Patent Grant
11925344
The present invention relates generally to a surgical suturing device, more specifically, to an ergonomic Rotational Action Needle Driver which enhance the tissue suturing procedure, particularly the one performed on restricted, deep and less accessible locations, by incorporating an angled needle grasping mechanism that prevents problems associated with loss of needle control during the suturing procedure and the ones associated with prior needle driver's handedness. It also enhances the control surgeons has over the suturing needle by enabling a multiple angles rotational movement of a needle while driving the suturing needle through the tissue permitting to place the needle in the right location in order to continue the subsequent steps of the suturing cycle.
Surgical procedures have proliferated among the medical practice as new treatments are developed to effectively treat common and extraordinary conditions. The spectrum of invasiveness goes from simple tissue suturing of small open wounds to complicated procedures as those performed in vascular or neurological surgeries. It is undoubted that each and every step on any surgical procedure is of great importance and could cause negative consequences for the patient if it is inadequately performed. The suturing procedure, in particular, could end in serious consequences for the patient if negligently conducted, causing damages to adjacent tissues or even organs.
It is known that the suturing procedure consumes a considerable amount of time of the surgical treatment. Simplification of the suturing procedure by developing more effective suturing devices will reduce the time spent on that task and at the same time will reduce the risk of negative consequences arising from damages caused to adjacent tissues or organs.
Generally, the instruments used in suturing procedures are the suturing material, the suturing needle and the suturing driver. Efforts made to reduce the suturing time and to enhance the suturing procedures' safety have been focused on performing needle driver's modifications. For instance, Luis Almodovar, in U.S. Pat. No. 9,192,376, here incorporated by reference, discloses a device to drive a needle through the tissue allowing more control over the suturing needle.
Similarly, Yoon in U.S. Pat. No. 5,759,188 discloses a suturing instrument comprising a needle driver and a needle catcher to be used in laparoscopic procedures.
However, one of the generally unattended deficiencies of the available needle drivers is the angular position of the needle. Ordinarily, needle drivers provide a single angle arrangement and rotational motion of the needle. This increases the risks of negative outcomes for patients from wrong needle driver maneuverings and problem with reaching small, deep and restricted areas. That is why there is a need for a rotational driver for left and right handed surgeons that effectively control the needle displacement and angular position while suturing.
All references, including any Pat. or patent applications cited in this specification are hereby incorporated by reference. No admission is made that any reference constitutes prior art. The discussion of the references states what their authors assert, and the applicants reserve the right to challenge the accuracy and pertinence of the cited documents. It will be clearly understood that, although a number of prior art publications are referred to herein, this reference does not constitute an admission that any of these documents form part of the common general knowledge in the art.
It is acknowledged that the term ‘comprise’ may, under varying jurisdictions, be attributed with either an exclusive or an inclusive meaning. For the purpose of this specification, and unless otherwise noted, the term ‘comprise’ shall have an inclusive meaning—i.e. that it will be taken to mean an inclusion of not only the listed components it directly references, but also other non-specified components or elements. This rationale will also be used when the term ‘comprised’ or ‘comprising’ is used in relation to one or more steps in a method or process.
The disclosed invention provides an effective suturing device including a needle that enhances the maneuvering and safety of suturing procedures, more particularly the process of handling the needle. The rotational driver comprises a interactive portion, wherein each interactive portion comprises a first extended member and a second extended member, a rotational system, wherein said first extended member comprises a first distal end, a first proximal end and a first mam extended member body, wherein said first main member body in between said first distal end and said first proximal end, wherein said first distal end comprises a first contact distal end, wherein said second extended member comprises a second distal end, a second proximal end and a second main member body, wherein said second main member body is between said second distal end and said second proximal end, wherein said second distal end comprises a second contact distal end, wherein said rotational system comprises a rotational actuator mechanically coupled to at least an action transmitter mechanism, wherein said action transmitter mechanism is mechanically connected to said first extended member providing rotating action upon said first distal end; and wherein said first distal end and said second distal end contact each other. Further the device comprises a distal end motion system comprising mechanical means to provide displacement of said second distal end with respect to said first distal end (or vice versa) and wherein said distal end displacement exert compressing force against the other distal end, wherein said compressing force is concentrated at said first contact distal end and said second contact distal. It has to be understood that the contact between distal ends may be an oblique contacts or a flat contact.
