CAP FOR ENDOSCOPE
20220151653 · 2022-05-19
Inventors
- Reza Mohammadpour (Willoughby Hills, OH, US)
- Mohamed Lababidi (Olmsted Falls, OH, US)
- Alex Uspenski (Chardon, OH, US)
- Cynthia Ann Ranallo (Eastlake, OH, US)
- Michael Charles Hauser (Chardon, OH, US)
- Holden Szalek (Mentor, OH, US)
Cpc classification
A61B18/1492
HUMAN NECESSITIES
A61B2018/1495
HUMAN NECESSITIES
A61B17/320016
HUMAN NECESSITIES
A61B2018/00982
HUMAN NECESSITIES
International classification
Abstract
A device for fragmenting a surgical implant includes a cap. The cap includes a first channel extending from a first end of the cap to the second end of the cap. The device includes a first electrode, a second electrode, and an endoscope coupled with the cap.
Claims
1. A device for fragmenting a surgical implant, the device comprising: a cap comprising a first end and a second end; wherein the cap comprises a first channel and a second channel, the first channel and the second channel extending from the first end of the cap to the second end of the cap, wherein the first channel receives a first electrode, and wherein the second channel receives a second electrode, wherein the cap is configured to attach to an endoscope.
2. The device of claim 1, wherein the cap comprises one or more protrusions extending from the cap.
3. The device of claim 1, wherein the cap is made from a nonconducting material.
4. The device of claim 1, wherein the first electrode and the second electrode comprise a bipolar electrode pair.
5. The device of claim 1, further comprising a third channel extending from the first end of the cap to the second end of the cap, wherein the third channel is configured to receive an endoscopic instrument.
6. The device of claim 5, further comprising a fourth channel extending from the first end of the cap to the second end of the cap, wherein the fourth channel is configured to receive the endoscope.
7. The device of claim 1, further comprising a power supply coupled to the first electrode and the second electrode via wiring.
8. The device of claim 7, wherein the first electrode and the second electrode receive a direct electric current from the power supply via the wiring, wherein the first electrode and the second electrode introduce a high-frequency current into the implant, wherein the implant is separated or distanced from a tissue of a hollow organ during introduction of the high-frequency current from the first electrode and the second electrode to the implant.
9. The device of claim 1, further comprising a hood coupled with the cap, wherein the hood is moveable relative to the cap.
10. A device for fragmenting a surgical implant, the device comprising: a cap comprising a first end and a second end, an endoscope coupled with the cap; a first electrode coupled with the cap; and a second electrode coupled with the cap.
11. The device of claim 10, wherein the first electrode and the second electrode comprise a bipolar electrode pair.
12. The device of claim 10, wherein the cap comprises a first channel extending from the first end of the cap to the second end of the cap, wherein the first channel receives the first electrode and the second electrode.
13. The device of claim 10, wherein the cap comprises one or more protrusions extending from the cap.
14. The device of claim 10, wherein the cap is made from a nonconducting material.
15. The device of claim 10, further comprising an endoscopic instrument coupled with the cap.
16. The device of claim 10, wherein the endoscope is disposed in a channel of the cap.
17. The device of claim 10, wherein a distal end of at least of the first electrode and the second electrode are positioned proximal to a distal end of the cap.
18. The device of claim 17, wherein the first electrode and the second electrode receive a direct electric current from a power supply via a wiring, wherein the first electrode and the second electrode introduce a high-frequency current into the implant, wherein the implant is separated or distanced from a tissue of a hollow organ during introduction of the high-frequency current from the first electrode and the second electrode to the implant.
19. The device of claim 10, further comprising a hood coupled with the cap, wherein the hood is moveable relative to the cap.
20-41. (canceled)
42. A device for fragmenting a surgical implant, the device comprising: a cap comprising a first end and a second end, an endoscope coupled with the cap; a first fragmentation instrument coupled with the cap; and a second fragmentation instrument coupled with the cap.
