Impression and compression guide

Abstract

An external needle guide includes a body having one or more grip features and an indentation surface. The indentation surface includes protrusions, that when impressed against skin of a patient, leaves an indentation on the skin above an access aperture of an implant. A method of using the external needle guide includes feeling for an indication of the implant, aligning, using the one or more grip features, the indentation surface over the access aperture of the implant, and impressing the indentation surface into the skin of the patient over the access aperture of the implant so as to leave the indentation on the skin of the patient.

Description

IMPRESSION AND COMPRESSION GUIDEBACKGROUND

[0001] Repeated cannulations in the same spot can cause injury to a patient, including painful hematomas and unnecessary blood loss as well as potential for infection due aneurysm formation from the weakened vessel and skin breakdown Patients on dialysis who have a high flowing arteriovenous fistula (e.g., connection of an artery to a vein), require needle punctures with large needles into the fistula three days a week at two locations for each treatment after their kidneys have failed. If the same site is punctured over and over, these repetitive cannulations can cause weakening of the vessel wall and formation of an aneury sm. The weakened vessel wall and aneurysm can breakdown and put the patient at risk for catastrophic bleeding as well as prevent the patient from receiving dialysis treatment which is critical for patient survival.. When the vessel develops an aneurysm, the patient may be forced to undergo additional surgeries to repair the existing arteriovenous fistula and aneurysm or create a new arteriovenous fistula. In addition, many arteriovenous fistulas last about three years, commonly failing due to repetitive single site punctures.

[0002] Even in cases where the vessel is protected by a surgical implant, bad punctures (including those that miss the access aperture of the surgical implant) can still cause painful injuries, increase the risk of infection due to the skin not having time to heal correctly, and lead to the damage of the vessel and / or port. In addition, simply marking on the skin, for example, with a pen and / or marker, is not effective because the alcohol or chlorhexidine used to clean the skin prior to cannulation generally removes ink from the skin.

[0003] Another issue with dialysis patients is after the large dialysis needles are removed from the high flowing arteriovenous fistulas, compression is not applied to the correct area corresponding to the site of needle insertion. Incomplete compression after needle removal can result in excessive bleeding under the skin causing a large collection of blood in the tissues called hematoma. Also, the leaking vessel can form a pseudoaneurysm (aneurysm which does not have a wall but contains circulating blood and is confined in place by the surrounding soft tissues). Both a hematoma and pseudoaneurysm are at risk for catastrophic bleeding as well as loss of the patient’s fistula which is their lifeline for dialysis treatments.

[0004] Therefore, there is a need to provide an exterior marker so that cannulations can be rotated in order to give the skin and the wall of the vessel time to heal between cannulations while also providing accurate placement of the needles to prevent bad punctures that damage the vessel and surrounding tissue. There is also a need for a compression device that providesaccurate placement and compression to the correct area corresponding to the site of needle insertion once the needle is removed.BRIEF SUMMARY

[0005] External needle guides are provided to facilitate accurate cannulation of surgical implants. As mentioned above, vessels and / or ports in surgical implants may be repeatedly punctured for treatment, which can cause painful injuries, increase the risk of infection due to the skin not having time to heal correctly, and lead to the damage of the underlying vessel and / or port. Advantageously, the external needle guides described herein provide accurate markings, in the form of indentation(s) on the skin of the patient so that cannulations can be rotated in order to give the skin and the wall of the vessel and / or port time to heal between cannulations while also preventing bad punctures that damage the vessel and surrounding tissue. The impression left in the skin is temporary and harmless to the patient but lasts long enough to facilitate cleaning of skin and subsequent needle insertion.

[0006] An external needle guide includes a body having one or more grip features and an indentation surface. The indentation surface includes protrusions, that when impressed against skin of a patient, leaves an indentation on the skin above an access aperture of an implant. In some cases, a detachable compression feature may be included with the external needle guide. The detachable compression feature can be made of silicone and / or material that includes similar properties to silicone. The detachable compression feature can include a compression body that is shaped and / or configured to fit within a boundary of an access aperture of the underlying implant.

[0007] A method of using the external needle guide includes feeling for an indication of the implant, aligning, using the one or more grip features, the indentation surface over the access aperture of the implant, and impressing the indentation surface into the skin of the patient over the access aperture of the implant so as to leave the indentation on the skin of the patient.

[0008] This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter.BRIEF DESCRIPTION OF THE DRAWINGS

[0009] FIG. 1 illustrates an external needle guide.

