Medical tissue wrap
By designing a medical tissue wrap with a curled wall structure with discontinuous radial spacing, the difficulties in closing and fixing damaged anatomical structures in the existing technology are solved, stable support is provided, the risk of unwanted growth is reduced, surgical operations are simplified, and repeatability is improved.
Patent Information
- Application Number
- CN202380074856.0
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2022-10-26
- Filing Date
- 2023-10-24
- Publication Date
- 2025-09-23
AI Technical Summary
Existing medical tissue wraps have problems with unavoidable unwanted tissue growth, complex surgical procedures, and poor reproducibility when closing and fixing damaged internal anatomical structures, especially nerves and tendons.
A medical tissue wrap is formed by a curled wall having a circumferential inner end portion and an outer end portion, which overlap with each other at discontinuous radial intervals to provide a longitudinal through-hole, thereby ensuring stable accommodation and fixation of anatomical structures, reducing unwanted tissue growth, and simplifying surgical operations.
It achieves stable support and protection for damaged nerves and tendons, reduces the risk of unwanted tissue growth, simplifies the surgical procedure, and improves the repeatability and flexibility of the operation.
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Figure CN120693111A_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to a medical tissue wrap for the internal anatomical structure of a mammal, and uses and methods of using the medical tissue wrap to treat nerve damage. In particular, the present invention relates to a medical tissue wrap for supporting nerve tissue for repairing peripheral nerve damage. Technical Background
[0002] When a person is injured, tissue damage may occur to internal anatomical structures, such as muscle tissue, tendons, blood vessels, or nerve tissue. These internal anatomical structures generally extend in a longitudinal direction and may include a substantially cylindrical or tubular shape. This tissue damage can result in impaired motor skills and / or partial loss of sensation, requiring treatment to at least partially promote recovery of the affected tissue and function.
[0003] Impaired motor skills and / or partial sensory loss may be particularly pronounced in cases of nerve tissue damage, which may involve damage to one or more nerves or trauma to the peripheral nervous system. Such injuries involving nerve damage are particularly common in the upper limbs, such as a person's hand or fingers. If the nerve damage is not properly treated, the person may experience, for example, a loss of touch or tactile feedback and / or difficulty controlling fine motor skills in the injured area.
[0004] Current treatments for nerve damage include joining nerve endings by various suturing techniques to provide connections between the nerve endings in a substantially tension-free manner. If there is a more serious defect, where the nerve endings are not directly adjacent to each other, reconstruction may be required to overcome the corresponding gap. Reconstruction can be provided by, for example, autologous nerve transplantation or allogeneic nerve transplantation. Alternatively, reconstruction can be carried out by providing a tubular structure to provide nerve guidance. This tubular structure can be provided, for example, by an autologous venous structure or an allogeneic venous structure or by an artificially manufactured nerve conduit made of a biocompatible material.
[0005] The use of tubular structures may further facilitate repair of injuries regardless of the presence of gaps, for example, by providing further mechanical support and structural stability, providing tension-free repair, providing guidance for axonal growth to limit the risk of neuroma development, reducing the inflammatory response at the injury site, and / or limiting the extent of fibrous tissue development.
[0006] This tubular structure can also be provided in the form of a medical tissue wrap, such as a sheet of material, that can be rolled or coiled around damaged internal tissue. The medical tissue wrap can, for example, be applied to a peripheral nerve that has been prepared by guiding the medical tissue wrap around a designated portion of the nerve in an at least partially expanded state and by allowing or ensuring that the tissue wrap is rewound after being correctly positioned. In contrast to a catheter, the medical tissue wrap can therefore also be advantageously applied to damaged anatomical structures that are not separated by gaps but at least partially include a continuous longitudinal extension. Subsequently, the medical tissue wrap is typically closed by multiple sutures at the outer circumference.
[0007] Hereinafter, elements of the present invention will be described. These elements are listed together with specific embodiments, but it should be understood that they can be combined in any way and in any quantity to create other embodiments. The example embodiments and preferred embodiments of various descriptions should not be interpreted as limiting the present invention to only the embodiments clearly described. This description should be understood as supporting and including embodiments that combine the embodiments clearly described with any number of disclosed and / or preferred elements. In addition, unless the context indicates otherwise, any arrangement and any combination of all description elements in this application should be considered to be disclosed in the description of the application.
[0008] In this specification and the claims that follow, unless the context requires otherwise, the term "comprising" will be understood to mean the inclusion of the recited members, integers, or steps, but not the exclusion of any other non-recited members, integers, or steps. The term "consisting of is a special embodiment of the term "comprising," in which any other non-recited members, integers, or steps are excluded. In the context of the present invention, the term "comprising" encompasses the term "consisting of." Thus, the term "comprising" encompasses "including" as well as "containing," e.g., a composition "comprising" X may consist solely of X, or may include something else, e.g., X+Y.
[0009] No quantifiers before an element and similar references used in the context of describing the present invention (particularly in the context of the claims) should be interpreted as including one and multiple, unless otherwise indicated herein or clearly contradicted by the context. The recording of numerical ranges herein is merely a shorthand method for individually referring to each individual value falling within the range. Unless otherwise indicated in the text, each individual value is incorporated into the specification as if it were individually recorded in the text. Any language in the specification should not be interpreted as indicating an undeclared element necessary to implement the present invention.
[0010] The term "about" in relation to a value x refers to x ± 10%.
[0011] In numerical values with decimal places, a comma (",") or a period (".") is used interchangeably in the text, i.e., throughout this specification and claims. Accordingly, numerical values with decimal places can be represented by a comma (",") or a period ("."). For example, the exemplary value "0.5" can also be represented as "0,5", and the same applies to other values with decimal places. Specifically, a comma (",") in a numerical value indicates the number of decimal places, but is not used as a "thousands separator". Summary of the Invention
[0012] Based on the known prior art, there is a need to further advance the repair of damaged internal anatomical structures, in particular nerve damage or tendon damage.
[0013] According to the present invention, it has been recognized that proper closure and fixation of medical tissue wraps applied to internal anatomical structures, such as damaged peripheral nerves or tendons, is often difficult to achieve. Such closure and fixation are necessary to prevent the contained damaged tissue from inadvertently protruding beyond the medical tissue wrap, and vice versa, to prevent undesirable tissue growth, particularly scar tissue or fibrous tissue growth, into the medical tissue wrap. In other words, proper closure and fixation of the medical tissue wrap is preferably required to prevent undesirable communication between the damaged tissue and surrounding tissue.
[0014] The closure and fixation of medical tissue wraps can be improved by providing excess material, that is, by increasing the number of layers of the medical tissue wrap wrapped around the damaged anatomical structure (as described in US 9061464) or by integrating interlocking portions into a flexible body to facilitate its wrapping and attachment around the tissue (as described in EP 3662940). However, the inventors have found that such additional wrapping systems or interlocking systems can be cumbersome to implement in situ, or even anatomically impossible. In addition, the increase in the number of layers can make it more difficult to provide a medical tissue wrap in an at least partially expanded state, wherein sufficient space is provided to insert and / or accommodate the damaged anatomical structure. In addition, the additional material can cause the radial dimension of the medical tissue wrap to increase and / or can change the overall properties of the medical tissue wrap, for example, in terms of structural stability, toughness, optical and / or biochemical properties. The provision of additional layers can also affect the inner diameter of the medical tissue wrap, and therefore may require oversizing to avoid compressing the damaged anatomical structure.
[0015] As described above, the closure and fixation of the medical tissue wrap can also be ensured by multiple sutures. However, this can complicate the surgical procedure because, on the one hand, perforation of delicate and damaged anatomical structures is generally avoided because it generates tension, which is associated with poor tissue regeneration, and on the other hand, the structural stability or integrity of the medical tissue wrap may be reduced. The provision of sutures further increases the time required to perform the surgical procedure.
[0016] Furthermore, providing additional layers and / or providing suturing makes it more difficult to perform the surgical procedure in a reproducible manner.
[0017] Attempting to secure a medical tissue wrap to the contained anatomical structure by providing sutures at the longitudinal ends of the medical tissue wrap may also reduce the reproducibility of the surgical procedure. Furthermore, such securing means may not be sufficient to contain the anatomical structure within the medical tissue wrap or may complicate the surgical procedure and / or handling of delicate tissue. Alternative methods using medical adhesives have been found to be difficult to apply and / or maintain in a reproducible manner to secure the medical tissue wrap to the damaged internal anatomical structure.
[0018] Therefore, the object of the present invention is to further facilitate the repair of damaged internal anatomical structures, such as nerve damage or tendon damage, and in particular to ensure proper closure and / or fixation of medical tissue wraps without damaging the internal anatomical structures inserted into the medical tissue wrap.
[0019] The above objects are achieved by the independent claims. Preferred embodiments are described in the dependent claims, the description and the drawings.
[0020] Thus, in a first aspect, a medical tissue wrap for an internal anatomical structure of a mammal is provided, wherein the medical tissue wrap is formed from a coiled wall having a circumferential inner end portion and a circumferential outer end portion extending around and overlapping the circumferential inner end portion. The wall thus defines a longitudinal through-hole for receiving at least a portion of the anatomical structure. According to the present invention, the circumferential outer end portion is radially spaced from the circumferential inner end portion by a discontinuous spacing in the circumferential direction.
[0021] Generally speaking, the circumferential outer end portion of the wall and the circumferential inner end portion of the wall substantially correspond to the mutually overlapping inner and outer portions of the wall. Thus, the circumferential extension of the circumferential outer end portion substantially corresponds to the circumferential extension of the circumferential inner end portion of the wall, such that the outer end portion (completely) overlaps the inner end portion. This avoids circumferential gaps in the curled wall, ensuring that at least one internal anatomical structure housed within the through-hole remains within the medical tissue wrap and is substantially completely covered and / or surrounded along its (complete) circumference. Thus, the medical tissue wrap can provide improved support, protection, and / or suspension functions for the anatomical structure housed therein.
[0022] The circumferential outer end portion is (completely) radially separated from the circumferential inner end portion. In other words, due to the radial spacing between the inner end portion and the outer end portion, the circumferential outer end portion does not have any direct contact with the circumferential inner end portion. Due to the radial spacing of all overlapping portions of the medical tissue wrap in the curled state, it is at least partially conducive to the deployment or unrolling of the medical tissue wrap compared to a medical tissue wrap configuration in which one or more (outer) layers are in direct contact with the respectively overlapping and adjacent (inner) layers. Therefore, the overlapping portions are separated and do not contact each other in the curled state of the wall. Therefore, a gap sufficient to insert the internal anatomical structure into the through hole can be provided. In addition, such radial spacing can facilitate the application of an optional medical adhesive, for example, providing adhesion between the outer end portion and the inner end portion once the medical tissue wrap is properly applied and positioned.
