US20180296802A1 - Methods and apparatus for securing a medical clamp to a patient - Google Patents
Methods and apparatus for securing a medical clamp to a patient Download PDFInfo
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- US20180296802A1 US20180296802A1 US15/956,865 US201815956865A US2018296802A1 US 20180296802 A1 US20180296802 A1 US 20180296802A1 US 201815956865 A US201815956865 A US 201815956865A US 2018296802 A1 US2018296802 A1 US 2018296802A1
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- Prior art keywords
- patient
- clamp
- staple
- medical
- catheter
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/02—Holding devices, e.g. on the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
- A61B17/0682—Surgical staplers, e.g. containing multiple staples or clamps for applying U-shaped staples or clamps, e.g. without a forming anvil
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/064—Surgical staples, i.e. penetrating the tissue
- A61B17/0644—Surgical staples, i.e. penetrating the tissue penetrating the tissue, deformable to closed position
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
- A61B17/0682—Surgical staplers, e.g. containing multiple staples or clamps for applying U-shaped staples or clamps, e.g. without a forming anvil
- A61B17/0684—Surgical staplers, e.g. containing multiple staples or clamps for applying U-shaped staples or clamps, e.g. without a forming anvil having a forming anvil staying above the tissue during stapling
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/02—Holding devices, e.g. on the body
- A61M2025/024—Holding devices, e.g. on the body having a clip or clamp system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/02—Holding devices, e.g. on the body
- A61M2025/028—Holding devices, e.g. on the body having a mainly rigid support structure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/02—Holding devices, e.g. on the body
- A61M2025/0286—Holding devices, e.g. on the body anchored in the skin by suture or other skin penetrating devices
Definitions
- This application relates to an improved medical clamp fastener system and a surgical stapler for same.
- a central venous catheter is a catheter typically placed into a large vein in the neck, chest or groin.
- the catheter may be used to administer medication or fluids, obtain blood tests, obtain cardiovascular measurements, and the like.
- a catheter clamp system may be used to secure the catheter in place on the patient.
- One conventional catheter clamp system includes a sleeve about the catheter.
- a clamp with apertures for receiving sutures is then attached to the sleeve.
- the clamp is then stitched through the apertures and into the skin of a patient to secure the clamp in place on the patient.
- stitching a conventional catheter clamp system to the skin of a patient takes time and is more prone to accidental needle stick injuries to the medical professional and/or transmission of infection from the patient to the medical professional as a result of such needle stick injuries.
- a fixation apparatus includes opposing wings that include a staple receiving portion allegedly configured to receive surgical staples.
- the stapling receiving portions each have distal and proximate ends that include staple retaining ends that are configured to inhibit the staple receiving portions from dislodging from staples.
- the fixation apparatus also includes apertures 27 used for conventional sutures.
- One embodiment described herein is directed to a fastening device for actuating first and second fasteners to secure a medical clamp to a patient.
- the fastening device comprises a first rotatable member configured to rotate from an outward position to an inward position to engage the first fastener and a second rotatable member configured to rotate from an outward position to an inward position to engage the second fastener.
- the first and second rotatable members are mechanically coupled to enable concurrent engagement of the first and second fasteners.
- the apparatus comprises a medical clamp and a fastening device for the actuating first and second fasteners to secure the medical clamp to a patient.
- the fastening device comprises a first rotatable member configured to rotate from an outward position to an inward position to engage the first fastener and a second rotatable member configured to rotate from an outward position to an inward position to engage the second fastener.
- the first and second rotatable members are mechanically coupled to enable concurrent engagement of the first and second fasteners.
- a further embodiment described herein is directed to a method of actuating first and second fasteners to secure a medical clamp to a patient.
- the method comprises rotating a first rotatable member of a fastening device from an outward position to an inward position to engage the first fastener and, concurrent with rotating the first rotatable member, rotating a second rotatable member of the fastening device from an outward position to an inward position to engage the second fastener.
- FIG. 1 is a three-dimensional view of a central venous catheter with a conventional catheter clamp system attached thereto;
- FIG. 2 is a three-dimensional view showing a silicone sleeve of the conventional catheter clamp system shown in FIG. 1 ;
- FIG. 3 is a three-dimensional view showing a clamp of the conventional catheter clamp system shown in FIG. 1 ;
- FIG. 4 is a three-dimensional view showing an enlarged view of the conventional catheter clamp system of FIG. 1 ;
- FIG. 5 is a three-dimensional view of one embodiment of the medical clamp fastener system of this invention.