Another object of the present invention is to provide a mechanism to drive the needle in different angles. The present suturing device comprises disposable or not disposable tips at the distal end. Said tips is configured at the needle contact area to be shape with angular or predetermined angular configurations. The distal end maintain the needle tightly fixed to the needle driver in order to have a best control over the needle and the movements related to the suturing process. The present configuration permits the user to position the suturing needle at the exact angle at which the suturing material has to be inserted into the tissue.
Another object of the present invention is to provide a needle configured to match a distal end tip in order to be drove in different angles. The present suturing device comprises needle comprising an outer surface that matches the distal end tip in order to assists the angular driving process of the needle. Said tips is configured at the needle contact area to be shape in a manner that matches the needle countour. The distal end maintain the needle tightly fixed to the needle driver in order to have a best control over the needle and the movements related to the suturing process. The present configuration permits the user to position the suturing needle at the exact angle at which the suturing material has to be inserted into the tissue.
Another deficiency presented by the prior art is the lack of disclosure of needle driver having a rotational mechanism that permits to fix the needle to a specific angle before inserting it into the tissue and combining the said rotation with ergonomic characteristics in order to facilitate the suturing processes.
None of the prior art considered above, taken either simply or in combination teaches the use of a suturing needle driver suitable to left and right handed users and comprising a pull locking mechanism and a rotational mechanism. In light of the foregoing, it will be appreciated that what is needed in the art is a suturing needle driver lacking of handedness and combining a pull locking mechanism and a rotational mechanism. Thus, the object of the present invention is to provide a surgical device that eases the suturing procedure associated with deep, restricted areas.
Another object of the present invention is to provide a surgical suturing needle driver that permits to grasp, secure and rotate a curved surgical needle without requiring a rotational motion at the surgeon's wrist.
It is the object of the present invention to provide a surgical suturing needle driver which incorporates a distal end that secures the needle to the needle driver and permits to diminish the number of maneuvers actually needed for performing the surgical suturing process, reducing the risk of damaging peripheral tissues.
The system of the invention itself, both as to its configuration and its mode of operation will be best understood, and additional objects and advantages thereof will become apparent, by the following detailed description of a preferred embodiment taken in conjunction with the accompanying drawing.
When the word “invention” is used in this specification, the word “invention” includes “inventions”, that is, the plural of “invention”. By stating “invention”, the Applicant does not in any way admit that the present application does not include more the one patentable and non-obviously distinct invention and Applicant maintains that the present application may include more than one patentably and non-obviously distinct invention. The Applicant hereby asserts, that the disclosure of the present application may include more than one invention, and, in the event that there is more than one invention, that these inventions may be patentable and non-obvious one with respect to the other.
Further, the purpose of the accompanying abstract is to enable the U.S. Patent and Trademark Office and the public generally, and especially the scientists, engineers, and practitioners in the art who are not familiar with patent or legal terms or phraseology, to determine quickly from a cursory inspection the nature and essence of the technical disclosure of the application. The abstract is neither intended to define the invention of the application, which is measured by the claims, nor is it intended to be limiting as to the scope of the invention in any way.
To provide an overall understanding of the invention, certain illustrative embodiments and examples will now be described. However, it will be understood by one of ordinary skill in the art that the same or equivalent functions and sequences may be accomplished by different embodiments that are also intended to be encompassed within the spirit and scope of the disclosure. The compositions, apparatuses, systems and/or methods described herein may be adapted and modified as is appropriate for the application being addressed and that those described herein may be employed in other suitable applications, and that such other additions and modifications will not depart from the scope hereof
As used in the specification and claims, the singular forms “a”, “an” and “the” include plural references unless the context clearly dictates otherwise. For example, the term “a transaction” may include a plurality of transaction unless the context clearly dictates otherwise. As used in the specification and claims, singular names or types referenced include variations within the family of said name unless the context clearly dictates otherwise.