[0023] According to a first embodiment, the radial spacing is discontinuous. As used herein, a "discontinuous" spacing refers to a radial distance between the circumferential outer end portion and the circumferential inner end portion that varies along the circumferential extension of the radial spacing (i.e., the overlapping circumferential extension). Accordingly, in a portion of the radial spacing, the distance between the circumferential outer end portion and the circumferential inner end portion is typically smaller than in another portion of the (same) radial spacing. Accordingly, in the overlapping portion, there is typically a portion with a reduced radial spacing (but no contact surface between the circumferential inner end portion and the circumferential outer end portion). The discontinuous spacing further provides at least an overlapping portion with a reduced radial spacing, which facilitates the closure of the through-hole toward the surrounding tissue environment. Thus, the risk of external tissue growth into the through-hole can be effectively reduced while maintaining improved anatomical structure within the through-hole. In addition, the discontinuity can define a barrier to an optionally applied medical adhesive at the outer surface and / or the interface between the outer end portion and the inner end portion. This barrier can be sized based on the viscosity of the medical adhesive to be used and the minimum radial spacing required to facilitate the deployment or spreading of the medical tissue wrap.
[0024] In other words, the discontinuous spacing ensures that improved closure of the medical tissue wrap can be provided while still being able to temporarily provide a circumferential gap between the outer and inner end portions to facilitate accommodation of damaged internal anatomy, such as an injured nerve or tendon.
[0025] Preferably, the medical tissue wrap is configured to contain neural tissue, preferably a damaged peripheral nerve. The medical tissue wrap is configured to contain the proximal and distal ends of a single damaged peripheral nerve, for example, with a predefined gap therebetween due to trauma or with substantially no gap.
[0026] Therefore, the through hole can be adjusted and sized to accommodate the corresponding diameter of the nerve or nerve ending. For example, the diameter of the through hole (understood as the diameter of the inner part) can be 1mm to 12mm, depending on the diameter of the nerve (ending). In order to accommodate smaller nerves, the diameter of the through hole can be, for example, 1mm to 6.5mm or 1.5mm to 6.5mm (e.g., 1mm, 1.5mm, 2mm, 2.5mm, 3mm, 3.5mm, 4mm, 4.5mm, 5mm, 5.5mm, 6mm or 6.5mm). This size has been found to be particularly beneficial for providing the required support for the growth or repair of nerves (endings) and / or nerves. Depending on the desired therapeutic effect of the medical tissue wrap and the nerve, the extension of the wall and the through hole in the longitudinal direction is preferably 5mm to 25mm, more preferably 7mm to 22mm (e.g., 7mm, 7.5mm, 8mm, 8.5mm, 9mm, 9.5mm, 10mm, 10.5mm, 11mm, 11.5mm, 12mm, 12.5mm, 13mm, 13.5mm, 14mm, 14.5mm, 15mm, 15.5mm, 16mm, 16.5mm, 17mm, 17.5mm, 18mm, 18.5mm, 19mm, 19.5mm, 20mm, 20.5mm, 21mm, 21.5mm or 22mm). In addition, such a size may be particularly advantageous for bridging nerve defects or nerve damage. The desired or predefined size can therefore provide a continuous guiding structure that is particularly conducive to guiding and / or promoting neurogenesis for the internal anatomical structure.
[0027] Although the preferred dimensions described above relate to (peripheral) nerve applications, it should be understood that the medical tissue wrap may also be applied to provide support structures for tendons, blood vessels (veins and / or arteries) or small ligaments. Accordingly, such support structures may be adapted to the respective dimensions, tissue properties and / or support levels provided. For example, the diameter of the through-holes may be selected to ensure direct contact with internal anatomical structures, e.g., for very fragile tissue structures, or to provide a predefined radial spacing between the wall and the internal anatomical structure, e.g., to provide a cushion in the event of impact with adjacent tissue. Similarly, the wall thickness may be selected based on the desired structural support and toughness of the wall, given the internal anatomical structure to be treated.
[0028] For the convenience of the application of the medical tissue wrap, the wall preferably defines a through hole with a tubular shape having a continuous inner diameter. This configuration also corresponds to the typical cylindrical and / or tubular extension of the preferred internal anatomical structure to be accommodated in the through hole. In addition, this provides a predefined and / or more uniform structural stability that can achieve the medical tissue wrap. The wall limiting the through hole optionally includes grooves, internal structures and / or holes on its inner surface. This (inner) wall modification can also improve the mechanical properties of the medical tissue wrap and / or promote the repair of the internal anatomical structure retained in the through hole, for example, by promoting nerve growth to damaged peripheral nerves. However, in some embodiments, the inner surface of the wall limiting the through hole can be smooth, that is, it also may not include grooves, internal structures and / or holes.
[0029] The tubular shape can provide a substantially continuous outer dimension, which may be advantageous for implanting a medical tissue wrap relative to surrounding tissue. Furthermore, the tubular or cylindrical shape can provide sufficient structural stability and / or prevent sharp bending or kinking during tissue movement, i.e., compression or stretching. Thus, the tubular shape can also provide a uniform structure that reacts in a predefined manner when forces act on the wall, such as an impact.
[0030] The tubular structure can also substantially correspond to the shape of the through hole, thereby providing a continuous guiding structure for tissue repair or support (protection), such as neurogenesis or nerve growth, without providing undesirable deviation. Therefore, the present invention achieves that the size of the through hole can be kept to a desired and / or required minimum value.
[0031] The wall, in particular its inner surface, may also contain a drug, for example by coating or integration in the material of the wall, which drug may be released over time and may, for example, promote tissue repair. In some embodiments, the wall may be covered / coated with a composition containing, for example, a drug, such as a gel (so that the through-holes may be at least partially or completely filled with the composition). For example, the drug may be a bioactive agent, such as an anti-inflammatory agent, an immunosuppressant, a neurotrophic factor, and a neuroprotectant. Examples of such bioactive agents include cytokines, nerve growth factor, hyaluronic acid, tacrolimus, cyclosporin A, melatonin, vitamin B12, methylprednisolone, riluzole, paclitaxel, cetuximab, 4-aminopyridine (4-AP), temorelin; a preferred example is tacrolimus.
[0032] The circumferential outer end portion is preferably formed by a single wall layer that overlaps the circumferential inner end portion. The circumferential inner end portion is preferably formed by a single wall layer. Thus, compared to structures having multiple adjacent layers that overlap each other in the radial direction, the application of the medical tissue wrap can be significantly facilitated. For example, when treating internal anatomical structures with no gaps, the single wall layer can facilitate the unfolding and rewinding of the medical tissue wrap to accommodate the internal anatomical structure.
[0033] Although a variety of curled wall configurations can be provided, the wall is preferably curled only in a (single or double) circumferential direction, in particular around one or two longitudinal axes extending through (along) the through hole. Thus, a spiral extension of the wall is avoided. In other words, the wall is preferably curled around a single or two longitudinal axes (corresponding to the circumferential outer end portion of the wall and the circumferential inner end portion of the wall, respectively), but is not advanced in the longitudinal direction. Accordingly, a substantially continuous and / or gapless circumferential covering of the internal anatomical structure can be provided. This not only provides improved support and / or protection for the contained tissue, but also facilitates unfolding and / or rewinding when the medical tissue wrap is applied.
[0034] Preferably, the circumferential inner and outer end portions are arranged at circumferentially opposed end portions of the wall. Accordingly, the wall does not extend circumferentially beyond the circumferential inner and outer end portions, neither in a curled state nor in a partially unfolded state. In the curled state, the wall preferably defines a medical tissue wrap having a substantially cylindrical shape, wherein the cross-section of the through-hole is preferably substantially circular. By providing the outer and inner end portions at circumferentially opposed end portions of the wall, the radial dimension of the medical tissue wrap in the curled state can be reduced.
[0035] As mentioned above, advantageously, the discontinuous spacing comprises at least a portion defining a reduced radial spacing, wherein radial spacing is understood to be the radial distance between radially immediately adjacent surfaces of the circumferentially outer end portion and the circumferentially inner end portion.
[0036] Preferably, the discontinuous spacing comprises a reduced radial spacing formed by the curvature of the circumferential inner end portion and / or the curvature of the circumferential outer end portion. In particular, the reduced radial spacing can be formed as a gradually decreasing spacing and / or can extend from an overlapping portion having a continuous radial spacing.
[0037] For example, a curvature may be provided at the circumferentially outer end portion, wherein the overlapping portion defines a gradually decreasing radial spacing, i.e., from the circumferentially inner end portion to the circumferentially outer end portion or from the circumferentially outer end portion to the circumferentially inner end portion in the circumferential direction. Similarly, a curvature may be provided at the circumferentially inner end portion, wherein the overlapping portion defines a gradually decreasing radial spacing, i.e., from the circumferentially outer end portion to the circumferentially inner end portion or from the circumferentially inner end portion to the circumferentially outer end portion in the circumferential direction.
[0038] Such curvatures can be provided separately, i.e. (gradually) decreasing in the circumferential direction from the circumferential inner end portion to the circumferential outer end portion or from the circumferential outer end portion to the circumferential inner end portion. However, such curvatures can also be provided simultaneously (in the same package), wherein a continuous radial spacing and / or a local maximum radial spacing is provided between the above-mentioned curvatures. In this regard, it is also possible to provide a decreasing radial spacing formed by two curvatures of the circumferential outer end portion, which define a gradually decreasing radial spacing in opposite circumferential directions and surround a circumferential inner end portion with a substantially continuous pitch or radius. Similarly, it can also be provided that the decreasing radial spacing is formed by two curvatures of the circumferential inner end portion, which define a gradually decreasing radial spacing in opposite circumferential directions surrounded by a circumferential outer end portion with a substantially continuous pitch or radius.
[0039] In some embodiments, the radial spacing at the circumferential end face of the circumferential inner end portion is less than the radial spacing at the circumferential end face of the circumferential outer end portion. Therefore, the radial spacing may (gradually) decrease toward the circumferential end face of the circumferential inner end portion. Therefore, a maximum radial spacing may be provided at the circumferential end face of the circumferential outer end portion; and / or a minimum radial spacing may be provided at the circumferential end face of the circumferential inner end portion. For example, the radial spacing at the circumferential end face of the circumferential inner end portion may be about 80% to about 99% of the radial spacing at the circumferential end face of the circumferential outer end portion, preferably 85% to 95%, more preferably about 90%. Further, the minimum radial spacing may be about 80% to about 99% of the maximum radial spacing, preferably 85% to 95%, more preferably about 90%.