- FIG. 6 is a three-dimensional bottom view of the medical clamp shown in FIG. 5 ;
- FIG. 7 is a three-dimensional view showing one example of the medical clamp shown in FIGS. 5 and 6 secured to a sleeve coupled to a catheter;
- FIG. 8 is a three-dimensional view of a conventional surgical stapler which may be used to secure the medical clamp shown in FIGS. 5-7 to the skin of a patient;
- FIG. 9 is a three-dimensional view of another embodiment of the medical clamp fastener system of this invention used to secure a G-tube or J-tube in place on a patient;
- FIG. 10 is a three-dimensional view showing an example of a G-tube or J-tube in place in the abdomen of a patient;
- FIG. 11 is a schematic front view of one embodiment of the surgical stapler of this invention used to secure a medical clamp to a patient, such as the medical clamp shown in FIGS. 5-7 and 9 ;
- FIG. 12A is a perspective view showing in further detail the structure of the anvil members and the plunger shown in FIG. 11 ;
- FIG. 12B is a cross-sectional view of the portion of the surgical stapler shown in FIG. 12A ;
- FIG. 13 is a schematic side view of the surgical stapler shown in FIG. 11 ;
- FIG. 14 is an enlarged view showing one example of a surgical staple in place below the plunger shown in FIG. 13 ;
- FIG. 15 is a three-dimensional view showing in further detail one example of the shape of the anvils shown in FIG. 12B ;
- FIGS. 16 and 17 are three-dimensional views showing one example of the operation of the surgical stapler shown in FIGS. 11-15 ;
- FIG. 18A is a side view of a conventional staple in an undeployed state
- FIG. 18B is a side view of the staple of FIG. 14 in an undeployed state
- FIG. 18C is a side view of the staple of FIG. 18A in a deployed state.
- FIG. 18D is a side view of the staple of FIG. 18B in a deployed state.
- FIG. 1 shows an example of a typical central venous catheter 10 having a large bore which is coupled to a three-port catheter system 12 .
- Conventional catheter clamp system 14 is used to secure catheter 10 in place on the skin of a patient.
- Conventional catheter clamp system 14 FIG. 4 , includes sleeve 15 , FIG. 2 , which is inserted over catheter 10 and clamp 18 , FIG. 3 , which is secured (snapped) to sleeve 15 .
- FIG. 4 shows an example of a conventional catheter clamp system 14 , comprising sleeve 15 , FIG. 2 , in place over catheter 10 and clamp 18 , FIG. 3 , secured to sleeve 15 .
- Conventional catheter clamp system 14 is then stitched to the skin of a patient to hold it in place.
- stitching catheter clamp system 14 to the skin of a patient takes time and is more prone to accidental needle stick injuries to the medical professional and/or transmission of infection from the patient to the medical professional as a result of such needle stick injuries.
- medical clamp fastener system 20 FIG. 5 of one or more embodiments of this invention includes a sleeve 16 which is placed over catheter 10 , FIG. 7 , similar as discussed above with reference to FIGS. 1-4 .
- System 20 FIG. 5
- Clamp 22 preferably includes circular shaped notches 23 , FIG. 6 , which engage circular shaped grooves 25 , FIG. 5 , in sleeve 16 to secure clamp 22 to sleeve 16 .
- FIG. 7 shows one example of sleeve 16 about catheter 10 and clamp 22 secured to sleeve 16 .
- Medical clamp 22 includes flanges 24 and 26 which each include notches, e.g., notches 28 , 30 on flange 24 , and notches 29 , 31 (shown in further detail in FIG. 6 ) on flange 26 , each of which are configured to receive a surgical staple therein.
- the notches on the flanges allow the surgical staples to extend into the skin of the patient to secure clamp 22 to the skin of a patient.
- conventional surgical stapler 35 FIG. 8 , may be used to staple medical clamp 22 , FIG. 7 , to the skin of patient to secure medical clamp system 20 coupled to catheter 10 .
- Medical clamp system 20 may be used to secure catheters or other devices, such as gastric feeding tubes (or “G-tubes”), jejunostomy tubes (“J-tubes”), or wires, to a patient's skin.
- catheters or other devices such as gastric feeding tubes (or “G-tubes”), jejunostomy tubes (“J-tubes”), or wires.
- G-tubes gastric feeding tubes
- J-tubes jejunostomy tubes
- wires wires
- One exemplary device that may be used with medical clamp system 20 is a temporary transvenous pacemaker.
- the wire of a temporary transvenous pacemaker may be affixed to the skin of a patient using medical clamp system 20 or a variation thereof.
- the wire of the temporary transvenous pacemaker may have a diameter that is approximately one-fifth the diameter of a central venous catheter.
- sleeves having different inner diameters may be used with medical clamp system 20 .
- G-tubes and J-tubes may have diameters about ten times greater than catheter tube 10 , FIG. 7 .
- FIG. 10 shows an example of G-tube 40 inserted through abdomen 42 of a patient.
- Clamp 22 ′, FIG. 9 in this example, preferably includes a plurality of flanges 30 , 32 , 34 , 36 , which each similarly include notches, e.g., notches 38 and 40 on flange 30 , designed to receive a surgical staple and secure medical clamp 22 ′ to the skin of a patient to ensure the G-tube or J-tube stays in place on a patient.
