IMPLANTATION NEEDLE FOR INSERTING A SUBCUTANEOUSLY INSERTABLE ELEMENT INTO A BODY TISSUE

Abstract

An implantation needle for inserting a subcutaneously insertable element into a body tissue, a kit for inserting a subcutaneously insertable element into a body tissue and a method of manufacturing an implantation needle are described. The implantation needle comprises at least one covering comprising at least one pharmaceutical compound. The pharmaceutical compound is configured to remain at least partially in the body tissue after insertion of the subcutaneously insertable element.

Claims

1. An implantation needle for inserting a subcutaneously insertable element into a body tissue, the implantation needle comprising a covering comprising a pharmaceutical compound, wherein the pharmaceutical compound is configured to remain at least partially in the body tissue after insertion of the subcutaneously insertable element.

2. The implantation needle according to claim 1, wherein the pharmaceutical compound is selected from the group consisting of an immunosuppressive, an anti-allergic and an anti-inflammatory agent.

3. The implantation needle according to claim 1, wherein the pharmaceutical compound is selected from the group consisting of dexamethasone, a derivative of dexamethasone, betamethasone and a derivative of betamethasone.

4. The implantation needle according to claim 1, wherein the pharmaceutical compound comprises at least one compound configured to improve tolerance of the subcutaneously insertable element.

5. The implantation needle according to claim 1, wherein the pharmaceutical compound is configured to reduce at least one of an immune rejection, a scarring, a growth of infectious agents.

6. The implantation needle according to claim 1, wherein the covering comprises at least one excipient.

7. The implantation needle according to claim 6, wherein the excipient is selected from the group consisting of a polylactide, a polyglycolide and a polydioxanone.

8. The implantation needle according to claim 1, wherein the implantation needle comprises an outer surface facing an outer environment of the implantation needle and an inner surface facing an interior space of the implantation needle, wherein the covering at least partially covers the outer surface.

9. The implantation needle according to claim 1, wherein the implantation needle comprises a subcutaneously insertable element receiving portion and a tip portion that is at least partially covered with the covering.

10. The implantation needle according to claim 9, wherein the tip portion further comprises an adhesive coating arranged between a surface of the implantation needle and the covering.

11. The implantation needle according to claim 1, wherein the pharmaceutical compound is configured to be released via a mechanical stripping process during withdrawal of the implantation needle from the body tissue.

12. The implantation needle according to claim 1, wherein the pharmaceutical compound is configured to be released via a dissolving process of the pharmaceutical compound.

13. A kit for inserting a subcutaneously insertable element into a body tissue, the kit comprising: an implantation needle according to claim 1; and a subcutaneously insertable element.

14. The kit of claim 13, wherein the needle comprises a receiving portion configured to house the insertable element.

15. A method of manufacturing the implantation needle according to claim 1, the method comprising: a) providing at least one needle element; and b) covering at least one surface of the needle element with a pharmaceutical compound by a covering process to form the implantation needle.

16. The method according to claim 15, wherein the covering process is selected from the group consisting of dip coating; powder coating; spray coating; printing; lamination; dispensing; physical vapor deposition; chemical vapor deposition; electrospinning; electroplating; chemical surface functionalizing.

17. A method of inserting an implantable sensor subcutaneously in a patient, the method comprising: providing an implantation needle; providing an implantable sensor carried by the implantation needle; at least partially covering an exterior surface of the implantation needle with a pharmaceutical compound; inserting the implantation needle into the skin of the patient; removing the implantation needle while retaining the implantable sensor at least partially within the skin of the patient; retaining at least a portion of the pharmaceutical compound within and/or on the skin of the patient after the step of removing the implantation needle.

18. The method of claim 17, further comprising providing an adhesive disposed between an outer surface of the implantation needle and the pharmaceutical compound.

19. The method of claim 18, further comprising using the adhesive to prevent the pharmaceutical compound from delaminating during the insertion.

20. The method of claim 18, further comprising peeling the pharmaceutical compound from the implantation needle and depositing the pharmaceutical compound on and/or in the skin during removal of the implantation needle.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0108] The above-mentioned aspects of exemplary embodiments will become more apparent and will be better understood by reference to the following description of the embodiments taken in conjunction with the accompanying drawings, wherein:

[0109] FIG. 1 shows an exemplary embodiment of a kit according to this disclosure in a top view; and

[0110] FIG. 2 shows an exemplary embodiment of an implantation needle according to this disclosure in a cross-sectional view.