[0040] Preferably, the radial spacing at the circumferential end surface of the circumferential outer end portion is smaller than the radial spacing at the circumferential end surface of the circumferential inner end portion. Therefore, the radial spacing may (gradually) decrease toward the circumferential end surface of the circumferential outer end portion. Therefore, a maximum radial spacing may be provided at the circumferential end surface of the circumferential inner end portion; and / or a minimum radial spacing may be provided at the circumferential end surface of the circumferential outer end portion. For example, the radial spacing at the circumferential end surface of the circumferential outer end portion may be about 80% to about 99% of the radial spacing at the circumferential end surface of the circumferential inner end portion, preferably 85% to 95%, more preferably about 90%. Further, the minimum radial spacing may be about 80% to about 99% of the maximum radial spacing, preferably 85% to 95%, more preferably about 90%.
[0041] A reduced radial spacing is provided at the end faces, wherein the radial spacing preferably decreases gradually towards the respective end face, thereby providing a significant improvement in the closure of the through-hole.
[0042] In some embodiments, the radial spacing at the circumferential end surface of the circumferential inner end portion and the circumferential end surface of the circumferential outer end portion is less than the radial spacing of the overlapping portion between the circumferential end surface of the circumferential inner end portion and the circumferential end surface of the circumferential outer end portion (thereby providing a maximum radial spacing that is neither at the circumferential end surface of the circumferential inner end portion nor at the circumferential end surface of the circumferential outer end portion).
[0043] In particular, it has been found that the reduced radial spacing between the circumferential end surfaces of the circumferential inner terminal portion and the circumferential end surfaces of the circumferential outer terminal portion can further improve closure of the through-hole by forming a double barrier, ensuring that the internal anatomical structure is securely retained within the through-hole and minimizing the risk of external tissue growth into the through-hole. It should be understood that such a configuration can be provided by the corresponding curvatures as described above, wherein the overlapping portions between the end surfaces and / or between the curvatures can define a continuous radial spacing or a local maximum radial spacing.
[0044] Depending on the desired closure and the size of the medical tissue wrap, a reduced radial spacing may also be provided only at the circumferential end faces of the circumferential outer terminal portion, which may in turn provide sufficient outer closure of the overlapping portion while defining a more rounded outer surface of the medical tissue wrap.
[0045] Similarly, a reduced radial spacing may be provided only on the circumferential end surfaces of the circumferential inner terminal portion. Due to the greater radial spacing of the circumferential end surfaces of the circumferential outer terminal portion, sufficient internal closure of the overlapping portions can be provided, while facilitating the opening or deployment of the medical tissue wrap. Such a configuration may also facilitate the optional application of a medical adhesive, for example, by forming longitudinal grooves defined by the reduced radial spacing adjacent to each end surface. While the reduced radial spacing itself may be sufficient to maintain closure of the medical tissue wrap and avoid the need for one or more sutures in the wall, providing such grooves for the application of a medical adhesive may be advantageous in providing improved retention and a more reproducible material bond between the circumferential inner terminal portion and the circumferential outer terminal portion.
[0046] In some embodiments, the radial spacing at the circumferential end faces defining the reduced radial spacing may be 50 to 99 percent, preferably 60 to 99 percent, more preferably 80 to 98 percent, even more preferably 85 to 95 percent, still more preferably 87 to 92 percent, for example about 90 percent of the maximum radial spacing of the discontinuous spacing. The reduced spacing may, for example, depend on the inner diameter determined by the through hole and / or by the outer diameter of the wall and / or on the circumferential extension of the circumferential outer end portion.
[0047] The radial spacing of the circumferential end faces defining the reduced radial spacing is preferably 50 μm to 300 μm. In particular, the radial spacing may be 80 μm to 200 μm. Similarly, the maximum radial spacing of the discontinuous spacing is preferably 100 μm to 350 μm, and in particular may be 150 μm to 250 μm. For example, the maximum radial spacing may be approximately 200 μm, while the reduced (or minimum) radial spacing may be 100 μm to 190 μm. Such dimensions can provide optimized closure of the medical tissue wrap in the curled state of the wall, while the radial spacing also facilitates the unfolding of the wall to accommodate internal anatomical structures when the medical tissue wrap is applied. In addition, this size has been found to be particularly advantageous for closing medical tissue wraps with smaller through-hole inner diameters of 1 mm to 6.5 mm or 1 mm to 5 mm (e.g., 1 mm, 1.5 mm, 2 mm, 2.5 mm, 3 mm, 3.5 mm, 4 mm, 4.5 mm, 5 mm, 5.5 mm, 6 mm or 6.5 mm), such as for small diameter peripheral nerves.
[0048] To ensure that no circumferential spacing is provided between the circumferential outer end portion and the circumferential inner end portion in the curled state of the wall, the overlapping portion can be dimensioned accordingly. Accordingly, the circumferential extension of the circumferential outer end portion can correspond to 5 degrees to about 120 degrees of the outer circumference of the tissue wrap, preferably to 10 degrees to 100 degrees, and more preferably to 20 degrees to 90 degrees of the outer circumference of the tissue wrap.
[0049] Thus, the wall can form less than 1.5 turns, i.e., the overlap provided by the circumferential outer end portion defines less than half a turn along the circumference. While preferably, the degrees represent the portion of the circumferential outer end portion relative to the circumference of the medical tissue wrap as a whole in the curled state (and forming 360 degrees, i.e., relative to a single complete turn without overlap), the above degrees can also be defined as corresponding percentages. Accordingly, the circumferential extension of the circumferential outer end portion can correspond to about 2.8 percent to about 28 percent of the outer circumference of the medical tissue wrap, preferably about 5.6 percent to about 25 percent.
[0050] More preferably, the circumferential extension of the circumferential outer end portion may be 20 to 60 degrees, and even more preferably 30 to 45 degrees, of the outer circumference of the tissue wrap. Based on the above, this angular extension may correspond to about 5.6 to about 17 percent or about 8.3 to about 13 percent of the outer circumference of the medical tissue wrap.
[0051] It has been found that the overlap provided by the circumferential outer end portion can be advantageously selected depending on the inner diameter of the through-hole, wherein for inner diameters up to about 3 mm, such as for smaller peripheral nerves in the fingers or hand of a patient to be treated, the circumferential extension is preferably less than 45 degrees; and wherein for inner diameters of about 4 mm and more, such as for larger peripheral nerves in, for example, the wrist or arm of a patient to be treated, a circumferential extension of more than 20 degrees and up to 45 degrees can be selected. In particular, the circumferential extension of the outer circumference of the medical tissue wrap can be greater than 25 degrees, for example, about 30 degrees or about 30 degrees to about 45 degrees.
[0052] In conjunction with discontinuous spacing, i.e., including portions with reduced radial spacing, it has been found that such circumferential extension provides improved closure of the medical tissue wrap and its through-hole while still facilitating opening or deployment of the medical tissue wrap for application to the target tissue. Such deployment may not be facilitated to the same extent for circumferential extensions greater than 45 degrees, but such greater extensions may be selected based on, for example, the internal anatomy to be accommodated within the through-hole and / or the desired mechanical and / or closure properties of the medical tissue wrap.
[0053] The radial spacing between the circumferential inner end portion and the circumferential outer end portion can also be tapered in opposite circumferential directions, extending at equal angles from the maximum radial spacing of the discrete spacings. As described above, such tapering can be provided by respective curvatures having a different pitch or radius than adjacent wall portions, wherein the curvatures of the outer end portion and / or the inner end portion can have the same angular extension, for example, extending at each of approximately 30 degrees around the outer circumference of the medical tissue wrap, such that the circumferential outer end portion forms an overall angular extension of approximately 60 degrees.
[0054] While medical tissue wraps can be applied to internal anatomical structures separated by gaps, such as due to trauma or dissection, where opposing ends of the anatomical structures can be inserted into the through-holes of the medical tissue wrap through corresponding openings at opposing longitudinal ends of the through-holes, such application may be cumbersome and / or undesirable for small diameter anatomical structures and / or in terms of repeatability.
[0055] Therefore, the wall is preferably at least partially expandable and recoilable in the circumferential direction. Preferably, the wall is fully expandable, such that the wall can be defined as a sheet-like structure extending only in the longitudinal direction. By ensuring that the wall is expandable, the wall can be wrapped around the internal anatomical structure to be treated, such as a damaged peripheral nerve or tendon, and can be recoiled after the wall is properly positioned.
[0056] The wall can be formed at least in part from a tough or elastic material, preferably a 3D-printed material. This toughness can not only facilitate providing a desired level of support and / or flexibility suitable for surrounding tissue movement, but also facilitates the unfolding and rewinding of the wall to apply the medical tissue wrap around the internal anatomical structure to be treated. For example, this toughness can be provided by 3D printing, where localized stresses in the material can provide a corresponding biasing force.
[0057] Depending on the structural support provided by the medical tissue wrap layer to the internal anatomical structures, the wall thickness can be selected accordingly. Preferably, the wall comprises a thickness of 50 μm to 400 μm, preferably 150 μm to 250 μm. This thickness has been found to provide sufficient support for various applications while ensuring a degree of transparency so that the accommodation of the internal anatomical structures within the through-hole can be monitored or inspected once the wall is in the curled state. Depending on the material used for the wall, the above thickness can also be adapted to the desired biodegradation rate of the medical tissue wrap. In addition, this thickness can facilitate the deployment of the wall and improve the flexibility for handling the medical tissue wrap. For example, a preferred thickness range can, for example, facilitate the deployment of the wall. A wall thickness of approximately 200 μm has been found to be particularly advantageous in this regard.
[0058] While the wall comprises a continuous portion having a preferred thickness range, localized increases in wall thickness may be provided to provide or support further functionality of the medical tissue wrap.
[0059] In some embodiments, the radial spacing that reduces can be provided by the curvature of the circumferential inner end portion. In some embodiments, the radial spacing that reduces can be provided by the wall thickness of the circumferential inner end portion and / or the wall thickness of the adjacent portion of the non-overlapping portion of the wall (gradually) increasing. Although the increase of this wall thickness can be applied to medical tissue wraps generally, in these parts of medical tissue wraps with structural outer surface modification, particularly retaining surface, it may be particularly advantageous, as described below. Therefore, the increase of this wall thickness is preferably in the longitudinal end portion with structural outer surface modification, particularly retaining surface, as described below.