- the medical clamp system 20 described herein may save time by using surgical staples that can be quickly and easily used to secure medical clamp 22 to the skin of a patient. Because system 20 uses surgical staples, system 20 provides a more secure attachment to the skin of a patient than conventional catheter clamp systems. Using staples is also less prone to accidental needle stick injuries to the medical professional and/or transmission of infection from the patient to the medical professional as a result of such needle stick injuries.
- a conventional surgical stapler may be used to secure medical clamp system 20 to a patient
- problems associated with using a conventional surgical stapler For example, using a conventional surgical stapler may be cumbersome and difficult to use with medical clamp 22 because it may require the use of both right and left hands. Moreover, aligning the anvil with the notches of one or more embodiments of the medical clamp may be difficult.
- Another problem associated with using a conventional surgical stapler may be that the thickness of flanges 24 , 26 , FIGS. 5-7 of medical clamp 22 and/or flanges 30 - 36 of clamp 22 ′, FIG. 9 , may be too thick for the surgical staples used with a conventional surgical stapler. As a result, the staples may not extend at a sufficient depth to effectively secure medical clamp 22 to the skin of a patient.
- Surgical stapler 50 FIG. 11 of one embodiment of this invention is designed to be used with medical clamp 22 , FIGS. 5-7 and 9 , or similar type medical clamps.
- Surgical stapler 50 FIG. 11 , includes handle 52 pivotably attached to base 54 .
- Linking member 56 is attached to handle 52 on one end and to moveable plunger 58 on the other end.
- Plunger 58 is preferably symmetrical on both sides, as shown in further detail in FIG. 12B , and includes ends 59 which each engage a staple, e.g., staples 61 , 63 .
- Ends 59 preferably have a rounded shape, e.g., as shown at 79 , FIG.
- FIG. 14 shows an enlarged top view of one side of plunger 58 with end 59 which, in this example, engages staple 61 .
- Surgical stapler 50 includes two opposing anvil members 60 and 62 pivotably coupled to base 54 , e.g., with screws 67 , 69 .
- springs e.g., spring 81 , FIG. 12A
- Anvil members 60 , 62 , FIGS. 12A and 12B each include anvils 64 , 66 , respectively.
- Anvils 64 , 66 are shaped to bend staples 61 , 63 , respectively, above flanges 24 , 26 , FIGS. 5-7 , of clamp 22 and into the skin of a patient.
- FIG. 15 shows an enlarged view of anvil members 60 and 62 and anvils 64 and 66 .
- Anvil members 60 and 62 , FIG. 11 are spread out, or in the open position, as discussed above, when handle 52 is not depressed.
- Plunger 58 FIG. 12B , preferably includes opposing sloped shoulders 80 , 82 which engage anvil members 60 , 62 , respectively, when plunger 58 is moved downward.
- plunger 58 moves in the downward direction, as shown by arrow 70 .
- shoulders 80 , 82 , FIG. 12B to pass through the notches in anvil members 60 , 62 and move them to the closed position as shown in FIG. 17 .
- shoulder 80 FIG.
- plunger 58 passes through notch 84 and area 86 of plunger 58 causes anvil member 60 to move to the closed position, as shown in FIG. 17 .
- plunger 58 has pushed staples 61 and 63 , FIG. 12B into the notches of medical clamp 22 , FIG. 5-7 , while anvils 64 and 66 , FIG. 12B , bend staples 61 and 63 above the flanges of medical clamp 22 to secure medical clamp 22 to the skin of a patient.
- stapler 50 may be designed to deliver one staple for use with a medical clamp, such as medical clamp 22 ′, FIG. 9 , e.g., for gastric G-tubes, J-tubes, and the like.
- Stapler 50 may align the surgical staples with the notches of medical clamp 22 and insert them at a sufficient depth so that medical clamp 22 is properly secured to the skin of a patient. Stapler 50 is easy to use with medical clamp 22 and can be used with one hand.
- FIGS. 18A-D show a conventional staple 88 contrasted with an exemplary staple 61 that may be used with the stapler 50 and medical clamps 22 and 22 ′ described herein.
- the conventional staple 88 has a width of 9 mm and a height of 5 mm prior to deployment.
- the top of staple 88 includes two rounded bumps having a height of 2.5 mm, as measured from the base of the bumps to the top of the bumps.
- staple 61 shown in FIG. 18B , has a greater height, which allows deeper penetration of the staple into the skin.
- staple 61 has a width of approximately 9 mm and a height of approximately 7 mm prior to deployment.
- the top of staple 61 includes two rounded bumps having a height of approximately 4 mm, as measured from the base of the bumps to the top of the bumps.
- FIG. 18C shows the conventional staple 88 after deployment. The staple 88 is deployed by applying a downward force to the bumps, thereby flattening them. The ends of the deployed staple 88 are pushed together, but do not overlap. The deployed staple 88 has a width of 6.5 mm and a height of 5 mm.
