Aspects of this disclosure generally relate to medical systems, devices, and related methods. In particular, aspects of this disclosure relate to medical systems, devices, and related methods for traction in tissue removal.
Endoscopic submucosal dissection (ESD) is a technique for the minimally invasive removal of tumors and lesions, especially gastrointestinal tumors and lesions. This procedure offers several advantages, including reduced patient discomfort, shorter hospital stays, and/or faster recovery times when compared to many other surgical methods. However, ESD procedures often rely heavily on precise and/or controlled tissue manipulation, which may be challenging due to the anatomical complexities of the gastrointestinal tract. To address these challenges, traction devices are often used to facilitate visualization and/or manipulation of the mucosal and submucosal layers during ESD procedures.
While traction devices improve the feasibility and safety of ESD, current devices have certain limitations. For example, many traction devices and related methods employ grasping forceps or clips, which may cause tissue trauma, hinder the endoscope's movement, or obscure a user's view. Moreover, these devices often require complex setup or assembly, specialized training, or multiple personnel for effective utilization, which may increase the costs, risks, duration, etc. of the procedure.
Systems, devices, and methods of the current disclosure may rectify some of the deficiencies described above or address other aspects of the art.
Examples of this disclosure relate to, among other things, medical devices configured for increasing traction during tissue removal.
In one aspect, a medical device may include a connection member for connecting a homeostasis clip to the medical device; a biasing member; and a needle with at least one barb. The biasing member may bias the medical device toward a compressed configuration. The connection member may be connected to the biasing member such that, with the needle inserted into tissue past the at least one barb and the biasing member pulled toward a tensioned configuration by the homeostasis clip connected to the connection member, the needle and the at least one barb may pull the tissue in a direction parallel to a direction of tension placed on the biasing member.
In some aspects, the medical device may include a longitudinal axis, and the biasing member may apply tension along the longitudinal axis when pulled by the connection member. The medical device may further include a base member, and the base member may be coupled to the connection member and the biasing member. The base member may include a disc having two holes for connecting the connection member to the disc. The base member may be a flat circular plate that may have one or more connection portions for connecting to the connection member. The medical device may also have a needle base member that couples the biasing member and the needle. The needle may include a plurality of barbs on at least two sides of the needle. At least one of the barbs may include one or more projections that extend at an angle that is not parallel to a longitudinal axis of the needle. The connection member may include a loop made from one or more of nylon and linear low density polyethylene. The connection member may be configured to be removably coupled to a subject's anatomy with a homeostasis clip. The biasing member may comprise stainless steel. The needle may have four projections at a distal end of the needle. The projections at the distal end of the needle may be of equivalent size. The connection member may be capable of being cut by an end effector of one or more medical device systems to sever the connection member. The connection member may be formed from one or more of nylon and linear low density polyethylene.
In another aspect, a tissue traction device may include: a biasing member comprising a compliant or semi-compliant material biasing the tissue traction device toward a compressed configuration; a needle attached to a distal end of the biasing member; and a connection member attached to proximal end of the biasing member. The needle may include one or more projections at a distal end of the needle that are angled away from a longitudinal axis of the needle so as to impede removal of the needle from tissue, and the connection member may include a first end and a second end and the first end and the second end of the second attachment member are coupled to the biasing member. The tissue traction device may also include a needle base member that couples the biasing member and the needle.
In yet another aspect, a method of resecting tissue from a body lumen of a subject includes: inserting a needle including at least one barb into a tissue of a subject, the needle being positioned at a distal portion of a medical device comprising the needle, a connection member, and a biasing member coupling the needle with the connection member; coupling the connection member to a portion of a subject's anatomy to anchor the medical device; commencing a resection of the tissue, wherein the tension on the biasing member eases as the tissue is resected; and fully resecting the tissue from surrounding tissue. The biasing member can include a compliant or semi-compliant material biasing the biasing member toward a compressed configuration. The connection member may be clipped to a portion of the subject's anatomy with a homeostasis clip to place the biasing member under tension.
It may be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the disclosure, as claimed.
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary aspects of the present disclosure and together with the description, serve to explain the principles of the disclosure.