[0060] Accordingly, in the circumferential direction, the wall of the circumferential inner end portion can be thinner than the wall of the outer end portion and the wall of the (most) non-overlapping circumferential portion of the wall. In particular, if the medical tissue wrap includes a structural outer surface modification, such as a retention surface, and thus has an increased wall thickness at the longitudinal end portions as described herein below, the wall thickness of the circumferential inner end portion at the longitudinal end portion can be substantially the same as the wall thickness of the central portion (the wall thickness is preferably substantially the same throughout the circumferential direction).
[0061] In some embodiments, the wall thickness of the circumferential inner end portion may be reduced by up to 75%, preferably 30% to 65%, more preferably 40% to 60%, for example about 50%, compared to the wall thickness of the circumferential outer end portion and / or the wall thickness of (most of) the non-overlapping circumferential portion of the wall.
[0062] However, the non-overlapping circumferential portion of the wall may also include a cross-section with reduced wall thickness, which is directly adjacent to the circumferential inner end portion with reduced wall thickness. Thus, a smooth transition can be provided between: (i) the (substantially constant) wall thickness of the outer end portion and the (mostly) non-overlapping circumferential portion of the wall; and (ii) the inner end portion with reduced wall thickness compared to (i). Accordingly, the wall thickness can gradually decrease in the portion of the non-overlapping circumferential portion of the wall facing the inner end portion (starting from), reaching a minimum wall thickness at (the circumferential end face of) the (circumferential) inner end portion. Therefore, it is preferred to avoid sharp edges, thereby preferably providing a uniform and stepless outer surface without sharp edges.
[0063] The cross-section of the non-overlapping circumferential portion of the wall of reduced wall thickness may cover an angle in the circumferential direction of 1° to 90°, preferably 2° to 45°, more preferably 3° to 30°, and even more preferably 5° to 20° (circumferential deviation).
[0064] Since the inner end portion of the non-overlapping circumferential portion of wall 12, and optionally, the further adjacent portion 35, has a reduced wall thickness, manufacturing can be facilitated and the circumferential outer end portion 22 can be better aligned with the adjacent outer circumference of the wall. Further, by providing a visual cue and providing a small gripping cavity, the gripping of medical tissue wrap 10, especially the ease of gripping of circumferential outer end portion 22, can be facilitated, thereby supporting the deployment of wall 12 and medical tissue wrap 10.
[0065] To ensure that relative movement between the internal anatomical structure and the medical tissue wrap is reduced or even avoided under normal physiological behavior, it may be advantageous to secure the internal anatomical structure to the medical tissue wrap using a medical adhesive.
[0066] In a second aspect, the present invention also provides a medical tissue wrap for an internal anatomical structure of a mammal, the medical tissue wrap being formed by a curled wall having a circumferential inner end portion and a circumferential outer end portion extending around and overlapping the circumferential inner end portion, thereby defining a longitudinal through hole for accommodating a portion of the internal anatomical structure; wherein the circumferential outer end portion is radially spaced from the circumferential inner end portion, and the wall includes a structural outer surface modification at its opposite longitudinal end portions. The detailed description of the wrap substantially corresponds to the detailed description of the medical tissue wrap described above according to the first aspect, with the only difference that the radial spacing in the wrap described according to the second aspect is not necessarily discontinuous. In addition, the medical tissue wrap described according to the second aspect includes a structural outer surface modification of at least one opposite longitudinal end portion of its wall. Otherwise, the above (and below) description of the first aspect corresponds to the second aspect.
[0067] Accordingly, the medical tissue wrap according to the present invention can have a discontinuous spacing as described above, or a continuous spacing in combination with a structural outer surface modification of at least one of the opposite longitudinal end portions of its wall. Preferably, however, the medical tissue wrap comprises both features, namely the discontinuous spacing as described above and the structural outer surface modification of at least one (preferably two) opposite longitudinal end portions of its wall. Accordingly, according to the first aspect, the wall of the medical tissue wrap preferably comprises a structural outer surface modification at least at one (preferably two) opposite longitudinal end portions of the wall. Similarly, the wrap according to the second aspect preferably comprises the typical discontinuous spacing as described in detail above.
[0068] With respect to the wall comprising the structural exterior surface modification at opposite longitudinal end portions of the wall, the wall preferably defines a longitudinally extending central portion disposed between and adjacent the opposite longitudinal end portions, wherein only (or at least one) of the longitudinal end portions comprises the structural exterior surface modification. At least one, and preferably both, of the longitudinal end portions comprises a surface roughness resulting from the structural exterior surface modification that is greater than a surface roughness of an exterior surface of the central portion.
[0069] An advantage of modifying the outer surface of a structure and / or increasing the surface roughness is that the bond strength of an optionally applied medical adhesive to the modified surface can be improved, thereby enhancing the fixation and / or anchoring of the medical adhesive to the respective surface. For example, the modification can provide an increased surface area and / or form fit for the applied medical adhesive and / or improve adhesion due to modified surface tension. Thus, the medical adhesive applied to the modified surface and adjacent tissue of the internal anatomical structure extending through the through-hole can ensure that the medical tissue wrap remains in place and / or remains fixed in place relative to the treated internal anatomical structure.
[0070] The structural outer surface modification may be formed on a wall portion at each longitudinal end portion that is thicker than the wall thickness of the central portion. For example, the thickness of the thickened wall portion may be 1.1 to 5.0 times the thickness of the adjacent central portion, preferably 1.5 to 2.5 times. The thickness of the thickened wall portion may be 100 μm to 600 μm, preferably 300 μm to 500 μm. As described above, the thickness of the wall portion without local modification may be 50 μm to 400 μm, preferably 150 μm to 250 μm.
[0071] Alternatively, a continuous and substantially uniform wall thickness can also be provided, wherein the structural outer surface modification is embedded in the wall. In this case, the overall wall thickness can be adapted to the structural outer surface modification to ensure the structural stability of the modified portion, for example, with a minimum wall thickness of about 50 μm, preferably (at least) 50 μm to 100 μm.
[0072] The thickened wall portion can be circumferentially deviated from the circumferential inner end portion, wherein the deviation preferably includes a gradual increase in wall thickness from the inner end portion to the thickened wall portion (in non-overlapping circumferential wall portions). The above-mentioned circumferential deviation can have a circumferential extension from 5 degrees to 25 degrees of the outer circumference of the medical tissue wrap. Preferably, the circumferential extension of the above-mentioned deviation is 10 degrees to 20 degrees, more preferably about 15 degrees of the outer circumference of the medical tissue wrap. Accordingly, the circumferential inner end portion does not have a structural outer surface modification and can have a corresponding (reduced) wall thickness. The deviation has the advantage that the circumferential outer end portion can be more conveniently aligned with the circumferential inner end portion, and the circumferential outer end portion can be easily handled, for example, for unfolding the wall. The gradual transition between the thickened wall portion and the wall portion of the circumferential inner end portion ensures that sharp edges or steps can be omitted.
[0073] The structural outer surface modification preferably forms one or more retention surfaces, for example, at least a portion of an outer structure having a specific geometry or surface irregularities configured to secure the medical adhesive to the respective longitudinal end portions. Thus, even after the medical adhesive has cured, the medical adhesive applied to the corresponding longitudinal end portion region of the internal anatomical structure and / or adjacent tissue portion can remain in place without any significant movement. In other words, the retention surface can be used to secure the medical adhesive in place, preferably in a form that matches the one or more retention surfaces. The retention surface can provide an increased contact surface with the medical adhesive. Furthermore, it can provide a predefined surface roughness, thereby improving the effectiveness of the medical adhesive in bonding to the respective longitudinal end portions. Thus, the shape and / or surface of the retention surface can effectively prevent the medical adhesive from loosening or slipping.
[0074] The retaining surface of each longitudinal end portion can form a plurality of (for example, ellipsoidal or circular) holes, which can be arranged in at least one row along the circumferential direction of the wall. Therefore, the holes can be positioned in a linear manner along the circumference of the wall. The number of rows is preferably 1 to 10 rows. Each row preferably comprises 2 to 20 holes. In the circumferential direction of the elongated body, the holes can advantageously be equidistantly spaced. Preferably, the holes are arranged in 2 to 4 rows and / or each row comprises 4 to 8 holes. Thus, the holes of adjacent rows are preferably arranged in a staggered arrangement. For example, two rows can be provided in the respective end regions, wherein each row can comprise, for example, six holes.
[0075] The number of holes and rows, as well as their arrangement, have been found to be advantageous for providing improved retention of a medical adhesive to a medical tissue wrap while also providing and maintaining the desired structural stability. Furthermore, such embodiments can exhibit rotational symmetry, which can facilitate proper placement of the medical tissue wrap at the target tissue site. In certain embodiments, the hole size or diameter can be 50 μm to 750 μm, and to further enhance structural stability, preferably 150 μm to 600 μm, and particularly can be approximately 500 μm.
[0076] Each hole can be formed as a cutout, a cavity, or a radial through-hole in the wall. This can thus provide improved fixation of the medical adhesive. In particular, radial through-holes can be further advantageous. Such radial through-holes can facilitate the medical adhesive encircling the wall at its respective longitudinal ends, particularly at the exterior and interior of the medical tissue wrap, depending on the selected dimensions and / or, in particular, the diameter of the hole. Similarly, this can also provide for contact between the medical adhesive and internal anatomical structures contained within the through-hole. Thus, the hole can have a radial height or depth corresponding to the strength or thickness of the wall, but can also have a reduced height. Preferably, the hole has a minimum height or depth of approximately 50 μm. The height or depth of the hole can be between 50 μm and 500 μm or between 50 μm and 600 μm, more preferably between 150 μm and 300 μm or between 150 μm and 400 μm.
[0077] In some embodiments, it may be preferred to form one or more retaining surfaces of the respective longitudinal end portion as at least one groove extending in a helical direction along the longitudinal axis defined by the wall. The helical shape may define a thread extending along the outer surface of the respective longitudinal end portion.
[0078] Although one or more grooves may define sharp edges, at least one groove preferably includes a rounded edge. A rounded edge is understood to mean that there is no straight (angled) edge or step at the interface of the groove with the top outer surface of the respective longitudinal end portion and / or at the bottom surface of the groove opposite the side wall (of the groove). Instead, a gradual transition can be provided at the corner surface of the groove. By rounding the edges, stresses in the internal material of the wall can be reduced, thereby reducing the occurrence of cracks or fractures. Therefore, the provision of a rounded edge can also reduce the wall thickness required at least at the longitudinal end portion of the support groove.