- FIG. 18D shows the staple 61 after deployment. Similar to staple 88 , staple 61 is deployed by applying a downward force to the bumps, thereby flattening them. The ends of the deployed staple 61 are pushed together and overlap in parallel fashion by approximately 1.5 mm. The deployed staple 61 has a width of approximately 6.5 mm and a height of approximately 7 mm. Staple 61 may be formed of surgical stainless steel or another suitable material.
- Staple 61 which may be the same as staple 63 described herein, differs from staple 88 in at least two ways.
- the height of the staple 61 is greater, which allows for deeper penetration of the staple into the skin.
- the height of staple 61 may be such that the staple penetrates tissue by an optimal holding depth without risking damages to the structures underlying the skin, such as blood vessels and nerves.
- the staple 61 in the deployed state, includes overlapped ends, which form a “virtual” closed circle.
- the deployed staple 61 may be more stable in the skin than staple 88 , which does not have overlapping ends in the deployed state.
- inventive embodiments are presented by way of example only and that, within the scope of the appended claims and equivalents thereto, inventive embodiments may be practiced otherwise than as specifically described and claimed.
- inventive embodiments of the present disclosure are directed to each individual feature, system, article, material, kit, and/or method described herein.
- inventive concepts may be embodied as one or more methods, of which an example has been provided.
- the acts performed as part of the method may be ordered in any suitable way. Accordingly, embodiments may be constructed in which acts are performed in an order different than illustrated, which may include performing some acts simultaneously, even though shown as sequential acts in illustrative embodiments.
- a reference to “A and/or B”, when used in conjunction with open-ended language such as “comprising” can refer, in one embodiment, to A only (optionally including elements other than B); in another embodiment, to B only (optionally including elements other than A); in yet another embodiment, to both A and B (optionally including other elements); etc.
- the phrase “at least one,” in reference to a list of one or more elements, should be understood to mean at least one element selected from any one or more of the elements in the list of elements, but not necessarily including at least one of each and every element specifically listed within the list of elements and not excluding any combinations of elements in the list of elements.
- This definition also allows that elements may optionally be present other than the elements specifically identified within the list of elements to which the phrase “at least one” refers, whether related or unrelated to those elements specifically identified.
- “at least one of A and B” can refer, in one embodiment, to at least one, optionally including more than one, A, with no B present (and optionally including elements other than B); in another embodiment, to at least one, optionally including more than one, B, with no A present (and optionally including elements other than A); in yet another embodiment, to at least one, optionally including more than one, A, and at least one, optionally including more than one, B (and optionally including other elements); etc.
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Abstract
Methods and apparatus for actuating first and second fasteners to secure a medical clamp to a patient. An exemplary fastening device comprises a first rotatable member configured to rotate from an outward position to an inward position to engage the first fastener and a second rotatable member configured to rotate from an outward position to an inward position to engage the second fastener. The first and second rotatable members are mechanically coupled to enable concurrent engagement of the first and second fasteners.
Description
- This application claims a priority benefit, under 35 U.S.C. § 119(e), to U.S. provisional patent application Ser. No. 61/518,680, entitled “Medical Clamp Fastener System and Surgical Stapler for Same,” filed on May 10, 2011. This application is incorporated herein by reference.
- This application relates to an improved medical clamp fastener system and a surgical stapler for same.
- A central venous catheter is a catheter typically placed into a large vein in the neck, chest or groin. The catheter may be used to administer medication or fluids, obtain blood tests, obtain cardiovascular measurements, and the like.
- A catheter clamp system may be used to secure the catheter in place on the patient. One conventional catheter clamp system includes a sleeve about the catheter. A clamp with apertures for receiving sutures is then attached to the sleeve. The clamp is then stitched through the apertures and into the skin of a patient to secure the clamp in place on the patient.
- However, stitching a conventional catheter clamp system to the skin of a patient takes time and is more prone to accidental needle stick injuries to the medical professional and/or transmission of infection from the patient to the medical professional as a result of such needle stick injuries.
- One conventional medical device anchoring system for securing a catheter to a patient is disclosed in U.S. Pat. No. 7,799,000. As disclosed therein, a fixation apparatus includes opposing wings that include a staple receiving portion allegedly configured to receive surgical staples. The stapling receiving portions each have distal and proximate ends that include staple retaining ends that are configured to inhibit the staple receiving portions from dislodging from staples. The fixation apparatus also includes apertures 27 used for conventional sutures.
- One embodiment described herein is directed to a fastening device for actuating first and second fasteners to secure a medical clamp to a patient. The fastening device comprises a first rotatable member configured to rotate from an outward position to an inward position to engage the first fastener and a second rotatable member configured to rotate from an outward position to an inward position to engage the second fastener. The first and second rotatable members are mechanically coupled to enable concurrent engagement of the first and second fasteners.
- Another embodiment described herein is directed to an apparatus for securing a medical device to a patient. The apparatus comprises a medical clamp and a fastening device for the actuating first and second fasteners to secure the medical clamp to a patient.
