Patent Application
20160174982
This disclosure relates to an apparatus and method for use of a wound closure assistance apparatus and, more particularly, to a wound closure assistance apparatus and method that is placed upon the patient tissue and assists with reapproximating the tissue after a surgical procedure.
Access site complications (bleeds, arteriovenous fistula formation, and dissections), which are some of the possibly serious and costly complications of percutaneous intervention and structural interventions, may add to the cost, mortality, and morbidity of procedures. The current methodology is to close an access site surgical wound after the procedure is finished, or to use one or more suture-based devices to pre-close the arteriotomy or other surgical wound. Limitations of the latter, pre-closure method include operator-dependence and a limited timeframe for availability (i.e., can only pre-close in the cath lab, so indwelling devices, such as Impella or ECMO cannulae, cannot be preclosed).
In an aspect, an apparatus for assisting with wound closure is provided. The apparatus comprises oppositely disposed, and oppositely facing, proximal and distal surfaces separated by an apparatus body. The distal surface is configured for selective attachment to a patient tissue surface. At least one of the proximal surface, the distal surface, and the apparatus body is made substantially from an polymeric material. The polymeric material includes a structurally incorporated ability to self-repair damage caused by mechanical usage over time.
In an aspect, a method of assisting with wound closure is provided. An apparatus including oppositely disposed, and oppositely facing, proximal and distal surfaces separated by an apparatus body is provided. The apparatus is at least partially made from an polymeric material having a structurally incorporated ability to self-repair damage caused by mechanical usage over time. The distal surface is selectively attached to a patient tissue surface. A surgical wound is created through an entire thickness of the apparatus body and into the attached patient tissue. The surgical wound is maintained open via at least one of interposition of a surgical item through the surgical wound and application of tension to the patient tissue on laterally opposite sides of the surgical wound. With the apparatus attached to the patient tissue, the surgical item is removed. With the apparatus attached to the patient tissue, the polymeric material is permitted to self-repair the surgical wound through the apparatus body by reducing a size of the surgical wound.
For a better understanding, reference may be made to the accompanying drawings, in which:
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as is commonly understood by one of skill in the art to which the present disclosure pertains.
As used herein, the term “subject” can be used interchangeably with the term “patient” and refer to any warm-blooded organism including, but not limited to, human beings, pigs, rats, mice, dogs, goats, sheep, horses, monkeys, apes, rabbits, cattle, farm animals, livestock, etc.
As used herein, the singular forms “a,” “an” and “the” can include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and/or “comprising,” as used herein, can specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof.
As used herein, the term “and/or” can include any and all combinations of one or more of the associated listed items.
As used herein, phrases such as “between X and Y” and “between about X and Y” can be interpreted to include X and Y.
As used herein, phrases such as “between about X and Y” can mean “between about X and about Y.”
As used herein, phrases such as “from about X to Y” can mean “from about X to about Y.”
It will be understood that when an element is referred to as being “on,” “attached” to, “connected” to, “coupled” with, “contacting,” etc., another element, it can be directly on, attached to, connected to, coupled with or contacting the other element or intervening elements may also be present. In contrast, when an element is referred to as being, for example, “directly on,” “directly attached” to, “directly connected” to, “directly coupled” with or “directly contacting” another element, there are no intervening elements present. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed “directly adjacent” another feature may have portions that overlap or underlie the adjacent feature, whereas a structure or feature that is disposed “adjacent” another feature may not have portions that overlap or underlie the adjacent feature.
Spatially relative terms, such as “under,” “below,” “lower,” “over,” “upper” and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms can encompass different orientations of a device in use or operation, in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as “under” or “beneath” other elements or features would then be oriented “over” the other elements or features.
It will be understood that, although the terms “first,” “second,” etc. may be used herein to describe various elements, these elements should not be limited by these terms. These terms are only used to distinguish one element from another. Thus, a “first” element discussed below could also be termed a “second” element without departing from the teachings of the present disclosure. The sequence of operations (or steps) is not limited to the order presented in the claims or figures unless specifically indicated otherwise.
The invention comprises, consists of, or consists essentially of the following features, in any combination.
The apparatus 100 may be made at least partially from a material which is bioresorbable, bio-absorbable, and/or non-degrading and biocompatible, and may be relatively flexible, as shown in
At least a portion of the material forming the apparatus 100 may be applied and/or cured in situ to a patient tissue for assistance with a surgical wound in and/or around a blood vessel or any other patient tissue through which access, in the form of a surgical wound, is desired. Though depicted as a standalone sheet in the Figures for ease of description, the apparatus 100 could be provided to the patient tissue as a liquid, gel, paste, sheet, bracelet, tape, or the like, and may be applied to the patient tissue via any suitable device or applicator.
Any suitable device, substance, and/or applicator could also or instead be used to chemically, mechanically, and/or adhesively attach part or all of a surface of the apparatus 100 to the patient tissue. While many use environments of the apparatus 100 will include direct attachment of the apparatus 100 to the patient tissue, it is also contemplated that some intervening member (e.g., an adhesive sheet or other adhesive component, not shown, for selectively attaching the distal surface 104 to the patient tissue surface) may be interposed between the apparatus 100 and the patient tissue.
The apparatus 100 may be made at least partially from a self-healing polymer, which is characterized herein as an elastomeric material including a structurally incorporated ability to self-repair damage caused by mechanical usage over time. Any suitable “self-healing” material may be provided for use with the apparatus 100. The apparatus 100 may additionally or alternatively be made from an at least partially elastic material, which is capable of substantially regaining an initial configuration after a temporary mechanical alteration or damage, even if the actual structure of the material retains some “memory” or artifact of that alteration or damage. The term “self-repair” is used herein to indicate, without preference, either or both of these two types of material for a particular situation.