Certain terminology is used in the following description for convenience only and is not limiting. The words “lower,” “upper,” “bottom,” “top,” “front,” “back,” “left,” “right” and “sides” designate directions in the drawings to which reference is made, but are not limiting with respect to the orientation in which the modules or any assembly of them may be used.
The present disclosure is related to a rotational driver 100 and a suturing needle. Turning to the diagram,
The handle 102 is ergonomically designed to rest against surgeon's palm his hand, permitting its proper use to right and left handed surgeons. The handle 102 serves as a housing for the rotational motion mechanism. The linear mechanism, more particularly the actuator 104 extends away from the handle. The actuator 104 is pressed against the handle 102 in order to provide a clamping action and a rotational action at the distal ends.
A linear motion system is mechanically coupled to a rotational mechanism 150 in order to provide rotational motion on to the tips, more particularly the distal ends (120, 122, 124, 126). In the instant case the actuator 104 is configured to be pressed by the users' hand. The press force exert at the actuator 104 is transferred to rotational mechanism 150, wherein said rotational mechanism 150 comprises a first shaft 152 mechanically couple to multiple gears 154. The surgeon will maintain the handle 102 in the palm of his hand while the linear motion of the actuator 104 is converted into the rotational motion at the distal ends (120, 122, 124, 126). The handle 102 may be divided into the actuator section and the extended distal ends section, wherein the extended distal ends section is interchangeable and/or disposable configured to different types of needles more particularly the driving radius of each needle.
When the suturing procedure begins, a curved needle having an outer surface configured to interact with the distal ends provides a selected angle (explain below). For the needle to be tightly fixed to the invention, the surgeon has to press the actuator towards the handle. This makes the distal ends to come closer and consequently tightening the needle. The movement towards the handle makes the two distal ends comprised in a locking mechanism. When this happens, the disclosed embodiment locks, exerting the necessary force to maintain the needle still. Once the needle is tightened, the actuator comprises extended member with a shaped tooth that interacts with a first rotational shaft in order to create a rotational movement on the distal ends where it is attached. When the desired angle is attained by the needle and the distal ends, the surgeon will drive the needle through the tissue as the distal ends roll the needle out. When the desired rotation is completed, the surgeon releases the locking mechanism. This method is repeated on the other tissue that wants to be joined to the tissue already perforated by the needle. All the above is repeated as many times as stitches have to be performed.
This design permits rotation of an angled curved surgical needle without requiring a rotational motion of the wrist. Therefore, the instrument can be held in a position that may not allow wrist rotation and still carry out its function. In some situations the structures to be sutured lie very deep. Doing surgery on the vertebral column of very obese patients is one such situation. For example, if the dura mater (a membrane that protects and envelops the spinal cord) is cut it needs to be sutured. The dura mater lies within a deep constricted space. In a very obese patient the additional thickness of the adipose (fatty) tissue makes the dura lie even deeper from the surface.
The surgeon may have to lean towards the patient and rotate the arm bearing the needle driver. This is necessary to get his forearm in a vertical position so he can maneuver the instrument properly. The new needle driver design may be operated while held like a t-shaped control lever. In this position the long axis of the instrument lies perpendicular to the palm of the hand. The surgeon does not need to position his forearm vertically in order to rotate the instrument. There is a powerful advantage when using this instrument that goes beyond any individual benefit granted by its design features. The fact that suturing can become a more streamlined process permits a more continuous flow of the procedure. The surgeon does not have to stop as often to think what he needs to do next. He does not need to refocus on which segment of the tissue to grasp after looking away from the tissue to reposition a needle. The end result is a procedure that is faster, more energy-efficient and safer for both the patient and the surgeon.