43-50. (canceled)
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] To further clarify various aspects of embodiments of the present disclosure, a more particular description of the certain embodiments will be made by reference to various aspects of the appended drawings. It is appreciated that these drawings depict only typical embodiments of the present disclosure and are therefore not to be considered limiting of the scope of the disclosure. Moreover, while the figures can be drawn to scale for some embodiments, the figures are not necessarily drawn to scale for all embodiments. Embodiments and other features and advantages of the present disclosure will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:
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DETAILED DESCRIPTION
[0029] The following description refers to the accompanying drawings, which illustrate specific embodiments of the present disclosure. Other embodiments having different structures and operation do not depart from the scope of the present disclosure.
[0030] Exemplary embodiments of the present disclosure are directed to devices and methods for fragmenting a surgical implant. It should be noted that various embodiments of devices and systems for fragmenting a surgical implant are disclosed herein, and any combination of these options can be made unless specifically excluded. In other words, individual components of the disclosed devices and systems can be combined unless mutually exclusive or otherwise physically impossible.
[0031] As described herein, when one or more components are described as being connected, joined, affixed, coupled, attached, or otherwise interconnected, such interconnection may be direct as between the components or may be indirect such as through the use of one or more intermediary components. Also, as described herein, reference to a “member,” “component,” or “portion” shall not be limited to a single structural member, component, or element but can include an assembly of components, members, or elements.
[0032] Unless otherwise indicated, all numbers such as, for example, numbers or number ranges expressing measurements or physical characteristics, used in the specification and claims are to be understood as being modified in all instances by the term “about.” “Substantially” and “about” are defined as at least close to (and includes) a given value or state (preferably within 10% of, more preferably within 1% of, and most preferably within 0.1% of). Accordingly, unless otherwise indicated, the numerical properties set forth in the specification and claims are approximations that may vary depending on the suitable properties sought to be obtained in embodiments of the invention. Any numerical values, however, inherently contain certain errors necessarily resulting from error found in their respective measurements.
[0033] The present application describes various components as being “proximal” or “distal.” As used herein, the term “proximal” refers to a portion of a component that is situated nearer to the center of the body of a device for fragmenting a surgical implant, or to a direction toward the center of the body of the device for fragmenting a surgical implant, unless the context clearly indicates otherwise. As used herein, the term “distal” refers to a portion of a component that is situated away from the center of the body of a device for fragmenting a surgical implant, or to a direction away the center of the body of the device for fragmenting a surgical implant, unless the context clearly indicates otherwise.
[0034] Referring to
[0035] With reference to
[0036] In various embodiments, the cap 20 can include one or more protrusions extending from the cap 20. The cap 20 can include, one or more of a first protrusion 22 and a second protrusion 24 extending from the cap 20. The first protrusion 22 and the second protrusion 24 can extend from the cap 20 in a first direction A from the cap 20 (see
[0037] The protrusions can be made of various shapes and sizes. For example, as shown in
[0038] In various embodiments, the protrusions can be longer than the electrodes in order to protect the patient from the relatively sharp electrodes during insertion and from heating of the electrodes during implant removal. The protrusions are spaced apart from the electrodes (above and below) such that they allow space for the implant to wedge between them and the electrodes in order to improve the electrical contact between the electrodes and the implant. The protrusions can thus protect the patient and promote electrical connection between the implant and electrodes.
[0039] An outer surface 28 of the cap 20 can be smooth so as to avoid injuring tissue and other portions of a patient's anatomy as cap 20 is inserted into an internal cavity of the patient. In some embodiments, the surface 28 may have various surface configurations to enhance fixation, such as, for example, rough, arcuate, undulating, porous, semi-porous, dimpled and/or textured, according to the requirements of a particular application.
