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

• US 9,510,838 B2
• Filed: 03/06/2016
• Issued: 12/06/2016
• Est. Priority Date: 07/12/2013
• Status: Active Grant

• Current Assignee: VasoInnovations, Inc.
• Original Assignee: VasoInnovations, Inc.
• Inventors: Pancholy, Samir Bipin
• Primary Examiner(s): Holwerda, Kathleen
• Assistant Examiner(s): Boutsikaris, Socrates L
• Application Number:
  US15/062,150
• Publication Number:
  US 20160183951A1
• Time in Patent Office: 275 Days
• Field of Search: 606201-203, 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 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 hemostatic pressure to the radial artery while simultaneously increasing radial artery flow by applying an ulnar pressure to an ulnar artery at an ulnar pressure site;

(ii) maintaining continued partial compression of the ulnar artery, thereby maintaining an increased flow of blood inside the radial artery, at least until hemostasis of the radial artery is achieved.

2. The method of claim 1, further comprising means for applying the ulnar pressure to the ulnar artery.

3. The method of claim 1, wherein the ulnar pressure site is a Guyon'"'"'s canal.

4. The method of claim 1, further comprising monitoring patency of the radial artery by sensing.

5. The method of claim 4, further comprising confirming patency of the radial artery while applying pressure to the radial artery to obtain hemostasis at the access site.

6. The method of claim 1, wherein applying the ulnar 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.

7. The method of claim 1, wherein applying the ulnar 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.

8. The method of claim 5, wherein the step of confirming patency further comprises the use of digital plethysmography.

9. The method of claim 4, wherein the sensing is performed downstream of the access site.

10. The method of claim 4, wherein the sensing is performed upstream of the access site.

11. The method of claim 6, wherein the ulnar impinger comprises of a mechanical device with a constricting band worn around the wrist sufficient to cause an object to press on the ulnar artery.

12. The method of claim 7, wherein the band having the inflatable bladder comprises:

a trunk having said inflatable bladder, the trunk defined by a lower portion and an upper portion, and the bladder defined by an envelopment existing between the lower portion and the upper portion;

a pair of limbs connected to and extending from the upper portion of the trunk, the pair of limbs together with the trunk forming a general Y-shape;

a first limb of the pair of limbs adapted to lay across the palm of a hand, between the thumb and the index finger and connect to the trunk to secure the first limb to the trunk and to secure the bladder to a portion of the patient'"'"'s wrist corresponding with the ulnar pressure site;

a second limb of the pair of limbs adapted to lay over the wrist/distal forearm and connect to the trunk to secure the second limb to the trunk and to further secure the bladder on the ulnar pressure site;

one or more connectors for fixing the pair of limbs to the trunk;

wherein the bladder is located at the ulnar pressure site, and the pair of limbs are fixed around the hand and wrist to the trunk with the connectors, the bladder is inflated with a tube connected to an inflator to cause the bladder to impinge upon the ulnar pressure site.

13. The method of claim 1 further comprising the step of removing the ulnar pressure to the ulnar artery.

14. The method of claim 13 wherein the step of removing the ulnar pressure to the ulnar artery is performed after hemostasis of the radial artery is achieved.

15. A method of obtaining hemostasis of a radial artery of a patient after performing a catheterization procedure at an access site of the radial artery, comprising performing the following steps:

(a) applying hemostatic pressure to the radial artery while simultaneously increasing radial artery flow by applying an ulnar pressure to an ulnar artery at an ulnar pressure site;

(b) maintaining continued partial compression of the ulnar artery while achieving cessation of bleeding at the access site of the radial artery;

(c) attaining hemostasis of the radial artery; and

(d) removing pressure to the ulnar artery, wherein steps (a) and (b) precede step (c).

16. The method of claim 15 wherein the step (c) is accomplished while continuing to apply the ulnar pressure to the ulnar artery and step (d) is performed after step (c).

17. The method of claim 15, wherein applying the ulnar 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.

18. The method of claim 15, wherein applying the continued partial compression of the ulnar artery thereby allows less flow through the ulnar artery than when the ulnar artery is not compressed at all.

19. The method of claim 15, further comprising monitoring patency of the radial artery by sensing.