Examples of this disclosure include medical systems, devices, and related methods for traction in tissue removal. The systems, devices, and methods discussed herein may help to overcome the shortcomings of existing systems, devices, and methods, for example, helping to provide users (e.g., surgeons) with a more effective and/or user-friendly system or tool for endoscopic submucosal dissection (ESD). It is to be noted, however, that the scope of subject matter of this application is defined by the features listed in the claims, and not an ability to rectify any particular deficiency.
Reference will now be made in detail to examples of this disclosure described above and illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.
The terms “proximal” and “distal” are used herein to refer to the relative positions of the components of an exemplary medical device. When used herein, “proximal” refers to a position relatively closer to the exterior of the body of a subject or closer to a user, such as a medical professional, holding or otherwise using a medical device (e.g., an endoscope) to insert the traction devices described herein into tissue. In contrast, “distal” refers to a position relatively further away from the medical professional or other user holding or otherwise using the medical device, or closer to the interior of the subject's body. As used herein, the terms “comprises,” “comprising,” “has,” “having,” “includes,” “including,” or other variations thereof, are intended to cover a non-exclusive inclusion, such that a system(s), device(s), or method(s) that comprises a list of elements does not include only those elements, but may include other elements not expressly listed or inherent thereto. Unless stated otherwise, the term “exemplary” is used in the sense of “example” rather than “ideal.” As used herein, the terms “about,” “substantially,” and “approximately,” indicate a range of values within +/−10% of a stated value.
The biasing member 112 can be made from a compliant or semi-compliant material and may bias the medical device 100 toward a compressed configuration and/or an expanded configuration depending on a tuning of the biasing member as described in greater detail herein. In some embodiments, the connection member 108 is connected to the base member 110. In these aspects, with the needle 114 inserted into tissue (e.g., such that the barb 116 is positioned within the tissue) at a target site (e.g., tissue of the subject inside the subjects GI tract), the biasing member 112 can be pulled or urged toward the expanded configuration by the clip 118 connected to the connection member 108. In these aspects, the biasing member 112 may help to place tension on the tissue at the target site, for example, at least partially in a direction parallel to the direction of tension of the biasing member 112.
The features of the medical device 100 may generally extend from the proximal portion 102 to the distal portion 106 along a longitudinal axis 126 of the medical device 100. The longitudinal axis 126 may be common to one or more features of the medical device 100. The barbs 116 may be projections that extend away from the longitudinal axis 126 at an angle 130 along a barb axis 128. In these aspects, with the needle 114 at least partially inserted into tissue, the barbs 116 may help to impede removal of the needle 114 from the tissue when the medical device 100 is pulled or urged away from the tissue. That is, in some aspects, the barbs 116 may be non-parallel with the longitudinal axis 126 of the medical device 100.
The connection member 108 can be a semi-rigid, or pliable structure that forms a loop or partial loop that provides a structure for connecting one or more external devices or features to the medical device 100. The connection member 108 can be made from one or more materials including, for example, nylon, linear low density polyethylene (LLDPE), low density polyethylene (LDPE), medium density polyethylene (MDPE), polytetrafluoroethylene (PTFE), polychlorotrifluoroethylene (PCTFE), perfluoroalkoxy (PFA), tetrafluorethylene-perfluoropropylene (FEP), or one or more other materials.
The base member 110 may be a disc-shaped (i.e., flat and circular) portion of the medical device 100 that may include one or more features for connecting the connection member 108 with one or more other features (e.g., the biasing member 112) of the medical device 100. The base member 110 may be formed from one or more materials including, for example, stainless steel (including medical grade stainless steel), nickel, titanium, platinum, gold, or one or more other materials. The base member 110 can be affixed to a distal portion of the biasing member 112. In embodiments, the base member 110 can be welded or otherwise permanently affixed to the base member 110.