[0010] FIG. 2A illustrates an external needle guide and a detachable compression feature.

[0011] FIG. 2B illustrates an external needle guide and a detachable compression feature in relation to an implant.

[0012] FIG. 3 illustrates an indentation surface in relation to an access aperture of an implant.

[0013] FIG. 4A illustrates an external needle guide being impressed into skin of a patient.

[0014] FIG. 4B illustrates cannulating a vessel of the patient within a first impression on the skin of the patient.

[0015] FIG. 5 illustrates a method of using an external needle guide.DETAILED DESCRIPTION

[0016] External needle guides are provided to facilitate accurate cannulation of surgical implants. As mentioned above, vessels and / or ports in surgical implants may be repeatedly punctured for treatment, which can cause painful injuries, increase the risk of infection due to the skin not having time to heal correctly, and lead to the damage of the underlying vessel and / or port. Advantageously, the external needle guides described herein provide accurate markings, in the form of indentation(s) on the skin of the patient so that cannulations can be rotated in order to give the skin and the wall of the vessel and / or port time to heal between cannulations while also preventing bad punctures that damage the vessel and surrounding tissue. The impression left in the skin is temporary and harmless to the patient but lasts long enough to facilitate cleaning of skin and subsequent needle insertion.

[0017] FIG. 1 illustrates an external needle guide. Referring to FIG. 1, an external needle guide 100 includes a body 102 having one or more grip features 104 and an indentation surface 106. The indentation surface 106 includes protrusions 108, that when impressed against skin of a patient, leaves an indentation on the skin (e.g., as illustrated in FIG. 4B) above an access aperture of an implant.

[0018] The protrusions 108 of the indentation surface 106 are shaped to provide the indentation when impressed against the skin of the patient. In some cases, a perimeter of the indentation surface 106 is further shaped to align with a boundary of the of the implant and underlying vessel. In some cases, the indentation caused by the protrusions 108 of the indentation surface 106 when impressed against the skin of the patient includes a plurality of cannulation zones above the access aperture of the implant. In some cases, the indentation surface 106 extends perpendicular from the body 102.

[0019] In this embodiment, the protrusions 108 of the indentation surface 106 cause three cannulation zones to be formed when impressed against the skin of the patient since dialysispatients frequently undergo dialysis treatments 3 times per week. However, different configurations of protrusions 108 of the indentation surface 106 are contemplated herein to cause any number of cannulation zones to be formed. For example, the indentation caused by the protrusions 108 of the indentation surface 106 when impressed against the skin of the patient can include one cannulation zone, two cannulation zones, three cannulation zones, four cannulation zones, five cannulation zones, six cannulation zones, seven cannulation zones, eight cannulation zones, nine cannulation zones, or ten cannulation zones. Advantageously, cannulations can be rotated across cannulation zones to give the skin and the wall of the vessel and / or port time to heal between cannulations while also preventing bad punctures that damage the vessel and surrounding tissue. Furthermore, the number of cannulation zones can be adjusted based on the access aperture and / or port of the implant and the frequency in which cannulations are needed (e.g., daily, bi-weekly, weekly, etc.)

[0020] In some cases, the body 102 further includes a plurality of apertures 110 corresponding to the protrusions 108 of the indentation surface 106. In some cases, the protrusions 108 of the indentation surface 106 are spaced one centimeter in length (e.g., center to center). In some cases, the plurality of cannulation zones are each one centimeter in length (e g., center to center).

[0021] In some cases, the one or more grip features 104 include a first fingerhold 112 at a first end 114 of the body 102 and a second fingerhold 116 at a second end 118 of the body 102.The first fingerhold 112 and / or the second fingerhold 116 can be arcuate in shape. In some cases, the first fingerhold 112 and the second fingerhold 116 have the same shape as one another. In some cases, first fingerhold 112 may have a different shape than the second fingerhold 116. For example, the first fingerhold 112 may be shaped for an index and / or middle finger of a user while the second fingerhold 116 may be shaped for a thumb of a user. Any shape of the one or more grip features 104 that provide the ability for a user to hold and place the external needle guide correctly are contemplated herein.

[0022] FIG. 2A illustrates an external needle guide and a detachable compression feature.FIG. 2B illustrates an external needle guide and a detachable compression feature in relation to an implant. Referring to FIGs. 2A and 2B, an external needle guide 200 includes a body 202 having one or more grip features 204 and an indentation surface 206. The indentation surface 206 includes protrusions 208, that when impressed against skin of a patient, leaves an indentation on the skin (e.g., as illustrated in FIG. 4B) above an access aperture 220 of an implant 222. The body 202 further includes a plurality of apertures 210 corresponding to the protrusions 208 of the indentation surface 206.