DESCRIPTION

[0111] The embodiments described below are not intended to be exhaustive or to limit the invention to the precise forms disclosed in the following detailed description. Rather, the embodiments are chosen and described so that others skilled in the art may appreciate and understand the principles and practices of this disclosure.

[0112] FIG. 1 shows an exemplary embodiment of a kit 108 for inserting a subcutaneously insertable element 112 into a body tissue. The kit 108 comprises an implantation needle 110 and a subcutaneously insertable element 112.

[0113] The implantation needle 110 may host the subcutaneously insertable element 112. The subcutaneously insertable element 112 may exemplarily be an analyte sensor 114. The analyte sensor 114 may extend along a longitudinal axis A-A′ (denoted by reference number 116) in FIG. 1. The subcutaneously insertable element 112 may be received within the implantation needle 110.

[0114] Specifically, the implantation needle 110 may have an insertable element receiving portion 118 and a tip portion 120. Further, the implantation needle 110 may be a slotted needle 122. The slotted needle 122 may have a first slot 124 forming an angle of 10° to 80° to the longitudinal axis 116 of the implantation needle 110. The first slot 124 comprises the at least one cut surface 126 extending from an edge point 128 of the implantation needle 110. Specifically, the implantation needle 110 may comprise at least one outer surface 130 facing an outer environment 132 of the implantation needle 110 and at least one inner surface 134 facing an interior space 136, specifically a lumen 138, of the implantation needle 110. The interior space 136 may specifically be at least partially enclosed by walls 146 of the implantation needle 110. The cut surface 126 specifically may correspond to an intermediate area 140 formed between at least one outer edge 142 of the outer surface 130 and at least one inner edge 144 of the inner surface 134. Further the implantation needle 110 may have a second slot 148 extending along the longitudinal axis 116.

[0115] Moreover, the implantation needle 110 comprises at least one covering (not illustrated in FIG. 1). The covering comprises at least one pharmaceutical compound. The covering may exemplarily cover the tip portion 120, specifically the outer surface 130 of the tip portion 120 and/or the cut surface 126. Still, however, a different distribution of the covering onto the implantation needle 110 is feasible.

[0116] FIG. 2 shows an exemplary embodiment of an implantation needle 110 in a cross-sectional view. The implantation needle 110 corresponds at least in wide parts to the implantation needle 110 as illustrated in FIG. 1. Thus, reference can be made to the description of FIG. 1 above.

[0117] As outlined above, the implantation needle may comprise the at least one outer surface 130 facing the outer environment 132 of the implantation needle 110. One first portion 150 of the outer surface 130 may be covered with at least one adhesive coating 152. One second portion 154 may be covered with at least one non-stick coating 156. Specifically, the first portion 150 may correspond to the tip portion 120 as described above and the second portion 154 may correspond to the insertable element receiving portion 118 as described above. However, other embodiments may be feasible.

[0118] Further, the implantation needle 110 comprises the at least one covering, as denoted with reference number 158 in FIG. 2. The covering 158 comprises at least one pharmaceutical compound. The adhesive coating 152 may be arranged between the outer surface 130 and the covering 158. Specifically, the adhesive coating 152 may be configured to provide a bonding between the implantation needle 110 and the covering 158. Specifically, the coating 158 may be arranged on top of the adhesive coating 152 and the non-stick coating 156. However, also other embodiments may be feasible.

[0119] While exemplary embodiments have been disclosed hereinabove, the present invention is not limited to the disclosed embodiments. Instead, this application is intended to cover any variations, uses, or adaptations of this disclosure using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this invention pertains and which fall within the limits of the appended claims.

LIST OF REFERENCE NUMBERS

[0120] 108 Kit [0121] 110 implantation needle [0122] 112 subcutaneously insertable element [0123] 114 analyte sensor [0124] 116 longitudinal axis [0125] 118 insertable element receiving portions [0126] 120 tip portion [0127] 122 slotted needle [0128] 124 first slot [0129] 126 cut surface [0130] 128 edge point [0131] 130 outer surface [0132] 132 outer environment [0133] 134 inner surface [0134] 136 interior space [0135] 138 Lumen [0136] 140 intermediate space [0137] 142 outer edge [0138] 144 inner edge [0139] 146 Wall [0140] 148 second slot [0141] 150 first portion [0142] 152 adhesive coating [0143] 154 second portion [0144] 156 non-stick coating [0145] 158 Covering