Method of transradial catheterization, device for ulnar artery compression, and method of use

• US 9,308,000 B2
• Filed: 07/12/2013
• Issued: 04/12/2016
• Est. Priority Date: 07/12/2013
• Status: Active Grant

• Current Assignee: VasoInnovations, Inc.
• Original Assignee: VasoInnovations, Inc.
• Inventors: Pancholy, Samir
• Primary Examiner(s): Aleman, Sarah W
• Assistant Examiner(s): Boutsikaris, Socrates L
• Application Number:
  US13/941,219
• Publication Number:
  US 20150018868A1
• Time in Patent Office: 1,005 Days
• Field of Search: 606/203, 606/202, 606/201, 601/132, 601/151, 601/33, 601/40
• US Class Current: 1/1
• CPC Class Codes: A61B 17/12 for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord specially adapted for vas deferens or fallopian tubes A61F6/20; materials for ligaturing blood vessels A61L17/00
• CPC Class Codes: A61B 17/1325 with means for applying local pressure pressure pads A61F5/30
• CPC Class Codes: A61B 17/135 inflatable for measuring blood pressure A61B5/022; inflatable pressure pads A61F5/34
• CPC Class Codes: A61B 2017/12004 for haemostasis, for prevention of bleeding

Abstract

Disclosed are methods and devices for obtaining patent hemostasis of the radial artery by compressing the uninstrumented ulnar artery to increase radial artery flow. The device comprises a band having an inflatable bladder for applying blunt pressure to the ulnar artery. The method comprises applying a pressure to the homolateral ulnar artery and applying a pressure to the radial artery at the access site to obtain hemostasis at the access site.

Claims

1. A method of catheterization of a radial artery of a patient, directed at minimizing occurrences of radial artery occlusion, comprising the steps of:

(a) inserting a sheath into the radial artery at an access site;

(b) performing a catheterization procedure using the sheath to access the radial artery;

(c) applying a first pressure to a homolateral ulnar artery at an ulnar pressure site while the sheath remains inserted in the radial artery, thereby increasing flow in the radial artery;

(d) removing the sheath from the radial artery while maintaining the first pressure to the ulnar artery; and

(e) applying a second pressure to the radial artery at the access site to obtain hemostasis at the access site, wherein step (c) precedes step (e).

2. The method of claim 1, further comprising the step of:

prior to step (e), confirming that the step of applying the first pressure has reduced blood flow through the ulnar artery by monitoring flow of the ulnar artery prior to and after the applying the first pressure.

3. The method of claim 2, wherein the step of monitoring flow of the ulnar artery includes sensing skin blood flow and/or pulsation at a fingertip or other location downstream of the ulnar pressure site.

4. The method of claim 1, further comprising the step of:

monitoring and/or confirming patency of the radial artery during the step of applying the second pressure to the radial artery by sensing skin blood flow and/or pulsation at a fingertip or other location downstream of the access site.

5. The method of claim 4, wherein the sensing is performed while the ulnar artery is fully compressed or partially compressed.

6. The method of claim 4, wherein the step of confirming patency further comprises obtaining a metric relating to the sensing and comparing the metric with a standard metric for the patient, or with a previously-sensed metric.

7. The method of claim 6, wherein the previously sensed metric is read after the step (c) of applying the first pressure and before the step (d) of removing the sheath from the radial artery.

8. The method of claim 7, wherein the step of confirming patency further includes the use of digital plethysmography.

9. The method of claim 1, wherein the step of applying the first pressure to the ulnar artery comprises:

providing a band having an inflatable bladder, securing the band over a wrist such that the bladder contacts the ulnar pressure site, and inflating the bladder to compress the ulnar artery at the ulnar pressure site.

10. The method of claim 9, wherein the ulnar pressure site is a Guyon'"'"'s canal.

11. The method of claim 1, wherein the step of applying the second pressure to the radial artery at the access site to obtain hemostasis at the access site is accomplished while maintaining the first pressure to the ulnar artery.

12. The method of claim 1, wherein the step of applying the first pressure to the ulnar artery comprises:

providing an ulnar impinger, securing the ulnar impinger over a wrist such that the impinger contacts the ulnar pressure site, and activating the impinger to press on the ulnar artery at the ulnar pressure site.

13. The method of claim 12, wherein the ulnar pressure site is a Guyon'"'"'s canal.

14. A method of obtaining patent hemostasis of a radial artery of a patient after performing a catheterization procedure using a sheath to access the radial artery wherein the sheath is inserted into the radial artery at an access site, comprising performing the following steps in sequence:

(i) applying a first pressure to a homolateral ulnar artery at an ulnar pressure site while the sheath remains inserted in the radial artery, thereby increasing flow in the radial artery;

(ii) reading a first metric comprising a sensing of skin blood flow and/or pulsation at a fingertip or other location downstream of the access site;

(iii) removing the sheath from the radial artery while maintaining the first pressure to the ulnar artery;

(iv) applying a second pressure to the radial artery at the access site to obtain hemostasis at the access site; and

(v) confirming patency of the radial artery by obtaining a second metric relating to the sensing and comparing the second metric with the first metric.

15. The method of claim 14 further comprising means for applying the first pressure to the homolateral ulnar artery.

16. The method of claim 14, wherein the ulnar pressure site is a Guyon'"'"'s canal.

17. The method of claim 14, wherein the sensing in step (v) is performed while the ulnar artery is fully compressed or partially compressed.

18. The method of claim 14, wherein the step of applying the second pressure to the radial artery at the access site to obtain hemostasis at the access site is accomplished while maintaining the first pressure to the ulnar artery.

19. The method of claim 14, wherein confirming patency of the radial artery is performed during the step of applying the second pressure to the radial artery to obtain hemostasis at the access site.