[0023] The external needle guide 200 further includes a detachable compression feature 212 that couples to the indentation surface 206. The detachable compression feature 212 can be made of silicone and / or material that includes similar properties to silicone. The detachable compression feature 212 can include a compression body 214 that is shaped and / or configured to fit within a boundary' of an access aperture 220 of the implant 222.

[0024] The detachable compression feature 212 can further include a set of attachment plugs 216. Each of the set of attachment plugs 216 is shaped to fit within an aperture of the plurality of apertures 210 corresponding to the protrusions 208 of the indentation surface 206. Therefore, when a patient is finished cannulating their vessel and / or port, the detachable compression feature 212 can be attached to the external needle guide 200 using the set of attachment plugs 216. The compression body 214 can then be placed on the surface of the skin and within the boundary of the access aperture 220 of the implant 222 and compressed against the skin to promote healing and / or directly stop bleeding from the cannulation site.

[0025] FIG. 3 illustrates an indentation surface in relation to an access aperture of an implant. Referring to FIG. 3, an external needle guide 300 includes a body 302 having one or more grip features 304 and an indentation surface 306. The indentation surface 306 includes protrusions 308, that when impressed against skin of a patient, leaves an indentation on the skin (e.g., as illustrated in FIG. 4B) above an access aperture of an implant 310. The indentation surface 306 is shaped to align with the access aperture 312 of the implant 310. A perimeter 314 of the indentation surface 306 is further shaped to align with a boundary 316 of the access aperture 312 of the implant 310.

[0026] FIG. 4A illustrates an external needle guide being impressed into skin of a patient.FIG. 4B illustrates cannulating a vessel of the patient within a first impression on the skin of the patient. A photograph showing the imprint / indentation on the skin is included in the inset of FIG. 4B. FIG. 5 illustrates a method of using an external needle guide. Referring to FIGs.4A, 4B, and 5, a method 500 of using an external needle guide 400 includes feeling (502) for an indication of the implant, aligning (504), using the one or more grip features 404 of the body 402, the indentation surface over the access aperture of the implant, and impressing (506) the indentation surface into the skin 410 of the patient over the access aperture of the implant so as to leave the indentation 412 on the skin 410 of the patient.

[0027] In some cases, impressing (506) the indentation surface into the skin 410 of the patient over the access aperture of the implant includes impressing the indentation surface into the skin 410 of the patient over the access aperture of the implant for at least five seconds. Of course, more or less time may be used to impress the indentation surface into the skin 410 ofthe patient over the access aperture of the implant so as to leave the indentation 412 on the skin 410 of the patient depending on. for example, the force that is used to impress the indentation surface into the skin 410 of the patient over the access aperture of the implant and / or the sensitivity of the skin 410 of the patient. For example, impressing (506) the indentation surface into the skin 410 of the patient over the access aperture of the implant can include impressing the indentation surface into the skin 410 of the patient over the access aperture of the implant for any time period within the range of one second to one minute.

[0028] In some cases, the method 500 further includes compressing a detachable compression feature (e.g., detachable compression feature 212 of FIGs.2A and 2B) within the boundary of the access aperture of the implant after the vessel and / or port has been cannulated. In some cases, the method 500 further includes coupling the detachable compression feature to the indentation surface before compressing the detachable palpable feature within the boundary of the access aperture of the implant and uncoupling the detachable compression feature from the indentation surface (e.g., after the vessel and / or port has been cannulated).

[0029] In some cases, the method 500 further includes cannulating (508) a vessel or port of the patient within a first cannulation zone 414 of the plurality of cannulation zones 416 of the indentation 412. In some cases, the method 500 further includes feeling (510) for the indication of the access aperture of the implant, aligning (512), using the one or more grip features 404 of the body 402, the indentation surface over the access aperture of the implant, impressing (514) the indentation surface into the skin 410 of the patient over the access aperture of the implant so as to leave the indentation 412 on the skin 410 of the patient, and cannulating (516) the vessel or port of the patient within a second cannulation zone 418 of the plurality of cannulation zones 416 of the indentation 412.