- The fastening device comprises a first rotatable member configured to rotate from an outward position to an inward position to engage the first fastener and a second rotatable member configured to rotate from an outward position to an inward position to engage the second fastener. The first and second rotatable members are mechanically coupled to enable concurrent engagement of the first and second fasteners.
- A further embodiment described herein is directed to a method of actuating first and second fasteners to secure a medical clamp to a patient. The method comprises rotating a first rotatable member of a fastening device from an outward position to an inward position to engage the first fastener and, concurrent with rotating the first rotatable member, rotating a second rotatable member of the fastening device from an outward position to an inward position to engage the second fastener.
- Other objects, features and advantages will occur to those skilled in the art from the following description of a preferred embodiment and the accompanying drawings, in which:
-
FIG. 1 is a three-dimensional view of a central venous catheter with a conventional catheter clamp system attached thereto; -
FIG. 2 is a three-dimensional view showing a silicone sleeve of the conventional catheter clamp system shown inFIG. 1 ; -
FIG. 3 is a three-dimensional view showing a clamp of the conventional catheter clamp system shown inFIG. 1 ; -
FIG. 4 is a three-dimensional view showing an enlarged view of the conventional catheter clamp system ofFIG. 1 ; -
FIG. 5 is a three-dimensional view of one embodiment of the medical clamp fastener system of this invention; -
FIG. 6 is a three-dimensional bottom view of the medical clamp shown inFIG. 5 ; -
FIG. 7 is a three-dimensional view showing one example of the medical clamp shown inFIGS. 5 and 6 secured to a sleeve coupled to a catheter; -
FIG. 8 is a three-dimensional view of a conventional surgical stapler which may be used to secure the medical clamp shown inFIGS. 5-7 to the skin of a patient; -
FIG. 9 is a three-dimensional view of another embodiment of the medical clamp fastener system of this invention used to secure a G-tube or J-tube in place on a patient; -
FIG. 10 is a three-dimensional view showing an example of a G-tube or J-tube in place in the abdomen of a patient; -
FIG. 11 is a schematic front view of one embodiment of the surgical stapler of this invention used to secure a medical clamp to a patient, such as the medical clamp shown inFIGS. 5-7 and 9 ; -
FIG. 12A is a perspective view showing in further detail the structure of the anvil members and the plunger shown inFIG. 11 ; -
FIG. 12B is a cross-sectional view of the portion of the surgical stapler shown inFIG. 12A ; -
FIG. 13 is a schematic side view of the surgical stapler shown inFIG. 11 ; -
FIG. 14 is an enlarged view showing one example of a surgical staple in place below the plunger shown inFIG. 13 ; -
FIG. 15 is a three-dimensional view showing in further detail one example of the shape of the anvils shown inFIG. 12B ; -
FIGS. 16 and 17 are three-dimensional views showing one example of the operation of the surgical stapler shown inFIGS. 11-15 ; -
FIG. 18A is a side view of a conventional staple in an undeployed state; -
FIG. 18B is a side view of the staple ofFIG. 14 in an undeployed state; -
FIG. 18C is a side view of the staple ofFIG. 18A in a deployed state; and -
FIG. 18D is a side view of the staple ofFIG. 18B in a deployed state. - Aside from the preferred embodiment or embodiments disclosed below, this invention is capable of other embodiments and of being practiced or being carried out in various ways. Thus, it is to be understood that the invention is not limited in its application to the details of construction and the arrangements of components set forth in the following description or illustrated in the drawings. If only one embodiment is described herein, the claims hereof are not to be limited to that embodiment. Moreover, the claims hereof are not to be read restrictively unless there is clear and convincing evidence manifesting a certain exclusion, restriction, or disclaimer.