The invention is not limited to the precise configuration described above. While the invention has been described as having a preferred design, it is understood that many changes, modifications, variations and other uses and applications of the subject invention will, however, become apparent to those skilled in the art without materially departing from the novel teachings and advantages of this invention after considering this specification together with the accompanying drawings. Accordingly, all such changes, modifications, variations and other uses and applications which do not depart from the spirit and scope of the invention are deemed to be covered by this invention as defined in the following claims and their legal equivalents. In the claims, means-plus-function clauses, if any, are intended to cover the structures described herein as performing the recited function and not only structural equivalents but also equivalent structures.
All of the patents, patent applications, and publications recited herein, and in the Declaration attached hereto, if any, are hereby incorporated by reference as if set forth in their entirety herein. All, or substantially all, the components disclosed in such patents may be used in the embodiments of the present invention, as well as equivalents thereof. The details in the patents, patent applications, and publications incorporated by reference herein may be considered to be incorporable at applicant's option, into the claims during prosecution as further limitations in the claims to patentable distinguish any amended claims from any applied prior art.
This application is a Continuation of U.S. patent application Ser. No. 15/724,845 filed 4 Oct. 2017; which claims the benefit of U.S. Provisional Patent Application 62/403,745 filed 3 Oct. 2016; which is herein fully incorporated by reference for all purposes.
| Number | Name | Date | Kind |
|---|---|---|---|
| 5897563 | Yoon | Apr 1999 | A |
| 6126665 | Yoon | Oct 2000 | A |
| 10786245 | Almodovar | Sep 2020 | B2 |
| 20030109825 | Loser | Jun 2003 | A1 |
| 20060064116 | Allen et al. | Mar 2006 | A1 |
| 20070016287 | Cartledge et al. | Jan 2007 | A1 |
| 20070021755 | Almodovar | Jan 2007 | A1 |
| 20070135913 | Moaddeb et al. | Jun 2007 | A1 |
| 20080262609 | Gross et al. | Oct 2008 | A1 |
| 20090326559 | Almodovar | Dec 2009 | A1 |
| 20110054499 | Almodovar | Mar 2011 | A1 |
| 20110270281 | Malkowski | Nov 2011 | A1 |
| 20120150199 | Woodard, Jr. et al. | Jun 2012 | A1 |
| 20120239011 | Hyodo et al. | Sep 2012 | A1 |
| 20120316580 | Belman | Dec 2012 | A1 |
| 20140277405 | Wilson et al. | Sep 2014 | A1 |
| 20140296417 | Hans et al. | Oct 2014 | A1 |
| 20150081014 | Gross et al. | Mar 2015 | A1 |
| 20150127025 | Hamilton et al. | May 2015 | A1 |
| 20180116653 | Almodovar | May 2018 | A1 |
| Number | Date | Country |
|---|---|---|
| WO2009039506 | Mar 2009 | WO |
| WO2015074066 | May 2015 | WO |
| WO2016011594 | Jan 2016 | WO |
| Entry |
|---|
| Fontanelli et al., A New Laparoscopic Tool with In-Hand Rolling Capabilities for Needle Reorientation, IEE Robotics and Automation Letters, Jan. 2018 (8 pages). |
| International Search Report and Written Opinion dated May 14, 2019 in related International Application No. PCT/US2019/012199 filed Jan. 3, 2019 (14 pages). |
| International Search Report and Written Opinion dated Jan. 10, 2019 in related International Application No. PCT/US2019/038308 filed Jun. 20, 2019 (5 pages). |
| Number | Date | Country | |
|---|---|---|---|
| 20210100549 A1 | Apr 2021 | US |
| Number | Date | Country | |
|---|---|---|---|
| 62403745 | Oct 2016 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 15724845 | Oct 2017 | US |
| Child | 17035674 | US |