[0040] In various embodiments, with reference to
[0041] With reference to
[0042] With reference to
[0043] Channels 90, 92, 94, and 96 can have various cross section configurations, such as, for example, oval, oblong, triangular, rectangular, square, polygonal, irregular, uniform, non-uniform, variable, tubular and/or tapered. In some embodiments, the cross sectional configurations of channels 90, 92, 94, and 96 can be the same or different. In some embodiments, axis B, C, D, and E are parallel. In various embodiments, axes B, C, D, and E may be disposed at alternate orientations, relative to the other axes, such as, for example, transverse, perpendicular and/or other angular orientations such as acute or obtuse, co-axial and/or may be offset or staggered. As shown in
[0044] With reference to
[0045] In various embodiments, the first electrode 32 is disposed in channel 90 such that the first end surface 126 of the first electrode 32 extends beyond the distal surface 122 of channel 90. In various embodiments, the first end surface 126 of the first electrode 32 can be flush with the distal surface 122 of channel 90, or can even be positioned within the channel 90. In various embodiments, the first end surface 126 of the first electrode 32 is positioned between the distal surface 122 of channel 90 and the distal end 18 of the cap 20.
[0046] The second electrode 34 is disposed in the channel 92 of cap 20. In some embodiments, the cap 20 flexible such that the cap 20 can be stretched to fit around the second electrode 34. The second electrode 34 has a diameter that is less than diameter D2 such that an outer surface 38 of the second electrode 34 forms a friction fit with the inner surface 82 of cap 20 when the second electrode 34 is disposed within the channel 92 and coupled with the cap 20.
[0047] In various embodiments, the second electrode 34 is disposed in channel 92 such that the first end surface 128 of the second electrode 34 extends beyond the distal surface 124 of channel 92. In various embodiments, the first end surface 128 of the second electrode 34 can be flush with the distal surface 124 of channel 92 or even be positioned within the channel 92. In various embodiments, the first end surface 128 of the second electrode 34 is positioned between the distal surface 124 of channel 92 and the distal end 18 of the cap 20.
[0048] In some embodiments, the first electrode 32 and second electrode 34 are oriented parallel to one another. In various embodiments, the first electrode 32 and second electrode 34 may be disposed at alternate orientations, relative to the other axes, such as, for example, transverse, perpendicular and/or other angular orientations such as acute or obtuse, co-axial and/or may be offset or staggered. As shown in
[0049] In various embodiments, the first end surface 126 of the first electrode 32 and the first end surface 128 of the second electrode 34 can extend to be substantially the same length of the one or more of the protrusion (e.g., protrusions 22, 24, 26) of the cap 20. In various embodiments, the first end surface 126 of the first electrode 32 is positioned between the distal surface 122 of channel 90 and the distal end of the one or more of the protrusion (e.g., protrusions 22, 24, 26) of the cap 20. In various embodiments, the first end surface 128 of second electrode 34 is positioned between the distal surface 124 of channel 92 and the distal end of the one or more of the protrusions (e.g., protrusions 22, 24, 26) of the cap 20.
[0050] In various embodiments, with reference to
[0051] In various embodiments, the shaft 132 is disposed in channel 96 such that a first end surface 136 of shaft 132 is flush with the distal surface 116 of channel 96 (see
[0052] In various embodiments, with reference to
[0053] By setting the voltage at a predetermined amount, and by measuring the approximate resistance of the human body and the implant, a sufficient current can be determined such that the application of energy does not harm the patient during performance of the fragmenting process. Further, pulsing the DC energy significantly reduces the current load on the implant and patient and therefore reduces the heat generated by the implant during fragmentation. The medical direct current generator preferably has the CPU or is connected to a CPU or another control device of this kind, for example analogue control circuit. The CPU can be adapted to determine and control the electric current flowing through the electrodes such that the performance of the fragmenting process is implemented.
[0054] The power source 50 is designed to send an electrical direct current through the first electrode 32 and the second electrode 34. This DC pulse flows through the surgical implant, wherein the first electrode 32 and second electrode 34 at the distal tip of the device 10 are establishing physical contact with the implant 120 (see also
[0055] In various embodiments, the voltage or the pulse width can be adjusted to selectively break one side or multiple sides of the implant. A pulse width of 200 ms and voltage of 20 V is generally sufficient for breaking one link or portion on the implant, whereas increasing the pulse width to at least 300-400 ms can allow for breaking multiple links or portions of the implant. Higher voltages can be also used to promote faster heating and subsequent fracture of the implant. The lowest voltage that can be used to achieve can be preferable in certain instances to reduce excessive heating of surrounding tissue. Fracturing multiple portions of the implant in one pulse can be advantageous because you can remove the implant with one shot of energy. Extra energy may be required to do this, resulting in additional heat being delivered into the surrounding tissue. In various embodiments, the user can select a “single point” cutting setting vs a “multiple point” cutting setting.