-
FIG. 1 shows an example of a typical centralvenous catheter 10 having a large bore which is coupled to a three-port catheter system 12. Conventionalcatheter clamp system 14 is used to securecatheter 10 in place on the skin of a patient. Conventionalcatheter clamp system 14,FIG. 4 , includessleeve 15,FIG. 2 , which is inserted overcatheter 10 andclamp 18,FIG. 3 , which is secured (snapped) tosleeve 15.FIG. 4 shows an example of a conventionalcatheter clamp system 14, comprisingsleeve 15,FIG. 2 , in place overcatheter 10 andclamp 18,FIG. 3 , secured tosleeve 15. - Conventional
catheter clamp system 14,FIGS. 1 and 4 , is then stitched to the skin of a patient to hold it in place. However, stitchingcatheter clamp system 14 to the skin of a patient takes time and is more prone to accidental needle stick injuries to the medical professional and/or transmission of infection from the patient to the medical professional as a result of such needle stick injuries. - In contrast, medical
clamp fastener system 20,FIG. 5 , of one or more embodiments of this invention includes asleeve 16 which is placed overcatheter 10,FIG. 7 , similar as discussed above with reference toFIGS. 1-4 .System 20,FIG. 5 , also includesmedical clamp 22 configured to be secured tosleeve 16.Clamp 22 preferably includes circular shapednotches 23,FIG. 6 , which engage circular shapedgrooves 25,FIG. 5 , insleeve 16 to secureclamp 22 tosleeve 16.FIG. 7 shows one example ofsleeve 16 aboutcatheter 10 and clamp 22 secured tosleeve 16. -
Medical clamp 22,FIG. 5 , includesflanges notches flange 24, andnotches 29, 31 (shown in further detail inFIG. 6 ) onflange 26, each of which are configured to receive a surgical staple therein. The notches on the flanges allow the surgical staples to extend into the skin of the patient to secureclamp 22 to the skin of a patient. In one example, conventionalsurgical stapler 35,FIG. 8 , may be used to staplemedical clamp 22,FIG. 7 , to the skin of patient to securemedical clamp system 20 coupled tocatheter 10. -
Medical clamp system 20 or variations thereof may be used to secure catheters or other devices, such as gastric feeding tubes (or “G-tubes”), jejunostomy tubes (“J-tubes”), or wires, to a patient's skin. The portion of such devices affixed to the patient's skin may have a generally tube-shaped configuration. - One exemplary device that may be used with
medical clamp system 20 is a temporary transvenous pacemaker. In particular, the wire of a temporary transvenous pacemaker may be affixed to the skin of a patient usingmedical clamp system 20 or a variation thereof. The wire of the temporary transvenous pacemaker may have a diameter that is approximately one-fifth the diameter of a central venous catheter. To compensate for such differences, sleeves having different inner diameters may be used withmedical clamp system 20. - G-tubes and J-tubes may have diameters about ten times greater than
catheter tube 10,FIG. 7 .FIG. 10 shows an example of G-tube 40 inserted throughabdomen 42 of a patient.Clamp 22′,FIG. 9 , in this example, preferably includes a plurality offlanges notches flange 30, designed to receive a surgical staple and securemedical clamp 22′ to the skin of a patient to ensure the G-tube or J-tube stays in place on a patient. - The
medical clamp system 20 described herein may save time by using surgical staples that can be quickly and easily used to securemedical clamp 22 to the skin of a patient. Becausesystem 20 uses surgical staples,system 20 provides a more secure attachment to the skin of a patient than conventional catheter clamp systems. Using staples is also less prone to accidental needle stick injuries to the medical professional and/or transmission of infection from the patient to the medical professional as a result of such needle stick injuries. - Although as discussed above, a conventional surgical stapler may be used to secure
medical clamp system 20 to a patient, there may be problems associated with using a conventional surgical stapler. For example, using a conventional surgical stapler may be cumbersome and difficult to use withmedical clamp 22 because it may require the use of both right and left hands. Moreover, aligning the anvil with the notches of one or more embodiments of the medical clamp may be difficult. Another problem associated with using a conventional surgical stapler may be that the thickness offlanges FIGS. 5-7 ofmedical clamp 22 and/or flanges 30-36 ofclamp 22′,FIG. 9 , may be too thick for the surgical staples used with a conventional surgical stapler. As a result, the staples may not extend at a sufficient depth to effectively securemedical clamp 22 to the skin of a patient. - To overcome these problems,
surgical stapler 50,FIG. 11 of one embodiment of this invention is designed to be used withmedical clamp 22,FIGS. 5-7 and 9 , or similar type medical clamps.Surgical stapler 50,FIG. 11 , includes handle 52 pivotably attached tobase 54. Linkingmember 56 is attached to handle 52 on one end and tomoveable plunger 58 on the other end.Plunger 58 is preferably symmetrical on both sides, as shown in further detail inFIG. 12B , and includes ends 59 which each engage a staple, e.g.,staples 61, 63. Ends 59 preferably have a rounded shape, e.g., as shown at 79,FIG. 13 , which is designed to engage the top ofstaples 61, 63,FIG. 12B , as they are stapled to the skin of a patient.FIG. 14 shows an enlarged top view of one side ofplunger 58 withend 59 which, in this example, engagesstaple 61. -
Surgical stapler 50,FIG. 11 , includes two opposinganvil members base 54, e.g., withscrews spring 81,FIG. 12A , may be used to maintainanvil members FIG. 11 .Anvil members FIGS. 12A and 12B , each includeanvils Anvils staples 61, 63, respectively, aboveflanges FIGS. 5-7 , ofclamp 22 and into the skin of a patient.FIG. 15 shows an enlarged view ofanvil members anvils -