[0079] Alternatively, or (preferably) in addition to the rounded edge, at least one groove may define at least one undercut. The provision of an undercut can improve the anchoring of the medical adhesive to the corresponding longitudinal end portion. The undercut is formed so that the bottom of the groove is at least partially covered by the outer surface of the wall. That is, the outer wall surface can extend at least partially longitudinally above the groove. Preferably, this extension (between the groove bottom and the groove sidewall) forms an angle of 45 to 90 degrees, preferably 60 to 85 degrees, more preferably 70 to 80 degrees, and even more preferably about 75 degrees or about 90 degrees. As a result, the fit or positive lock between the applied medical adhesive and the corresponding longitudinal end portion can be improved.
[0080] To reduce the radial extension of the elongated body and nerve wrap as a whole, at least one groove can define the outermost edge of each longitudinal end portion along the longitudinal direction of the wall. Thus, the groove can terminate at the longitudinal end surface of the wall and extend along the circumference of the end surface, reducing the radial extension at the end surface. This can reduce the overall dimensions of the medical tissue wrap. Alternatively, the groove can terminate at a longitudinal offset from the longitudinal end surface, which may further enhance structural stability.
[0081] The depth or (top) longitudinal extension of the groove is substantially constant along the circumference and throughout its longitudinal extension. Preferably, the groove may have a minimum depth of about 50 μm. The groove may have a depth of 50 μm to 500 μm, more preferably a depth of 150 μm to 300 μm. Preferably, the groove may have a minimum (top) longitudinal extension of about 20 μm. The groove may have a thickness (width) of 10 μm to 100 μm, more preferably 15 μm to 50 μm. According to the invention, the (top) longitudinal extension between the positive and negative grooves may be the same or different.
[0082] The extension and / or angle of the at least one groove may vary. Preferably, the at least one groove extends from 0.5 to 10 turns around the longitudinal axis defined by the wall, thereby providing a helical structure (at (at) at least one longitudinal end). Preferably, the groove extends for more than one turn around the longitudinal axis defined by the wall. In particular, the number of turns may be 2 to 6 turns, preferably 3 to 5 or 4 turns.
[0083] In some embodiments, the longitudinal end portion (or each in the two longitudinal end portions) may comprise a single groove. In other embodiments, each one or more than one longitudinal end portion may also comprise at least two grooves. In particular, if two or more than two grooves are provided in the identical longitudinal end portion, each groove may extend 0.5 to 5 turns around the longitudinal axis. At least two grooves may extend in parallel, for example, forming two or more than two parallel (non-intersecting) spirals. Therefore, the arc length, curvature and torsion of the parallel grooves / spirals are preferably identical, so that they differ only in their position (at the longitudinal end portion). Preferably, the distance between the two or more parallel grooves / spirals is regular (i.e., roughly the same).
[0084] In some embodiments, at least two grooves can extend in opposite circumferential directions and intersect each other. Two embodiments can also be combined, i.e. two or more grooves extending in parallel and two or more additional grooves extending in parallel, optionally also extending in parallel (so that the grooves intersecting in parallel provide a "lattice" or "pineapple" pattern). The number of grooves in each circumferential direction can be 1 to 10, preferably 6 to 8 or 7, depending on the longitudinal extension of each end and the angle of the groove. In addition, for each circumferential direction, the number of grooves is preferably equal. In addition, at a single longitudinal end portion (or at each end), the groove / spiral is preferably different only in its direction (and position on the end), but preferably does not differ in other spiral parameters. In other words, for all grooves / spirals (except the direction of the intersecting spirals) of a specific longitudinal end portion, the arc length, curvature and torsion may be substantially the same. By providing multiple grooves (e.g., two or more grooves) in each circumferential direction, a diamond or diamond pattern similar to a pineapple surface is provided on the outer surface of each longitudinal end portion. Thus, a plurality of retention surfaces having a plurality of edges may be provided, wherein the retention surfaces may facilitate securing of a medical adhesive to the respective longitudinal end portions.
[0085] In some embodiments, the one or more retaining surfaces at each end are formed as one or more circumferential ribs (elongated protrusions) extending from the outer surface of the wall. The extension of the one or more ribs can be linear (e.g., parallel) with the circumferential direction, or can include deviations from the circumferential direction in the longitudinal direction of the wall (e.g., diagonal). Preferably, if there are multiple ribs at each end portion, for example, from 3 to 6, these ribs can be equally spaced and non-intersecting, i.e., the ribs are preferably arranged parallel to each other.
[0086] One or more retention surfaces can generally be provided on thickened wall portions of respective longitudinal end portions, with the thickened wall portions being adapted to the desired retention surfaces and the structural requirements of the longitudinal end portions. Examples of preferred thicknesses or thickness ranges have been described above. By appropriately rounding or providing fillets, the thickened wall portions can be made flush with the outer surface of the central portion.
[0087] Similarly, one or more holes, and in particular recesses, may also be provided as raised features on the outer surface of a wall having a substantially continuous thickness. Thus, the wall may include a positive protrusion or buildup at the respective longitudinal end portions defining the corresponding recess or hole, while the wall portion between the opposite longitudinal end portions does not include the raised feature. In this case, the outer surface of the wall thus preferably defines the inner radius of the corresponding recess or hole.
[0088] To increase the efficacy of the medical adhesive and, preferably, to increase the fit or interlocking of the medical adhesive with the medical tissue wrap, a portion of the wall directly adjacent to the respective longitudinal end portion may also at least partially comprise a retention surface. For example, one or more grooves may extend over the wall portion directly adjacent to the longitudinal end portion without exhibiting an increase in wall thickness, e.g., originating from or terminating in the center or middle portion of the wall. This extension of the retention surface may provide a gradual transition of the retention surface while improving load distribution on the wall (and overall medical tissue wrap).
[0089] It may be provided that one or more retention surfaces are provided on only one respective end portion of the medical tissue wrap. Preferably, both longitudinally opposing end portions, i.e., two opposing end portions, are provided with one or more retention surfaces (of the same medical tissue wrap). The longitudinal end portions may have different types of retention surfaces, i.e., one longitudinal end portion may include grooves while the other end portion includes a plurality of holes. However, preferably, the plurality of longitudinal end portions have identically formed retention surfaces.
[0090] The retention surfaces at the opposing ends can be mirror images relative to the transverse midplane of the wall (or medical tissue wrap), e.g., such that they are aligned in opposite directions. For example, each opposing longitudinal end portion (of the same medical tissue wrap) can include one or more grooves / spirals as described above, wherein the grooves or spirals at different longitudinal end portions can substantially correspond to each other (e.g., have the same number and / or pattern); however, the different longitudinal end portions differ from each other in that the grooves / spirals are formed in a mirror image arrangement about the transverse midplane of the wall (or the entire medical tissue wrap) such that they are aligned in opposite directions. For example, at one longitudinal end portion, the grooves can extend in a clockwise direction, while at another longitudinal end portion, the grooves can extend in a counterclockwise direction. Alternatively, however, the retention surfaces at different longitudinal end portions of the same medical tissue wrap can be oriented or arranged in the same direction, e.g., having grooves or threads in the same (clockwise or counterclockwise) direction.
[0091] According to a particular embodiment, the outermost edge of each longitudinal end portion may be offset in the longitudinal direction of the wall, with the wall thickness being reduced in the offset portion (which may increase the amount of medical adhesive that can be used at the edge of the medical tissue wrap). According to this particular embodiment, the retention surface, if present, may be included on the portion of the wall between the offset and the central portion of the longitudinal end portion.
[0092] The walls of the medical tissue wraps described herein can be formed from biocompatible materials, inert materials, bioimplantable materials, and / or biodegradable materials. Materials can be selected that provide a predefined structural stability while substantially avoiding or at least reducing an inflammatory response in the patient being treated. For example, a biocompatible material can be selected that gradually degrades over time after implantation but initially provides sufficient structural support to adequately repair nerve damage, such as during tissue movement.
[0093] To improve treatment outcomes, specific materials may be further advantageously selected to promote or support repair, such as nerve growth, for example by containing or otherwise incorporating or including a corresponding coating, such as containing a bioactive agent and / or one or more neurotrophic factors. Other examples of such bioactive surface functions include, but are not limited to, anti-inflammatory agents, immunosuppressants, neurotrophic factors, and neuroprotective agents. Examples of such bioactive agents include cytokines, nerve growth factors, hyaluronic acid, tacrolimus, cyclosporin A, melatonin, vitamin B12, methylprednisolone, riluzole, paclitaxel, cetuximab, 4-aminopyridine (4-AP), tesmorelin; a preferred example is tacrolimus. The bioactive agent may be surface-bound and / or embedded in the structure defining the medical tissue wrap, such as its wall.
[0094] Preferably, the wall is formed from a polymer-based material, preferably an elastomer. This has the advantage of being applicable to a variety of manufacturing methods and / or providing specific material properties based on, for example, the polymer units. In particular, the polymer-based material can be a biocompatible material that further exhibits elastic properties, such that, in the implanted state, the medical tissue wrap can adapt to tissue movement around the internal anatomical structure being treated.
[0095] The wall may be formed from polymerized and / or cross-linked polymer units, preferably comprising an ester-based component and an acid ester-based component. The ester-based component is preferably a polyol. The acid ester-based component is preferably a polyacid.
[0096] The material used for the wall can preferably be the same as that along its entire circumference and longitudinal extension. Therefore, manufacturing can be further facilitated and the structural characteristics of the wall can be substantially uniform along the longitudinal direction of the medical tissue wrap. In this regard, if the medical tissue wrap is configured accordingly, biodegradation (and / or bioresorption) can also occur in a predefined or expected manner. However, it can also be provided that at least a portion of the wall is formed by a material that is different from one or more other parts of the wall. Such a configuration may be advantageous, for example, if a longitudinal end portion has a specific function and may require different characteristics, for example, if such a longitudinal end portion is configured as a main entrance for applying a medical adhesive.