[0056] In order to avoid tissue damage, the one or more protrusions extending from the cap 20 (e.g., first protrusion 22, a second protrusion 24, and/or third protrusion 26) serve to space the implant 120 from the tissue of the patient against which it lies or by which it is surrounded, thereby protecting the tissue from damage by an electrically charged electrode. For this purpose, the cap 20 can be formed from heat-resistant and arc-resistant material and can therefore be electrically insulating. By this means, an implant 120 can be separated from the tissue in a simple manner in order to prevent tissue from coming between the implant and the electrode. In various embodiments, the one or more protrusions act as a guide configured such that when the cap 20 is pressed against the tissue or the implant, the implant can be positioned between the one or more protrusions and the electrodes. Surrounding tissue can thereby be protected when localized heating and melting of the implant 120, resulting in the fracturing of the implant 120.
[0057] The one or more electrodes can connect to the implant 120 at separate points along the implant's length, delivering energy between them instead of at a distinct point on the implant 120. This allows for cutting of portions of the implant 120 that are not easily accessible with endoscopes and is enabled by the size of the conductors we can use by routing them outside the scope, by, for example, 18 Ga-12 Ga insulated copper, including 14 Ga insulated copper.
[0058] In various embodiments, with reference to
[0059] In various embodiments, with reference to
[0060] With reference to
[0061] In some embodiments, cap 20 can be flexible such that cap 20 can be stretched to fit the fragmentation instrument 140. The fragmentation instrument 140 has a diameter that is less than diameter D3 such that an outer surface 142 of the fragmentation instrument 140 can be moved within the inner surface 84 of cap 20 when the fragmentation instrument 140 is disposed within third channel 94. In various embodiments, the diameter of the fragmentation instrument 140 can be from about 2.0 mm to about 3.0 mm. In various embodiments, the diameter of the fragmentation instrument 140 is preferably 2.5-2.6 mm. In various embodiments, fragmentation instrument 140 has a distal end 144 of the instrument comprises a nonconducting material.
[0062] With reference to
[0063] In various embodiments, the distance F between the first electrode 160 and the second electrode 180 decreases as the second component 170 moves in a first direction G. The distance between the first electrode 160 and the second electrode 180 increases as the second component moves in a second direction H.
[0064] In various embodiments, the fragmentation instrument 140 is coupled to a power source (e.g., power source 50). The power source preferably contains a current source which is adapted to apply a direct current of predetermined or adjustable strength (current value in ampere) in a pulsed or timed way to the first electrode 160 and the second electrode 180. In this manner, a quantity of current, or energy density, is provided in at least one current pulse is sufficient to melt a surgical implant material between the electrodes. The medical direct current generator preferably has the CPU or is connected to a CPU or another control device of this kind, for example analogue control circuit. The CPU can be adapted to determine and control the electric current flowing through the electrodes such that the performance of the fragmenting process is implemented.
[0065] In various embodiments, the implant 120 (see
[0066] Thereafter, the power source can send an electrical direct current through the electrodes and to the surgical implant. This can result in localized heating and melting of the implant and subsequent fracturing of the implant. The power source 50 delivers a direct pulse of preferably optionally between 15-40 volts.