The apparatus 100 may also include a “valve” like feature (not shown). For example, the apparatus 100 could include a valving mechanism and/or one or more “flaps” which coapt, much like heart valve leaflets, to selectively provide a fluid path through the apparatus body 106. During catheterization or other invasive procedures, surgical tools can go through the “valve” feature of the apparatus 10 and then penetrate the patient tissue. At the end of the procedure, upon removal of the surgical tools, the “valve” may close off access through the apparatus body 106, such as by flattening or coapting of flap(s) under fluid (e.g., blood) pressure from inside a patient tissue lumen.
Regardless of its exact configuration, the apparatus 100 may be used to assist with wound closure, such as via the example sequence of operation shown in
As shown in
The surgical wound 110 is then held open, such as via interposition of a surgical item 112 through the surgical wound 110 as shown in
When access to the patient tissue 108 through the surgical wound 110 is no longer desired by the user, the surgical item 112 is removed from the surgical wound 110, and/or any lateral tension applied to the surgical wound 110 is ceased. As shown in
The marker(s) 514 may be encapsulated within the apparatus body 106, particularly if the marker 514 material is potentially irritating to the patient or undesirably protruding from the proximal surface 102. The marker(s) 514 may also or instead be directly attached to a chosen one of the proximal surface 102 and the distal surface 104.
As shown in the example configurations of
As another example configuration for the apparatus 100, and as shown in
While the “ring” body layer in
As another example,
Turning to
During use of an apparatus 100 having a coupling feature 818, the apparatus 100 may be selectively attached to an installation device via the coupling feature 818. The apparatus 100 is then manipulated into a predetermined installation position with respect to the patient tissue 108 via the installation device. The coupling feature 818 may then be released from the installation device at the predetermined installation position.
Self-repairing of the apparatus 100 may have the effect of bringing the edges of the surgical wound 110 made in the patient tissue 108 into close enough proximity to achieve and/or facilitate closure. For example, if the self-repairing properties of the apparatus 100 are sufficiently strong, the apparatus 100 may be able to achieve approximation which presses together the wound edges of the underlying patient tissue 108, achieving closure and healing without any additional interaction. Another example is that, by simply bringing the patient tissue 108 wound edges into close enough proximity (even if not under approximation pressure or even necessarily touching), wound closure can be achieved through scar tissue formation between the wound edges without an additional closure device being provided.
A third example includes, in the case of large-bore device procedures, the apparatus 100 drawing the wound edges of the patient tissue 108 back to a size compatible with a commercially available closure device—or even sutures—designed for small-bore incisions, to minimize the size of the closure device used. In this third example, the apparatus 100 could include features to assist with the installation and/or retention of one or more closure devices.
It is contemplated that the apparatus 100 could be applied, additionally or alternatively, to patient tissue 108 incorporating an existing at-least-partial surgical wound 110, or even to an existing accidental/traumatic wound (not shown), particularly in situations where medical considerations/strategies make creation of the surgical wound 110 before application of the apparatus 100 to the patient tissue 108 desirable.
It is also contemplated that some additional material (e.g., an adhesive such as, but not limited to, a glue or sticky gel) may be provided to any form of self-repairing material for the apparatus 100 to assist with the desired wound closure.
While aspects of this disclosure have been particularly shown and described with reference to the example aspects above, it will be understood by those of ordinary skill in the art that various additional aspects may be contemplated. For example, the specific methods described above for using the apparatus are merely illustrative; one of ordinary skill in the art could readily determine any number of tools, sequences of steps, or other means/options for placing the above-described apparatus, or components thereof, into positions substantively similar to those shown and described herein. In an effort to maintain clarity in the Figures, certain ones of duplicative components shown have not been specifically numbered, but one of ordinary skill in the art will realize, based upon the components that were numbered, the element numbers which should be associated with the unnumbered components; no differentiation between similar components is intended or implied solely by the presence or absence of an element number in the Figures. Any of the described structures and components could be integrally formed as a single unitary or monolithic piece or made up of separate sub-components, with either of these formations involving any suitable stock or bespoke components and/or any suitable material or combinations of materials; however, the chosen material(s) should be biocompatible for many applications. Any of the described structures and components could be disposable or reusable as desired for a particular use environment. Any component could be provided with a user-perceptible marking to indicate a material, configuration, at least one dimension, or the like pertaining to that component, the user-perceptible marking potentially aiding a user in selecting one component from an array of similar components for a particular use environment. A “predetermined” status may be determined at any time before the structures being manipulated actually reach that status, the “predetermination” being made as late as immediately before the structure achieves the predetermined status. The term “substantially” is used herein to indicate a quality that is largely, but not necessarily wholly, that which is specified—a “substantial” quality admits of the potential for some relatively minor inclusion of a non-quality item. Though certain components described herein are shown as having specific geometric shapes, all structures of this disclosure may have any suitable shapes, sizes, configurations, relative relationships, cross-sectional areas, or any other physical characteristics as desirable for a particular application. Any structures or features described with reference to one aspect or configuration could be provided, singly or in combination with other structures or features, to any other aspect or configuration, as it would be impractical to describe each of the aspects and configurations discussed herein as having all of the options discussed with respect to all of the other aspects and configurations. A device or method incorporating any of these features should be understood to fall under the scope of this disclosure as determined based upon the claims below and any equivalents thereof.
Other aspects, objects, and advantages can be obtained from a study of the drawings, the disclosure, and the appended claims.
This application claims priority from U.S. Provisional Application No. 62/095,324, filed 22 Dec. 2014, the subject matter of which is incorporated herein by reference in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 62095324 | Dec 2014 | US |