Anvil members FIG. 11 , are spread out, or in the open position, as discussed above, whenhandle 52 is not depressed.Plunger 58,FIG. 12B , preferably includes opposing slopedshoulders anvil members plunger 58 is moved downward. For example, whenhandle 52,FIG. 16 , is pressed downward, as shown byarrow 68,plunger 58 moves in the downward direction, as shown byarrow 70. This causes shoulders 80, 82,FIG. 12B , to pass through the notches inanvil members FIG. 17 . For example,shoulder 80,FIG. 16 , passes throughnotch 84 andarea 86 ofplunger 58 causesanvil member 60 to move to the closed position, as shown inFIG. 17 . At this point,plunger 58 has pushedstaples 61 and 63,FIG. 12B into the notches ofmedical clamp 22,FIG. 5-7 , whileanvils FIG. 12B ,bend staples 61 and 63 above the flanges ofmedical clamp 22 to securemedical clamp 22 to the skin of a patient. - Although as discussed above with reference to
FIGS. 11-17 , surgical stapler is shown to staple two staples in the notches on the opposing flanges ofmedical clamp 22 as shown inFIGS. 5-7 , this is not a necessary limitation of this invention. In other examples,stapler 50 may be designed to deliver one staple for use with a medical clamp, such asmedical clamp 22′,FIG. 9 , e.g., for gastric G-tubes, J-tubes, and the like. -
Stapler 50 may align the surgical staples with the notches ofmedical clamp 22 and insert them at a sufficient depth so thatmedical clamp 22 is properly secured to the skin of a patient.Stapler 50 is easy to use withmedical clamp 22 and can be used with one hand. -
FIGS. 18A-D show aconventional staple 88 contrasted with anexemplary staple 61 that may be used with thestapler 50 andmedical clamps FIG. 18A , theconventional staple 88 has a width of 9 mm and a height of 5 mm prior to deployment. The top ofstaple 88 includes two rounded bumps having a height of 2.5 mm, as measured from the base of the bumps to the top of the bumps. In contrast,staple 61, shown inFIG. 18B , has a greater height, which allows deeper penetration of the staple into the skin. In particular,staple 61 has a width of approximately 9 mm and a height of approximately 7 mm prior to deployment. The top ofstaple 61 includes two rounded bumps having a height of approximately 4 mm, as measured from the base of the bumps to the top of the bumps.FIG. 18C shows theconventional staple 88 after deployment. The staple 88 is deployed by applying a downward force to the bumps, thereby flattening them. The ends of the deployedstaple 88 are pushed together, but do not overlap. The deployedstaple 88 has a width of 6.5 mm and a height of 5 mm.FIG. 18D shows the staple 61 after deployment. Similar to staple 88,staple 61 is deployed by applying a downward force to the bumps, thereby flattening them. The ends of the deployedstaple 61 are pushed together and overlap in parallel fashion by approximately 1.5 mm. The deployedstaple 61 has a width of approximately 6.5 mm and a height of approximately 7 mm.Staple 61 may be formed of surgical stainless steel or another suitable material. -
Staple 61, which may be the same as staple 63 described herein, differs fromstaple 88 in at least two ways. First, the height of the staple 61 is greater, which allows for deeper penetration of the staple into the skin. The height ofstaple 61 may be such that the staple penetrates tissue by an optimal holding depth without risking damages to the structures underlying the skin, such as blood vessels and nerves. Second, in the deployed state, thestaple 61 includes overlapped ends, which form a “virtual” closed circle. Thus, the deployedstaple 61 may be more stable in the skin thanstaple 88, which does not have overlapping ends in the deployed state. - While various inventive embodiments have been described and illustrated herein, those of ordinary skill in the art will readily envision a variety of other means and/or structures for performing the function and/or obtaining the results and/or one or more of the advantages described herein, and each of such variations and/or modifications is deemed to be within the scope of the inventive embodiments described herein. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the inventive teachings is/are used. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific inventive embodiments described herein. It is, therefore, to be understood that the foregoing embodiments are presented by way of example only and that, within the scope of the appended claims and equivalents thereto, inventive embodiments may be practiced otherwise than as specifically described and claimed. Inventive embodiments of the present disclosure are directed to each individual feature, system, article, material, kit, and/or method described herein. In addition, any combination of two or more such features, systems, articles, materials, kits, and/or methods, if such features, systems, articles, materials, kits, and/or methods are not mutually inconsistent, is included within the inventive scope of the present disclosure.
- Also, various inventive concepts may be embodied as one or more methods, of which an example has been provided. The acts performed as part of the method may be ordered in any suitable way. Accordingly, embodiments may be constructed in which acts are performed in an order different than illustrated, which may include performing some acts simultaneously, even though shown as sequential acts in illustrative embodiments.
- All definitions, as defined and used herein, should be understood to control over dictionary definitions, definitions in documents incorporated by reference, and/or ordinary meanings of the defined terms.
- The indefinite articles “a” and “an,” as used herein in the specification and in the claims, unless clearly indicated to the contrary, should be understood to mean “at least one.”
- The phrase “and/or,” as used herein in the specification and in the claims, should be understood to mean “either or both” of the elements so conjoined, i.e., elements that are conjunctively present in some cases and disjunctively present in other cases. Multiple elements listed with “and/or” should be construed in the same fashion, i.e., “one or more” of the elements so conjoined. Other elements may optionally be present other than the elements specifically identified by the “and/or” clause, whether related or unrelated to those elements specifically identified. Thus, as a non-limiting example, a reference to “A and/or B”, when used in conjunction with open-ended language such as “comprising” can refer, in one embodiment, to A only (optionally including elements other than B); in another embodiment, to B only (optionally including elements other than A); in yet another embodiment, to both A and B (optionally including other elements); etc.