[0097] Medical tissue wraps can be formed by 3D-printing processes. It is particularly advantageous for the material of the medical tissue wrap to be a polymer-based material, wherein the material can be cured essentially instantly, for example using (UV) light. In addition, this provides a level of precision that is (not easily) achievable through extrusion and / or dipping processes and / or molding. In particular, the 3-D printing process is capable of obtaining a specific shape of the medical tissue wrap, wherein, for example, the printing process can provide for integrating specific bioactive substances into the 3-D structure according to a predefined pattern, such as within a mesh structure and / or particularly in pockets or cavities formed by the 3-D structure. Therefore, the coordination and support of tissue repair can be further improved and / or biodegradation may be achieved in a more controlled manner. Further, this 3-D printing process can provide the introduction of local material stress, thereby providing a predefined biasing force, thereby promoting the rewinding function of the wall, for example, by generating a predefined toughness.
[0098] The above-mentioned objects are further achieved by using the above-mentioned medical tissue wrap for repairing, supporting and / or guiding neural tissue, in particular for repairing peripheral nerve damage. In addition, the medical tissue wrap can be used in combination with a medical adhesive. The medical adhesive according to the present invention can be any medical adhesive in the art. In some embodiments, the medical adhesive is capable of polymerizing when exposed to light. Prior to such polymerization, the medical adhesive can be fluid or viscous. Preferably, the medical adhesive is a photocurable compound. In some embodiments, the above-mentioned photoinitiator is sensitive to ultraviolet (UV) radiation. According to a preferred embodiment, the medical adhesive is or comprises polyglycerol sebacate acrylate (PGSA) or PGSAA (for example, as described in WO 2021 / 078962).
[0099] According to a further aspect, the present invention also provides a kit of parts comprising at least one medical tissue wrap as described above. In some embodiments, the kit of parts comprises at least two (e.g., 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more than 10) different medical tissue wraps as described above. The different medical tissue wraps can differ, for example, in their size (e.g., inner diameter and / or longitudinal extension). In some embodiments, the kit of parts comprises at least one medical tissue wrap as described above and at least one medical adhesive as described above.
[0100] According to another aspect of the present invention, a method for treating peripheral nerve damage is provided, comprising the following steps:
[0101] - providing a medical tissue wrap as described above;
[0102] - expanding the wall of the medical tissue wrap to provide a circumferential gap between the circumferential end surface of the circumferential inner end portion and the circumferential end surface of the circumferential outer end portion;
[0103] - inserting the damaged nerve through the gap into a medical tissue wrap; and
[0104] -Fixes the damaged nerve within the wall by rerolling the wall.
[0105] According to other aspects, the present invention also provides a method for supporting (protecting) nerves, comprising the steps of:
[0106] - providing a medical tissue wrap according to any one of the preceding claims;
[0107] - expanding the wall of the medical tissue wrap to provide a circumferential gap between the circumferential end surface of the circumferential inner end portion and the circumferential end surface of the circumferential outer end portion;
[0108] - inserting the nerve to be supported through the gap into the medical tissue wrap; and
[0109] -Fixes the nerve within the wall by rerolling the wall.
[0110] Preferably, fixation of the (damaged or to be supported) nerve is further performed by applying a medical adhesive outside the through hole, at the circumferential end faces of the circumferential outer portion and / or at the opposite longitudinal end portions of the wall and / or at the interface with the nerve tissue.
[0111] Similarly, the method of the present invention can be used to fix tendons (damaged or to be supported) or blood vessels. BRIEF DESCRIPTION OF THE DRAWINGS
[0112] The present disclosure will be more readily understood by reference to the following detailed description when considered in conjunction with the accompanying drawings, in which:
[0113] Figure 1 A schematic depiction of a medical tissue wrap according to the present invention is shown in the form of a schematic perspective view;
[0114] Figure 2 A schematic depiction of a medical tissue wrap according to the present invention is shown in cross-sectional view;
[0115] Figure 3 A schematic depiction of a medical tissue wrap according to the present invention is shown in side perspective view and having a longitudinal end portion with a retaining surface;
[0116] Figure 4 Shown in longitudinal cross-section Figure 3 Tissue wraps for traditional Chinese medicine;
[0117] Figure 5 Shown in a cross-sectional view of a longitudinal end portion Figure 3 Tissue wraps for traditional Chinese medicine;
[0118] Figures 6 to 9 A schematic depiction of a medical tissue wrap having end portions with different retention surfaces according to the present invention is shown in side perspective view;
[0119] Figure 10 Shown according to Figure 3 a schematic depiction of the undercut defined by the mid-groove; and
[0120] Figure 11 A cross-sectional view of a medical tissue wrap according to the present invention is shown having another configuration of circumferential inner and outer ends.
[0121] Figure 12A schematic depiction of a medical tissue wrap according to the present invention is shown, with the outermost edges of each longitudinal end portion of the medical tissue wrap offset in the longitudinal direction of the wall. DETAILED DESCRIPTION
[0122] Hereinafter, the present invention will be described in more detail with reference to the accompanying drawings. In the drawings, similar elements are represented by the same reference numerals, and their repeated description may be omitted to avoid redundancy.
[0123] exist Figure 1 In the figure, a medical tissue wrap 10 according to the present invention is shown in a schematic perspective view. The medical tissue wrap is essentially formed by a wall 12 extending in a longitudinal direction and curled to define a substantially continuous through hole 16. The wall 12 is curled about two longitudinal axes so that in the curled state of the wall 12, the through hole 16 is closed toward the outside and is completely surrounded by the wall along its entire circumference. The closure is provided by a circumferential inner end portion 20 of the wall 12 and a circumferential outer end portion 22 of the wall 12 overlapping, as shown in FIG. Figure 2 As shown in further detail in .
[0124] In the present non-limiting example, the through hole 16 comprises a tubular shape, in particular having a substantially circular shape with a continuous inner diameter in a cross-sectional view. This configuration may be advantageous because it corresponds to the typical cylindrical and / or tubular extension of the preferred internal anatomical structure to be accommodated within the through hole 16, in particular a damaged peripheral nerve. Further, this can achieve a predefined structural stability and / or a more uniform structural stability of the medical tissue wrap. Similarly, in the present example, the wall thickness is substantially continuous throughout the entire longitudinal extension and along the circumference of the medical tissue wrap 10. The above wall thickness can be selected based on the structural support and toughness required of the wall 12 in view of the internal anatomical structure to be treated.
[0125] The tubular shape and continuous wall thickness of wall 12 can also provide a substantially continuous outer dimension, which may facilitate surrounding tissue implantation of medical tissue wrap 10. Further, the tubular or cylindrical shape can provide sufficient structural stability and prevent abrupt bending or twisting during tissue movement, i.e., compression or stretching.
[0126] like Figure 2As shown, the closure of the through hole 16 is provided by the overlapping portion of the wall 12 in the circumferential direction. In the curled state, the overlapping portion is provided by the circumferential outer end face 22 of the wall 12 surrounding the corresponding circumferential inner end face 20 in the area of the circumferential end face 28, 28'. In other words, the circumferential extension 40 of the circumferential outer end portion 22 corresponds to the circumferential extension of the circumferential inner end portion 20, thereby providing a complete overlap. The circumferential extension 40 shown in this embodiment corresponds to approximately 30 degrees of the outer circumference of the medical tissue wrap 10 defined by the wall 12. The circumferential extension 40 ensures that no circumferential gap is provided between the circumferential end faces 28, 28' of the wall 12 in the curled state, so that the internal anatomical structures contained in the through hole 16 are firmly retained in the through hole 16.
[0127] Also like Figure 2 As shown, the circumferential outer end portion 22 is separated from the circumferential inner end portion 20 by a radial spacing 24. That is, the circumferential outer end portion 22 is radially spaced from the circumferential inner end portion 20 along its entire circumferential extension 40. Thus, handling of the medical tissue wrap 10 is improved by facilitating deployment of the wall 12 to facilitate application of the medical tissue wrap 10 around the target tissue to be treated.
[0128] However, the radial spacing 24 is discontinuous, meaning that there are portions of the overlapped portion having a reduced radial spacing 24 (but not providing a contact surface between the circumferential inner end portion 20 and the circumferential outer end portion 22). In the present example, this reduced radial spacing 24 is provided by a curvature 26 of the circumferential outer end portion 22, which defines a gradual decrease in radial spacing 24 from the level of the circumferential end surface 28' of the circumferential inner end portion 20 to the circumferential end surface 28 of the circumferential outer end portion 22. Thus, while maintaining improved usability and deployment potential of the medical tissue wrap 10, improved closure of the through-hole 16 to the surrounding tissue is provided. In particular, the reduction in radial spacing 24 results in a maximum radial spacing 38 at the level of the circumferential end surface 28' of the circumferential inner end portion 20.
[0129] Figures 3 to 5 1 and 2 show different views of an embodiment of a medical tissue wrap 10 according to the present invention having a longitudinal end portion 18 with a retention surface 42. Figure 3 , wherein a wall 12 defines a central portion 14 and includes two longitudinal end portions 18 disposed at longitudinally opposite ends of the wall 12 and disposed directly adjacent to the central portion 14. Figure 3As shown in the schematic diagram of FIG, the outer surfaces of the two longitudinal end portions 18 are aligned or flush with the outer surface of the central portion 14, thereby providing a uniform and stepless outer surface that is free of sharp edges, cavities and / or protrusions that may adversely affect surrounding tissues when the medical tissue wrap 10 is implanted.
[0130] The longitudinal end portions 18 according to this embodiment have the same shape and size so that during the implantation process, the reverse positioning of the medical tissue wrap 10 does not affect the process.
[0131] The medical tissue package 10 is substantially similar to Figure 1 In the illustrated embodiment, however, the longitudinal end portions 18 have retention surfaces 42 configured to facilitate securing a medical adhesive to each longitudinal end portion 18 on the exterior surface of the wall 12. In an alternative, optional embodiment, the retention surface 42 may also be at least partially included on the central portion 14 directly adjacent each longitudinal end portion 18.
[0132] according to Figures 3 to 5 In the depicted embodiment, a plurality of retention surfaces 42 are provided in the form of grooves 46 that extend helically along the outer surface of the wall 12 and along the longitudinal axis defined by the wall 12. The helical shape of the grooves 46 essentially defines a thread shape extending along the outer surface of each longitudinal end portion 18. The grooves 46 or threads are formed in a mirror-image arrangement about the transverse midplane of the wall 12, such that they extend in opposite directions, i.e., clockwise and counterclockwise. While the number of turns can vary, the present embodiment describes grooves 46 having four turns, which has been found to be particularly advantageous in promoting the fixation of medical adhesives while maintaining the structural stability and flexibility of the medical tissue wrap 10. In addition, the grooves 46 terminate at a longitudinal offset from the longitudinal end surface of each end portion 18, which is further advantageous in terms of structural stability.
