaft having a distal portion comprising a cutter forming a cutting window, the distal end region further comprising an electrode assembly, the outer shaft and the inner shaft forming a fluid passage therebetween;
- cutting tissue at the operative site with the inner shaft cutter and the outer shaft cutter by moving the inner shaft relative to the outer shaft;
- arranging the debridement device in a home position in which the inner shaft cutter is shielded;
- enabling an RF energy mode in which the debridement device is maintained in the home position; and
- supplying RF energy to the electrode assembly while the RF energy mode is enabled to apply RF energy to tissue of the operative site.
39. The method of claim 38, wherein the cutter of the inner shaft includes a cutting surface at a perimeter of the inner shaft cutting window, and further wherein the home position includes the cutting surface disposed within the lumen of the outer shaft.
40. The method of claim 39, wherein the cutting surface includes a plurality of teeth each terminating at a tip, and further wherein the home position includes the tip of each of the plurality of teeth not being exposed at the outer shaft cutting window.
41. A method of surgically cutting and sealing tissue comprising:
- positioning a distal end region of a debridement device at an operative site within a patient, the debridement device having an outer shaft comprising a lumen and a distal end comprising a cutter forming a cutting window, the device further comprising an inner shaft rotatably disposed within the lumen of the outer shaft, the inner shaft having a distal portion comprising a cutter forming a cutting window, the outer shaft and the inner shaft forming a fluid passage therebetween, the device further comprising a bipolar electrode assembly including first and second electrodes that are electrically isolated from one another and positioned at the distal end region;
- cutting tissue at the operative site with the inner shaft cutter and the outer shaft cutter by moving the inner shaft relative to the outer shaft;
- indicating a rotational relationship of the inner shaft relative to the outer shaft appropriate for provision of bipolar RF energy to the first and second electrodes; and
- supplying bipolar RF energy to the first and second electrodes to apply RF energy to tissue of the operative site.
Type: Application
Filed: Nov 25, 2015
Publication Date: Jun 20, 2019
Patent Grant number: 10653478
Applicant: Medtronic Advanced Energy LLC (Minneapolis, MN)
Inventor: Eliot F. Bloom (Hopkinton, NH)
Application Number: 14/951,697