The biasing member 112 can be a flexible structure capable of developing and/or imparting a spring force along a longitudinal dimension of the biasing member 112. The biasing member 112 can be formed from, for example, a metal such as stainless steel (including medical grade stainless steel), platinum, gold, titanium, or another suitably rigid material. The biasing member 112 may have a helical shape with one or more wires that surround the longitudinal axis 126 of the medical device 100. The biasing member 112 can have a length of between 1-20 mm, between 3-15 mm, between 5-10 mm, for example, approximately 7 mm. The biasing member 112 can have an outer diameter of between 1-5 mm, 2-4 mm, 2-3 mm, for example, approximately 2.5 mm. In some embodiments, the biasing member 112 may be a helical spring, and the helical spring can have a spring constant of between 0.01-0.02 N/mm, between 0.0115-0.0125 N/mm, between 0.0118-0.0120 N/mm, for example, approximately 0.0119 N/mm. In some embodiments, the helical spring may have between 10-40 coils, between 15-35 coils, between 29-31 coils, for example, approximately 30. In some embodiments, the biasing member 112 may extend between 15-30 mm during a medical procedure using the medical device 100. In some aspects, the biasing member 112 may extend between 20-25 mm during a medical procedure. The biasing member 112 may extend for a total distance of between 30-34 mm.
The needle 114 can be a needle structure that tapers from a proximal end 114b (nearer the proximal portion 102) to a distal end 114a (nearer the distal portion 106). The proximal end of the needle 114 may be fixedly coupled to the biasing member 112. In some embodiments, the needle 114 may be welded, soldered, or otherwise permanently affixed to the biasing member 112.
Referring to
Referring to
At a step 602, a user (e.g., physician, medical technician, etc.) may insert the needle 114 into the tissue of a subject (e.g., a patient). As shown in
At a step 604, a user may couple the medical device 100 to a portion of the subject's anatomy to anchor the medical device 100 and put the subject tissue (i.e., the lesion 10) under tension. In the embodiment shown in
The user may commence (or continue) tissue resection at the lesion 10 at a step 606. As the lesion 10 is resected, one or more portions of the lesion 10 may separate from the surrounding tissue 16. As one or more portions of the lesion 10 are separated from the surrounding tissue 16, portion(s) of the lesion 10 may move toward the wall 14, which eases the tension on the biasing member 112, for example, allowing the biasing member 112 to at least partially transition toward the relaxed or untensioned configuration of the biasing member 112.
Thus, at step 608, the medical device 100 may aid in the resection of tissue because as tension on the biasing member 112 continues to ease with increased cutting or resection of the lesion 10, the biasing member 112 will contract and help raise the tissue (e.g., the lesion 10) until the forces in the biasing member 112 and the tension forces in the tissue are equivalent. The biasing member 112 may help to prevent the portion of the lesion 10 that is pulled away from the surrounding tissue 16 from interfering with further resection still occurring at the interface between the lesion 10 and the surrounding tissue 16. The biasing member 112 may also help to keep the interface between the lesion 10 and the surrounding tissue 16 under tension, which may help to improve the precision of the resection at the interface.
At step 610, a user may fully resect the target tissue from the surrounding tissue and may remove the resected tissue. For example, step 610 may include fully separating the lesion 10 from the surrounding tissue 16. The fully resected tissue is thus free to move irrespective of the surrounding tissue 16 and the user can remove the tissue.
To remove the tissue, the user may decouple the medical device 100 from the wall 14 of the GI tract. For example, the user may cut the connection member 108, and/or may unclip the clip 118 from the wall 14. The lesion 10 may then be removed from the GI tract at step 612 using, for example, the end effector 132 of an endoscope 124 or other medical device system. Because the needle 114 is inserted into the lesion 10 with the one or more barbs 116, the tissue (e.g., the lesion 10) may remain attached to the needle 114 during the removal step.
Embodiments of this disclosure may be applicable to various and different medical procedures. In addition, certain aspects of the aforementioned embodiments may be selectively used in collaboration, or removed, during practice, without departing from the scope of the disclosure.
While principles of this disclosure are described herein with reference to illustrative aspects for particular applications, it should be understood that the disclosure is not limited thereto. Those having ordinary skill in the art and access to the teachings provided herein will recognize additional modifications, applications, aspects, and substitution of equivalents all fall within the scope of the aspects described herein. Accordingly, the disclosure is not to be considered as limited by the foregoing description.
This application claims the benefit of priority to U.S. Provisional Application No. 63/593,268, filed on Oct. 26, 2023, which is incorporated by reference herein in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 63593268 | Oct 2023 | US |