[0133] Given that Figure 3 The dotted circle in Figure 10 As will be shown in further detail below, the groove 46 can further include rounded edges and define a substantially continuous undercut to enhance the efficacy of the medical adhesive by forming a conformable geometry.
[0134] A structural outer surface modification in the form of a retaining surface 42 is further provided on the thickened portion of the wall 12 compared to the thickness 30 of the wall 12 defining the central portion 14, as shown in FIG. Figure 4 A direct comparison is shown in the longitudinal section view of FIG.
[0135] exist Figure 5In the embodiment of the present invention, radial spacing 24 is discontinuous, meaning that portions with reduced radial spacing 24 exist in the overlapping portions. Specifically, the reduction in radial spacing 24 results in a maximum radial spacing 38 at the level of circumferential end surface 28' of circumferential inner end surface 20. In this example, this reduced radial spacing 24 is provided by the curvature of circumferential outer end surface 22. More specifically, the reduced radial spacing 24 at circumferential end surfaces (28, 28') is approximately 90 percent of the maximum radial spacing 38 of the discontinuous spacing.
[0136] As described above, the longitudinal end portion 18 includes a structural outer surface modification in the form of a retention surface 42 which is located on a thickened portion of the wall 12. Thus, the wall 12 of the circumferential inner end portion 20 is thinner in the circumferential direction than the (thickened) wall 12 of the outer end portion 22 and the (mostly) non-overlapping circumferential portion of the (thickened) wall 12. However, as Figure 5 As shown, the non-overlapping circumferential portion of the wall 12 may include a cross section 35 with reduced wall thickness, which cross section is also directly adjacent to the circumferential inner end portion 20 with reduced wall thickness. Thus, a smooth transition may be provided between (i): the substantially constant wall thickness of the outer end portion and the (mostly) non-overlapping circumferential portion of the wall 12, and (ii): the reduced wall thickness of the inner end portion 20 compared to (i). Thus, the wall thickness may gradually decrease (starting) in the cross section 35 of the non-overlapping circumferential portion of the wall 12 to the inner end portion 20, reaching a minimum wall thickness (in the circumferential direction) at the (circumferential end face 28') of the inner end portion 20. Sharp edges are thus preferably avoided, thereby preferably providing a uniform and stepless outer surface without sharp edges. The thinned portion 35 of the non-overlapping circumferential portion of the wall 12 is provided as a circumferential offset 36. Since the inner end portion of the non-overlapping circumferential portion of wall 12, and optionally, the further adjacent portion 35, has a reduced wall thickness, manufacturing can be facilitated and the circumferential outer end portion 22 can be better aligned with the adjacent outer circumference of the wall. In addition, this can provide ease of handling of medical tissue wrap 10, in particular, ease of access to circumferential outer end portion 22, so that deployment of wall 12 and medical tissue wrap 10 can be supported by providing visual cues and providing a small gripping cavity.
[0137] Figures 6 to 9 Describes the basis Figures 3 to 5 An alternative embodiment of the retention surface 42 of the embodiment of Figure 6An embodiment of the retention surface 42 at the opposite longitudinal end portions 18 is depicted, wherein each longitudinal end portion 18 includes a plurality of grooves 46 extending in opposite circumferential directions and intersecting each other, as indicated by the corresponding arrows. According to an embodiment, four grooves 46 are provided in each circumferential direction of each end portion 18, and the number of grooves 46 is equal in each circumferential direction. Figure 6 As shown, the plurality of grooves 46 in each circumferential direction, together with their half-rotation in a spiral manner along the longitudinal axis defined by the wall 12, provide a diamond or rhombus-like shape on the outer surface of each longitudinal end portion 18 that tends to resemble the surface of a pineapple. Thus, a plurality of retention surfaces 42 having a large number of edges can be provided, which may facilitate the fixation of medical adhesives on each end portion 18. Such a pineapple-like surface can also be provided by providing a plurality of rhombus-shaped chambers, wherein the grooves 46 in the opposite circumferential directions are not completely aligned with each other.
[0138] In accordance with Figure 7 In an embodiment, a plurality of retention surfaces 42 are provided in the form of holes 44. The holes 44 according to this embodiment are substantially circular, but have a slightly ellipsoidal shape, which may, for example, occur during the manufacturing process and are formed as through-holes through the wall 12 defining the medical tissue wrap 10. In an exemplary embodiment, the holes 44 are arranged in two longitudinally spaced rows along the circumference of the wall 12, i.e., within each row, they are arranged linearly along the circumference of the wall 12 and longitudinally offset from each other. A row of holes 44 of the corresponding longitudinal end portion 14 can also be (at least partially) arranged at the center portion 14 directly adjacent to the corresponding longitudinal end portion 18, or at the interface between the center portion 14 and the corresponding longitudinal end portion 18. In the case of a constant wall thickness, the center portion 14 and the longitudinal portion 18 can also be characterized, for example, by structural and / or (bio)chemical properties and / or the materials used for the wall portions. In addition, it is understood that the holes 44 can also be located exclusively at each longitudinal end 18. Each row includes six holes 44 that are equally spaced in the circumferential direction of the wall 12 and arranged in a staggered pattern between adjacent rows.
[0139] according to Figure 8 and Figure 9 The embodiment is basically similar to Figure 3 However, rather than providing embedded grooves in the thickened wall portion of the longitudinal end portion, the longitudinal end portion 18 comprises a plurality of protrusions, such as a combination of ribs 41, located on top of the substantially continuous wall defining the through hole 16 and the medical tissue wrap 10. The ribs 41 are substantially arranged in accordance with Figure 8 The spiral arrangement of the embodiment is arranged according to Figure 9 The ribs 41 of the embodiment are arranged in a linear and circumferential manner.
[0140] Figure 10 Shown in the longitudinal section according to Figure 3 Schematic depiction of the undercut defined by groove 46, as shown in dashed lines. As shown, the top outer surface and bottom surface of groove 46, corresponding to outer radius 50 and inner radius 48, respectively, and defining groove depth 54, are rounded to reduce stress that would otherwise occur in the material of groove 46 having sharp edges. Further, the top surface extends longitudinally over the bottom surface, thereby forming an angle 52 on the bottom surface and a corresponding undercut of groove 46, as shown in dashed lines, wherein the bottom longitudinal extension can be greater than the top longitudinal extension of groove 46. Angle 52, preferably about 75 degrees, and the corresponding undercut form a fit or positive lock with the applied medical adhesive. Corresponding longitudinal end portions 18 can also be provided in the radial direction, further enhancing the effectiveness of the medical adhesive in securing internal anatomical structures at the corresponding longitudinal end portions 18.
[0141] Figure 11 A cross-sectional view of a medical tissue wrap 10 according to the present invention is shown having an optional configuration of a circumferential inner end portion 20 and a circumferential outer end portion 22. This embodiment may be substantially similar to Figure 5 In the embodiment shown, however, in this embodiment, the circumferential inner end portion 20 and the circumferential outer end portion 22 each include a curvature, wherein the curvatures extend in opposite circumferential directions. Thus, each circumferential end face 28, 28' is provided with a gradually decreasing radial spacing 24, wherein the radial spacing 24 decreases starting from a local maximum radial spacing 38.
[0142] The maximum radial spacing 38 described in the present example is arranged such that the circumferential extension 40 of each curvature is substantially the same, i.e., each curvature spans approximately equal angles of the outer circumference of the medical tissue wrap 10. For example, the total angle or circumferential extension of the circumferential outer end portion 22 can be approximately 60 degrees of the outer circumference of the medical tissue wrap 10, with each curvature thus spanning an angle of approximately 30 degrees.
[0143] and Figure 5 The embodiment shown is similar, Figure 11 The embodiment also includes an inner end portion 20 having a reduced wall thickness and a portion 35 of a non-overlapping portion of the wall 12 having a reduced wall thickness and adjacent to the inner end portion 20. Figure 11 As shown, the wall 12 of the circumferential inner end portion 20 is thinner in the circumferential direction than the (thickened) wall 12 of the outer end portion 22 and the (mostly) non-overlapping circumferential direction portions of the (thickened) wall 12 .
[0144] Figure 12A schematic diagram of a medical tissue wrap according to the present invention is shown, wherein the outermost edges of each longitudinal end portion thereof are offset in the longitudinal direction of the wall, and the grooves begin to minimize the additional thickness at the edge of the conduit.
[0145] It will be apparent to those skilled in the art that these embodiments and projects merely describe examples of a plurality of possibilities. Therefore, the embodiments shown here should not be construed as limiting the formation of these features and configurations. Any possible combination and configuration of the described features may be selected according to the scope of the present invention.
[0146] List of Reference Numbers
[0147] 10 Medical tissue wraps
[0148] 12 walls
[0149] 14 Center
[0150] 16 through holes
[0151] 18 longitudinal end portion
[0152] 20 Circumferential inner end portion
[0153] 22 Circumferential outer end portion
[0154] 24 radial spacing
[0155] 26 Curvature
[0156] 28, 28' circumferential end face
[0157] 30 wall thickness
[0158] 32 Internal curvature
[0159] 34 External curvature
[0160] 35 Cross-section of non-overlapping circumferential portion of wall with reduced wall thickness
[0161] 36 Deviation
[0162] 38 Maximum radial spacing
[0163] 40 Circumferential extension
[0164] 41 ribs
[0165] 42 Preserve Surface
[0166] 44 holes
[0167] 46 grooves
[0168] 48 inner radius
[0169] 50 External Radius
[0170] 52 Angle
[0171] 54 Groove Depth
Claims
1. A medical tissue wrap (10) for an internal anatomical structure of a mammal, the tissue wrap (10) being formed from a coiled wall (12), the wall (12) having a circumferential inner end portion (20) and a circumferential outer end portion (22) extending around and overlapping the circumferential inner end portion (20), whereby the wall (12) defines a longitudinal through-hole (16) for receiving at least a portion of the internal anatomical structure, wherein: The circumferential outer end portion (22) is radially spaced from the circumferential inner end portion (20) by a discontinuous spacing in the circumferential direction, and the circumferential outer end portion (22) is free from any direct contact with the circumferential inner end portion (20).
2. The medical tissue wrap (10) of claim 1, wherein the discontinuous spacing comprises a reduced radial spacing (24) formed by a curvature (26) of the circumferential inner end portion (20) and / or a curvature (26) of the circumferential outer end portion (22).
3. The medical tissue wrap (10) of claim 2, wherein the reduced radial spacing (24) is formed as a gradually decreasing spacing; and / or wherein the reduced radial spacing (24) extends from an overlapping portion having a continuous radial spacing.