[0067] In order to avoid tissue damage, the distal end 144 of the fragmentation instrument 140 can space the implant 120 from the tissue of the patient against which it lies or by which it is surrounded, thereby protecting the tissue from damage by an electrically charged electrode. For this purpose, the fragmentation instrument 140 can be formed from heat-resistant and arc-resistant material and can therefore be electrically insulating. By this means, an implant 120 can be separated from the tissue in simple manner in order to prevent tissue from coming into contact with the electrodes. In various embodiments, the distal end 144 of the fragmentation instrument 140 can act as a guide such that when the fragmentation instrument 140 is pressed against the tissue near the implant 120, the implant 120 can be positioned between the first electrode 160 and the second electrode 180.
[0068] In various embodiments, the cap 20 can include two or more fragmentation instruments 140 extending through the channels of the cap. In various embodiments, the two or more fragmentation instruments 140 can be moved through their respective channels of the cap independent from each other. The two or more fragmentation instruments 140 can attach to the implant 120 at different points of the implant 120.
[0069] With reference to
[0070] With reference to
[0071] In various embodiments, the cap 20 can include a fragmentation instruments 140 extending through the third channel 94, and a second fragmentation instrument 140 extending through one of the first channel 90, the second channel 92, or an accessory channel of the endoscope 132 (see
[0072] With reference to
[0073] In various embodiments, with reference to
[0074] With reference to
[0075] With reference to
[0076] In various embodiments, the first electrode 232 and second electrode 234 are disposed in channel 290. First electrode 232 has a diameter that is less than width D5 such that an outer surface of first electrode 232 forms a friction fit with the inner surface 280 of cap 220 when the first electrode 232 is disposed within channel 290 and coupled with the cap 220. Second electrode 234 also has a diameter that is less than width D5 such that an outer surface of second electrode 234 forms a friction fit with the inner surface 280 of cap 220 when the second electrode 234 is disposed within channel 290 and coupled with the cap 220.
[0077] With reference to
[0078] In some embodiments, the first electrode 232 and second electrode 234 are oriented parallel to one another. In various embodiments, the first electrode 232 and second electrode 234 may be disposed at alternate orientations, relative to the other axes, such as, for example, transverse, perpendicular and/or other angular orientations such as acute or obtuse, co-axial and/or may be offset or staggered. As shown in
[0079] In various embodiments, with reference to
[0080] In various embodiments, with reference to
[0081] The reference to
[0082] With reference to
[0083] Any structure that can allow the hood 350 to move proximally or distally relative to the cap 320 can be used. In one exemplary embodiment, with reference to
[0084] While various inventive aspects, concepts and features of the disclosures may be described and illustrated herein as embodied in combination in the exemplary embodiments, these various aspects, concepts, and features may be used in many alternative embodiments, either individually or in various combinations and sub-combinations thereof. Unless expressly excluded herein all such combinations and sub-combinations are intended to be within the scope of the present application. Still further, while various alternative embodiments as to the various aspects, concepts, and features of the disclosures—such as alternative materials, structures, configurations, methods, devices, and components, alternatives as to form, fit, and function, and so on—may be described herein, such descriptions are not intended to be a complete or exhaustive list of available alternative embodiments, whether presently known or later developed. Those skilled in the art may readily adopt one or more of the inventive aspects, concepts, or features into additional embodiments and uses within the scope of the present application even if such embodiments are not expressly disclosed herein.
[0085] Additionally, even though some features, concepts, or aspects of the disclosures may be described herein as being a preferred arrangement or method, such description is not intended to suggest that such feature is required or necessary unless expressly so stated. Still further, exemplary or representative values and ranges may be included to assist in understanding the present application, however, such values and ranges are not to be construed in a limiting sense and are intended to be critical values or ranges only if so expressly stated.
[0086] Moreover, while various aspects, features and concepts may be expressly identified herein as being inventive or forming part of a disclosure, such identification is not intended to be exclusive, but rather there may be inventive aspects, concepts, and features that are fully described herein without being expressly identified as such or as part of a specific disclosure, the disclosures instead being set forth in the appended claims. Descriptions of exemplary methods or processes are not limited to inclusion of all steps as being required in all cases, nor is the order that the steps are presented to be construed as required or necessary unless expressly so stated. The words used in the claims have their full ordinary meanings and are not limited in any way by the description of the embodiments in the specification.