[0030] In some cases, feeling (502) for the indication of the implant comprises feeling for the indication of the access aperture of the implant. In some cases, feeling (502) for the indication of the implant comprises feeling for one or more margins of the implant. In some cases, feeling (502) for the indication of the implant comprises feeling for one or more margins of the vascular access aperture of the implant. In some cases, feeling (502) for the indication of the implant comprises feeling for a shape of a feature on the implant.

[0031] These steps may be performed, for example, on a subsequent day and / or time when treatment is necessary, thereby giving the skin 410, vessel, and / or port adequate time to heal between each new puncture. Furthermore, the feeling, aligning, impressing, and cannulating steps may be performed for each cannulation zone of the plurality of cannulation zones to give skin 410, vessel, and / or port adequate time to heal between each new puncture. Then, thefeeling, aligning, impressing, and cannulating steps can be repeated beginning with the first cannulation zone of the plurality of cannulation zones. In some cases, such as when an implant having a single access aperture is used for removal and return of blood to the vessel for dialysis treatment, the feeling (510), aligning (512), and impressing (514) steps may not be necessary; and both cannulating (508, 516) steps are performed in response to the feeling (502), aligning (504), and impressing (506) steps.

[0032] Although the subject matter has been described in language specific to structural features and / or acts, it is to be understood that the subject matter defined in the appended claims is not necessarily limited to the specific features or acts described above. Rather, the specific features and acts described above are disclosed as examples of implementing the claims and other equivalent features and acts are intended to be within the scope of the claims.

Claims

CLAIMSWhat is claimed is:

1. An external needle guide comprising:a body having one or more grip features and an indentation surface.wherein the indentation surface comprises protrusions, that when impressed against skin of a patient, leaves an indentation on the skin above an access aperture of an implant and blood vessel.

2. The external needle guide of claim 1, wherein the indentation surface is shaped to align with the access aperture of the implant.

3. The external needle guide of claim 1, wherein the protrusions of the indentation surface are shaped to provide the indentation when impressed against the skin of the patient.

4. The external needle guide of claim 1, wherein the indentation comprises a plurality of cannulation zones above the access aperture of the implant.

5. The external needle guide of claim 4, wherein the plurality of cannulation zones are at least three cannulation zones.

6. The external needle guide of claim 4, wherein the body further comprises a plurality of apertures corresponding to the protrusions of the indentation surface.

7. The external needle guide of claim 4, wherein the plurality of cannulation zones are each one centimeter in length.

8. The external needle guide of claim 1, wherein the indentation surface extends perpendicular from the body.

9. The external needle guide of claim 1, wherein the one or more grip features comprise a first fingerhold at a first end of the body and a second fingerhold at a second end of the body.

10. The external needle guide of claim 1, further comprising a detachable compression feature that couples to the indentation surface.

11. The external needle guide of claim 10, wherein the detachable compression feature is configured to fit within a boundary of an access aperture of the implant.

12. The external needle guide of claim 1, wherein a perimeter of the indentation surface is further shaped to align with a boundary of the access aperture of the implant.

13. A method of using the external needle guide of claim 1, comprising:feeling for an indication of the implant;aligning, using the one or more grip features, the indentation surface over the access aperture of the implant; andimpressing the indentation surface into the skin of the patient over the access aperture of the implant so as to leave the indentation on the skin of the patient.

14. The method of claim 13, wherein impressing the indentation surface into the skin of the patient over the access aperture of the implant comprises impressing the indentation surface into the skin of the patient over the access aperture of the implant for at least five seconds.

15. The method of claim 13 and the external needle guide of claim 11, further comprising compressing the detachable compression feature within the boundary of the access aperture of the implant.

16. The method 15, further comprising:coupling the detachable compression feature to the indentation surface before compressing the detachable palpable feature within the boundary of the access aperture of the implant; anduncoupling the detachable compression feature from the indentation surface.

17. The method of claim 13 and the external needle guide of claim 4, further comprising cannulating a vessel or port of the patient within a first cannulation zone of the lurality of cannulation zones of the indentation.

18. The method of claim 17, further comprising:feeling for the indication of the access aperture of the implant;aligning, using the one or more grip features, the indentation surface over the access aperture of the implant;impressing the indentation surface into the skin of the patient over the access aperture of the implant so as to leave the indentation on the skin of the patient; andcannulating the vessel or port of the patient within a second cannulation zone of the plurality of cannulation zones of the indentation.

19. The method of claim 13, wherein feeling for the indication of the implant comprises feeling for the indication of the vascular access aperture of the implant.

Images