4. A medical tissue wrap (10) according to any one of the preceding claims, wherein the radial spacing (24) at the circumferential end surface (28') of the circumferential inner end portion (20) is smaller than the radial spacing (24) at the circumferential end surface (28) of the circumferential outer end portion (22).
5. The medical tissue wrap (10) according to any one of claims 1 to 3, wherein the radial spacing (24) at the circumferential end surface (28) of the circumferential outer end portion (22) is smaller than the radial spacing (24) at the circumferential end surface (28') of the circumferential inner end portion (20).
6. The medical tissue wrap (10) according to any one of claims 1 to 3, wherein the radial spacing (24) at the circumferential end surface (28') of the circumferential inner end portion (20) and the circumferential end surface (28) of the circumferential outer end portion (22) is smaller than the radial spacing (24) at the overlapping portion between the circumferential end surface (28') of the circumferential inner end portion (20) and the circumferential end surface (28) of the circumferential outer end portion (22).
7. The medical tissue wrap (10) according to any one of claims 4 to 6, wherein the radial spacing (24) at the circumferential end surface (28, 28') defining the reduced radial spacing (24) is 50 to 99 percent of the maximum radial spacing (38) of the discontinuous spacing, preferably 60 to 99 percent, more preferably 80 to 98 percent, even more preferably 85 to 95 percent, still more preferably 87 to 92 percent, for example about 90 percent.
8. The medical tissue wrap (10) according to any one of claims 4 to 7, wherein the radial spacing (24) at the circumferential end surface (28, 28') defining the reduced radial spacing (24) is 50 μm to 300 μm, preferably 80 μm to 200 μm.
9. The medical tissue wrap (10) according to any one of the preceding claims, wherein the maximum radial spacing (38) of the discontinuous spacing is 100 μm to 350 μm, preferably 150 μm to 250 μm.
10. The medical tissue wrap (10) according to any one of the preceding claims, wherein the circumferential extension (40) of the circumferential outer end portion (22) corresponds to 10 to 100 degrees, preferably 20 to 90 degrees, of the outer circumference of the tissue wrap (10).
11. The medical tissue wrap (10) according to claim 10, wherein the circumferential extension (40) of the circumferential outer end portion (22) corresponds to 20 to 60 degrees, preferably 30 to 45 degrees, of the outer circumference of the tissue wrap (10).
12. A medical tissue wrap (10) according to claim 10 or 11, wherein the radial spacing (24) between the circumferential inner end portion (20) and the circumferential outer end portion (22) starts from the maximum radial spacing (38) of the discontinuous spacing and gradually decreases along the relative circumferential direction; preferably extending at equal angles.
13. A medical tissue wrap (10) for an internal anatomical structure of a mammal, the tissue wrap (10) being formed by a curled wall (12), the wall (12) having a circumferential inner end portion (20) and a circumferential outer end portion (22) extending around and overlapping the circumferential inner end portion (20), whereby the wall (12) defines a longitudinal through-hole (16) for accommodating a portion of the internal anatomical structure, wherein the circumferential outer end portion (22) is radially spaced from the circumferential inner end portion (20), and wherein the wall (12) includes a structural outer surface modification located at at least one opposing longitudinal end portion (18) of the wall (12).
14. A medical tissue wrap (10) according to claim 13, wherein the longitudinally extending central portion (14) of the tissue wrap (10) is arranged between and adjacent to the opposite longitudinal end portions (18) of the tissue wrap (10); preferably, wherein only the longitudinal end portions (18) include structural outer surface modifications.
15. The medical tissue wrap (10) of claim 14, wherein the longitudinal end portion (18) comprises an increased surface roughness compared to the surface roughness of the outer surface of the central portion (14), which is formed by a structural outer surface modification of the longitudinal end portion (18).
16. The medical tissue wrap (10) according to claim 14 or 15, wherein a structural outer surface modification is formed on a wall portion of each longitudinal end portion (18) that is thicker than the wall thickness (30) of the central portion (14).
17. The medical tissue wrap (10) according to claim 16, wherein the wall thickness (30) of the thickened wall portion is 1.1 to 5.0 times, preferably 1.5 to 2.5 times, of the wall thickness (30) of the adjacent central portion (14), and / or is 100 μm to 600 μm, preferably 300 μm to 500 μm.
18. A medical tissue wrap (10) according to claim 16 or 17, wherein the thickened wall portion deviates (36) from the circumferential inner end portion (20) in the circumferential direction, and the deviation (36) preferably includes a gradual increase in wall thickness (30) and / or a circumferential extension of 5 degrees to 25 degrees of the outer circumference of the tissue wrap (10).
19. The medical tissue wrap (10) according to any one of claims 13 to 18, wherein the structural outer surface modification is formed into one or more retention surfaces (42), and the retention surfaces (42) are configured to fix a medical adhesive to each longitudinal end portion (18).
20. The medical tissue wrap (10) according to claim 19, wherein one or more retaining surfaces (42) of each longitudinal end portion (18) are formed as a plurality of ellipsoidal or circular holes (44) arranged in at least one row in the circumferential direction of the wall (12).
21. The medical tissue wrap (10) according to claim 20, wherein the holes (44) are arranged in 2 to 4 rows, wherein each row preferably comprises 4 to 8 holes (44) and / or wherein the holes (44) in adjacent rows are preferably arranged in a staggered manner.
22. The medical tissue wrap (10) according to claim 20 or 21, wherein each of the holes (44) is formed as a cutout, a cavity or a through hole on the wall (12).
23. The medical tissue wrap (10) of claim 19, wherein one or more retaining surfaces (42) of each longitudinal end portion (18) is formed as at least one groove (46) extending in a helical direction along the longitudinal axis defined by the wall (12).
24. The medical tissue wrap (10) of claim 23, wherein the at least one groove (46) includes rounded edges and / or wherein the at least one groove (46) defines at least one undercut.
25. The medical tissue wrap (10) according to claim 23 or 24, wherein the at least one groove (46) defines the outermost edge of each longitudinal end portion (18) in the longitudinal direction of the wall (12).
26. The medical tissue wrap (10) of any one of claims 23 to 25, wherein the at least one groove (46) extends 0.5 to 10 turns around the longitudinal axis defined by the wall (12).
27. The medical tissue wrap (10) of claim 26, wherein the at least one groove (46) extends 2 to 6 turns around the longitudinal axis defined by the wall (12).
28. The medical tissue wrap (10) according to claim 26, wherein each longitudinal end portion (18) includes at least two grooves (46) extending in opposite circumferential directions and intersecting each other, each groove (46) extending 0.5 to 5 turns around the longitudinal axis.
29. The medical tissue wrap (10) of claim 19, wherein the one or more retaining surfaces (42) of each longitudinal end portion (18) are formed as one or more circumferential ribs (41) extending from the outer surface of the wall (12).
30. The medical tissue wrap (10) according to claim 29, wherein the extension of one or more ribs (41) is linear in the circumferential direction or includes a deviation relative to the circumferential direction in the longitudinal direction of the wall (12).
31. A medical tissue wrap (10) according to any one of claims 1 to 12, wherein the wall (12) includes a structural outer surface modification of the wall (12) defined in any one of claims 13 to 30 at least at the opposite longitudinal end portions (18).
32. The medical tissue wrap (10) according to any one of the preceding claims, wherein the medical tissue wrap (10) is configured to accommodate nerve tissue, preferably a damaged peripheral nerve, more preferably the proximal and distal ends of a single damaged peripheral nerve.
33. The medical tissue package (10) of any one of the preceding claims, wherein the circumferential outer end portion (22) is formed by a single wall layer overlapping the circumferential inner end portion (20).
34. The medical tissue wrap (10) of any one of the preceding claims, wherein the wall (12) is curled only in the circumferential direction.
35. The medical tissue wrap (10) according to any one of the preceding claims, wherein the circumferential inner end portion (20) and the circumferential outer end portion (22) are arranged on circumferentially opposite end portions (20, 22) of the wall (12).
36. The medical tissue wrap (10) of any one of the preceding claims, wherein the wall (12) is at least partially expandable and rerollable in a circumferential direction.
37. The medical tissue wrap (10) according to any of the preceding claims, wherein the wall (12) is at least partially formed from a tough or elastic material, preferably a three-dimensionally printable material.
38. The medical tissue wrap (10) according to any one of the preceding claims, wherein the wall (12) comprises a thickness (30) of 50 μm to 400 μm, preferably 150 μm to 250 μm.
39. The medical tissue wrap (10) of any one of the preceding claims, wherein the wall (12) is formed of a biocompatible material, an inert material, a bioimplantable material, and / or a biodegradable material.
40. The medical tissue wrap (10) according to any one of the preceding claims, wherein the wall (12) is formed from a polymer-based material, preferably an elastomer.
41. A medical tissue wrap (10) according to any one of the preceding claims, wherein the wall (12) is formed by polymerized and / or cross-linked polymer units, and the polymer units preferably include an ester component and an acid ester component, wherein the ester component is preferably a polyol and / or the acid ester component is preferably a polyacid.
42. The medical tissue wrap (10) according to any one of the preceding claims, formed by a 3D printing process.
43. Use of the medical tissue wrap (10) according to any one of the preceding claims for repairing, supporting and / or guiding nerve tissue, in particular for repairing peripheral nerve damage.
44. Use of the medical tissue wrap (10) according to claim 43, wherein the medical tissue wrap (10) is used in combination with a medical adhesive.
45. A method for treating peripheral nerve damage, comprising the following steps: - providing a medical tissue wrap according to any one of the preceding claims; - expanding the wall of the medical tissue wrap to provide a circumferential gap between the circumferential end surface of the circumferential inner end portion and the circumferential end surface of the circumferential outer end portion; - inserting the damaged nerve through the gap into the medical tissue wrap; and -Fixes the damaged nerve within the wall by rerolling the wall.
46. A method of supporting a nerve, comprising the steps of: - providing a medical tissue wrap according to any one of the preceding claims; - expanding the wall of the medical tissue wrap to provide a circumferential gap between the circumferential end surface of the circumferential inner end portion and the circumferential end surface of the circumferential outer end portion; - inserting the nerve to be supported through the gap into the medical tissue wrap; and - The nerve to be supported is fixed within the wall by rerolling the wall.
47. The method according to claim 45 or 46, wherein the step of fixing the nerve is further performed by applying a medical adhesive outside the through hole at the circumferential end faces of the circumferential outer portion and / or at the opposite longitudinal end portions of the wall.
Citation Information
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