- As used herein in the specification and in the claims, “or” should be understood to have the same meaning as “and/or” as defined above. For example, when separating items in a list, “or” or “and/or” shall be interpreted as being inclusive, i.e., the inclusion of at least one, but also including more than one, of a number or list of elements, and, optionally, additional unlisted items. Only terms clearly indicated to the contrary, such as “only one of” or “exactly one of,” or, when used in the claims, “consisting of,” will refer to the inclusion of exactly one element of a number or list of elements. In general, the term “or” as used herein shall only be interpreted as indicating exclusive alternatives (i.e. “one or the other but not both”) when preceded by terms of exclusivity, such as “either,” “one of,” “only one of,” or “exactly one of.” “Consisting essentially of,” when used in the claims, shall have its ordinary meaning as used in the field of patent law.
- As used herein in the specification and in the claims, the phrase “at least one,” in reference to a list of one or more elements, should be understood to mean at least one element selected from any one or more of the elements in the list of elements, but not necessarily including at least one of each and every element specifically listed within the list of elements and not excluding any combinations of elements in the list of elements. This definition also allows that elements may optionally be present other than the elements specifically identified within the list of elements to which the phrase “at least one” refers, whether related or unrelated to those elements specifically identified. Thus, as a non-limiting example, “at least one of A and B” (or, equivalently, “at least one of A or B,” or, equivalently “at least one of A and/or B”) can refer, in one embodiment, to at least one, optionally including more than one, A, with no B present (and optionally including elements other than B); in another embodiment, to at least one, optionally including more than one, B, with no A present (and optionally including elements other than A); in yet another embodiment, to at least one, optionally including more than one, A, and at least one, optionally including more than one, B (and optionally including other elements); etc.
- In the claims, as well as in the specification above, all transitional phrases such as “comprising,” “including,” “carrying,” “having,” “containing,” “involving,” “holding,” “composed of,” and the like are to be understood to be open-ended, i.e., to mean including but not limited to. Only the transitional phrases “consisting of” and “consisting essentially of” shall be closed or semi-closed transitional phrases, respectively, as set forth in the United States Patent Office Manual of Patent Examining Procedures, Section 2111.03.
Claims (2)
1. A fastening device for actuating first and second fasteners to secure a medical clamp to a patient, the fastening device comprising:
a first rotatable member configured to rotate from an outward position to an inward position to engage the first fastener; and
a second rotatable member configured to rotate from an outward position to an inward position to engage the second fastener;
wherein the first and second rotatable members are mechanically coupled to enable concurrent engagement of the first and second fasteners.
2.-27. (canceled)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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US15/956,865 US20180296802A1 (en) | 2011-05-10 | 2018-04-19 | Methods and apparatus for securing a medical clamp to a patient |
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US201161518680P | 2011-05-10 | 2011-05-10 | |
PCT/US2012/037032 WO2012154791A1 (en) | 2011-05-10 | 2012-05-09 | Methods and apparatus for securing a medical clamp to a patient |
US201414116168A | 2014-01-15 | 2014-01-15 | |
US15/956,865 US20180296802A1 (en) | 2011-05-10 | 2018-04-19 | Methods and apparatus for securing a medical clamp to a patient |
Related Parent Applications (2)
Application Number | Title | Priority Date | Filing Date |
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PCT/US2012/037032 Continuation WO2012154791A1 (en) | 2011-05-10 | 2012-05-09 | Methods and apparatus for securing a medical clamp to a patient |
US14/116,168 Continuation US9974928B2 (en) | 2011-05-10 | 2012-05-09 | Apparatus for securing a medical clamp to a patient |
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US20180296802A1 true US20180296802A1 (en) | 2018-10-18 |
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US14/116,168 Active 2032-11-15 US9974928B2 (en) | 2011-05-10 | 2012-05-09 | Apparatus for securing a medical clamp to a patient |
US15/956,865 Abandoned US20180296802A1 (en) | 2011-05-10 | 2018-04-19 | Methods and apparatus for securing a medical clamp to a patient |
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CA (1) | CA2835126C (en) |
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KR101368368B1 (en) * | 2013-11-07 | 2014-02-28 | (주)지온메드 | Medical tube fixing device and fixing method of medical tube using the same |
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2012
- 2012-05-09 WO PCT/US2012/037032 patent/WO2012154791A1/en active Application Filing
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- 2012-05-09 US US14/116,168 patent/US9974928B2/en active Active
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2018
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US20140148789A1 (en) | 2014-05-29 |
CA2835126C (en) | 2019-06-11 |
WO2012154791A1 (en) | 2012-11-15 |
US9974928B2 (en) | 2018-05-22 |
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